Summary of NCEHR Listserv for October 2003


TOPICS

1. Chirac Urges Global Ethics Law

2. Community Capacity Research and Ethics Resources

3. Counselling Referral as a Tool to Access Risk

4. Ethics is Very Much Alive

5. CIHR: Ethics Alive!

6. Impact of Provincial Privacy Legislation

7. International Ethics Applications

8. Interviewing Participants Needing Counselling

9. Job Posting: REB Coordinator St. Michael's Hospital

10. PRE Online Consultation for Prioritizing REB Procedures

11. Teaching Research Ethics

12. Oral History Exempt from IRB Review

13. Quality Assurance and Research

14. Research Subject vs. Research Participant

15. Students Learning About Research Ethics

16. The Death of Ethics

17. Signed Consent Forms as Legal Documents, True or False?

 

Files to Download

Adverse Events Reporting - From Accountability in Research

PRE - Prioritizing and Procedural and Related Definitional Issues in the TCPS

When Does Quality Assurance in Health Care Required Independent Ethical Review?

A Synthesis Paper on the Conceptualization and Measurement of Community Capacity

Children in Clinical Research: A Conflict of Moral Values (AJB)

Signed Consent Forms in Criminological Research: Protections of Researchers and Ethics Committees but a Threat to Research Participants?

Complaint Civil Action: Plaintiff Beverly H. Scheer was the wife of decedent R. Scott Scheer (“Scheer”)

Reference: Ethical and Philosophical Issues in Community-Based Research

Wil van den Hoonaard Graduate Ethics Course

1. Chirac Urges Global Ethics Law

For those on the List with an interest in addressing issues in bioethics at
the 'international level' here find a cross-posting from IRB Forum
(apologies if duplicated) ... elisabeth

>
>The SCIENTIST reports that Jacqaues Chirac, France's President endorses aninternational
>convention to establish a global bioethics policy to ensure that industry and scientists
>do not abuse biotechnological processes.
>
>The main threats listed by Chirac are:
> “discrimination based on genetic heritage, selling of gametes over the
>Internet,
>'surrogate mother' services, traffic in human organs, clinics specializing
>in
>euthanasia, and medical experiments under conditions that are contrary to
>human dignity.”
>
>UNESCO officials are reported to be skeptical about bringing the international bioethics
>community to the negotiating table at this time.
>
>The story first appeared in Le Monde, October 14, 2003.
>“Jacques Chirac souligne l'urgence d'un code universel de bioéthique,”

<http://www.lemonde.fr/web/recherche_articleweb/1,13-0,36-337950,0.html>
>
>THE SCIENTIST
>Chirac urges global ethics law
>French president says international convention needed to address bioethics
>| By Jane Burgermeister
>Oct. 15, 2003
>
>France's President Jacques Chirac has called for an international convention
>on bioethics to prevent breakthroughs in scientific research from being
>abused.
>
>In a strongly worded warning to the United Nations Educational, Scientific
>and Cultural Organization's (UNESCO's) general conference yesterday, Chirac
>said that bioethical principles that carried the force of international law
>were needed to address new issues raised by advances in genetic engineering
>and biotechnology.
>
>“New threats and new abuses,” he told UNESCO, “made it necessary to set out
>principles of bioethics in international public law.”
>
>He listed the main threats as “discrimination based on genetic heritage,
>selling of gametes over the Internet, 'surrogate mother' services, traffic
>in human organs, clinics specializing in euthanasia, and medical experiments
>under conditions that are contrary to human dignity.”
>
>Denouncing an “absence of morality, greed, [bordering on] madness,” Chirac
>said that urgent action was needed to protect human dignity in the future.
>
>The French president condemned existing laws for being riddled with
>loopholes, saying that they allowed those who wanted to get around current
>regulations—for example, those prohibiting techniques such as cloning—“to
>find a way easily.”
>
>He said that a universal declaration outlining basic bioethical principles
>should be made within the framework of the United Nations (UN) as a first
>step toward establishing an international bioethics convention.
>
>Insisting that scientific progress and the protection of human rights were
>compatible, Chirac argued that “clear ethical standards that are universally
>recognized to serve humankind and civilization” would allow science to
>continue with greater assurance.
>
>He urged the members of the UN, who have failed to reach an agreement on a
>ban on human reproductive cloning, to reach a consensus as quickly as
>possible.
>
>France is already a leading opponent of human cloning, but Chirac said that
>a concerted, international approach was needed.
>
>However, UNESCO's Director-General Koichiro Matsuura has already warned that
>it will be difficult to persuade different countries to agree on a common
>set of principles for an international convention on bioethics.
>
>In an interview with La Croix, Matsuura argued that the majority of UNESCO
>member states considered it “too early to have a discussion about a
>convention.” He noted that UNESCO had to abandon a plan to formulate common
>principles about stem cell research because members could not agree.
>
>Scientists in France have welcomed Chirac's initiative.
>
>“Everyone thinks it was very courageous of President Chirac to speak out
>forcefully on these questions and so oppose many vested financial interests,
>“ Christiane Bouchard from the Ethics Committee of the Centre National de la
>Recherche Scientifique, a French research institute, told The Scientist.
>“Even though there are many barriers to be overcome, we believe that it is
>realistic to propose an international convention on bioethics. In view of
>the enormous dangers, laws are needed.”
>
>Links for this article
>“Jacques Chirac souligne l'urgence d'un code universel de bioéthique,” Le
>Monde, October 14, 2003.
<http://www.lemonde.fr/web/recherche_articleweb/1,13-0,36-337950 ,0.html>
>
>United Nations Educational, Scientific and Cultural Organization
> <http://www.unesco.org/>
>
>Koichiro Matsuura
>
<http://portal.unesco.org/en/ev.php@URL_ID=6038&URL_DO=DO_TOPIC&URL_SECTION=
201.html
>
>
>La Croix
> <http://www.la-croix.com/index.jsp>
>
>Centre National de la Recherche Scientifique
> <http://www.cnrs.fr/>

2. Community Capacity Research and Ethics Resources

From: "james frankish" <frankish@interchange.ubc.ca>
Hello

Two new documents are attached. The first is our recent report on community
capacity and its measurement. Special thanks to Brenda Kwan, Julieta
Flores, Darryl Quantz (UBC), Suzanne Jackson (University of Toronto), Irv
Rootman (University of Victoria) and Jerry Spiegel (UBC). We also wish to
thank our project advisors: Eva Cheung Robinson (Vancouver Foundation),
Betsy Mackenzie (Health Canada), Rod McCormick (UBC), Jim Sands (Social
Planning and Research Council of BC), Malcolm Shookner (Atlantic Health
Promotion Research Centre), Susan Stevenson (HRDC), Jean Thompson
(Vancouver Coastal Health), Vince Verlaan (UBC), and Lezlie Wagman
(Vancouver Coastal Health)

The second is a 12-page, word document with references related to ethics
and community research. We make no claims as to the completeness of the
list; just thought it might be useful to some people.

Both documents were produced with support from CIHR, Health Canada and the
Michael Smith Foundation for Health Research.

Jim

3. Counselling Referral as a Tool to Access Risk

From: "Lindley, Pat" <plindley@kilcom1.ucis.dal.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Counselling referral as a tool to address risk
Date: Tuesday, October 21, 2003 9:11 AM

We frequently see studies where it can reasonably be anticipated that
emotional distress (sometimes severe) could arise from the experience
that subjects have... generally interviews around highly sensitive subjects. In
the past it has been our practice, in addition to requiring the researchers
be explicit about the subject of the research and the potential for emotional
upset, to suggest that researchers provide 'referrals' or at least information
regarding sources of counselling support.

The reality is that the best most non-medical researchers can do is provide
a list of counselling services that are available in the vicinity. This is of
course not a 'referral' in the medical sense, nor is it actually of much use for
individuals without private medical insurance that could cover the cost of
counselling.

How has this been dealt with by others.... Do you require that the
researchers include the capacity to provide counselling directly via the
research team (i.e. a co-investigator who has agreed to attend)? Do you
just suggest that people seek help from their family doctor (who may or
may not be available when the need arises)?

We have a concern that suggesting that researchers provide information
on counselling to subjects is really offering the illusion of help, rather than
anything that might actually be available.

We plan to discuss this next week at our Board meetings. Any information
(directly to me or through the list) or suggestions would be appreciated.

Pat Lindley
Patricia Lindley
Office of Human Research Ethics Administration
Room 321 Henry Hicks Arts and Administration Building
Dalhousie University
Halifax, Nova Scotia
B3H 4H6 ~~~~~~~~~~~~~~~~~~~
ph. (902) 494-1462
fax. (902) 494-1595
e-mail Patricia.Lindley@dal.ca
________________________________

From: "Bill Marr" <bmarr@wlu.ca>
To: <Patricia.Lindley@dal.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Counselling referral as a tool to address risk
Date: Tuesday, October 21, 2003 3:25 PM

Pat:

We have often had researchers do exactly what you have mentioned in the
first two paragraphs of your e-mail: provide information about sources
of counselling guidance and support, and provide a list of counselling
services. I agree that usually the researcher must not suggest or
appear to suggest that she or he can provide those services.

We have not required that the research team include someone who can
provide such services. This would be unworkable for many of the
research projects that students undertake at Laurier, even thought they
have some probability of causing emotional upset for a few participants.
The student researcher does know where help is available and makes this
know to participants.

4. Ethics is Very Much Alive

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Ethics is very much alive...
Date: Tuesday, October 21, 2003 10:14 AM

Agreed, but REBs need to be helped by the development and implementation of
practical, effective oversight/enforcement mechanisms for the CONDUCT of
research the REB¹s activities.

Jack Corman
President/Secretary

IRB Services
14845-6 Yonge Street
Suite 328
Aurora, ON, L4G 1H6
CANADA.
Phone: (905) 727-7989 ext. 25
Fax: (905) 727-7990
Email: jcorman@irbservices.com
Web: http://www.irbservices.com

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>

As a 'glass half-full person' i'm pleased Marie has reminded us to get on
with it together ...

I agree with the view that "ethics is very much alive"and growing with a
level of international activity that i have not previously noticed.
Admittedly, i with others on this List, are involving ourselves in the
Canada/US/WHO project known as FOCUS that may be tilting observed frequency
of discourse on global initiatives, or perhaps the newly perceived tendancy
to address issues, 'where the world meets' is a natural progression within
the field to create a professional response to globalizing forces.

Again today apologies for cross-posting from "IRB Forum" but there is a lot
going on out there that this List needs to be aware of. What follows is
from John Noble:

"IRB Forum members may be curious to learn more about this new (to me)
source of information about what's known about pharmaceutical products
being touted for their efficacy and safety. Check out:
<http://www.healthyskepticism.org>
--JHN"


At 20:17 10/20/2003 -0400, Marie Buy wrote:
A quick comment:

I'm just coming back from a international congress on biomedical issues :
ethics is very much alive on the international arena !
Let us be realistic: as long as human being will live, so will the realm of
ethics !

To see ethics dead or alive is beside the point. How we qualify something
as "ethical" or "unethical" is another matter as history of moral
philosophy and study of various religious morals (refered as "ethics of
religion") prove it, not to mention the various discussions on this
listserve...

It seems education should be the objective! Whether it's biomedical reseach
or not, REBs members should focus on their prime responsibility, i.e.: an
ethical review of proposed projects. But... More and better education on
how to ethically review a research protocole, is clearly needed ! National
guidelines... on various subjects... This is in my view essential... No
more comments!

Marie Buy

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Ethics is very much alive...
Date: Tuesday, October 21, 2003 11:50 AM

Eh Bien! Un autre coeur battement. another beating heart. Merci Marie.

Difficult to argue with your premise. Hopefully we can all avoid
slipping into the facile trap of labelling actions ethical or unethical.
Many human actions raise ethical issues, might be a more constructive
insight.

Dr Michael D E Goodyear FRACP FRCPC FACP

Assistant Professor, Division of Medical Oncology, Department of
Medicine, Dalhousie University

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Ethics is very much alive...
Date: Tuesday, October 21, 2003 12:44 PM

Marie, Michael and Others --
I found an old note saying that a 'primer' on how to read (review) a
research protocol was available from Breast Cancer Action (name might be
wrong), i think Dr. Sharon Batt was involved with the organization when i
took the note.

Does anyone have a current link to that group's website or the tutorial?

thanks ... elisabeth
From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Ethics is very much alive...
Date: Tuesday, October 21, 2003 1:27 PM

Apologies for incomplete message sent earlier. The point was that the REB is
an important part of the research endeavour, but by itself can only do so
much. If anything, the REB community is highly attuned to ethical issues,
and is exquisitely sensitive to possible malfeasance by those involved in
research policy development, governance, design, funding, review and
conduct. We can only do so much ourselves. If too much attention is
focussed on the REB and the research ethics review, insufficient attention
may be paid to where harms may be perpetrated, i.e., those involved with
the actual CONDUCT of the research.

Education and good REB review alone are not enough, we need an effective and
practical system of oversight and enforcement of codes of ethical research
conduct and regulations of same. Inevitably, when regulatory bodies are
involved, the details re: verification of compliance seem to take over.
Who then cares whether a good ethics review was done and the research
carried out according to the Belmont Report/Declaration of Helsinki/TCPS?
The documentation-of-compliance game takes over. And so the sentiment,
Œdeath of ethics¹, with which I empathize. When the paper chase overcomes
principle, the pendulum has swung too far, to mix metaphors. However, ours
is a society that demands accountability of its elites (elected or
otherwise), if through no other medium than the press. What choice do we
have but to construct an appropriate oversight and enforcement mechanism for
the review and conduct of research involving humans (as both participants
and subjects)?

Jack Corman
President/Secretary

IRB Services

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Ethics is very much alive...
Date: Tuesday, October 21, 2003 1:40 PM

I certainly agree that REBs can only do so much, which is why I have
consistently stated that they have to work closely with the research
community. I also believe that they need to work closely with consumer
groups, and i was recently at a European meeting trying to persuade the
research ethics community there that one of the reasons the regulator is
not listening to them is that the regulator beleives it is protecting
the general public, but that nobody thought of asking consumer groups
for their input. A joint approach is more likelyto be successful.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Ethics is very much alive...
Date: Tuesday, October 21, 2003 2:05 PM

Jack, i think you're making the case for existance of a Human Research
Protection Program to provide complete oversight. The model is described
in the Institute of Medicine (IOM) report produced with the National
Academies.

Such a total program would be accreditied by an independant group like
AAHRPP and to quote Marjorie Speers the approach represents a "broad focus
of responsibility beyond that of IRBs or REBs".

Such involvement includes integrating aspects such as contract review
including for COI, accounting of resource utilization, and billing for
research acts, adhereance to pharmacy dispensing the benefits accrue.

The the answer to your question, "Who then cares whether a good ethics
review was done and the research carried out according to the Belmont
Report/Declaration of Helsinki/TCPS?" becomes easier.

The institution and its governance structure clearly would care that
research oversight is consistant with it's public service mandate where the
conduct of human research is concerned ... elisabeth


At 14:14 10/21/2003 -0400, Jack Corman wrote:
Education and good REB review alone are not enough, we need an effective
and practical system of oversight and enforcement of codes of ethical
research conduct and regulations of same. Inevitably, when regulatory
bodies are involved, the details re: verification of compliance seem to
take over. Who then cares whether a good ethics review was done and the
research carried out according to the Belmont Report/Declaration of
Helsinki/TCPS?

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Ethics is very much alive...
Date: Tuesday, October 21, 2003 2:25 PM

Of course I am talking about accreditation of Human Research Protection
Program, but that's only the beginning. Just because a programme is
accredited doesn't mean it's being consistently implemented, or won't drift
over time. At the end of the day, a robust, practical verification/audit
mechanism beyond accreditation is still needed if the system is to be fully
accountable.

Jack Corman

From: "John Mueller" <mueller@ucalgary.ca>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Ethics is very much alive...
Date: Tuesday, October 21, 2003 2:49 PM

On Tue, 21 Oct 2003, Jack Corman (IRB Services) wrote:
>
> Date: Tue, 21 Oct 2003 15:21:23 -0400
> From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
> Reply-To: ethics@lists.ncehr-cnerh.org
> To: NCEHR <ethics@lists.ncehr-cnerh.org>
> Subject: Re: [Ethics] Ethics is very much alive...
>
> Of course I am talking about accreditation of Human
> Research Protection Program, but that's only the
> beginning. Just because a programme is accredited doesn't
> mean it's being consistently implemented, or won't drift
> over time. At the end of the day, a robust, practical
> verification/audit mechanism beyond accreditation is still
> needed if the system is to be fully accountable.


I had vowed to just lurk, but I have to ask here,
following up the notion of being "unencumbered by
objective evidence:"
1- where is the evidence we NEED accreditation?
2- how will we know accreditation WORKS?

Objective evidence is badly needed before we
press ahead with yet more bureaucracy. Making
laws-rules-regulations is easy enough, making
effective ones and documenting the benefit is
another matter altogether. "It seems like a
good idea" is how we arrived at the tangled web
we now live with.

-- John. (M)

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Ethics is very much alive...
Date: Tuesday, October 21, 2003 3:24 PM

John, i'm no authority on accreditation programs, nor am i aware of any
results presumed to be measured to date. I agree with your underlying
point that i think is the same as i heard echoed by many speakers at the
recent FOCUS conference, i.e. we need more research on research. This
would appear to be one of the areas.

Dr. Marjorie Speers, Executive Director, AAHRPP provided the history of
accreditation that has been relatively short, only in the US and laregly
driven by suspensions of US federally-sponsored research, as follows:

US accreditation programs
2000 - Department of Veterans Affairs – mandatory accreditation

2001 - AAHRPP – voluntary accreditation
Association of American Medical Colleges
Association of American Universities
Consortium of Social Science Associations
Federation of American Societies for Experimental Biology
National Association of State Universities and Land-Grant Colleges
National Health Council
Public Responsibility in Medicine and Research

2003 - PHRP – voluntary accreditation
National Committee on Quality Assurance
Joint Commission on Accreditation of HealthCare Organizations

I understood Dr. Speers to say that defined outcome measures that provide a
basis for demonstrating improvement will only be measured over time ...
obviously literature needs to grow ... elisabeth


At 13:35 10/21/2003 -0600, you wrote:
>On Tue, 21 Oct 2003, Jack Corman (IRB Services) wrote:
>>
>> Date: Tue, 21 Oct 2003 15:21:23 -0400
>> From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
>> Reply-To: ethics@lists.ncehr-cnerh.org
>> To: NCEHR <ethics@lists.ncehr-cnerh.org>
>> Subject: Re: [Ethics] Ethics is very much alive...
>>
>> Of course I am talking about accreditation of Human
>> Research Protection Program, but that's only the
>> beginning. Just because a programme is accredited doesn't
>> mean it's being consistently implemented, or won't drift
>> over time. At the end of the day, a robust, practical
>> verification/audit mechanism beyond accreditation is still
>> needed if the system is to be fully accountable.
>
>
>I had vowed to just lurk, but I have to ask here,
>following up the notion of being "unencumbered by
>objective evidence:"
> 1- where is the evidence we NEED accreditation?
> 2- how will we know accreditation WORKS?
>
>Objective evidence is badly needed before we
>press ahead with yet more bureaucracy. Making
>laws-rules-regulations is easy enough, making
>effective ones and documenting the benefit is
>another matter altogether. "It seems like a
>good idea" is how we arrived at the tangled web
>we now live with.
>
>-- John. (M)
>
>

5. CIHR: Ethics Alive!

From: "Blake, Andrea" <ablake@ncehr-cnerh.org>
To: "List Serv (E-mail)" <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] FW: Ethics Live! @ CIHR - L'Éthique en direct! @ IRSC
Date: Tuesday, October 07, 2003 2:25 PM

CIHR's Ethics Office is pleased to announce
Ethics Live! @ CIHR

a newsmagazine about CIHR's research and policy initiatives related to
ethical, legal and social issues in health and health research. Thanks go
out to Gabrielle Gray, our summer student who wrote this first issue and to
Nathalie Lahaie who conceptualized the design . The newsmagazine will be
published twice a year. You can find Ethics Live! @ CIHR on our website at:
<http://www.cihr-irsc.gc.ca/e/publications/18709.shtml>
http://www.cihr-irsc.gc.ca/e/publications/18709.shtml

We invite you to share and discuss the newsmagazine with interested
colleagues. All comments and feedback are welcome, as are any new ideas for
future feature articles. Contact Nathalie Lahaie by email
<mailto:nlahaie@cihr-irsc.gc.ca> nlahaie@cihr-irsc.gc.ca.

