Summary of NCEHR Listserv for September 2003


TOPICS

1. Job - Ethics Office - Canadian Life-Long Health Initiative

2. ICF Witness Signature and the VA

3. Individuals Under 18 in Research Studies

4. Inquiry about Correctional Services Canada

5. International Ethics Applications

6. Internet Research and Ethics

7. Investigator Databases

8. Must Consent Forms be Witnessed?

9. NCEHR Training in Research Ethics

10. Non-compensable Research Injury

11. Records Retention Schedule

12. Third Party Insurance

13. Truth or Fiction - Tales from the Trenches

14. Update OHRP Guidelines on Expedited Review

 

Files to Download

NCEHR Training in Research Ethics at McMaster, Hamilton - Biomedical and Social/Science Behavioural

 

1. Job - Ethics Office (Canadian Life-long Health Initiative)

From: "Blake, Andrea" <ablake@ncehr-cnerh.org>

Subject: COMPETITION / CONCOURS #CRI-03-201 (1114)



Le texte français suit le texte anglais.

COMPETITION NUMBER: CRI-03-201 (1114)
CLOSING DATE: Friday, September 12, 2003

SPECIFIED APPOINTMENT (12 MONTHS)
POSITION TITLE: Ethical, Legal and Social Issues Coordinator for the
Canadian Life-long Health Initiative
BRANCH/PORTFOLIO: Ethics Office (Canadian Life-long Health Initiative)
GROUP & LEVEL: ES-06
SALARY: $ 76,801 to $ 88,259 per annum (under review)
LANGUAGE REQUIREMENTS: English or French
SECURITY: Secret

OPEN TO: All employees of the Public Service of Canada including federal
agencies (Separate Employers) and the general public.

MORE INFORMATION REGARDING THIS COMPETITION IN ON THE INTERNET AT THE
FOLLOWING ADDRESS:
http://www.cihr-irsc.gc.ca/e/about/17960.shtml

2. ICF Witness Signature and the VA

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
Subject: [Ethics] ICF Witness signature and the VA

Here is the US Veteran¹s Administration position, as posted on IRB Forum
about 2 years ago (my italics):

.... Yet another function the witness signature serves is to verify that a
'subject' or 'subject's representative' actually signed the form (and not,
perish the thought, the PI!). Witness signature is a requirement in VA
Cooperative Studies Program research.

Charlotte Giese, Ph.D. (151K MPD)
Chair, Human Rights Committee
Cooperative Studies Program Coordinating Center
Dept. of Veterans Affairs
3801 Miranda Ave.
Palo Alto, CA 94304

More grist for the chaqu¹un a son gout mill.

Jack Corman
President/Secretary

 

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>

Actually also more recently (August 21) new VA regulations (without any statement of rationale):

IRBs that review research conducted or supported by the VA, may wish to note
that the new Manual, Appendix C, 3.a.(2) requires a witness to the signature
of the subject or the subject's legally authorized representative. Section
C.3.b. adds, "If the sponsor or IRB requires a witness to the consenting
process in addition to the witness to the subject's signature; if the same
person needs to serve both capacities then a note to that effect must be
placed under the witness's signature line."

45 CFR 46.117(b)(2) requires a witness "to the oral presentation" when a
short form is used. The witness must sign both the short form and the
summary.

Neither regulation specifies what kind of relationship can or cannot exist
between the witness and the researcher or the witness and the subject. In
neither case is the witness attesting to the competence or comprehension of
the subject, or to the adequacy of the consent process.

Helen McGough
Human Subjects Division
University of Washington
3945 Fifteenth Ave., NE
Seattle, WA 98105-6607
(206) 543-0098 (Tel.)
(206) 543-9218 (Fax)
hmcgough@u.washington.edu

>>> jcorman@irbservices.com 09/05/03 04:21PM >>>
Here is the US Veteran's Administration position, as posted on IRB Forum about 2 years ago (my italics):

.... Yet another function the witness signature serves is to verify that a 'subject' or 'subject's representative' actually signed the form (and not, perish the thought, the PI!). Witness signature is a requirement in VA Cooperative Studies Program research.

Charlotte Giese, Ph.D. (151K MPD)
Chair, Human Rights Committee
Cooperative Studies Program Coordinating Center
Dept. of Veterans Affairs
3801 Miranda Ave.
Palo Alto, CA 94304

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>

Lucky we are not yet a 51st (or would it be 52nd?) state...
Philip Hebert MD PhD FCFPC
REB Chair, SWCHSC

From: "Francis Rolleston" <frolleston@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] ICF Witness signature and the VA
Date: Monday, September 08, 2003 7:21 PM

Definition of the regulations in some agencies etc is very helpful. But are
regulations always ethical?