Thank you.

6. Impact of Provincial Privacy Legislation

From: <skb@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] impact of provincial privacy legislation
Date: Friday, October 10, 2003 10:44 AM

Asking for help, yet again.

I'm writing to request comment on the impact of provincial privacy
legislation on research in your province. I was asked by a government
committee drafting provincial privacy legislation for health (the current
privacy legislation, yet to be proclaimed is very, very general) to come
tell them how such legislation might impact research. They asked what I
knew about the impact elsewhere, particularly in Manitoba. I would be most
grateful for your comments so that I can compile them to send to this
committee. If you have legislation or proposed legislation which has not or
is expected not to have a negative impact, what is it about the legislation
- additions, omission, wording, etc. which has avoided potential problems.
Our legislation is being framed around the CSA principles. The ones most
likely to cause problems is the requirement for consent for secondary use of
data and data retention (though I think our government will give this a very
lenient interpretion to allow for drug trials, the university retention
policy etc.); identifying purposes gets linked into the consent issue. I
have given them the CIHR document on the interpretation of the critical
areas of PIPEDA; this was well received as helpful in fleshing out some of
the issues.

Your input would be much appreciated.

Sharon .

Sharon K. Buehler, PhD
Honorary Research Professor
Faculty of Medicine
Health Sciences Centre
Memorial University
St. John's, NL   A1B 3V6
T:  709-777-6219
F:  709-777-7382
Email:  skb@mun.ca


From: "Luc Simon" <Luc.Simon@vrr.ulaval.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] impact of provincial privacy legislation
Date: Friday, October 10, 2003 3:26 PM


Not exactly to the point, but a nice resource with an extensive reference
section:
http://www.ethique.gouv.qc.ca/eng/whatsnew.html


Luc Simon

rom: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] impact of provincial privacy legislation
Date: Friday, October 10, 2003 3:31 PM

Once again we acknowledge the leadership of Quebec in Research Ethics

>>> Luc.Simon@vrr.ulaval.ca 10/10/03 05:21PM >>>

Not exactly to the point, but a nice resource with an extensive reference
section:
http://www.ethique.gouv.qc.ca/eng/whatsnew.html


Luc Simon

7. International Ethics Applications

rom: "Joan Stevenson" <stevensj@post.queensu.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] International Ethics Applications
Date: Wednesday, October 22, 2003 11:23 AM

Listserv members,

Two quick questions.
1. Do you require full University REB reviews if an application is
international?
2. Do you have specific criteria by which an international application
would automatically go to full University REB review?

Many thanks from our General Reserach Ethics Board
Joan Stevenson, PhD, Chair GREB

From: "Richard Neuman" <rneuman@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] International Ethics Applications
Date: Wednesday, October 22, 2003 11:44 AM

Joan,
It is not clear if the project is international and the P.I. is local
at Queen's or if the study and P.I. are both international.

Our REB would follow the normal guidelines for full and expedited review
if the project were international and the P.I. local with the
expectation that local review would also take place in the country in
which the study was to run. If the P.I. were international we would
expect a local contact to be in place. We would also review a copy of
the application from the home country. Depending on the study we would
require either expedited or full review. If a written consent was
required we would expect that our consent form template would be used.
Richard Neuman
Co-Chair, Human Investigation Committee

Joan Stevenson wrote:

From: "Laurel Evans" <levans@mcmaster.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] International Ethics Applications
Date: Wednesday, October 22, 2003 12:01 PM

Joan, we at McMaster will be reviewing our guidelines pertaining to what goes
to full-board and what doesn't at our next meeting. At the moment, we do not
have any requirement that "international" protocols automatically go to
full-board, it really depends on the individual application and the judgment of
the Chair, and the reviewers relative to the degree of risk. We have had at
least one of our professors who is involved in international research stress to
us the importance of ensuring that the researcher has an appropriate "support
system" in the foreign locale, both for the protection of the foreign
participants and the researcher. International research does automatically
raise a potential red flag if for no other reason than that our board is less
likely to be able to confidently put itself in the shoes of the participant,
when assessing the level of risk of the research. If there is an equivalent to
an REB in the other location, and its approval will also be obtained,
obviously, the concerns of our Board can be somewhat ameliorated. Laruel
Evans.

Joan Stevenson wrote:

From: "Lindley, Pat" <plindley@kilcom1.ucis.dal.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] International Ethics Applications
Date: Wednesday, October 22, 2003 2:58 PM

Two quick answers:
>
> Two quick questions.
> 1. Do you require full University REB reviews if an application is
> international?

Not necessarily: our criteria for full review are as follows - greater than
minimal risk, involves a vulnerable population, deals with highly sensitive
information where confidentiality is a significant issue, presents new
aspects of methodology which have not previously been discussed at the
Board level. Often the last criterion, whereby there are particular
social/cultural circumstances bearing on risk to subjects and/or the
researcher that are new to the Board, is the one that pushes an
international study to full review, but not always.

2. Do you have specific criteria by which an
> international application would automatically go to full University
> REB review?

See above. We are especially concerned where there is risk to the safety
of the researcher -- by extension this usually compromises the
confidentiality of the information they are collecting, and sometimes the
safety of the subjects they have involved. The kind of risk I am referring to is
political instability (i.e. political or social conflict in the region), illegality of
activity being examined (e.g. blood diamond trade, prostitution), safety
issues (e.g. women alone in certain urban environments). We have often
had to work with students to reconfigure studies where we could easily see
the potential for real safety risks.

Pat Lindley

> Many thanks from our General Reserach Ethics Board
> Joan Stevenson, PhD, Chair GREB

8. Interviewing Participants Needing Counselling

From: "will" <will@unb.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Interview participants' needing counselling: a query
Date: Tuesday, October 28, 2003 5:51 PM

Dear All:
We usually make a big fuss about interview participants' needing
counselling when faced with traumas as a result of being interviewed
about
such traumatic events as e.g. abuse. Does anyone on the listserv actually
know of research where this has happened? (No urban legends, please).
I appreciate your usual, potential thoughtful contributions. Will

From: "Sandy Auld" <sauld@uoguelph.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Interview participants' needing counseling: a query
Date: Wednesday, October 29, 2003 10:21 AM

A very informal survey tells me that it does happen that participants
either talk to the research after the study about their feelings, or
take advantage of professional counseling offered by the researcher. One
experienced research claimed to recall half a dozen times in his career
that participants reported having sought counseling. Undoubtedly, there
were more unreported cases. The point was raised, however, that the
offer of counseling only be included in cases where the risk is higher
than minimal - such as cases of discussion of abuse.

Sandy Auld
Research Ethics Officer
Office of Research
REY203, X56606

From: "Sarah Warden" <swarden@uhnres.utoronto.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Interview participants' needing counselling: a query
Date: Wednesday, October 29, 2003 10:35 AM

Hi Will

This may not be exactly the scenario you were asking about, but we review
studies for a cancer centre, and in many consents involving interviews
exploring difficult issues (including the terminal nature of their cancer), it
is stated that if patients have any concerns as a result of the study, the
study doctor will refer them to the Psychosocial Oncology dept for
counselling. I know on occasion, subjects do use this service and find it
helpful. It helps when it is identified upfront in the consent that there may
be a risk of stirring up difficult emotions, and that the PI has already
identified a treatment route.

Thanks
Sarah

From: "Lindley, Pat" <plindley@kilcom1.ucis.dal.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Interview participants' needing counselling: a query
Date: Wednesday, October 29, 2003 1:04 PM

Hi Will,
I think that getting feedback from subjects is rare, but I would be hesitant to
conclude that this means all is well, all the time. Prior to our instituting a
requirement for annual reports (in 2000) and for identifying our office as a
place where concerns could be brought, there was no way to know that
anything ever went wrong, or that subjects ever were distressed. No one
other than the researcher would know, and who would they tell?

However, I agree that it would be nice to move beyond anecdotal evidence
of the need for such supports as counselling (though I suspect that we all
may have some). At the moment, it would seem that this is all that is
available, and in answer to your questions, yes, I do know of at least three
instances where subjects were distressed. One involved asking people to
talk about how they felt about their body image (after having them ingest
alcohol) while being videotaped. They were told that people would be
viewing these tapes (which actually wasn't true). One subject broke down in
tears . Another project involved a disable individual who had gone from
being fully functional to being quadraplegic 6 months prior to the study. At
the end of the interview the person felt that they had been 'used as a
source of data' by a student whose project was intended to focus on the
feelings of disabled individuals. She felt that the student didn't give a damn
about her feelings and just wanted to complete his project. I have also
been told of an instance where a student was traumatized during a mass
screening exercise that involved reflecting on a recent trauma (the student
had been sexually assaulted recently) and, due to the public nature of the
screening (in a class), she controlled her reaction, and it was only many
days later (in discussion with a faculty member) that she broke down in his
office.

Taking a 'proportionate response' is of course sensible... my concern has
been that we use 'counselling' as a panacea where we feel that some
support may be needed, without giving much thought ... or asking
researchers to give much thought... to how realistic - or useful - that
suggestion is. Are there times when a clinical therapist should be attached
to a research project (especially one involving a graduate student), to
ensure that this resource is available? Do we need to see more than
"counselling information will be provided" when researchers want to delve
into highly sensitive and traumatic events of people's lives?

As I said before, it would be nice to move beyond anecdotal evidence.
Perhaps there is a study out there that has followed up on such research to
see how many silent, unhappy subjects these studies leave in their wake...
hopefully very few!

9. Job Posting: REB Coordinator St. Michael's Hospital

From: "Marleen Van Laethem" <VanlaethemM@smh.toronto.on.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] job posting - REB Coordinator
Date: Friday, October 17, 2003 10:18 AM

St. Michael's Hospital, Toronto, has two new positions for REB
Coordinators. Go to www.stmichaelshospital.com
follow Careers, Job Postings, and register in order to view posting and
apply online, or see below for information.

Position Title: Research Ethics Board Coordinator
Department: Research Administration

From: "Blake, Andrea" <ablake@ncehr-cnerh.org>
To: "List Serv (E-mail)" <ethics@lists.ncehr-cnerh.org>
Cc: <Joey.Weir@nrc-cnrc.gc.ca>
Subject: [Ethics] FW: Job posting
Date: Thursday, October 23, 2003 2:41 PM

Please respond directly to <mailto:Joey.Weir@nrc-cnrc.gc.ca>
Joey.Weir@nrc-cnrc.gc.ca and avoid posting to the entire list.
Please note that the closing date is 31 October 2003, and the position is
open to residents of Manitoba.

Joey Weir
Human Resources Generalist
Institute for Biodiagnostics
National Research Council
(204) 984-6270

10. PRE Online Consultation for Prioritizing REB Procedures

From: <Hanan.Abdel-Akher@pre.ethics.gc.ca>
To: <Ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] On-line consultation for prioritizing procedural anddefinitional issues in the TCPS
Date: Thursday, October 23, 2003 3:52 PM


French version follows in a separate e-mail

<<Announcement ProGroup - English.pdf>>
Subject: On-line consultation for prioritizing procedural and related
definitional issues in the TCPS - Interagency Advisory Panel on Research
Ethics (PRE) sub-group on TCPS Procedural Issues (ProGroup).


This is an open invitation to participate in an on-line consultation on
prioritizing procedural and related definitional issues in the Tri-Council
Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). The
purpose of the consultation is to assist the Interagency Advisory Panel on
Research Ethics (PRE) sub-group on TCPS Procedural Issues (ProGroup) in
determining which procedural and related definitional issues are most
important to address.

A management-consulting firm, Goss Gilroy Inc., has been hired by PRE to
facilitate this consultation. The consultation has been programmed to occur
on-line by visiting a web site and responding to a number of questions. We
estimate that the consultation will take approximately 10 to 20 minutes to
complete. You will need access to the Internet in order to complete the
consultation exercise.

For a more successful consultation, it is important that as many respondents
as possible participate. ProGroup is hoping to obtain feedback and
perspectives from a wide variety of individuals including researchers,
administrators, students, research ethics board (REB) members, research
participants, and research users.

We encourage you to visit the site by clicking on the link below. We
appreciate your input. If you have any questions, please do not hesitate to
contact the firm hired to conduct the consultation (Goss Gilroy Inc.) or the
Secretariat on Research Ethics (see contact information below).

Please help us distribute this public call for input as widely as possible
by sharing it with others who may be interested in responding. The web-site
will be available until November 21st, 2003.

To access the on-line consultation, please visit:

http://www.ggi.nf.ca/ethics_consultation_ethique/splash.asp
<http://www.ggi.nf.ca/ethics_consultation_ethique/splash.asp>

Sincerely,


Howard Brunt, RN, PhD
Chair of the Interagency Advisory Panel on Research Ethics (PRE) and its
sub-group on TCPS Procedural Issues (ProGroup)


**********************

Contacts:

Goss Gilroy Inc.: Sara Mayhew at research_ethics@ggi.ca or 1-800-611-0511.

Secretariat on Research Ethics: Hanan Abdel-Akher at
hanan.abdel-akher@pre.ethics.gc.ca
<mailto:hanan.abdel-akher@pre.ethics.gc.ca> or 1-613-996-2564

Informed Consent
As a volunteer participant, your responses to this consultation are
protected under the federal Privacy Act and will be used by Goss Gilroy Inc.
only for the purpose of this consultation and not for any other purpose.
The consultation report will provide aggregate data only. No individual
information will be transmitted to PRE or any other individual or
organization. Should individual comments be quoted, they will be made
anonymous. The consultation data obtained will be stored in a secure manner
with all the precautions appropriate for the sensitivity of the data. Data
containing information about identifiable individuals will be destroyed
after the final report has been accepted. At the end of the consultation you
will be asked if you would be willing to participate in further
consultations or working groups. If you agree to participate, Goss Gilroy
Inc. will provide only your contact information to PRE.

Hanan Abdel-Akher
Policy Analyst/Analyste des politiques
Secretariat on Research Ethics
Secrétariat en éthique de la recherche
Tel: (613)996-2564
Fax:(613)996-7117
Hanan.Abdel-Akher@pre.ethics.gc.ca

11. Teaching Research Ethics

From: <will@unb.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Onto the matter of teaching ethics ....
Date: Thursday, October 09, 2003 12:02 PM

Dear All:

Lesley at Carleton raised the issue of teachings ethics in the
classroom setting--and that was the real point of my raising
the issue of student research. I would be very interested
among members of the listserv if anyone can alert me to
(under)graduate courses on ethics in research.

I was asked to teach a graduate course, "Ethics in
Research," the first course of its kind at my university, I
believe. The TCPS recognizes "education" as one of the
two functions of REBs (the other is "ethics review"), but I
hear very little about that, except what Carleton does. I
would much appreciate hearing from anyone who can inform
me about ethics courses elsewhere (but not just as "part" of
a course on ethics).

I have taken enough of your time and look forward to
hearing from you. Will
--
"... hope is the oxygen of the human spirit." (Margaret Somerville,
The Ethical Canary, 2000: xvi)

Will C. van den Hoonaard
Department of Sociology, University of New Brunswick
POB 4400, Fredericton, NB E3B 5A3
Tel. (506) 453-4849; Fax (506) 453-4659

From: "Lee Woodson" <Leland.Woodson@kwantlen.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Onto the matter of teaching ethics ....
Date: Thursday, October 09, 2003 1:04 PM

Hello Will,

Per your question about who teaches a course on Research Ethics, be
advised that Kwantlen University College offers a 4th year undergraduate
course


PSYC 4800 cr-3
Professional & Ethical Issues
Students will examine ethical codes/requirements and issues in applied
research, and regulations governing the practice of psychology in Canada
and the US and, more specifically, in British Columbia.;

as part of the required curriculum for a Bachelor of Arts degree in
Psychology.

Cheers,

Lee

rom: "Salama Suzette" <salamsuz@HHSC.CA>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Onto the matter of teaching ethics ....
Date: Thursday, October 09, 2003 1:30 PM

A 12 week (50 hours' contact time) course on Ethics & Regulatory Affairs is
also offered at the Mohawk-McMaster Institute of Health Sciences in
Hamilton, Ontario. This is part of a 250 hour certificate program for
individuals who wish to acquire a clinical research associate degree. More
information is available on the Mohawk College website.

From: "Leslie_MacDonald-Hicks" <LeslieMacDonaldHicks@pigeon.carleton.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Onto the matter of teaching ethics ....
Date: Thursday, October 09, 2003 2:08 PM

Will,

The course I described is a fourth year course. Almost all research
methodology courses are covering off something about research ethics. Our
language people would like to introduce research ethics as early as the
second year of the undergraduate program.

Leslie

From: <will@unb.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Onto the matter of teaching ethics ....
Date: Friday, October 10, 2003 12:02 PM

Dear All:
If anyone is interested in receiving a copy of my course
outline, "Ethics in Research," that I use to teach graduate
students, please send me an INDIVIDUAL message (so as
not to occupy the listserv with personal messages). My
email is <will@unb.ca>.
--
"... hope is the oxygen of the human spirit." (Margaret Somerville,
The Ethical Canary, 2000: xvi)

Will C. van den Hoonaard

From: <will@unb.ca>
To: "Dave Hay" <DAVID.HAY@usask.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Onto the matter of teaching ethics ....
Date: Tuesday, October 14, 2003 9:41 AM

Dear David:
I have been thinking about you and our discussion and
wonder how you are faring with the "checklist" approach to
ethics review, as opposed to a more discursive approach.

During the "public" lecture at U of S., you raised the point
about participants of focus groups who tell others about the
focus groups, violating, in some sense, the anonymity. Well,
your remarks made me think....I am sure that's not the first
time you have instilled critical thinking in a wayfaring soul....
I felt compelled to write piece, "Is Anonymity an Artiffact in
Ethnographic Research?" It's coming out in The Journal of
Academic Ethics.

I am pleased to enclose, as an attachment (in WP. and .rtf
formats), a copy of my graduate-course outline, "Ethics in
Research." As this is the first time I am teaching a course of
this nature (and asked to do this at the last minute), I would
much appreciate any advice or emendations.

With kind regards, Will

--
"... hope is the oxygen of the human spirit." (Margaret Somerville,
The Ethical Canary, 2000: xvi)

Will C. van den Hoonaard

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Results of offering outline of graduate course onresearchethics
Date: Wednesday, October 15, 2003 12:30 PM

..And also the need for more formal education in research ethics, to
say nothing about whose responsibility it is...

Dr Michael D E Goodyear FRACP FRCPC FACP

12. Oral History Exempt from IRB Review

From: "Michael Owen" <mowen@spartan.ac.brocku.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Oral History now exempt from IRB review in US
Date: Friday, October 17, 2003 8:09 PM

http://www.dickinson.edu/organizations/oha/org_irb.html
ORAL HISTORY EXCLUDED FROM IRB REVIEW

The U.S. Office for Human Research Protection (OHRP),
part of the Department of Health and Human Services (HHS), working in
conjunction with the American Historical Association and the Oral
History Association, has determined that oral history interviewing
projects in general do not involve the type of research defined by
HHS regulations and are therefore excluded from Institutional Review
Board oversight.
At the October 2003 meeting of the Oral History
Association in Bethesda, Maryland, George Pospisil of the OHRP's
Division of Education and Development, explained the OHRP decision
regarding the application of the "Common Rule" (45 CFR part 46),
which sets regulations governing research involving human subjects.
These federal regulations define research as "a systematic
investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable
knowledge." The type of research encompassed by the regulations
involves standard questionnaires with a large sample of individuals
who often remain anonymous, not the open-ended interviews with
identifiable individuals who give their interviews with "informed
consent"that characterizes oral history. Only those oral history
projects that conform to the regulatory definition of research will
now need to submit theirresearch protocols for IRB review.
Following is the text of a policy statement that was
developed by the Oral History Association and the American Historical
Association in consultation with the Office of Human Research
Protection. This policy applies to oral history that takes place
within an institution that has filed a multiple project assurance
with OHRP. As one of the seventeen federal agencies that have signed
on to the Common Rule, the Department of Health and Human Services
deals most directly with the type of clinical research that the
federal regulations were originally intended to cover, and its
concurrence with the policy statement should set the way for a
uniform interpretation by other federal agencies. Oral historians
should make this statement available to department chairs, directors
of graduate study, deans, and other officers concerned with
institutional compliance with federal regulations.

Donald A. Ritchie
Linda Shopes
Oral History Association
American Historical Association

Application of the Department of Health and Human
Services Regulations
for the Protection of Human Subjects at 45 CFR
Part 46, Subpart A
to Oral
History Interviewing

Most oral history interviewing projects are not subject
to the requirements of the Department of Health and Human Services
(HHS) regulations for the protection of human subjects at 45 CFR part
46, subpart A, and can be excluded from institutional review board
(IRB) oversight because they do not involve research as defined by
the HHS regulations. HHS regulations at 45 CFR 46.102(D) define
research as "a systematic investigation, including research
development, testing and evaluation, designed to develop or
contribute to generalizable knowledge." The Oral History Association
defines oral history as "a method of gathering and preserving
historical information through recorded interviews with participants
in past events and ways of life."

It is primarily on the grounds that oral history
interviews, in general, are not designed to contribute to
"generalizable knowledge" that they are not subject to the
requirements of the HHS regulations at 45 CFR part 46 and, therefore,
can be excluded from IRB review. Although the HHS regulations do not
define "generalizable knowledge," it is reasonable to assume that
they term does not simply mean knowledge that lends itself to
generalizations, which characterizes every form of scholarly inquiry
and human communication. While historians reach for meaning that
goes beyond the specific subject of their inquiry, unlike researchers
in the biomedical and behavioral sciences they do not reach for
generalizable principles of historical or social development, nor do
they seek underlying principles or laws of nature that have
predictive value and can be applied to other circumstances for the
purpose of controlling outcomes. Historians explain a particular
past; they do not create general explanations about all that has
happened in the past, nor do they predict the future.

Moreover, oral history narrators are not anonymous
individuals, selected as part of a random sample for the purposes of
a survey. Nor are they asked to respond to a standard questionnaire
administered to a broad swath of the population. Those interviewed
are specific individuals selected because of their often unique
relationship to the topic at hand. Open-ended questions are tailored
to the experiences of the individual narrator. Although interviews
are guided by professional protocols, the way any individual
interview unfolds simply cannot be predicted. An interview gives a
unique perspective on the topic at hand; a series of interviews offer
up not similar "generalizable" information but a variety of
particular perspectives on the topic.

For these reasons, then, oral history interviewing, in
general, does not meet the regulatory definition of research as
articulated in 45 CFR part 46. The Office for Human Research
Protections concurs with this policy statement, and it is essential
that such an interpretation be made available to the many IRBs
currently grappling with issues of human subject research.


RESOURCE BIBLIOGRAPHY


--
Michael Owen, Ph.D., Director, Office of Research Services
& Interim Director, Cool Climate Oenology and Viticulture Institute (CCOVI)
Brock University
500 Glenridge Avenue
St Catharines, ON L2S 3A1

From: "Bill Marr" <bmarr@wlu.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Oral History now exempt from IRB review in US
Date: Monday, October 20, 2003 2:34 PM

Very interesting. In the context of the Canadian REB and review world,
if we applied the reasoning in this news release, we could stop
reviewing oral history projects (assuming that we ever did - we do at
Laurier). I would like to hear the opinions of NCEHR and PRE about the
need to review and approve oral history projects.

In general and not directly related to the news release, I would
disagree with some of the reasons for not undertaking REB review and
approval. First, while research in disciplines such as economics,
business, psychology, etc. may list "generalizability" as a
characteristic of its science (I base this on a casual examination of
several research methods or methodology textbooks in those disciplines),
other disciplines, such as history, may not do that. But what the later
disciplines "do" is still research and they do collect information from
people, publish it, store it, present it, etc. So I do not think that
"generalizabilty" is an universal characteristic of research and
therefore can not be used to exclude such research from REB review and
approval.

If oral history is excluded from REB review and approval because "oral
history narrators are not anonymous individuals" or because "they
[participants] are [not] asked to respond to a standard questionnaire
administered to a broad swath of the population" or because "an
interview gives a unique perspective on the topic at hand", REBs would
not need to review and approve a great deal of qualitative research
where exactly the same research methods are used. While we may well
argue that qualitative research should not need approval, both it and
oral history collect new information from people, present and publish
from that information, and store that information. The fact that the
information provided by people to oral historians may not be either
confidential or anonymous does not make oral history unique and can not
be used as a reason to exclude oral history from REB review and approval.

Within the context of each research project that involves human
participants, they need to be informed if the information that they
provide is confidential and anonymous, and then they decide to
participate or not based on what the researchers tell them.

Anyway, just a couple of thoughts on oral history.

13. Quality Assurance and Research

From: "Howard Brunt" <hbrunt@uvic.ca>
To: "NCEHR Listserve" <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Quality assurance etc. and "research"
Date: Tuesday, October 07, 2003 2:36 PM

A recurring problem at our institution and, from what I understand,
elsewhere in Canada, is the difficulty of differentiating between what
constitutes "research" and other activities such as quality assurance,
program review, program evaluation etc.. Under the TCPS, Quality Assurance
is not required to undergo REB review. However, we often have difficulty
discriminating between a "legitimate" research project and a quality
assurance study (for example). This lack of clarity can lead to problems of
commission and omission: 1) we end up inappropriately applying research
ethics criteria to other non-research activities that may or may not have
their own set of ethical requirements and 2) we are concerned that true
research sometimes gets re-cast as Quality Assurance in the hopes of not
having to undergo REB review. Our university is currently trying to craft
more precise operational definitions for activities such as quality
assurance and program evaluation so that we can provide clearer direction to
our community (and REB). We would be interested to learn how other
institutions are handling this issue, and more specifically, if you have any
good operational definitions that we could look at for Quality Assurance,
Program Evaluation etc.. In addition, if you know of any codes of ethics for
these types of activities, we would like to get the references.

Howard Brunt
Associate VP Research

From: <will@unb.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 6:38 AM

Dear Colleagues:
I like Richard's definition of research: "when the goal of the
project is to publish or present the study findings in a public
forum." This definition is about contributing to the scholarly
discourse and making a contribution to scholarship and
public understanding.

I have always felt that undergraduate student projects are
normally far removed from publishing or presenting findings
in a public forum. These projects are pedagogical
exercises, destined to train students in this or that
methodology or technique. Having said that, it does not
mean that ethical considerations do not apply. Of course
they do, but that gets sorted out in the classroom.

What else should not be considered "research?"

Will
--

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 9:20 AM

Hello all

We have had these problems as well. We also use the ruleset outlined
by Richard that defines work as research based on whether or not the
results are intended for the public domain to help distinguish
between research and non-research works. What I've tried to
encourage (with no real luck as yet) is to engender quality assurance
protocols as part of SOP in various areas, in employment contracts,
and in course outlines. Doing this, I think, supports an activity as
a genuine quality assurance process and adds transparency to the
process.

I think that we need to be cautious about applying this ruleset in
the converse, however. There are a number of activities that will
never be shared in the public domain. Will gave the example of many
student works. Others examples might include evaluations of data
gathering procedures. As part of a clinical trial I was an
investigator on, we assessed our intake protocol for participant
burden. That work was never intended for publication but the
participants recruited for that project underwent the same risks at
intake as "real" participants. It underwent REB review.

There are safeguards in place to protect employees from inappropriate
quality assurance processes: labour law, collective bargaining
agreements etc. I think we need to stay close to the spirit of the
intent of ethics review: protection of participants. This may mean
making a judgement that a work requires review if it walks like a
duck and quacks like a duck, even if it doesn't fly like a duck.

Cheers

Cam

From: "Joanne Gallivan" <joanne_gallivan@uccb.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 10:02 AM

Have I misunderstood the point in the second paragraph? Here, results of
undergraduate student projects are often published and presented in public
fora of various types including learned conferences, community
consultations/presentations, internal & external student research
conferences, research reports to sponsoring agencies, journal publications,
archived data sources, etc., etc.

Joanne Gallivan, Ph.D.
Professor of Psychology
Dean of Research
University College of Cape Breton
Sydney, N. S. B1P 6L2
902-563-1271
jgallivan@uccb.ns.ca

From: <helen@thegardiners.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research" (a bit long)
Date: Wednesday, October 08, 2003 10:13 AM

The issue of how to distinguish research from quality assurance and
program evaluation has become a considerable problem for universities as
well as applied settings. Unfortunately, using intention to publish as
a cut off criteria for REB review is not sufficient, particularly since
a growing number of program evaluation and quality assurance projects
are being published in the academic press. For example, Solberg et al
(2000) published the results of a quality improvement intervention
designed to increase the delivery of preventive services. They used a
randomized trial to carry out their work. There are many other
instances of published program evaluation and quality
improvement/assurance studies and the methodology is often
indistinguishable from traditional "research" methods, particularly when
one includes qualitative methods in that equation.

I attempted to go the definition route and found that it was useless.
Even if a reasonable definition was possible for research, quality
assurance and program evaluation, such definitions would be unlikely to
receive universal acceptance. Other individuals more expert than myself
have undertaken this route and given it up as a lost cause.

I then undertook an extensive series of interviews with experts in
research ethics (primarily chairs of REBs and individuals who have
published on the matter in the U.S.A. and Canada) and found that there
was little agreement regarding how to best distinguish projects which
needed review from those that did not. I concluded that perhaps the
question of "how do you distinguish research from non-research" was too
open ended, and once again undertook interviews with experts, this time
using vignettes from real world examples of research, quality assurance
and program evaluation pulled from an administrative review board I
participated on and published material. I thought that narrowing the
field of discussion to particularly instances would clarify the features
which experts used to determine whether a project needed REB review.
Unfortunately, this method did not accomplish that goal. There was
still no agreement among the experts which could be used for consistent
decision making regarding whether to submit a project for review.

I then surveyed the publishers of fifteen journals that could be
considered the "top" journals in medical research, program evaluation
and quality assurance. This part of the investigation showed that there
is no agreed upon standard amongst the journals regarding whether
projects submitted for publication require proof of REB approval, with
the possible exception of work that is clearly biomedical in
nature...and that was only among the medical journals.

I then took all of this information and distilled it to the critical
elements which appeared to be the points of agreement and disagreement
among the experts and used it to create a survey. The purpose of the
survey was to clearly distinguish those projects that need REB review
from those which do not, based on the planned ACTIVITIES and INTENTIONS
of the project. I asked respondents to consider each element and decide
what their decision would be, should such a project come to their
attention with the question of "should this project be submitted to an
REB for review". If they indicated that it should be reviewed, I then
asked whether that review should be a full review or an expedited
review. I was not entirely happy with this approach, since it could not
incorporate the complexity of decisions which REBs and PIs face with
regard to whether a project needs review, but I hoped it would allow the
points of disagreement and consensus to emerge clearly.

Responses were gathered from individuals who carry out their work in a
wide variety of environments (academic and applied, biomedical and
social sciences, qualitative and quantitative). After receiving
permission to access members of each organization, I sampled the
Canadian Evaluation Society, the American Evaluation Association, the
Canadian Society for Epidemiology and Biostatistics, the International
Society for Quality in Health Care, the Association for Health Services
Research and the Agency for Healthcare Research and Quality. In total,
200 responses from 41 countries were received (I also wanted to ensure
that the results were applicable in a variety of cultural settings).

The results are still being analyzed but will be complete before the
year end. It is quite clear from the data that there are some project
features which have a very high degree consensus regarding the need for
review. For instance 93.5% of all respondents agreed that if the study
involved participants who were cognitively impaired or who were
children, the project should be reviewed by an REB. 73.4% indicated
that the review should automatically be a full review. As might be
expected, 96.6% indicated that projects involving testing a new drug,
surgical technique or other invasive procedure should receive an REB
review and 96.6% agreed that it should be a full review (regardless of
whether the project was called research, program evaluation or quality
assurance).

I will happily share the details of the results when the analysis is
finalized. I am attempting to work the results into an "Ethics Decision
Guide" to help individuals in a wide variety of settings determine
whether they should seek the expertise of an REB before proceeding with
their intended work. Perhaps the members of the listserv will find it
helpful.

Cheers!


Helen Gardiner, M.Sc., Ph.D. (candidate)
University of Calgary
Partner, Vista Evaluation & Research Services, Inc.
234, 5149 Country Hills Blvd. N.W., Suite 833
Calgary, Alberta. T3A 5K8
(403) 275-3957 (telephone)
(403) 547-4317 (fax)

From: "Richard Neuman" <rneuman@mun.ca>
To: <helen@thegardiners.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Quality assurance etc. and "research" (a bit long)
Date: Wednesday, October 08, 2003 10:32 AM

Helen,
I beg to disagree to your argument on publishing QA. If there was
intention to publish our REB would consider that research, not QA, and
it would therefore require REB review. Most cases like that at our
institution would receive expedited review.
Cheers,
Richard Neuman
Co-Chair, Human Investigation Committee

From: <will@unb.ca>
To: "Joanne Gallivan" <joanne_gallivan@uccb.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 10:44 AM

Hello Joanne:
No, you have not misunderstood the 2nd para (I presume
the one that deals with u/g projects). It is not common at all
in sociology or anthropology (the fields I am most familiar
with) to take an "apprentice" approach to learning how to do
research. It is a painful process of learning/teaching things
step by step (such as doing just one interview).

There might be larger structural dimensions at work, too: for
example, unlike psychology (and some other fields), it is
quite unusual to find a whole bevy of names as "authors" in
articles. It might also be the fact that rejection rates of
articles in sociology journals run as high as 85%.

Naturally, some students do more elaborate work (e.g. an
honours research project) and those go through REB, but it
is still quite unusual to have u/g students present at
conferences. Our conferences are usually during the
summer which means that a student either has already left
the building, so to speak (apologies to Elvis), or fall during
the much-needed period of summer work. Sometimes,
though, a student does scrape enough money together to
present a paper, but, again, the structure of faculty's doing
research is quite different. I know this is an
overgeneralization, but I do find that it is only very seldom
that a faculty has a u/g student working on his or her
research project in the usual sense of the word.

Sorry to be so lengthy, but I do think that context can be
rather important. Will

It's a complex thing, but it is important to considers ethics
from the ground up, rooting it in the natural expressions of
each field.

On 8 Oct 2003 at 11:38, Joanne Gallivan wrote:

From: "Richard Neuman" <rneuman@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 11:03 AM

At our institution all student projects involving humans are reviewed by
the REB as most of us consider it a valuable learning experience for the
students. When a course requirement includes a research project to be
completed by each student, a subcommittee of our REB usually meets with
the course chair and reviews all of the projects. If major concerns
arise they are directed to the full committee for discussion and
disposition. The course chair provides feed back on the REB review to
the students to speed the process and assist the students in revising
their proposals as appropriate.
Richard Neuman
Co-Chair, Human Investigation Committee


will@unb.ca wrote:

From: "Richard Neuman" <rneuman@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 11:25 AM

Luc,
What would you suggest in the case of a chart review? A physician can
review charts for QA, but would your REB not expect to review a study
employing a chart review if the material was to be published? Does not
the publisher expect research to be reported has undergone ethics review?
Cheers,
Richard Neuman
Co-Chair, Human Investigation Committee
Luc Simon wrote:

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Quality assurance etc. and "research" (a bitlong)
Date: Wednesday, October 08, 2003 12:09 PM

It seems that a similar discussion has been running on the US list as well - indeed it comes up periodically on both lists, so the inference is that no matter how well people feel they have defined it, doubts remain as to the application to individual circumstances.

As one of my US colleagues like to say, stand back and take a deep beath.

REBs are supposed to be exercising oversight of research for the protection of human subjects. We get a bad name when we appear to be bogged down in regulations for their own sake.

So the guiding principle I use, is, who is potentially being harmed here? (which of course can have a very broad scope).


From: "Luc Simon" <Luc.Simon@vrr.ulaval.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 12:20 PM

If a physician wants to look at the charts of its own patients over a given
period and write a self-assesment report on its own practice, that may not
need REB review unless a local policy does require it.

A research hospital or a private clinic may very well decide that even if
such activity can be classified as QA/QI, a local policy that would
nonetheless require REB review may be put in place.

Given the sensitivity of the personal information contained in medical
records, it may very well be appropriate for hospitals and clinics to
develop such a policy. People involved in Public Health monitoring, Safety
officers, and the like should probably be consulted to make sure that the
local policy is well designed and does not unduly restrict their ability to
perform their work, with in some cases little or no benefit in term of
protection of subjects.

If such a policy is in place at a given institution, and that some QA/QI
work is allowed to proceed without REB review, an inquiry by a prospective
editor or publisher could be adequately answered by a letter from an
informed institutional officer explaining the situation.

Regards,

Luc Simon


From: <will@unb.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research" (a bit long)
Date: Wednesday, October 08, 2003 12:21 PM

Dear Helen:
You have our gratitude for sharing your findings with us. It is
a bold initiative to look at matters from the "ground up" and
arrive at some very interesting insights.