Francis Rolleston

3. Individuals Under 18 in Research Studies

From: "Lindley, Pat" <plindley@Kilcom1.UCIS.Dal.Ca>
Subject: Re: [Ethics] Individuals under 18 in research studies

We don't distinguish between students and other young people. I am not
sure what the reasoning is that would allow you to do so. If the study
methodology is one which, in the view of the Ethics Board requires
parental consent, then it is required. In general, we find psychology
protocols which involve some degree of risk limit participation to people 19
or older.

The issue of parental consent has never been satisfactorily resolved ... in
part because there are complications of different legal definitions of
capacity (with respect to adolescents) in different provinces. We are going
to try and develop a decision tree which integrates risk with age,
methodology etc. It may be an exercise in futility but at least it will hopefully
keep us from reinventing the wheel each time a protocol with
children/adolescents comes forward.

There is no legal age of consent for participation in research in NS...
however there are other benchmarks than can be used from the clinical
arena.

If someone has a resource that neatly sums it all up (vis a vis children and
consent) then I would appreciate the reference.

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: "Michael Owen" <mowen@spartan.ac.brocku.ca>
Subject: [Ethics] Individuals under 18 in research studies

Once again the issue has arisen in our REB about institutional
policies regarding the participation of university students, who are
under the age of 18 (in Ontario), in research studies (including
Psychology pools) require parental permission (and their own
consent/assent) or whether they are able to consent on their own. If
the former, do institutions seek, as part of the admission process
(e.g., a blanket consent) for all studies or approval of parents for
each study?

Thanks for your assistance

Micahel
--
Michael Owen, Ph.D., Director, Office of Research Services
& Interim Director, Cool Climate Oenology and Viticulture Institute (CCOVI)
Brock University

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
Subject: RE: [Ethics] Individuals under 18 in research studies

They are, by Ontario & case law, able to give consent -- if still at home,
prudence would recommend parental assent, however, if the participant
agrees, of course. The involvement of parents would depend on the sudy --
eg, sensitive studies might not require / ask for parental consent. We do
not routinely require it, but an interventional study with potential for
harm might make one take the path of prudence.

Philip C Hebert MD PhD FCFPC
Associate Professor, Family Medicine
Chair, Research Ethics Board, 416-480-6100 ext. 4276
Clinical Ethicist ext. 4818
Family Physician: Room A100 ext. 4963
Pager 237-3424
Messages: 480-6100 X 5081
Alternate E-mail: philiphebert@rogers.com

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Subject: Re: [Ethics] Individuals under 18 in research studies

Our view is that if you are a university student you are making independent decisions about your life, and it would not be respectful to require parental consent.

 

From: "Bill Marr" <bmarr@wlu.ca>
Subject: Re: [Ethics] Individuals under 18 in research studies

For a long time now the REB at Laurier has had the age of 16 for lone
consent by participants (i.e., when a participant is 16 years old or
older, parental/guardian consent is not required or sought). A
suggestion is to review the policy that requires parental/guardian
approval for 16 and 17 year olds to participate.

I can not imagine that parents/guardians, as part of the university's
admission process, would be asked to sign a consent form. That seems
too cumbersome since the majority of students will likely never be asked
to be participants. If 16 and 17 year olds must have parental/guardian
consent, and since each project is different, they would likely have to
give their consent for each project, on an individual basis, just as we
now do with non-university participants who require parental/guardian
consent. If there are good reasons for still requiring
parental/guardian consent for those university students, I do not think
that blanket approval could be given.

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
Subject: Re: [Ethics] Individuals under 18 in research studies

Hello Michael

As Philip has suggested, if they've left home, they would likely be
considered "emancipated minors". This makes them able to make
decisions as if they'd reached the age of majority (18 in Ontario).
For reference http://www.jfcy.org/age/milestone.html

We use age of 18 regardless, simply because of the difficulty in
determining emancipation status. I think it is reasonable to
consider, though, as Michael pointed out, that people attending
university could realistically be considered to be emancipated, even
if living at home.

Age of consent aside, I don't feel that "blanket consent" is informed
consent. It doesn't give enough detail to make an informed decision.
Blanket techniques, even for permission for contact - unless it's
very context specific, wouldn't be appropriate IMO.