WCvdH
--
"... hope is the oxygen of the human spirit." (Margaret Somerville,
The Ethical Canary, 2000: xvi)

Will C. van den Hoonaard
Department of Sociology, University of New Brunswick
POB 4400, Fredericton, NB E3B 5A3
Tel. (506) 453-4849; Fax (506) 453-4659

From: "Joanne Gallivan" <joanne_gallivan@uccb.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 12:25 PM

I understand there are disciplinary differences, but the larger issue is
what our policies/procedures should be. Incidentally, the disciplines in
which undergraduates here have published or done research-based public
presentations in recent years include chemistry, biology, English, Mi'kmaq
Studies, communication, psychology, community studies, anthropology
(linguistics), sociology, Integrative Science, history, philosophy,
religious studies, political science, and marketing. I think it likely that
undergraduates at smaller, mainly undergraduate institutions are liable to
have more opportunity for extensive research experience at that level and,
for those who are in fields that include human participants, going through
the research ethics process is an important part of their educational
experience.

regards, Joanne

Joanne Gallivan, Ph.D.
Professor of Psychology
Dean of Research

From: "Mary Kate Needler" <MaryKate.Needler@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>; <Luc.Simon@vrr.ulaval.ca>
Subject: Re: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 1:50 PM

Hello everyone,

I like the following definitions:
Research is a systematic investigation to establish facts, principles or generalizable knowledge. (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 1998)

Program evaluation is the systematic collection of information about the activities, characteristics and outcomes of programs to make judgments about the program, improve program effectiveness and/or inform decisions about future programming. (MQ Paton. Utilization-focused Evaluation. 3rd ed. Sage Publications; 1996)
Quality measurement techniques are designed to detect deficiencies and errors, control costs by preventing over-utilization, and ensure that services are provided in a timely, efficient manner. (JR Way, DA Lund & CC Atkinson. "Quality assurance in human service program evaluation." In: CC Atkinson, WA Hargreaves & MJ Horowitz, eds. Evaluation in Human Service Programs. New York Academic Press; 1978.)
Quality measurement techniques include quality assurance, quality management, continuous quality improvement, total quality management and performance measurement. (H Jarvis. "Differentiating among research, evaluation and measures to assure quality." Healthcare Management Forum 2000; 13(4):34-36.)
For further reading see A Casebeer & M Verhoef: "Adventures in Research Land: Another glance "through the looking glass" to see what constitutes research." Healthcare Management Forum 2001: 14(4):59-61.

Regards,

Mary Kate


Mary Kate Needler, MSc
Research Auditor, Capital Health
Room B23A, Centre for Clinical Research
5790 University Avenue, Halifax, NS B3H 1V7

From: "Francis Rolleston" <frolleston@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 2:02 PM

I agree with Luc.

In the policies and SOPs that we are developing for NRC, we have
deliberately defined research very broadly, so as to include any activity in
which people are involved to gain information. We did this because we
wanted to catch everything, and then to develop proportionate review
criteria, processes and authorities for deciding whether the activity should
be reviewed by the REB, and if so, how.

One issue that caused considerable discussion in development of the TCPS was
who should decide whether something should be reviewed by the REB. It was
my feeling that the Tri-Council Working Group did not want to leave this
decision to the researchers. The long list in Appendix 1 (which was derived
from the University of Alberta) was intended to show how inclusive the scope
of the REB is. A definition that allows for exclusions invites arguments
about interpretation of the definition. I think that the issue is who makes
the decision. I believe that the decision should rest with the REB, and
that the basic assumption should be that an activity requires REB review
unless the REB process says that it does not.

Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

frolleston@sympatico.ca
613 728-7163

From: "Williams, Robert" <RWilliams@tsh.to>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 3:11 PM

Hello Everyone,

Another interesting discussion. We have been trying to distinguish between
research, which requires ethics review, and QA/QI initiatives, which do not,
for the last number of years. This is more than an academic question of
definitions for us, since we already have barely enough resources (financial
and human) to review what is unquestionably research. If the research
department and REB were required to oversee even a small fraction of the
100s of QA/QI initiatives that go on here, I think we might as well just
pack up our tents and head out of town right now.

I would like to know how other hospitals, especially non-university,
teaching hospitals, deal with this question. In particular, if you do
review QA/QI initiatives, what types do you review, and more importantly,
how do finance these reviews?

Thanks.

Bob

From: "Luc Simon" <Luc.Simon@vrr.ulaval.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 5:08 PM

Francis,

As an observer of the whole process, would you agree that the Tri-Council
Working Group who did not want to leave this decision to the researchers was
mainly considering the context of "biomedical research", and that the
operational impact of channelling to the REB everything that could be
encompassed by a broad definition of "human subject research" in different
academic settings was not very seriously considered ?

The often observed position that can be summarized as "better be safe than
sorry" that is invoqued to require REB review by default fails to recognize
the "negative consequences" of "unnecessary REB review".

Many examples can be cited where a strict requirement to obtain REB review
can in some instances pose unreasonable burdens to the realization of the
"research-like activity", to a point where the net effect is not protection
of the subjects but a discredit to the importance of the role and function
of the REB.

Regards,

Luc Simon

From: "Richard Neuman" <rneuman@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Quality assurance etc. and "research"
Date: Wednesday, October 08, 2003 5:46 AM

Dear Howard,

We define a proposal as "research", thus requiring REB review, when the
goal of the project is to publish or present the study findings in a
public forum. Our REB would not consider a QA project "research" if the
findings were to be presented, providing the presentation is not made
outside the initiating group. For example, human resources could run
run a wellness survey as part of their QA program and report those
findings to university officials and to the group surveyed. However,
without first having received REB approval as a research project, it
would not be acceptable to publish those findings in, for example, a
journal.

Where our REB has faced difficulties with this issue is when a project
starts as QA and data collected and then the PI decides the findings
should be published or presented in a larger forum. We are awaiting a
response from our policy subcommittee on this matter.

Cheers,
Richard Neuman
Co-Chair, Human Investigation Committee

From: "Francis Rolleston" <frolleston@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Thursday, October 09, 2003 12:43 PM

Luc, with great respect, I would not agree with your proposition. The
Tri-Council Working Group strove to represent all sectors of research. The
fact that discussion of research ethics was then, and probably still is,
much more advanced in the biomedical area than in other areas, may
contribute to the perception of a biomedical bias in the TCPS. But is the
solution to erode the standards that are accepted in the biomedical area, or
to advance those in other areas? What principles of ethics theory, or even
of practice, distinguish them?

The second part of my previous intervention talked about a proportionate
review process, which includes a decision that a particular study does not
need REB review. Again, should this decision be made by the researcher, or
by the institutional authority that is responsible for oversight of research
ethics? I think the latter. Such decisions can be made on the basis of
policy decisions made in each institution. To try to encapsulate them in a
national policy seems unwise, at least to me.


Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

frolleston@sympatico.ca
613 728-7163

From: "John Lowman" <lowman@sfu.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Thursday, October 09, 2003 5:07 PM

Francis,

I have a very difficult time accepting your proposition that, when the TCPS
was written, "discussion of research ethics was then, and probably still
is, much more advanced in the biomedical area than in other areas." Ouch.

What contributes to the perception that the TCPS is biased towards
biomedical research is its utter failure to comprehend and incorporate the
language of alternative epistemologies in qualitative social research. For
example, its insistence on using the term "research subject" -- apparently
a point of contention when the first draft of the TCPS was written -- flies
in the face of several research traditions to which that term is anathema
and a mark of the biomedical ethical imperialism that is writ large in the
TCPS. The voices of dissent that were raised at the time were utterly ignored.

Hopefully, the Social Sciences and Humanities Research Ethics Special
Working Committee will establish that the difference between biomedical and
qualitative social science research ethics is not a matter of one being
"more advanced" than the other, but a matter of difference, and only that.
I for one would like to see a separate ethics code for biomedical and
qualitative social research so that inapplicable concepts -- such as
"research subject" -- are not foisted on qualitative researchers.

Sincerely,

JL

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Friday, October 10, 2003 10:37 AM

I have generallly advised researchers when making this sort of query, that it is probably a counsel of perfection to at least formally seek the opinion of the REB if in any doubt whatsoever.

I almost dfeel we need a templated "letter of no objection" when there is a concensus that the proposed activity does not meet the criteria for REB review. Better safe than sorry.

Actually we have no idea of what is going on out there, we do work on an 'honour' system. therefore the events at the US Navy do not come as a complete surprise.

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Friday, October 10, 2003 11:25 AM

The point about requirement criteria that would trigger REB is not
well-defined in TCPS, i.e. who makes the determination.. One approach
would have institutional policy delegate the REB with that responsibility,
developed further by local SOPs to delegate as they see fit specific
criteria for qualitative methodologies that could differ from the criteria
for quantitative work.

The issue of deciding 'when' REB review is indicated takes another turn
requiring criteria to define the situations where use of protected
information in a clinical database turns into research. Such database
development likely was not reviewed at its outset as it developed as part
of clinical practice, maybe for QI activities, but sharing or pooling
nominative data certainly triggers research review.

Another aspect of the 'decision-making' for REB review gets discussed from
time to time by our US colleagues whose 'interpretation documents' for
their federal codes clearly define criteria for 'exempt' and 'expeditied'
categories of review.

The problem i see with use of an 'exempt' category, whereby once a study is
"exempted" it falls off the REB radar, as no rule requires that an exempt
study be re-reviewed at a regular interval. During the initial approval
period modifications to the study design could take place, or the
investigator might get thrilled at the QI findings and want to share in a
public way. In either case the 'new intent' could prevail unknown to the
oversight process.

This is an area that needs tightening most usefully at the federal level,
or in a last resort manner at the level of institutional policy ... elisabeth

From: "Willison, Donald" <willison@mcmaster.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Friday, October 10, 2003 11:33 AM

I wonder whether the discussion has focused too narrowly on the question of when QA requires RESEARCH Ethics Board review, as opposed to INDEPENDENT ethics review more generally. Is part of the problem not one where, in absence of REB review, there is no review at all? Is not the need for ethics review a function of the risks, burdens, etc, regardless of whether this is a research study? This is certainly a long-standing gap in hospitals.

There is a document produced by the National Health and Medical Research Council in Australia that addresses this (attached). There is also a much larger discussion document on their website at: <http://www.health.gov.au/nhmrc/issues/pdf/qualassu.pdf> http://www.health.gov.au/nhmrc/issues/pdf/qualassu.pdf Highly recommended reading.

Don Willison

Don Willison, Sc.D.
Scientist, Centre for Evaluation of Medicines and
Assistant Professor, Dept. of Clinical Epidemiology & Biostatistics, McMaster University
105 Main St. East, P1
Hamilton, Ontario L8N 1G6
Tel: (905) 522-1155 x 4911 (Assistant: Anita x 5269)
Fax:(905) 528-7386
e-mail: willison@mcmaster.ca

From: "Francis Rolleston" <frolleston@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Sunday, October 12, 2003 9:49 AM

Thank you, John, for raising the issue of "subject", presumably versus
"participant".

As I reach (? enter) my anecdotage, I draw on personal experience. I have
participated in 4 research projects within the past few years, two clinical
and two qualitative social science/historical. One clinical research
protocol involved daily self-injection, quarterly blood work and movement
and mental capacity tests, and annual long questionnaires (with very
personal questions) and MRIs. The other was simply a blood sample for
future genetic analysis. The qualitative ones both involved recorded
interviews. I would suggest that I (together with the pother subjects) was
a very active participant in 3 of these 4 projects, and mildly so in the
fourth. But so also were many others, the researchers, their colleagues,
interviewers, testers etc. But I, and the others being studied, are unique
among the wide range of participants in the projects; all the others owe a
major duty of care to me (and the other research subjects). For each
project, both the researcher or delegate, and I, signed the consent form.
Their signatures meant a lot more than mine. They undertook a wide range of
responsibilities, from which they could not walk away. I could walk away
from any of these projects at any time, and even demand that previously
obtained data be destroyed. Also, all 4 consents dealt with the same
basic principles, as set out in the TCPS.

So I do not see "subject" as an example of ethics imperialism (more later),
but rather as a clear recognition that among all the partners or
participants in a research project, there is one group, the subjects, who
are absolutely unique, and to whom all the others owe duties. "Subject", a
harsh word, reflects this. "Participant" a soft, touchy-feely, word, does
not. Perhaps neither word is the best that can be found. But they are the
words that we use now.

So, in summary, I caution those seeking to use the imprecise word
"participant" to be very careful that it does not erode the undeniable
distinction between those who participate in a research project. "Subject"
is unambiguous. Also, the voices against this word were heard, not ignored;
they stimulated much debate. But in a decision between two alternatives,
one group will always be able to claim that they were ignored. They
weren't; rightly or wrongly, they just lost the argument, at that time, and
in that place.

The above may well raise howls of biomedical ethics imperialism or
arrogance, of which I have been accused in the past few days. There was
also a call for separate "Codes" (another word that caused problems in
development of the TCPS) for biomedical and for qualitative social research.
My problem with that is that there is nothing in the TCPS that is not
relevant to health research, in which biomedical and social aspects are
increasingly inseparable. To my mind, the clinical project outlined above,
with its lengthy questionnaire, included an aspect of qualitative research.
Research into mental health, pain, quality of life, community health care
delivery, palliative care, social determinants of health, links between
criminal, social, biological and health parameters, and many other areas,
all require qualitative research together with the full range of research
methodologies, including biomedical research. So for the broad range of
health research, separate "codes" are a non-starter. Then what are the
purely qualitative researchers to do? Develop a separate "code" for their
unique research paradigms that is not related to other types of research?
How would the public react to that?

Back to imperialism. First, would it be "arrogant" to say that the vast
majority of research involving human subjects deals with human health?
Second, I would remind you that TCPS was developed and formally adopted
jointly by the three research funding Councils. So to cite imperialism
implies that proponents of biomedical ethics exercised coercive power over
all three Councils. I would be astonished if those implied to have been
subjected to biomedical imperialism would accept this inference. To my
mind, what was achieved in the TCPS was to recognize, at a broad level, the
essential congruence of principles and practices of human research ethics.
I think that we should all remember always that what we are talking about is
public policy, for which the ultimate arbiters are the Canadian people.

In all the noise since 1998 and before about the essential differences
between qualitative and biomedical "quantitative", I have heard much use of
phrases such as "epistemological differences", but I have not yet heard any
statement that sets out clearly in a manner that the Canadian public would
understand, as to why the broad principles and practices in the TCPS do not
apply to qualitative research. I believe that this listserv would be a good
place to set out such viewpoints, so that they can be discussed.

Perhaps this will raise further accusations of "arrogance". But the essence
of academic debate is not debate is not character assassination, but putting
forward of views and opinions, and their theoretical, practical and ethical
foundations.

Finally, despite the above, I am certain that the TCPS is far from perfect,
and that it needs a lot of continuing attention to address mistakes that
were apparent when it was published, and that have arisen because things
have changed since then. In this regard, I very much look forward to the
work of the Social Sciences and Humanities Ethics Special Working Committee.

Now to pluck up the courage to press the "send" button.

Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

frolleston@sympatico.ca
613 728-7163

From: "Francis Rolleston" <frolleston@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Sunday, October 12, 2003 10:42 AM

Don, I think that you have added something very valuable to this discussion.
The issue is ethics review, not research ethics review. The question is
whether the institution is happy with activities that are going on within
it. If the REB is the only mechanism for assessing this, then it will be
REB review. But it need not be so.

Thanks for the clarification.


Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

From: "John Lowman" <lowman@sfu.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Sunday, October 12, 2003 2:17 PM

Francis, thanks for your continuing contribution to this debate. Let me
focus on just one of one of your paragraphs, because it so beautifully
demonstrates the point I made. It is this one:

"...I do not see "subject" as an example of ethics imperialism (more later),
but rather as a clear recognition that among all the partners or
participants in a research project, there is one group, the subjects, who
are absolutely unique, and to whom all the others owe duties. "Subject", a
harsh word, reflects this. "Participant" a soft, touchy-feely, word, does
not. Perhaps neither word is the best that can be found. But they are the
words that we use now."

It would be hard to find a better example of ethics imperialism than this.
I am horrified that you would dismiss use of the term "participant" as a
"touchy-feely" exercise in which the researcher owes no "duties" to
"subjects." If anything it expands the list of duties. My point is that the
TCPS does not use both terms, hence my using this example in the first place.

By the way, when I talk about qualitative research, I am referring to much
more than "interviews" with "subjects" that are subsequently coded and
analyzed quantitatively. I am talking about ethnography, participant
observation, standpoint feminism, etc.

Best,

JL

From: "Francis Rolleston" <frolleston@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Sunday, October 12, 2003 3:10 PM

John, you mis-interpreted my point (perhaps because I phrased it poorly).
Whatever word is used does not change in any way the responsibilities of the
researcher to the subject/participant. However, the word that is used can
perhaps make those responsibilities less evident to people who do not think
so deeply about such issues as you do.

I admit to a lot of ignorance in qualitative research. It would certainly
help me, and perhaps others on the list serv, if you would go deeper into
one or more of the examples that you raise, and comment on, or illustrate,
how the concept of participant versus subject is so important in terms of
research ethics and practice.

Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

From: "John Mueller" <mueller@ucalgary.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Quality assurance etc. and "research"
Date: Monday, October 13, 2003 7:40 PM


I seem to have misdirected a response last week such that it
went to the list rather than to the individual. I apologize
for the misdirection (though I stand by the substance of the
opinions I expressed).

I am glad to see that the thread has continued, maybe I can
add some thoughts that apply. If not, I can happy revert to
lurking. Let me extract a couple of excepts from Francis'
recent post; nothing personal, it just has the advantage
of providing a context, albeit perhaps not the one intended!
This is a bit long, I suspect mostly unwelcome, but your
delete key is right over there, get your finger in position
now.

>> to cite imperialism implies that proponents of biomedical
>> ethics exercised coercive power over all three Councils. I
>> would be astonished if those implied to have been subjected
>> to biomedical imperialism would accept this inference.

We oft-times talk about the American "elephant" and how its
actions affect Canada. We Canadians are badly outnumbered
(the infamous 10:1 ratio) and there is an monster trampling
around, oblivious to our presence, as we scramble to safety.

I think this metaphor MAY help to understand the present
situation between medical research and other disciplines.
Perhaps it does not explain everything but it's a start, and
I think fairly neutral and undeniable.

There is SO MUCH MONEY and attention devoted to medical
research these days that it is hard to remember there are
other disciplines. Some may go beyond this in terms of
intent, elitism, imperialism, arrogance, whatever, but for
the moment one doesn't have to go to any extreme to think
that this elephantine disparity in support for health
research versus "everything else" provides at the least a
blind spot with regard to appreciating intellectual inquiry
in general. (And, to be fair, outside the health industry
the pot of gold at the end of the health research rainbow
has led university administrators to devote their efforts
and local resources in at least the same disproportionate
manner.)

So, as a starting point, I think a case can be made for
the frustration outside health research lying in the simple
self-absorption of medical researchers with doing their own
thing well, the elephant oblivious to the rest of us.

>> First, would it be "arrogant" to say that the vast majority
>> of research involving human subjects deals with human
>> health?

I don't know about arrogant, but it may speak to an in-group
perspective, the elephant's eye view so to speak. For one
thing this is a rhetorical statement, not empirical, though
it may be somewhat quantifiable. Given the vast budget for
health research there may be SOME metric whereby the
"majority of human subjects research involves human health".
('vast' seems an over-statement, for the time-being).

But there are OTHER metrics. For example, I have worked with
human subjects for well over thirty years, and NONE of it
was about health (which I will return to below). And I know
many others who can say the same. Yes, I confess this may be
the out-group perception on my part, but in no way am I
convinced of being wrong just by being in the minority. (A
wise person once observed that "there are many more
cockroaches than humans, but do you really want to be one?")
I am willing to concede reality status to the needs of both
health and non-health researchers, but there needs to be
SERIOUS attention to this prospect from both sides, and I'm
haven't seen much evidence of mutuality, instead more
evidence of two solitudes.

There are other ways of questioning this position. Go to the
library, pull off all the American Psychological Association
journals (or your favorite discipline) for the last 10 or 20
years; do a content analysis on the articles, just a simple
classification with regard to health research versus not. Or
go to the archives of this discussion group, and count on
both hands the number of times non-health research is
discussed (bet you the difference is well over 10:1). And so
forth for other possible metrics.

Finally, in truth, even accepting the proposition about the
vast majority does NOT imply at all that the RESIDUAL
non-health human research should obey the policies that are
desired for health research. (After all, we are a caring
nation with regard to minorities, eh?) So if the implication
of 'vast majority' is to imply the rest of non-health
researchers should just get over it, then I must object -
that may be a bureaucratic convenience, but it's a logical
fallacy.

>> So, in summary, I caution those seeking to use the imprecise
>> word "participant" to be very careful that it does not erode
>> the undeniable distinction between those who participate in
>> a research project. "Subject" is unambiguous. Also, the
>> voices against this word were heard, not ignored; they
>> stimulated much debate. But in a decision between two
>> alternatives, one group will always be able to claim that
>> they were ignored. They weren't; rightly or wrongly, they
>> just lost the argument, at that time, and in that place.

I have some sympathy for the term "participant," more than
15 or 20 years ago, though I would hardly self-identify as a
qualitative researcher. I personally think the term
"subject" is quite serviceable for the most part. It's not
"bio med" vs. "qualitative social research" because there is
a LOT of nonqualitative psycho-social research. "Subject" is
quite appropriate for the latter, because in those cases it
is the independent variable being tests, not the person.

The word may be important in another way though, indirectly.
I think biomedical researchers actually think of their
subjects as "PATIENTS." I can't go there, never have my
research participants been patients in my mind, short-term
or long- term.

There are many variants of this to drive home the IMPLICIT
PATIENT MODEL, such as a recent observation in the 2003 CAUT
Bulletin, ""It made me think about where the line was drawn
between therapy and research." I can't imagine a situation
in all my years where that thought would have crossed my
mind. And I can say that many others find this baffling
self-absorbed observation just hard to identify with at all.
Of course, we are just doing "unimportant" research.

Biomedical research is about the subject-patient synthesis;
fair enought perhaps, but it isn't true of intellectual inquiry
in general. What's good for GM is not necessarily good for
Bombardier.

>> for biomedical and for qualitative social research. My
>> problem with that is that there is nothing in the TCPS that
>> is not relevant to health research, in which biomedical and
>> social aspects are increasingly inseparable.

Yes, actually, that's sort of the point, the problem, the
self-absorption - there is nothing in the TCPS that is not
relevant to HEALTH research, but there is more than health
research in the world. It may be that health research has
increasingly become aware of the need to consider
psycho-social factors (some might say long overdue!), BUT
there is still much human research that does not have health
treatment as its goal. The TCPS pretends this is not
relevant, or minor, or that the wise folks at the local REB
can sort it out (the latter being ill-equipped and
unmotivated to work with "exceptions"). It's not working,
though if you're not looking at non-health human research it
is possible to delude yourself. The American elephant
doesn't hear too well, or hears what it wants to hear, and
the medical elephant seems to have inherited the problem.

>> To my mind,
>> the clinical project outlined above, with its lengthy
>> questionnaire, included an aspect of qualitative research.
>> Research into mental health, pain, quality of life,
>> community health care delivery, palliative care, social
>> determinants of health, links between criminal, social,
>> biological and health parameters, and many other areas, all
>> require qualitative research together with the full range of
>> research methodologies, including biomedical research. So
>> for the broad range of health research, separate "codes" are
>> a non-starter.

Again, it's NOT for HEALTH research that separate codes are
needed, it's because of non-health research. There are many
and subtle tentacles to the presumption of
subject-as-patient and research-as-therapy perspectives. As
it stands though, there seems little interest in minimizing
the collateral damage.

>> In all the noise since 1998 and before about the essential
>> differences between qualitative and biomedical
>> "quantitative", I have heard much use of phrases such as
>> "epistemological differences", but I have not yet heard any
>> statement that sets out clearly in a manner that the
>> Canadian public would understand, as to why the broad
>> principles and practices in the TCPS do not apply to
>> qualitative research.

I think the Canadian public can indeed understand the
difference between PATIENT and SUBJECT. However, I am less
sure about Health Canada et al and the ethics industry in
general. I also think the public can understand the
difference between TREATMENT-ORIENTED RESEARCH and basic
research. (And, again, it's not really about the TCPS
applying to qualitative research per se, it's about how it
applies or not to non-health non-therapy human research of
all kinds.)


I have expressed other thoughts to the Social Science
Working committee, but not these. All things considered,
I don't expect (meaningful) change, but time will tell.
For one thing, the disingenuous dismissal as "noise" of
sincere efforts to communicate with the elephant is still
quite common.


-- John.
.................................................................
John Mueller http://mueller.educ.ucalgary.ca
Division of Applied Psychology 403-220-5664 (work)
University of Calgary 403-282-9244 (FAX)
Calgary, Alberta T2N-1N4 403-288-7342 (home)

14. Research Subject vs. Research Participant

From: "John Lowman" <lowman@sfu.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] "Research subject" and "research participant"
Date: Monday, October 13, 2003 11:34 PM

Hi again Francis,

Thanks for the clarification; here is mine.

The terms "research subject" and "research participant" are both
acceptable, depending on the research/researcher. What is nor acceptable is
foisting the term "research subject" on all research/researchers.

As I understand it, one of the most important reasons for preferring the
term "research participant" to "research subject" is that it changes the
power structure and, in turn, the ethics of the researcher-participant
relationship. No longer is the "subject" merely the object of knowledge,
but an active participant in the construction of knowledge. This is the
case with "collaborative" and/or "emergent" epistemologies. Examples are
community-based and certain kinds of feminist research. From their
standpoint, it would be unethical to walk into the community with the
"research instruments" in hand. The people providing information should be
included in the design of the research; indeed, the design process makes a
vital contribution to the researcher's understanding of the community
involved. Also it is a vital part of building the trust and respect that is
needed to yield valid and reliable research information. However, research
ethics boards generally assume that the research instruments will be
presented with the ethics application package, and that interaction with
"subjects" cannot proceed until the application has been approved.

Does it matter that we refer to research participants as "participants" in
these situations? To me it does. Research subjects are people who we
harvest information from -- indeed, I am coming to think that the term
"research object" comes closer to describing their role. In most instances,
researchers walk into the worlds of their "subjects" (or, at least, their
student assistants do) collect the information, and then depart never to be
seen again. And that is how the TCPS conceptualizes "research:" a series of
discrete projects in which "subjects" provide information. This
conceptualization captures only part of my experience as a prostitution
"researcher" over the past twenty-five years. In this regard, I'll make a
further comment about the way the TCPS conceptualizes "research" to help
explain how I conceptualize a "participant."

Over the course of my career I have received many grants and contracts to
conduct discrete studies of prostitutes, clients, pimps/managers, madams,
vice squad officers, and so on. But my work in the prostitution field is
not restricted to "research," and my research benefits tremendously as a
result. For the past ten years I have been a member of the Board of a
charitable service society run by former prostitutes. Some of the members
of the society have participated in my formal research, some of them have
not, but most of them have contributed to my knowledge of prostitution in
one way or another. The very process of knowing them over the long term
means that they tell me things that I doubt they would ever tell a
"one-off" researcher. I interact on an almost daily basis with people who
will be or who have been participants in the formal "studies" I conduct, a
couple of whom I have known for twenty years. For the past eight years I
have run a prostitution research web site that has received thousands of
hits, and during my career as a prostitution researcher I have probably
averaged one interview a week for print, radio and TV media, adding up to a
total of more than a thousand interviews. As a consequence, all sorts of
people -- including police, social workers, politicians and prostitutes
-- contact me to obtain information, or they interact with me at various
private and public meetings. In the process, they often provide unsolicited
information about their involvement in prostitution, and in many instances
they expect me to keep their identity confidential. I receive many an email
from people involved in prostitution that begins, "please keep this
confidential.' It is now hard for me to distinguish "research" from the
general flow of my life. Should I obtain permission from my REB to keep
living this life?

The most important point for me about use of terms like research "subject"
and "participant" is not whether everyone agrees or disagrees with my
reasons for preferring the one term over the other, but that researchers
should have the right to play it the way they see it. The more I think
about it, the more I think that the decision by the authors of the TCPS to
exclusively use the term "research subject" -- a term that is repeated in
every research ethics board protocol and application form I have ever seen
-- and exclude the term "research participant" constitutes an infringement
of academic freedom.

To everyone on the listserve, enjoy Thanksgiving...

Best wishes,

JL

From: "Francis Rolleston" <frolleston@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] "Research subject" and "research participant"
Date: Wednesday, October 15, 2003 8:00 AM

John Lowman, and John Mueller, thank you. Your inputs have been most
helpful to me. I hope that I have the wisdom to learn from them.

Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Subject or Participant? A rose is a rose....
Date: Wednesday, October 15, 2003 12:20 PM

Francis Rolleston writes of this interchange: " I hope that I have the
wisdom to learn from them"

Amen to that - may we all be granted wisdom.

Perhaps the most interesting thing about this debate, or discussion, if
you prefer, has been the amount of interest and feeling it has
generated. While it is interesting the way threads grow, there is always
the danger that we lose sight of where we started. Indeed the title of
the thread changed on October 13th from 'Quality Assurance and Research'
to 'Research Subject and Research Participant.'

A side effect of the strength of feeling that people have on issues is
the frequent opportunity for misunderstanding, as this exchange
demonstrates. Furthermore to complicate matters it ran on both sides of
the border, so people only subscribing to one list may have missed some
of the discussion, a problem that has been commented on before (See
Appendix). The Canadian list is unmoderated unlike its US counterpart.
We have often discussed whether we might gain from interpolating some
sort of referee or even summing up of the issues. Michael Wilson at
McMaster has done some work to this end.

So what have we achieved? If I recollect correctly this aspect
(terminology regarding those who volunteer for research) arose out of
discussions as to whether TCPS was or was not biased towards biomedical
research, and was introduced by John Lowman on the 9th. On a lighter
note I am not sure whether his use of the term 'elephant' refers to me
personally or to the issue - I will think about that, since it had only
been used in the discussion to refer to America.

It was useful to be reminded by Lowman that the term 'research subject'
had been debated early in the history of TCPS and he describes differing
viewpoints from the biomedical and social science perspectives. We
understand that 'subject' contains a strong connotations to social
scientists, not necessarily apparent to their biomedical brethren, and
we note that it is in qualitative research where the problem is
perceived most.

Rolleston wondered whether the alternative should be 'participant',
conceding that perhaps neither word fully conveyed the intended meaning.
Clearly there are different derivations and in a shared decision making
model, they imply different hierarchical relations. Some people in
research may feel more participatory than others. Similar divergences in
attitudes might be expected of researchers. On the other hand Rolleston
saw 'subject' as not necessarily hierarchical but defining those to whom
a duty is owed, an important ethical construct in terms of defining
relationships between groups. Rolleston also introduces the question as
to whether the exact word used influences the perception of
responsibility, while stating that the choice of word cannot change that
responsibility.
Lowman feels that both terms should be made acceptable alternatives. He
points out the need to include the objects of research in the
construction of research thereby diminishing the power hiatus and
emphasising collaborative participation. This can be seen as impacting
on the trust and respect of the relationship, but at the same time
Lowman points to a possible paradox in terms of REBs feeling that
interaction can only start after approval of a proposition. This would
presumably eliminate a community initiated project. Therfore Lowman
feels that the term used is important. He illustrates this in terms of
sociological researchers relationships with the communities or
professions that they interact with.

Mueller also pointed to a perceived dichotomy in research ethics between
social and biomedical sciences, although is comfortable with the term
'subject', being more concerned about 'patient' which blurs the area
between therapy and research (the therapeutic trial controversy).

My concern was that REBs might simply take a viewpoint that one or the
other term was preferred, and apply it as a rule. I have actually used
both, somewhat interchangeably over a lifetime. I have certainly used
the word participate in consent forms but recently dropped it because
being four syllables it raised the reading level, and substituted 'take
part in'. I probably inadvisably used the term 'politically correct'
thereby attracting criticism. As Watts (inspired by Weijer) says, a
definitional starting point is a strong base.

OK: "avoidance of expressions or actions that can be perceived to
exclude or marginalize or insult people who are socially disadvantaged
or discriminated against" or "demonstrating progressive ideals, esp. by
avoiding vocabulary that is considered offensive, discriminatory, or
judgmental, esp. concerning race and gender" Well perhaps that wasn't
precisely what I meant, which was the use of words that carry overtones
or connotations that may not be desirable in the context.

Whatever motivation for the choice of a word, we must not lose sight of
our responsibilities in research ethics, which may or may not be
conveyed by words. Clearly there is a lack of empirical data here, and a
fruitful area for research into research.

I think the interchange has been useful in terms of making us think more
deeply about the meaning of the words we use in this context, and may
help us to focus more on the relationship between the researcher and the
researched.

I maintain that it is not so much the words that we use as the meanings
we and others place on them.

And all this over the Thanksgiving/Columbus Day weekend.


APPENDIX (The Elephant Version)
For those of you who missed the US version of this interchange, it went
something like this:

It started 'We have been informed that the American Psychological
Association (APA) requires the use of the phrase human participant
rather than human subject.

Actually that is quite old and is a little bit more complicated than
that: The 4th edition of the publication manual states "Write about the
people in your study in a way that acknowledges their participation.
Replace the impersonal term subjects with a more descriptive term when
possible - participants, individuals, college students, children, or
respondents, for example (subjects and sample are appropriate when
discussing statistics)."

It was felt that the term 'subject' emphasised the risks of taking part
in research and was an important distinction from 'patient'.
Interestingly Dale E . Hammerschmidt considered this a Political
Correctness issue, while acknowledging that subject participation is a
gift which should be acknowledged. There seemed to be a feel that a
'gentler' term is needed. Again the power differential was stressed as
well as the fact that renaming does not take that away. Dale also
pointed out that there is potential confusion in that 'participant'
appears in the literature frequently as referring to the investigators!
The relationship and limits to autonomy was mentioned - subjects can
leave a study but not control it.

Anderson investigated the historical roots, pointing out that originally
subjects were objects, and that subject emphasised the voluntary nature
of research. Linguistically it was emphasised that subjects take action
rather than being acted upon (objects) despite the usage in civics.

There was concern that 'participant', also described as 'warm and
fuzzy', not only included all sorts of people other than the 'subjects'
but implied that the 'subject' did not realise that they were a means to
an end and had less control. In US regulation the term is unequivocally
'subject' but some preferred 'person or people studied'.

A distinction between biomedical and social science preference was
noted. Erica Heath pointed out the deebate in California over
Proposition 54 was largely one about the word 'subject' and its meaning,
I quote """Our attorneys say it is so broad that it can mean whatever
you want it to mean, and we want it to mean all medical subjects,
everything related to medical and health care - and we'll defend that in
court," said Diane Schacterle, coordinator of the Proposition 54
campaign."". I have a feeling that Humpty Dumpty would have enjoyed
this.

John Burke also pointed out the presumptuousness of deciding what people
should be called without consulting them. The debate became so vigorous
that 'participants' even deleted the potentially offending word from
their letterhead, thus we have "Director, Human ......... Protection
Program, University of Louisville".

Social scientists had the edge in terms of understanding semantics and
linguistics better. Thus we find:

"The words and patterns we choose and use express and form our value
systems. It is important that the linguistic "maps" we shape will
carefully and expertly correspond to the "territories" of our experience
and intentions. The words toward which we gravitate to express the place
of enrollees in human research express our own culturally/historically
bound conceptions of who they are and what they mean in the scheme of
things. These same words reveal who we are in relation to them and in
relation to the fundamental act of research." Dr. Edward F. Gabriele.

While the question was raised as to whether this was much ado about
nothing, and some argued that it was a waste of time when there were
more pressing issues in the world, Gabriele replies "Perhaps our
reflections and struggles are on the subconscious level a fermentation
or wondering about how we understand the fundamental freedom and dignity
of others and of ourselves within the research context. In a world where
those who yesterday were called "patients" are today referred to as
clients, customers, consumers.....and now worse yet as generators of
relative value units......the words we choose may be more important than
we realize. If our reflections and discussions are only about marketing
and advertising, then I think we best move on. But if our wrestling with
this and with related issues is about plumbing the depths of the meaning
of respect, beneficence, and justice as well as the meaning of what it
means to be human and humane, then this discussion should always be
fresh, perhaps even cutting edge. In a world where moral objectification
can be only a legislative-possibility stone's throw away, I welcome
discussions of this sort. They make me think about what it is I am
supposed to be doing in human research ethics leadership. It's something
far deeper than just keeping the regulations. It may have something to
do with protecting the one thing I never want to become trite: my own
freedom and that of others."

Naturally someone went to the dictionary, so we have:

"subject
adj.

1. Being in a position or in circumstances that place one under the
power or authority of another or others: subject to the law.
2. Prone; disposed: a child who is subject to colds.
3. Likely to incur or receive; exposed: a directive subject to
misinterpretation.
4. Contingent or dependent: a vacation subject to changing weather.


n.

1. One who is under the rule of another or others, especially one who
owes allegiance to a government or ruler.
2.
a. One concerning which something is said or done: a subject of gossip.
b. Something that is treated or indicated in a work of art.
c. Music. A theme of a composition, especially a fugue.
3. A course or area of study: Math is her best subject.
4. A basis for action; a cause.
5.
a. One that experiences or is subjected to something: the subject of
ridicule.
b. A person or animal that is the object of medical or scientific
study: The experiment involved 12 subjects.
c. A corpse intended for anatomical study and dissection.
d. One who is under surveillance: The subject was observed leaving the
scene of the murder.
6. Grammar. The noun, noun phrase, or pronoun in a sentence or clause
that denotes the doer of the action or what is described by the
predicate.
7. Logic. The term of a proposition about which something is affirmed
or denied.
8. Philosophy.
a. The essential nature or substance of something as distinguished from
its attributes.
b. The mind or thinking part as distinguished from the object of
thought.


tr.v. subjected, subjecting, subjects

1. To submit for consideration.
2. To submit to the authority of.
3. To expose to something: patients subjected to infection.
4. To cause to experience: subjected to extreme weather.
5. To subjugate; subdue.


[Middle English, from Old French, from Latin sbiectus, from past
participle of sbicere, to subject : sub-, sub- + iacere, to throw; in
Indo-European Roots.

Synonyms: subject, matter, topic, theme

There were also offers of alternatives, Eric Konicki writes "I prefer
the term "Human Research Volunteer" because I think it reminds everyone
that autonomous beings who need to be treated with dignity and respect
are giving of themselves to advance human knowledge. Sometimes the right
words are important."

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Cc: <Jeffrey.Kirby@dal.ca>; <christy.simpson@dal.ca>; <nuala.kenny@dal.ca>; <merril.pauls@dal.ca>; <charles.weijer@dal.ca>
Subject: [Ethics] Subjects or Participants
Date: Wednesday, October 15, 2003 3:02 PM

I am grateful to Howard Mann for drawing attention to these letters:

http://bmj.bmjjournals.com/cgi/eletters/318/7191/1141/a

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] "Research subject" and "research participant"
Date: Thursday, October 16, 2003 9:08 AM

A research participant could be the investigator, s/he participates in the
research by conducting it. It is also important to crystallize for the
subject that the relationship with the researcher is different than before,
i.e., no soft peddling. No point in sugar coating it.

It is also worth noting that one of the grounds for a recent law suit in the
US that included the IRB was failure to use the term Œresearch subject¹,
thus failing to fully inform the Œguinea pig¹ of the true nature of the
relationship. You may shake your head, but a court might agree and find the
IRB at fault. Not that I am advocating we work in fear.