Cheers

Cam

From: "Susan Hoddinott" <hoddinott@uwo.ca>
Subject: Re: [Ethics] Individuals under 18 in research studies

At UWO we consider university students (irrespective of age) to be sufficiently
mature to consent for themselves. We do not seek parental permission.

cheers
Susan

**********************************************************************
Susan Hoddinott, M.Sc., Director, Office of Research Ethics
Room 00045 Dental Sciences Building, The University of Western Ontario
London, Ontario, Canada N6A 5C1
PRIVATE LINE 519.661.2111 Ext. 84692 MAIN OFFICE 519.661.3036
FAX 519.850.2466 EMAIL hoddinott@uwo.ca
OFFICE WEBSITE http://www.uwo.ca/research/ethics/

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Subject: Re: [Ethics] Individuals under 18 in research studies

For those not university [or equivalent tertiary education] we have used an 'emancipation' criteria, but have left it up to investigators to make the judgement call in individual cases, ie we have only provided guidance. The home criteria is one of them.

I am not keen on blanket consent.

From: "Bob Bortolussi" <Bob.Bortolussi@iwk.nshealth.ca>
Subject: Re: [Ethics] Individuals under 18 in research studies

As a children's hospital the issue of approval for minors comes up frequently. The REB consulted widely some time ago when legislation changed in our province a couple of years ago. In our province the specific age is not the critical factor, the decision is made on basis of competence. With contribution from our Health Law Institute (Jocelyn Downie) we derived the following approach and definitions:
Consent: is reserved for situations of active knowledgeable decision making on ones own behalf, such as by an adult or emancipated minor.
Authorization: refers to situations where a parent, guardian or other authorized 3rd party has power to participate in decision making for the person (eg for a child).
Assent: is the agreement to participate by a person with some but not complete understanding for consent.
Persons participating can only give consent or authorization in research when they are fully informed. Information must be in written form in plain language (Grade 8 or as appropriate). In some situations all may types of agreement may apply and consent/ authorization/ and assent forms are reviewed by the REB.

We have developed a guide for researchers at our centre that outlines these issues and provides acceptable examples. Unfortunately this is not housed on a website but other Centres may have similar things.

Bob Bortolussi

Robert Bortolussi MD FRCPC
Chief of Research
IWK Health Centre
5850 University Ave.
Halifax NS
B3J 3G9
CANADA

From: "Adela Reid" <adela.reid@concordia.ca>
Subject: RE: [Ethics] Individuals under 18 in research studies

Dear all,

I have been following the list-serve discussion of this topic with great
interest. I would like a clarification of what is meant by "blanket
consent". Is this meant to be consent for all studies the student may
wish to participate in, or is this a "consent" that the
students/children may, from that point on, make their own choices with
their parent's blessing of their independence, if not their choices?
The former does not involve informed consent, which I find unacceptable,
but the latter may be useful. As previously mentioned, however, it
would be difficult and burdensome to orchestrate.


Adela M. Reid
Research Ethics and Compliance Officer
Agent, Éthique et Normes de la Recherche
Office of Research, Concordia University
1550 de Maisonneuve West, 902-4
adela.reid@concordia.ca

From: "Michael Owen" <mowen@spartan.ac.brocku.ca>
Subject: RE: [Ethics] Individuals under 18 in research studies

The issue of blanket parental permission -- not informed consent --
was noted on the irb-listserv some months ago in the following email.
This approach seemed to me (1) sensible, (2) workable and not too
great a burden on the researchers, (3) would allow university students
under 18 might participate in research studies of minimal risk, (4)
recognize the high degree of autonomy of these individuals, and (5)
ensure that parents receive information on the nature of the university
educational program in which students are enrolled.

Michael

"At UIC, we have a policy for the subject pool that stipulates full credit
is given for participation regardless of when a subject chooses to withdraw
(if they should choose to do so). There is always an alternative offered,
usually written evaluation of a published paper. For students who are
under 18, a blanket parental permission form is required. An information
sheet is then independently mailed to the student's parent(s) confirming
the student's enrollment in the subject pool and repeating the information
from the permission form. Both forms describe the kinds of studies that
are allowed for the subject pool (only minimal risk studies are allowed),
and offers website and phone information if parents want to learn more
about the subject pool, or the rights of research subjects. Assent or
written informed consent is obtained from all students on a study-specific
basis through the usual consent process and is documented by a signed
consent document.

We have allowed blanket parental permission for these students (who are
recognized as generally having a high degree of autonomy as University
students), but have never accepted blanket informed consent.

----------
Don E Workman, PhD
Director, Office for the Protection of Research Subjects (MC 672)
University of Illinois at Chicago"

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>

Subject: RE: [Ethics] Individuals under 18 in research studies

Hi Michael

Thank you for sharing this. The process described is predicated on a
couple of things that make sense

1. The stipulation of minimal risk
2. The stipulation of a description of the kinds of research that may
be involved going to the parent.