Jack Corman
President/Secretary

IRB Services
14845-6 Yonge Street
Suite 328
Aurora, ON, L4G 1H6
CANADA.

From: "John Lowman" <lowman@sfu.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] "Research subject" and "research participant"
Date: Thursday, October 16, 2003 1:02 PM


It's a heard of elephants...

The investigator is the "investigator" or "researcher"...

Could you supply the reference to the U.S. case.

Thanks.

JL

At 10:04 AM 16/10/03 -0400, you wrote:
>A research participant could be the investigator, s/he participates in the
>research by conducting it. It is also important to crystallize for the
>subject that the relationship with the researcher is different than
>before, i.e., no soft peddling. No point in sugar coating it.
>
>It is also worth noting that one of the grounds for a recent law suit in
>the US that included the IRB was failure to use the term research subject
>, thus failing to fully inform the guinea pig of the true nature of the
>relationship. You may shake your head, but a court might agree and find
>the IRB at fault. Not that I am advocating we work in fear.
>
>Jack Corman
>President/Secretary
>

From: "Laurel Evans" <levans@mcmaster.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] "Research subject" and "research participant"
Date: Thursday, October 16, 2003 3:05 PM

I would be interested in the reference as well. Thanks. Laurel Evans.

John Lowman wrote:

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] "Research subject" and "research participant"
Date: Thursday, October 16, 2003 3:33 PM

I'd also appreciate that citation, Jack. It's interesting that the
efforts of people like Rom Harre to influence research culture to
humanize research activity and provide dignity to people who
volunteer has backfired in a court of law.

Cheers

Cam

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: <cmcdermaid@cmcc.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] "Research subject" and "research participant"
Date: Thursday, October 16, 2003 4:47 PM

The reference is July 2003 Scheer v. Burke (MD), Duzy (DO), Heaney (RN),
Conroy (DO), Main Line Hospitals, Lankenau Hospital, Lankenau Institute for
Medical Research, Reichard (Ph.D, IRB Chair), and the Mainline Hospitals
IRB. It concerns an ALLHAT study subject that died, suit is being brought
in Pennsylvania by his wife. Not surprisingly, perhaps, it¹s Allan
Millstein, the lawyer in the Gelsinger case, who is bringing suit. Part
relevant to this discussion is as follows.

20. This section concerns perceived deficiencies in the consent document
that those IRBs approved - JC

d. it overstated the benefits subjects would receive from
participation; it describes participation in the experiment as ³treatment²,
and ³regular medical care², uses the phrase ³your doctor² instead of
³investigator or coordinator² and uses the word ³patient² instead of
³subject.²


Jack Corman
President/Secretary

IRB Services
14845-6 Yonge Street
Suite 328

From: "Sabina Watts" <sabinawatts@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] "Research subject" and "research participant"
Date: Thursday, October 16, 2003 7:21 PM

Re: [Ethics] "Research subject" and "research participant"It seems to me
that the rat is on the table here. (for the Mainline Hospital's IRB)

Mainline's people (if the perceived deficiencies are correct as stated; esp.
in Sect 20d) used less than optimal phrases in this consent. (yup! a civil
trial can be expected, if the drug trial or any research trial is not
continually transparent in its conduct) Y'all knew that!

With regard to "research subject" and "research participant" - has this case
of Scheer v Burke et al, as presented, actually moved us forward in this gut
wrenching debate?

scw
------------------------------------------------------------

From: "Jack Corman" <irbs@interlog.com>
To: <sabinawatts@sympatico.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] "Research subject" and "research participant"
Date: Friday, October 17, 2003 8:08 AM

I don¹t know the progress of the case so far, Sabina. In any event, my
personal view is that perhaps the term Œresearch subject¹ is less palatable
and somewhat dehumanizing, but in the spirit of true informed consent (at
least for medical experiments) puts it on the line better. Declaration of
Helsinki supports use of Œsubject¹, as previously pointed out by others.
Perhaps, though, if we use the term Œsubject¹, we should define it in the
consent document to make as sure as possible that people get it, i.e.,
things are not the same as if they are seeing the doctor (or other
therapist) for usual care.

Jack Corman

15. Students Learning About Research Ethics

From: <will@unb.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] "Research"--students
Date: Thursday, October 09, 2003 8:54 AM

Dear All:
I was glad to see the vigour and insights of the discussion
on this listserv about how various folks have defined
"research." I see there is a seabed of hidden assumptions
within all of us and I want to thank all those who have
brought insights into the discussion.

One of the contributors had mentioned something to the
effect that we must have students go through REB
application because that is something they must learn to do
anyway. It is a learning experience. I am not sure I agree
with that position.

Isn't the purpose, though, about being ethical in doing
research, rather than jumping through the "hoops" (as many
students interpret that process)? If the mark of civilization
rests on how we treat the most vulnerable groups in society,
then surely in a university, students are the most vulnerable
group. How we treat them is a profound statement about
how us (who are not vulnerable). Therefore, the statement
that ethics-review is something that students must learn to
go through seems out of place in this context. Is it not the
purpose to demonstrate ethical thinking in research? We
are sending a terrible message to students, I believe, about
the purpose of ethics review if it is only seen as a mandatory
exercise. Am I missing something?

Will


From: "Richard Neuman" <rneuman@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] "Research"--students
Date: Thursday, October 09, 2003 9:24 AM

Will,
I suggest that filling out an application for ethics review helps the
students appreciate the necessary ethical requirements that must be
fulfilled in order to conduct research on humans. First, they must have
a proposal which is scientifically sound. Second, they must deal with
ethical practices of recruitment. Third, they must deal with issues of
privacy and confidentially and must themselves take an oath of
confidentiality. Fourth, they must deal with data security.. Fifth,
they must deal with issues of consent, e.g., implied, verbal and written
consent. Sixth, they will have had to read through the guidelines on
the ethical conduct of research in order to fill out the application
form. Most students in my experience will have had little experience
with such considerations. As such, the requirement for ethics review is
educational on a broad range of topics.
Cheers,
Richard Neuman
Co-Chair, Human Investigation Committee

From: "Leslie_MacDonald-Hicks" <LeslieMacDonaldHicks@pigeon.carleton.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] "Research"--students
Date: Thursday, October 09, 2003 11:08 AM

Will,

The ethics process is just not an exercise. These students will at some
point be facing this process in their lives. I agree with many of the points
made by Richard in terms of what students are learning.

I would also like to bring to your attention the efforts of one of our
professors to familiarize students with the process. In the process of
learning how to conduct a research project he has had them do all the
necessary grunt work.

In the second stage of the process I was invited to the class to discuss the
ethics review process and what we mean by ethical conduct. The professor
emphasized several key points including a balance of risk and benefit,
informed consent, and dignity and respect for the participants. He also
stressed to them that more institutions are establishing ethics review
boards in order to protect participants and that they can expect to face
this a least once in their lifetime.

The third stage involved the students meeting with key representatives from
the community they would be researching. These potential participants have
reviewed the proposals and given them the benefit of their expertise. They
have also provided a real voice into their expectations and needs as
research participants.

The final step in this learning exercise is to have the students write up
their ethics proposal. I will go back into the classroom and review each one
with them with the students. We will work as a group picking out both strong
and weak points of each application.

Now, these proposals will not come to the committee because the research
will not happen but I believe the students will take away a great deal from
the experience of learning how to go through the process.

This is the first time such an exercise has been run here and I'm hoping it
is successful and everyone involved benefits. The feedback from students
will be important in deciding if we attempt this in other departments.

Leslie MacDonald-Hicks

From: "Lindley, Pat" <plindley@kilcom1.ucis.dal.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] "Research"--students
Date: Thursday, October 09, 2003 12:02 PM

I concur with the view that, when properly handled, students benefit from
going through the ethics review process.

I speak to groups of students and try to stress the notion that application of
the principles of research ethics is most effective and necessary at the
front end of designing a research project. This is very much the case in
areas of qualitative research where precise anticipation of how the project
will unfold is often difficult if not impossible. Acquiring an appreciation of
research ethics equips the student for making good decisions regarding
how to conduct themselves in the field when they encounter, for example, a
socio-political context for their work that is very different than what they
assumed in advance. Putting projects through the ethics review process at
the 'front end' is a concrete way of bringing students face to face with the
ethical issues they might reasonably expect to encounter, and gaining an
appreciation of the principles that need to inform their research.

I would go so far as to suggest that preparing for research ethics review
should be an integral part of any research methodology curriculum where
human subject research constitutes a part of a given discipline. It is not an
'administrative' hoop to be dealt with (like filling out a form for travel
funding). I recall one graduate student, several years ago, who submitted,
at the 11th hour before travelling to India to do his research, a very cursory
ethics submission for a very problematic study. When exhorted not to start
his research until he had revised his project to address the sticky issues,
he calmly wrote back that he was far too busy to deal with it and would
complete his ethics application when he had finished conducting his
research, if he was required to get an approval to complete his degree....
not exactly an appropriate attitude!!!

In my job here at the University about 80% of the 'complaints' that I have
received have been regarding student projects. Not because they are
intentionally hurtful, but because they are often naive, zealous, and
inexperienced. If anything more scrutiny of student projects is needed than
faculty projects... not less! The trick is to make it a positive experience!

Pat
Patricia Lindley
Office of Human Research Ethics Administration
Room 321 Henry Hicks Arts and Administration Building
Dalhousie University
Halifax, Nova Scotia
B3H 4H6 ~~~~~~~~~~~~~~~~~~~
ph. (902) 494-1462
fax. (902) 494-1595
e-mail Patricia.Lindley@dal.ca

From: "Ted Palys" <palys@shaw.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] "Research"--students
Date: Thursday, October 09, 2003 5:03 PM

Professors Neuman, Macdonald-Hicks, Lindley, Rolleston, etc:

Some of the discussion regarding "research," students, ethics review and
all has become so outlandish I have to comment.

First, I have to jump in at the implication that some of you might actually
believe that Prof van den Hoonaard thinks that "the ethics process" is
"just an exercise." His many writings about ethics in the social sciences
offer concrete evidence to the contrary. With respect to today's
interchange, it seemed to me that the topic of conversation and the source
of his concern was not "the ethics process" but "filling out forms required
by REBs," which are two quite different things. Equating the latter with
the former is like saying there was no such thing as research ethics before
the TCPS, which is, at least within the social sciences, patently untrue.
Formal research ethics codes were established in the social sciences
decades ago; ethics review has been a fundamental part of the research
process for most of that time; and debate about and consideration of ethics
issues within the social sciences is sufficiently voluminous to fill a
library. As for Prof MacDonald-Hicks's description of the revolutionary
things that are happening at Carleton -- where people actually talk about
ethics in courses -- I'm sorry to say that we were doing that in Carleton
at least as far back as the 1970s when I was a grad student in the psych
department there. Of course, we didn't have forms to fill out then, so we
probably weren't being as ethical as we could be.

In the case of Professor Neuman's most recent comment that "Most students
in my experience will have had little experience with such considerations"
-- he is referring to the process of thinking about ethics -- one thing we
should perhaps consider is the limitations of our own experience. That
said, I can see his point and can only hope he is helping to make a
difference out there at Memorial's Faculty of Medicine.

As for Dr. Rolleston's most recent submission, I just about fell off my
chair when I read that

>The Tri-Council Working Group strove to represent all sectors of
>research. The
>fact that discussion of research ethics was then, and probably still is,
>much more advanced in the biomedical area than in other areas, may
>contribute to the perception of a biomedical bias in the TCPS. But is the
>solution to erode the standards that are accepted in the biomedical area, or
>to advance those in other areas? What principles of ethics theory, or even
>of practice, distinguish them?

Wow. Thank you Dr. Rolleston. Rarely have I seen more blatant contempt for
and misunderstanding of the social sciences than is embedded in that quote.
Ethics thinking in the biomedical area is "more advanced"? Want to make
sure those of us who do research in those inferior "other areas" don't
"erode the standards" of the great biomedical ethicists who brought us the
Olivieri scandal, pervasive conflicts of interest with pharmaceutical
companies, and just about every other great ethics travesty of the 20th
century? Nothing to distinguish us? As a colleague of mine would say, I'm
gobsmacked.

My intention here is certainly not to inspire a "we're more ethical than
you" debate. I prefer to think that we're all doing our best to be ethical
in our little domains and trying to foster the same view and attitude in
our students, and until today had preferred to operate on the assumption
that the same good will was being extended our way by those in other parts
of the academy.

Perhaps those who have no background in social science research, and
particularly in social science research in the more qualitative traditions,
should take the time to become better informed about different traditions
before speaking about them, and tend to the weeds in their own back yard
first. For any of you who would like to start familiarizing yourself with
some of the epistemological considerations and ethical complexities that
"distinguish" the social sciences and particularly the more qualitative
research traditions, and to understand how unthinking imposition of
procedures and practices that make sense in the confines of the
paradigmatic clinical trial can endanger research participants and create
ethical injustice in field research, a good place to start is with Dr. van
den Hoonaard's latest book of readings entitled "Walking the Tightrope:
Ethical Issues for Qualitative Researchers" (U of T Press, 2002).

Best wishes,
Ted Palys
SFU/Criminology

From: "Sabina Watts" <sabinawatts@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] "Research"--students
Date: Thursday, October 09, 2003 6:08 PM

Ted, you said it all!
Thank you!

I am convinced that life is 10% what happens and 90% how I react to it...and
so it is...we are in charge of our attitudes! (C Swindoll)

ALL best wishes,
Sabina Calais Watts, RN MA PhD(c)
Clinical Research Coordinator
==============================================================

From: <skb@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] "Research"--students
Date: Friday, October 10, 2003 10:20 AM

Perhaps I should jump in as Richard's co-chair to say that the Division of
Community Health has had in its curriculum an introduction to research
ethics as far back as I can remember. We used to teach in the first
semester of their first year - now it is second semester - but I had always
included it in the introduction to epidemiology giving them the usual
background - Nuremberg, Tuskeegee, et al. - introducing the current
documents including , more recently, the TCPS and the university's integrity
statement. The rationale for the inclusion of research ethics in the
curriculum was simply that as physicians they would more than likely be
involved in research in one way or another at some time or other - a few as
PIs, more as co-investigators entering patients in trials - and they must be
responsible researchers, particularly as co-investigators, in asking
questions about design, safeguards, etc. etc. They all received the REB
application form and the consent template and were walked through why we ask
the questions we ask. They get a 'booster' before they do any course
projects. I am not now teaching the undergrads but I understand this
continues. In the last two years our graduate students (Faculty of
Medicine) have been required to take a course in research ethics which
includes a didactic session, online instruction and assignments (written
discussion of case scenarios) and small group discussion with a facilitator
of one or two case scenarios. They cannot continue to their second year of
their graduate program without having completed all components
satisfactorily.

Sharon

16. The Death of Ethics

From: "John Lowman" <lowman@sfu.ca>
To: <hrk@kloppenburg.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] The death of ethics
Date: Friday, October 17, 2003 4:38 PM

I hope the authors of the TCPS have an opportunity to read this as it will
surely have them cringing in their boots...

As many of us have always suspected (see, for example the article Russel
Ogden alerted us to), signed consent forms have very little to do with
ethics and much to do with liability, but I did not anticipate seeing such
a bald-faced admission as this.

How very depressing...

Biomedical Research Ethics Boards should be renamed Research Liability
Boards so that rest of us can get on with ethics. More than ever I am
convinced that we need separate ethics codes for biomedical and other research.

JL

From: "Russel Ogden" <rdogden@telus.net>
To: <nondrusek@sympatico.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] The death of ethics
Date: Saturday, October 18, 2003 12:15 PM

Dear Nancy Ondrusek and List,

I'm unconvinced that the recent debate about "subject vs participant" was
universally concerned with the interests of the
participants/subjects/volunteers. In my own research, ethics committee
members have been nakedly loyal to their parent institutions and they have
shown they will risk harm to participants if that is what the university
administration seems to want.

Example 1. Simon Fraser University did not protect the interests of my
research participants in court because its administration feared bad
publicity (1994). The REB did not challenge the university's position and
it did not take any measures to protect the participants.

Example 2. University of Exeter's administration refused to commit itself
to the protections the REB had extended to my research participants (2003).
This was despite a recommendation from its own Senate Committee of Academic
Enquiry to uphold this commitment (1999). The REB did not challenge the
administration and it did not take measures to protect research
participants, when it had the chance. Indeed, the REB abandoned its ethical
duties and turned the matter over to the lawyers representing the
administration.

Of course there are other examples, such as the Olivieri matter.

The reality is that the "emperor has no clothes" and too few are willing to
speak up. But, earlier this week a breath of fresh air on CBC Radio's "The
Current": Jocelyn Downie (Dalhousie Law Faculty) pointed out the inherent
conflict of interest and the pressures brought by the increasing
commercialisation of research and she made a strong case for the separation
of REB's from their parent institutions.

All the best,
Russel

From: "Russel Ogden" <rdogden@telus.net>
To: <nondrusek@sympatico.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] The death of ethics
Date: Saturday, October 18, 2003 12:15 PM

Dear Nancy Ondrusek and List,

I'm unconvinced that the recent debate about "subject vs participant" was
universally concerned with the interests of the
participants/subjects/volunteers. In my own research, ethics committee
members have been nakedly loyal to their parent institutions and they have
shown they will risk harm to participants if that is what the university
administration seems to want.

Example 1. Simon Fraser University did not protect the interests of my
research participants in court because its administration feared bad
publicity (1994). The REB did not challenge the university's position and
it did not take any measures to protect the participants.

Example 2. University of Exeter's administration refused to commit itself
to the protections the REB had extended to my research participants (2003).
This was despite a recommendation from its own Senate Committee of Academic
Enquiry to uphold this commitment (1999). The REB did not challenge the
administration and it did not take measures to protect research
participants, when it had the chance. Indeed, the REB abandoned its ethical
duties and turned the matter over to the lawyers representing the
administration.

Of course there are other examples, such as the Olivieri matter.

The reality is that the "emperor has no clothes" and too few are willing to
speak up. But, earlier this week a breath of fresh air on CBC Radio's "The
Current": Jocelyn Downie (Dalhousie Law Faculty) pointed out the inherent
conflict of interest and the pressures brought by the increasing
commercialisation of research and she made a strong case for the separation
of REB's from their parent institutions.

All the best,
Russel

From: <skb@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] The death of ethics
Date: Saturday, October 18, 2003 1:20 PM

I have not read through all the messsages that preceded this last exchange
but would like to ask John in what ways consent forms and the consent
process for non-biomedical research have improved on those for biomedical
research?

Our committee certainly does not view consent forms as documents required to
protect the researcher and/or to contribute to lawsuits. We see them as an
attempt to inform a participant about what the research is for, what they
will have to do or have done to them to take part, which of these things
would not be done as part of 'standard' treatment (in a clinical trial),
what the risks of taking part are considered to be and that there may be
unknown risks. We also consider the signature page to provide some
reassurance that the principal investigator has met with the participant and
answered any questions about the study before the participant signature is
witnessed. Our discussions much more focus on the protection of the
potential participant.

Sharon K. Buehler, PhD
Honorary Research Professor
Faculty of Medicine
Health Sciences Centre
Memorial University
St. John's, NL   A1B 3V6
T:  709-777-6219
F:  709-777-7382
Email:  skb@mun.ca

From: "John Mueller" <mueller@ucalgary.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] The death of ethics
Date: Saturday, October 18, 2003 2:19 PM

JL makes some good points here. So much of this is not about
research ethics, it's about "legal ethics" (which, in case
you didn't know, is a first-order oxymoron).

Anyone who thinks the consent form is to be a legal document
forestalling litigation is sadly mistaken: anyone can sue
about anything, and there will be a lawyer to oblige (and
increasingly a sensitive judge to agree). It's an
unattainable goal (and at a university when local resources
are expended in trying to achieve zero legal risk I have to
object strongly, it just means fewer class and larger
classes), especially in biomedical research. The consent
form was not intended to be legal protection, and I suspect
even were it witnessed by a third party it could still be
routinely challenged. (In fact, I'm not sure the regulations
per se are meant to be legal defenses either, but I defer.)

I agree that there are many doing their best, and typically
a good job to boot, with regard to reasonably informing the
reasonable subject. But the legal exposure has nothing to do
with reasonable, it has to do with "can we get some money
here," predicated on the notion that the rest of the world
must be perfect (whereas lawyers are allowed to fail).

The chilling part here is that there is someone looking
about for the subject, someone looking out for the
institution (but see Nature, editorial (2001). Time to cut
regulations that protect only regulators. Nature, 2001, 414,
379.), but any meaningful protection for the researcher is
missing? (And, no, I do not think that protecting the first
two automatically protects the researcher.)

It is not that the non-medical consent forms are more
bullet-proof, it's that medical research has a couple of
problems that non-medical research does not have.

First, the "informed" part of informed consent is almost
impossible to achieve with regard to the way the medical
community typically comminicates about medical conditions
and risks. The jargon is impenetrable, and thus a legal
challenge on the basis of incomprehension is easy to
initiate - and easy to sympathize with. It really isn't
relevant that the consent form has all the legal jargon and
medical acronyms, it's whether it communicates. That's a
linguistic and psychological issue, not a medical or legal
issue.

Second, the coverage of medical research, knowingly or not,
creates unrealistic expeectations, wonder drugs,
breakthrough cures and techniques, etc., and soft sells the
risks. This posturing nutures the expectation of perfection
in the lay community, knowingly or incidentally. When you
tantalize folks with high expectations, they and the legal
community will feel free to hold medical research to them.

Whether medical-research are resolve these two issues
remains to be seen. These are in fact research ethics
questions and not legal ethics, so perhaps there is so hope.

Non-medical research does not have these issues to deal
with, and in the meantime would be better handled by review
boards not focused on them.

For two cents,

-- John (M).

From: "John Lowman" <lowman@sfu.ca>
To: <nondrusek@sympatico.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] The death of ethics
Date: Saturday, October 18, 2003 9:26 PM


Hello Nancy,

Thanks for reaffirming that there are beating hearts in the biomedical
research community. I suspected as much, but I had to wonder when a posting
on an ethics listserve began talking about strategies for protecting
researchers and universities from research subjects/participants.

By way of clarification, I suggest that a fundamental conflict of interest
occurs whenever liability concerns are introduced into research ethics.
This is not to say that liability is not an issue for researchers and
Universities, it is. But it should never contaminate the ethics review
process. We cannot protect research participants from researchers,
universities and medical companies at the same time we are trying to
protect researchers, universities and medical companies from them.

While certain legal issues are relevant to research ethics boards,
discussion of ways to protect researchers and universities from research
participants is anathema to the fundamental purpose of research ethics:
protection of research participants from harm. As John Mueller pointed out,
the real issue for informed consent is not whether a research participant
signs a form, but whether they understand the risks they are being
subjected to. Perhaps volunteers asked to sign a consent form should be
warned that the university's lawyers might use it against them. I wonder if
they would be so willing to sign it in that event.

Cheers,

JL

From: "John Mueller" <mueller@ucalgary.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] The death of ethics
Date: Sunday, October 19, 2003 10:04 AM


In a recent message I made reference to a commentary
re protecting institutions; in response to a couple
of requests I have attached it below.

-- John. (M)

++++++++++++++++++++++++++++++++++++++++++++++++++++++++

22 November 2001 - EDITORIAL
Nature 414, 379 (2001) ) Macmillan Publishers Ltd.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Time to cut regulations that protect only regulators
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Researchers and their live subjects in US universities are
valuably protected by some regulatory processes but
pointlessly undermined by others. It is time to streamline
or scrap the latter.

The tragic deaths of two young people in clinical trials at
the University of Pennsylvania and Johns Hopkins University
have had a chilling impact on the scientific community, by
highlighting what can happen when well-intentioned research
goes wrong. Attention in the United States has
correspondingly been focused on the workings of the
Institutional Review Boards (IRBs) that review and approve
human experimentation.

No doubt all this will mean even more federally mandated
rules and regulations that US scientists and institutions
will have to follow in order to conduct scientific research
legally. Unfortunately, what seems to happen whenever such
controversies arise is a blanket application of 'the rules',
with no leeway for common sense. The overall effect is that
researchers and institutions alike are drowning in
paperwork. Sadly, much of the documentation bears little
relation to the realities of research, for it accomplishes
little beyond slowing down legitimate experiments and making
them harder to administer. The work still goes on scounted
by some as reflecting the blinkered interests of
researchers. Nature has not hesitated in the past to urge
scientists to be more responsive to ethical and social
concerns in this context. But it is important to
discriminate between what is truly a risk to the study
subject, whether human or animal, and what is not. The
former category of experiment requires rigorous review, to
prevent unnecessary deaths and injury. But much of the
research that falls under the purview of IRBs and
Institutional Animal Care and Use Committees (IACUCs) does
not warrant such close scrutiny, as it causes little real
risk for the study subject or, in the case of animals,
involves generally accepted procedures such as immunization,
taking blood or challenge with standard pathogens. The time
spent by committees reviewing such routine protocols to the
full extent required by law is time that could be better
spent on the more controversial applications.

Climate of fear

This point has been well made in the context of IRB reviews
by Robert Schooley, of the University of Colorado School of
Medicine, and colleagues in various publications, but it
applies to animal research as well. In one respect, the
situation with IACUCs is even worse than with IRBs.
Nowadays, IACUC reviews must take place before the grant
application can even be peer reviewed by the National
Institutes of Health (NIH). As most applications are
rejected upon peer review, an enormous amount of time is
wasted by IACUCs in approving animal experiments that will
never be performed. The procedure used to be that an IACUC
application was only necessary once a grant application had
fared well enough to be approved in principle; this sensible
process was changed through pressure on the NIH from
animal-welfare lobbyists, leading to yet more paperwork but
no real benefit to animals.

The climate under which even routine protocols are reviewed
by IACUCs and IRBs is now one of fear of approved
procedures, so each institutional committee must act as an
island unto itself. Indeed, if an experiment involves a
collaboration between institutions, each institution
(perhaps as many as three or four) must individually review
the application -- adding to the cost of the review but not
to the welfare of the humans or animals involved.
Non-controversial applications are multiply nit-picked;
forms are returned to the applicant because a single word
has been mistyped, or even because the wrong font has been
used.

It seems as if review committees 'must' find something wrong
with each and every application, so as to generate a paper
trail proving the thoroughness of their review. For
controversial applications this is entirely appropriate, but
the 'fear factor' means that enormous effort is now expended
on routine and mundane protocols. In some institutions,
scientists who never work with organisms more complex than
yeast and bacteria are now being forced to attend lectures
on how to conduct research on humans, "just in case". This
is yet another institutional response to pressure from
federal agencies, but what purpose does it serve in the real
world?

Does society want to support scientific research? If it
does, it should find ways to make the system work
efficiently as well as safely. At present, local and federal
administrators and scientists alike are frustrated by what
must be done to make research legal in the face of those who
would have it otherwise.

There's also a price to pay for the extra workload --
committee member burn-out. To use a topical analogy, how
many suitcases full of underwear and socks can an airline
security agent wade through before he or she is too tired to
find the hidden box-cutter? It's more efficient, surely, to
identify the threatening passenger before the suitcase is
packed, than to pick every case apart, just to check if
there's a problem. Just as travellers have to travel,
scientists still have to do science. It's a sad day when the
working scientist realizes that the most important person in
the laboratory is not the smartest postdoc nor the
hardest-working student, but the chief administrator.

++++++++++++++++++++++++++++++++++++++++

From: "Nancy Ondrusek" <nondrusek@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] The death of ethics
Date: Sunday, October 19, 2003 11:20 AM

Dear John and list,

Thank you for your clarification. I do agree that the job of the REB is to protect
the research participant, not those doing the research. However, there does have
to be awareness of the context in which research is done, so that the demands of
the REB do not grind research activities to a halt. It is a tension that can't be
completely eliminated, although there may be some systemic changes required to
reduce the pressure.

In some cases, an action initiated to protect participants may also serve other
purposes. While the real issue with the consent process, as you say, is whether
the participant understands the relevant information, the signed consent form has
been used in the name of subject protection as a method to monitor researchers to
make certain they they are at least obtaining consent (recognizing of course, that
the signature says nothing about the quality of the process). One might also argue
that by requiring a signature, the importance of the information is emphasized and
the reader may pay more attention to the content. This same signed form can then
be used against a subject in court, but has also been used by subjects against
researchers and institutions to prove what information was not communicated. It
seems like a damned if you do, damned if you don't situation.

Where does the balance lie? Is the signature is such a weak measure of the process
that it is should be abandoned? Would/could the researchers, institutions and
sponsors do the research without this "protection"? Maybe someone could suggest
some better options?

Regards,
Nancy

John Lowman wrote:

From: "H R Kloppenburg" <hrk@kloppenburg.ca>
To: <ethics@lists.ncehr-cnerh.org>; <nondrusek@sympatico.ca>
Subject: [Ethics] The death of ethics
Date: Sunday, October 19, 2003 2:50 PM


The decision whether having a paper record of obtaining informed consent in biomedical research involving human subjects is not a decision open to researchers individually, ad hoc or for the research ethics community.

Free and informed consent to participate in biomedical research is an essential element of ethical research. I don't have to quote chapter and verse for that proposition. That free and informed consent can occur without a written instrument recording the transaction to obtain such consent is undoubtedly true as well. Identifying circumstances when free and informed consent need not be recorded by a signed written instrument recording such consent is fraught with difficulty.

Secondly, it is a fact that in our culture transactions such as the giving of consent to participate in research (an acknowledgement that the risks to be run have been communicated) may have to be proved. This might be in litigation where the proper conduct of research is in issue, in university discipline process, inquiries and inquests, and professional discipline process. Experience has shown that a record of the consent to participate in research in writing with a signature can be achieved effectively by written document at reasonable cost in a way that binds the research subject.

Thirdly, we are living in an age when research subjects may see economic gain by denial of full disclosure of the risks to be run whether or not a mishap has occurred. A written record of obtaining consent will address this. If this is taking the side of investigators and research sponsors then so be it.

Finally, one can be assured that the governing bodies of the medical profession, the risk managers of universities and hospitals and their insurers, research sponsors, and Canadian Medical Protective would insist on having a written signed record of obtaining informed consent. In western culture this is done by use of a signature to an instrument which acknowledges the information contained in a written instrument has been made known.


H R Kloppenburg QC

From: "John Lowman" <lowman@sfu.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] The death of ethics
Date: Monday, October 20, 2003 2:09 AM

Hello Sharon,

More beating hearts. Thank you.

First a clarification in relation to Prof. Kloppenburg's October 19th
posting. Yes, liability is a concern for University administrators and
researchers, but my point is that it should not figure in the ethics
approval process as such. When research involves scalpels or
pharmaceuticals, a paper trail of the informed consent process may make
eminent ethical sense for the reasons you and Nancy Ondrusek have outlined.
The problems start when REBs believe that they also have a responsibility
to protect researchers and the University from research participants,
because it compromises their ability to protect those research
participants. In addition to the examples Russel Ogden cited, another is
the reign of "limited confidentiality" at SFU which has been mentioned in
several of our earlier postings (for an overview, see Lowman and Palys
http://www.sfu.ca/~palys/SociolPractice2000.pdf ). If Universities are
concerned about liability, it should be dealt with by some mechanism other
than ethics review. Nevertheless, for truly informed consent the onus
should be on researchers to explain to prospective subjects the legal
ramifications of their signing a consent form bearing in mind TCPS Article
2.4(e) (by consenting, subjects do not waive any legal rights).

As to your question, in what ways have consent forms and the consent
process for non-biomedical research improved on those for biomedical
research, the primary "improvement" has been to recognize that there is no
one size fits all procedure for informed consent. Indeed, the TCPS
recognizes that there are some situations where signed consent forms do not
make sense, even though written consent is the default option. In the case
of my criminological research, verbal consent is the default option. In
fact, I have never used signed consent forms.

Not too long ago at SFU, one "ethics czar" attempted to force all
researchers to extract from potential participants a signed consent
statement -- indeed, it was precisely this experience that led Ted Palys
and I to coin the term "ethics czar" in the first place. For my
participants, strict confidentiality is vital to their participation.
Imagine the effect on my research with madams, pimps, prostitutes and
members of organized crime groups were I to invite them to disclose
information about criminal activity for which they could be prosecuted, and
then ask them to identify themselves and leave evidence of their
participation by signing a consent form. I could not develop the trust
required to get valid and reliable information without meaningful
confidentiality. More importantly, I would abrogate my responsibility to
protect my research participants from harm by asking them to load a gun and
point it at their temple. For a different kind of example, see Ted Palys'
account of this dictate as it applied to one of his students conducting
research on a First Nations community (Research Decisions, edition 3 pp.
119-120).

Again, it is not a matter of "better," but "different." And I suspect that
the biomedical/non-biomedical distinction itself is limited in this regard,
but for the time being, it helps make the point.

Cheers,

JL

From: "Francis Rolleston" <frolleston@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] The death of ethics
Date: Monday, October 20, 2003 7:26 AM

I re-enter this one with some trepidation.

Some months ago I pleaded against labeling. It seems appropriate to do so
again. Throughout recent weeks, "biomedical" has been used as synonymous
with opprobrium, even as a surrogate for poor ethics. That insults very
many people, and is totally unjustified. I think that this listserv is not
well served by such name-calling.

As for all areas, that for biomedical research ethics is very broad, both in
its range of subject areas, its practitioners, its apologists, and others.
To label a whole area because of views perceived to be held may be
consistent with today's attack politics, but surely should not be part of a
listserv that is devoted to ethics. It is a sad commentary on serious
discussion, including political debate, that proponents seek to strengthen
their cases by denigrating others. Lest I be accused of preaching but not
practicing, I freely admit to, and regret, having fallen into this easy trap
at times.

To come to substance, in my view, the ONLY purpose of the consent form is to
inform the subject (yes, I will continue to use "subject" for research that
is designed without full participation of those who are to be studied in the
research, but I have learned in the past few weeks that "participant" is
preferable in some areas of research). Also, the consent form is only one
component of the processes of seeking consent. I agree with other
contributors to this discussion s that the consent form is a one way
contract, with no obligations on the research subject. For this reason, I
am unhappy with statements in the signature column to the effect that the
subject has understood the content of the form. Indeed, I believe that it
would be useful to hold a discussion on the wording of the signature section
of the consent form.

That said, as Henry has objectively and dispassionately pointed out, once
signed, the consent form, like any other evidence, can be used in court.
But the possibility that it might so be used should not influence its
design. The consent form is a document of ethics which might be used in the
law, but its design should not be influenced by the possibility that it
might help researchers in court.

As to John's repetition of his desire for separate "codes" for different
areas, in my personal opinion, unencumbered by any objective evidence, in
the eyes of the public, there is far more convergence than divergence in
fundamental ethics principles and practices between the various areas. I
believe that those who would seek separate codes will fare better in some
parts of the ivory tower than in the court of public opinion.

Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

frolleston@sympatico.ca
613 728-7163

-----Original Message-----
From: ethics-bounces@lists.ncehr-cnerh.org
[mailto:ethics-bounces@lists.ncehr-cnerh.org]On Behalf Of John Lowman
Sent: October 17, 2003 5:28 PM
To: hrk@kloppenburg.ca; ethics@lists.ncehr-cnerh.org
Subject: [Ethics] The death of ethics

I hope the authors of the TCPS have an opportunity to read this as it will
surely have them cringing in their boots...

As many of us have always suspected (see, for example the article Russel
Ogden alerted us to), signed consent forms have very little to do with
ethics and much to do with liability, but I did not anticipate seeing such
a bald-faced admission as this.

How very depressing...

Biomedical Research Ethics Boards should be renamed Research Liability
Boards so that rest of us can get on with ethics. More than ever I am
convinced that we need separate ethics codes for biomedical and other
research.

JL


At 02:18 PM 17/10/03 -0600, you wrote:
>A consent form amounts to this:
>
>1. the research subject acknowledges that the risks of participating in
>research have been communicated to him / her;
>
>2. the research subject signs the document for the benefit of the
>researcher to protect against manipulation of facts later, as in a law
>suit alleging the research subject was not fairly told of the risks to be
>run;
>
>3. the consent form is available as evidence (it is a record of
>communication) for the benefit of the the researcher as a defence if the
>research subject says the nature of the research was misrepresented;
>
>4. the consent form is usable and available as evidence of what the
>research subject was told as to the risks to be run (and the other
>elements of a sufficient consent required) should the research subject
>claim that s/he was violated by incomplete disclosure the of risk to be
>run by participating in the research.
>
>The consent form achieves all of these purposes without being a common
>law contract. To have a common law contract (I don't know anything about
>Quebec Civil law) additional elements are required. One of the reasons
>for taking consent to participate in genetic research is that a contract
>is required there where samples of bodily substance are stored and may
>result in commercially useful information. That being so, the research
>subject has to sign a contract. The same is not generally the case in
>drug trials, or in research for invasive therapies.
>
>Of course a consent form can go far beyond items one through four above.
>However, in my view researchers often take grave risks as to the
>effectiveness of forms where they attempt to make them into contracts
>such as to deal with medical costs in the evident of a mishap.
>
>H R Kloppenburg QC
>
>
>On October 17, 2003 2:04 PM, Francis Rolleston wrote:
> >
> >Date: Fri, 17 Oct 2003 16:04:12 -0400
> >From: Francis Rolleston
> >To: ethics@lists.ncehr-cnerh.org
> >Subject: RE: [Ethics] true or false ...
> >
> >Subject to the views of lawyers, I think that ethically we should regard
the
> >consent form as binding on the researcher but not on the
> >subject/participant. Whether that view corresponds with the law is for
> >lawyers to say.
> >
> >Francis Rolleston
> >500 Denbury Avenue
> >Ottawa, ON
> >K2A 2N7
> >
> >frolleston@sympatico.ca
> >613 728-7163
> >
> >-----Original Message-----
> >From: ethics-bounces@lists.ncehr-cnerh.org
> >[mailto:ethics-bounces@lists.ncehr-cnerh.org]On Behalf Of Clark,
Elisabeth
> >Sent: October 17, 2003 3:33 PM
> >To: ethics@lists.ncehr-cnerh.org
> >Cc: kathleen.glass@mcgill.ca
> >Subject: Re: [Ethics] true or false ...
> >
> >Hi Kathy, and yes that is precisely the discussion taking place within
our
> >Office of Clinical Contracts.
> >
> >Would the signed research consent document be viewed as a legally binding
> >contract if we were to face a court challenge ... elisabeth
> >
> >At 15:19 10/17/2003 -0400, Kathleen Glass wrote:
> >Elizabeth,
> >
> >Is your question whether a consent form is a legally binding contract?
> >
> >Kathy

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] The death of ethics
Date: Monday, October 20, 2003 4:17 PM

I hope we can be a little more optimistic than this. The title sounds
apocaplyptic - but then it was probably supposed to be - a wake up call.

Actually it is not so bad to consider why we are here every now and
again. And as our colleague notes if REBs adopt a defensive attitude and
slip into an institutional liability mode then we have all completely
missed the point.

And no I remain convinced that ethics is ethics and does not come in
different flavours depending on what faculty your office resides in.
Ethics is surprisingly simple (at times) and boils down to a simple
remembrance to treat others as you would expect to be treated. From this
'commandment' spring the famous triad of respect, beneficence and
justice, but they do not change the fundamental principle.

Without getting bogged down in utilitarian and deontological reasoning
or playing off Kant and Aristotle I cannot see how any of these can
differ between social scientists and biomedical scientists, even if
there were no overlap.

It is the trappings I fear that divide the common humanity.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] The death of ethics
Date: Monday, October 20, 2003 5:37 PM

Well we take some comfort here since Professor Downie is a consultant to
our REB. This is one of the models we have debated in the overall
governance discussion.

>>> rdogden@telus.net 10/18/03 02:11PM >>>
Dear Nancy Ondrusek and List,

I'm unconvinced that the recent debate about "subject vs participant"
was
universally concerned with the interests of the
participants/subjects/volunteers. In my own research, ethics committee
members have been nakedly loyal to their parent institutions and they
have
shown they will risk harm to participants if that is what the university
administration seems to want.

Example 1. Simon Fraser University did not protect the interests of my
research participants in court because its administration feared bad
publicity (1994). The REB did not challenge the university's position
and
it did not take any measures to protect the participants.

Example 2. University of Exeter's administration refused to commit
itself
to the protections the REB had extended to my research participants
(2003).
This was despite a recommendation from its own Senate Committee of
Academic
Enquiry to uphold this commitment (1999). The REB did not challenge the
administration and it did not take measures to protect research
participants, when it had the chance. Indeed, the REB abandoned its
ethical
duties and turned the matter over to the lawyers representing the
administration.

Of course there are other examples, such as the Olivieri matter.

The reality is that the "emperor has no clothes" and too few are willing
to
speak up. But, earlier this week a breath of fresh air on CBC Radio's
"The
Current": Jocelyn Downie (Dalhousie Law Faculty) pointed out the
inherent
conflict of interest and the pressures brought by the increasing
commercialisation of research and she made a strong case for the
separation
of REB's from their parent institutions.

All the best,
Russel

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] The death of ethics
Date: Monday, October 20, 2003 5:46 PM

Life might become a bit simpler for all of us if we consider the
so-called Informed Consent Form as a three compartmental model;
1. Information sheet (s) about the study
2. Information sheet about Clinical Trials
3. A consent form (signature to agree to participate as per 1 and 2).

There is no law to say they have to be a single document.


Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] The death of ethics
Date: Monday, October 20, 2003 5:51 PM

I think we need to refocus here, which is not such a bad idea anyway. If
people (some) are seeing the whole process in such a negative light
something is really really wrong.

For instance if consent forms are being approved that to quote
"impentrable" and "incomprehensible" then the process is a complete
waste of time.

>>> mueller@ucalgary.ca 10/18/03 04:12PM >>>
JL makes some good points here. So much of this is not about
research ethics, it's about "legal ethics" (which, in case
you didn't know, is a first-order oxymoron).

Anyone who thinks the consent form is to be a legal document
forestalling litigation is sadly mistaken: anyone can sue
about anything, and there will be a lawyer to oblige (and
increasingly a sensitive judge to agree). It's an
unattainable goal (and at a university when local resources
are expended in trying to achieve zero legal risk I have to
object strongly, it just means fewer class and larger
classes), especially in biomedical research. The consent
form was not intended to be legal protection, and I suspect
even were it witnessed by a third party it could still be
routinely challenged. (In fact, I'm not sure the regulations
per se are meant to be legal defenses either, but I defer.)

I agree that there are many doing their best, and typically
a good job to boot, with regard to reasonably informing the
reasonable subject. But the legal exposure has nothing to do
with reasonable, it has to do with "can we get some money
here," predicated on the notion that the rest of the world
must be perfect (whereas lawyers are allowed to fail).

The chilling part here is that there is someone looking
about for the subject, someone looking out for the
institution (but see Nature, editorial (2001). Time to cut
regulations that protect only regulators. Nature, 2001, 414,
379.), but any meaningful protection for the researcher is
missing? (And, no, I do not think that protecting the first
two automatically protects the researcher.)

It is not that the non-medical consent forms are more
bullet-proof, it's that medical research has a couple of
problems that non-medical research does not have.

First, the "informed" part of informed consent is almost
impossible to achieve with regard to the way the medical
community typically comminicates about medical conditions
and risks. The jargon is impenetrable, and thus a legal
challenge on the basis of incomprehension is easy to
initiate - and easy to sympathize with. It really isn't
relevant that the consent form has all the legal jargon and
medical acronyms, it's whether it communicates. That's a
linguistic and psychological issue, not a medical or legal
issue.

Second, the coverage of medical research, knowingly or not,
creates unrealistic expeectations, wonder drugs,
breakthrough cures and techniques, etc., and soft sells the
risks. This posturing nutures the expectation of perfection
in the lay community, knowingly or incidentally. When you
tantalize folks with high expectations, they and the legal
community will feel free to hold medical research to them.

Whether medical-research are resolve these two issues
remains to be seen. These are in fact research ethics
questions and not legal ethics, so perhaps there is so hope.

Non-medical research does not have these issues to deal
with, and in the meantime would be better handled by review
boards not focused on them.

For two cents,

-- John (M).

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] The death of ethics
Date: Monday, October 20, 2003 6:02 PM

In simple terms, I agree limiting liabilities to to anyone is not the
place of REBs, indeed the whole place of excluding exculpatory language
is addressed to this issue.

I think this is one of those creeping phenomena - everytime you think
you have cleared the deck and simplified the process, the issues start
creeping back in again, not only in our discussions but worse in consent
forms.
From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] The death of ethics
Date: Tuesday, October 21, 2003 7:32 AM

These are useful examples. Indeed the TCPS does correctly recognise
these (2.1(b)).

As an aside it is interesting how many people interpret 2.4 literally,
and I see the wording of TCPS turning up in consent forms. I would
maintain that is incomprehensible to most research
subjects/participants.

The consent of the participants shall not be conditional upon, or
include any statement to the effect that, by consenting, subjects waive
any legal rights.


By the way I think I am correct in saying that it is not 2.4(e) which
discusses legal rights - it actually addresses commercialisation - but
the codicil to 2.4

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] The death of ethics
Date: Tuesday, October 21, 2003 11:41 AM

Yes that was me (MG) - and for anyone out of the Golden Rule loop - this
might help (many other sources too):

http://www.jcu.edu/philosophy/gensler/et/et-08-00.htm


Ethics 08 - The Golden Rule


Directions: Read to the bottom (scrolling
if necessary); then click "forward =>."


The golden rule requires that we treat others only as we consent to
being treated in the same situation. GR can be derived from the moral
consistency requirements of our previous chapter -- and requires for its
completion some further elements, like knowledge and imagination, that
we'll discuss in the following chapter.
These questions are about Chapter 8 of Harry Gensler's Ethics: A
Contemporary Introduction (London and New York, Routledge: 1998). These
materials are copyrighted (c) 1998 by Harry J. Gensler; but they may be
distributed freely.
A golden rule theorem
Our golden rule theorem says: "Treat others only as you consent to being
treated in the same situation." To apply GR, I'd imagine myself in the
other person's place on the receiving end of the action. GR forbids this
combination:
* I do something to another.
* I'm unwilling that this be done to me in the same situation.
GR doesn't tell us what specific act to do. And it doesn't replace
regular moral norms. It only prescribes consistency -- that we not have
our actions (toward another) be out of harmony with our desires (about a
reversed-situation action). To apply GR adequately, we need knowledge
and imagination.
If we're conscientious and impartial, then we'll follow GR -- since then
we won't do something to another unless we believe it would be all right
-- and thus believe it would be all right to do to us in the same
situation -- and thus are willing that it be done to us in the same
situation.
Our formulation
The literal GR says: "If you want X to do something to you, then do this
same thing to X." This can lead to absurdities if we are in different
circumstances from X or if we have defective desires about how we are to
be treated. To avoid these, our GR uses a same-situation clause, a
present attitude toward a hypothetical situation, and a don't-combine
form.
The golden rule is close to being a global principle -- a norm common to
all peoples of all times. It makes a good summary of morality and a good
way to operationalize the idea of "loving your neighbor." Closely
related to GR are the self-regard and future-regard principles, and the
formula of universal law: "Act only as you're willing for anyone to act
in the same situation -- regardless of imagined variations of time or
person."
Why follow GR?
We could base the golden rule on practically any approach to ethics. For
example, we might base GR on social conventions, personal feelings,
self-interest, God's will, or self-evident truths.
Web resources -- click below for
Gensler's golden rule page and further links on the golden rule


Dr Michael D E Goodyear FRACP FRCPC FACP


From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] The death of ethics
Date: Tuesday, October 21, 2003 12:03 PM

Maybe I am naively holding my breath. As one might expect the more
particular and less general one gets in drafting a code of ethics, the
more problematic it will become in application.

What is clear is that there remains a significant cadre within the
social sciences and humanities who feel disenfranchised and this needs
addressing.

As a collectivist I would like to feel that we can all find shelter
under one roof or umbrella. In that way we can learn from one another
and derive insights outside of our congenital narrow focus.

Perhaps the answer - no that's simplistic - part of the answer lies in
wording within a TCPS like document that finds resonances within both
'camps', and which explicily realises the enormous scope of research
endeavours, and addresses the specific needs of the different areas
whether this be a biomedical/humanities or a quantitative/qualitative
spectrum.

Dr Michael D E Goodyear FRACP FRCPC FACP

 

17. Signed Consent Forms as Legal Documents, True or False?

From: "Russel Ogden" <rdogden@telus.net>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] true or false ...
Date: Friday, October 17, 2003 10:42 AM

Dear Elisabeth and List,

Depending on the situation, isn't any document potentially a legal document?

Signatures on informed consent forms often serve the interests of researcher
and institution, rather than research participant. Here's a link to:

"Signed Consent Forms in Criminological Research: Protection for Researchers
and Ethics Committees but a Threat to Research Participants" (2003) by Lynne
Roberts & David Indermaur, University of Western Australia.
www.aic.gov.au/conferences/evaluation/roberts.pdf

Yours,
Russel Ogden

From: "H R Kloppenburg" <hrk@kloppenburg.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] true or false ...
Date: Friday, October 17, 2003 11:31 AM



It is misleading to talk about a piece of paper with writing on it as a legal document or a document which does not have that status. In civil law a video tape, a paper with writing on it, a stone with writing on it, a tape recording, a floppy disk, or anything which is a repository of information can be a document for the purpose of legal discovery and sub poena.

A document has legal significance (I offer this not as an exhaustive catalogue but as illustrative only - you may be able to do better in the way of a complete listing):

1. it has the effect of transferring ownership of property (this might refer to an agreement to give to a research sponsor the ownership of intellectual property in samples of bodily substance taken for genetic research purposes);

2. it has the effect of giving notice to the person who receives it of certain facts stated in the document e.g. the facts stated in a paper writing proffered to a research subject to result in informed consent, or a proposal for research involving using human subjects;

3. where a particular form of writing with signature is required to comply with a statutory, regulatory or bureaucratic requirement;

4. it has the effect of surrendering, extinguishing, or transferring legal rights, e.g an informed consent;

5. it has the effect of communicating particular knowledge on the part of the maker or signer or it ( this might refer to the case of informed consent)

6. it has the effect of communicating consent on the part of the person who by his signature (typically) has adopted the statements in the document as his;

7. if for any reason a document in any media is a relevant document in any court or litigation or regulatory process whose outcome can affect rights or privileges of persons it is therefore ipso facto a legal document;

8. it is a record of action take or events or conversations, e.g. a tape recording of a conversation, or meeting, a transcription of such recording, or contemporaneous notes by a person recording events or a conversation: all of these items can be a legal document or a document admissible in evidence which can be acted on to affect the rights of person who are bound by it or affected by the interpretation of it);

Therefore, anything which can be evidence in a court of law, or be used to determine or curtail rights in any process e.g. inquest, criminal or civil law trial, arbitration, university academic discipline process, can be a legal document because it can be evidence. The medium is almost irrelevant if is machine readable, i.e. a floppy disk or film. It is more useful in my view to talk about documents in these terms that to do so by referring to it as legal or conversely as other than legal.

One may go through the above list with a cynical attitude and attempt to fit the various types of paper making up the processes of IRB's into the items listed. Go your best.

H R Kloppenburg Q.C.

From: "Kathleen Glass" <kathleen.glass@mcgill.ca>
To: <hrk@kloppenburg.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] true or false ...
Date: Friday, October 17, 2003 2:32 PM

Elizabeth,

Is your question whether a consent form is a legally binding contract?

Kathy
-----

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Cc: <kathleen.glass@mcgill.ca>
Subject: Re: [Ethics] true or false ...
Date: Friday, October 17, 2003 2:37 PM

Hi Kathy, and yes that is precisely the discussion taking place within our
Office of Clinical Contracts.

Would the signed research consent document be viewed as a legally binding
contract if we were to face a court challenge ... elisabeth

At 15:19 10/17/2003 -0400, Kathleen Glass wrote:
Elizabeth,

Is your question whether a consent form is a legally binding contract?

Kathy
From: "Martin Letendre" <mletendre@ethicaclinical.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] true or false ...
Date: Friday, October 17, 2003 2:53 PM

Hi Laurel,

In your opinion, what are the missing required criteria for the consent
form to be considered a contract? I had a discussion recently with a
colleague who considered that the way consent forms are now written,
they could be interpreted as a "contract of adhesion", i.e. a contract
where the adherent cannot negotiate any of its elements.

I am very curious to read the forum's thoughts on this affirmation.

Martin

-----Original Message-----
From: Laurel Evans [mailto:levans@mcmaster.ca]
Sent: October 17, 2003 11:23 AM
To: ethics@lists.ncehr-cnerh.org
Subject: Re: [Ethics] true or false ...

Elisabeth, it depends upon what you mean by "legal document". In a
previous listserve discussion we canvassed the issue of whether the consent was a
"contract" and I opined that it was not, as it does not meet all the
criteria required in law to be a contract. It is, however, a document that could
be used in a court of law as evidence of the agreement or understanding
that the researcher and the "human research subject volunteer"
(participant/subject) reached relating to the conduct of the research. The failure to comply
with the content of the consent could possibly be used as evidence of
negligence on the part of the researcher and/or the institution, but failure to comply
with its content would not be a "breach of contract" -- at least in my
opinion.
Thanks. Laurel.

From: "Francis Rolleston" <frolleston@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] true or false ...
Date: Friday, October 17, 2003 3:02 PM

Subject to the views of lawyers, I think that ethically we should regard the
consent form as binding on the researcher but not on the
subject/participant. Whether that view corresponds with the law is for
lawyers to say.

Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

From: "Luc Simon" <Luc.Simon@vrr.ulaval.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] true or false ...
Date: Friday, October 17, 2003 3:13 PM


Hi Elisabeth,

I am not a lawyer and this is not legal advice !!

H R Kloppenburg eloquently described that such a document could very well be
relied upon as evidence if a legal dispute was to occur.

We all understand that by signing a consent form, the subject/participant
cannot relinquish any legal right or recourse, and that the
subject/participant can always terminate its participation without
prejudice.

This may be construed as a "unilateral contract", where the
sponsor/researcher/institution recognizes its responsibility to conduct the
research as stated, but that the document could not be used to coherse the
subject/participant into any action or retribution.

Regards,

Luc Simon

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] true or false ...
Date: Monday, October 20, 2003 2:55 PM

Dear Elizabeth,

Nobody would ever suspect you of being frivolous. Unfortunately the
answer to this question comes back to the question - what exactly does
one mean by a legal document?

Is it a binding legal contract? No. Can it be used in a legal context as
evidence of an interaction between researcher and researched. Yes. Is it
proof of informed consent? No.

It is merely evidence that the signatory saw the document at some point
and signed it.

Perhaps you can explain the controversy that exists within your
institution, keeping in mind that at least part of the legal framework
in Quebec is unique within Canada.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "H R Kloppenburg" <hrk@kloppenburg.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] true or false ...
Date: Monday, October 20, 2003 3:44 PM


Let us deal with the two propositions advanced by Dr Goodyear here:


Is [a written informed consent document] proof of informed consent? No.

My answer: A written informed consent document signed by a research subject is prima facie evidence that the person who signed it agreed to its contents. This assumes a witness to the signature or signing. It is always open to allege forgery, or misrepresentation which vitiates the document. That is how researchers can be harassed and abused by research subjects. And it does happen.

Thus, a written informed consent is proof of informed consent until it is successfully impeached in a court / tribunal by evidence of coercion, undue influence or misrepresentation.

[A written informed consent] is merely evidence that the signatory saw the document at some point and signed it.

My answer: A written informed consent is much more than evidence that a research subject saw the document and signed it. The document is binding on the research subject as a consent (non a contract) until the signature is disproved i. e.. the document is shown to be a forgery, or facts such as coercion, undue influence or misrepresentation are proved in order to vitiate the document.


Thus, let me illustrate out how the issue of invalid consent is played out:

Scenario 1: Where the existence of an informed consent arises in the context of a civil suit the the research subject alleges the the consent instrument is not valid, i.e. . s/he denies that his / her consent was given. Typically the allegation is one of undue influence, coercion, or misrepresentation. The research subject as a witness will be examined and cross-examined on whether s/he understood the character of the document. One starts with the position that a person who signs a document is ordinarily bound by what one signs. However, if the research subject alleges misrepresentation or fraud or coercion inducing his / her signature he / she will have to satisfy the court or tribunal that the document is not an effective document. Thus, a signed document purporting to be a consent will ordinarily be considered as effective until a research subject successfully convinces the tribunal of fact / court by evidence in the witness stand that the informed consent instrument is invalid.

Scenario 2: If a researcher were charged in professional discipline process with coercion or misrepresentation with respect to the obtaining of a signature to a consent, the the lawyer for the professional governing body would call as a witness the research subject alleging coercion or undue influence or misrepresentation. The research subject would testify as the circumstances of the consent in issue. To avoid the effect of the signed consent form, the research subject would have to satisfy the judge or tribunal where s/he gave evidence that coercion or undue influence or misrepresentation invalidating the consent had occurred. Ordinarily, until the tribunal hearing the discipline process was satisfied that the signed consent instrument offered as informed consent had been induced by coercion, undue influence, or misrepresentation it would be considered as binding as effect on the research subject. I have to add this reservation: there may be institutional contexts where the researcher / investigator bears the onus of proof of showing an effective consent not tainted by coercion, undue influence or misrepresentation.

H R Kloppenburg QC


From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] true or false ...
Date: Monday, October 20, 2003 4:01 PM

I would say no - which doesn't stop anyone from trying. It is exactly
this concept that we are trying to escape from and get back to ICF's
being more information brochures. In this light people might write more
user friendly documents.

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] true or false ...
Date: Monday, October 20, 2003 4:03 PM

I think we need to think this one through a bit more - binding in what
way - to deliver an intervention as described in the document? What are
the likely or possible sources of straying from this path, and what are
the consequences.

>>> frolleston@sympatico.ca 10/17/03 04:58PM >>>
Subject to the views of lawyers, I think that ethically we should regard
the
consent form as binding on the researcher but not on the
subject/participant. Whether that view corresponds with the law is for
lawyers to say.

Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7