This provides a context for which a blanket "permission" may be
sought. I do wonder, though, if the distinction between parental
permission and consent is a little disingenious. If the student
requires parental consent due to their age, then is a blanket
"permission" not really "consent" if no further decisions are sought?
If students give assent, is parental consent considered passive?
Those ramblings aside, I think that providing parents information
isn't a bad idea.

I'd be happier dealing with the first principle, when can a minor
give consent for research? Unfortunately, these issues only seem to
come up when something bad happens, even if its parents getting
hysterical about finding out their "child" has participated in a
study of substance abuse or high risk sexual behaviour.

I must admit, I'm getting a little fatigued by this. Who wants to do
some research to try to provide some real data?

Cheers

Cam

From: "Don Workman" <dworkman@uic.edu>
Subject: RE: [Ethics] Individuals under 18 in research studies

Cam:
The distinction between parental permission and consent is an essential one
within research ethics. One cannot give consent except for one's self, not
for another. We often use the terms "surrogate consent" or "Parental
consent," but those are misnomers, as they really represent legal
permission to include someone of diminished autonomy in research. That
individual with diminished autonomy should be respected through a request
for assent, but the burden of the responsibility for making the decision is
on the surrogate/parent. We have allowed the blanket parental permission,
but continue to require assent by the minor for each and every
protocol--allowing the potential subject to exercise autonomous
decision-making in the context of parental permission to do so.

I'm game for initiating some practical empirical study in this regards to
better inform the discussion!

Regards,
Don

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
Subject: RE: [Ethics] Individuals under 18 in research studies

Hi Don

Thanks for your reply. I'll see who else responds and we can work
towards a project to try to answer some questions.

We are also dealing a language issue, probably due to the different
genesis of the guiding documents we use. The TCPS states that "the
researcher shall show how the free and informed consent will be
sought from the authorized third party, and how the subject's best
interests...". 45 CFR 46 uses the term "parental permission".
I appreciate the philosophical basis of permission, but I suspect
they would both be considered equally if any questions were raised
about "who gave consent".

I'm sure others can respond better to the pragmatic legal question of
the differences between the two.

Cheers

4. Inquiry about Correctional Services Canada

From: "Leslie_MacDonald-Hicks" <LeslieMacDonaldHicks@pigeon.carleton.ca>
Subject: [Ethics] Inquiry about Correctional Service Canada

In July I went to the new Panel on Research Ethics website and found several
interesting links. One was to CSC. After reviewing the directive from CSC it
was clear to me that CSC had a research review process in place.

Our committee had just approved a research project involving several federal
prisons so I informed the graduate student that he would have to submit his
proposal to the CSC research branch for their approval. He objected. His
department is taking the stand that the directive does not apply to
university researchers. They are arguing that it only applies if you have
funding from CSC?

I have made an inquiry about the policy from CSC. In the meantime - have I
read the directive incorrectly? Anyone out there had experience with CSC?

Your help is greatly appreciated.

Leslie J. MacDonald-Hicks

From: "Francis Rolleston" <frolleston@sympatico.ca>
Subject: RE: [Ethics] Inquiry about Correctional Service Canada

My guess would be that your graduate student and his department are way off
base. I would be astonished if Correctional Services Canada allowed
researchers into their facilities without approval of their research review
processes. NRC certainly would not, nor would any hospital. Or am I
missing something?


Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

From: "Heather Kitchin" <heather.kitchin@acadiau.ca>
Subject: RE: [Ethics] Inquiry about Correctional Service Canada

I am currently involved with research at the provincial level of corrections
in Nova Scotia and in Ontario.
For the Ontario system, I was required to submit my research proposal (with
a full consent form, etc.) to its research services department,
after my university REB provided approval for the research.
I would expect that the federal level of corrections would process
applications for research in a similar manner.
There is no guarantee that a researcher is granted access to the
correctional sites.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Heather A. Kitchin, Ph.D.
Department of Sociology
ACADIA University
Wolfville, Nova Scotia
B4P 2R6 Canada
Tel: (902) 585-1210
Fax: (902) 585-1769

From: "Lindley, Pat" <plindley@kilcom1.ucis.dal.ca>
Subject: Re: [Ethics] Inquiry about Correctional Service Canada

HI LEslie,
We have a forensic Psychology group who have been doing research with
offenders for many years. Their projects must be approved by the
correctional facility that they wish to work with. THey work closely with the
staff psychologists in the various correctional facilities in terms of getting
this done. There is also a research policy that CSC has posted on its
website (it is dated 1987, but is still the current one I believe). You have to
do a search for it. It applies to ALL research that involves offenders or data
of CSC, irrespective of funding.

Pat Lindley


From: "Catherine Paquet" <cpaquet@uottawa.ca>
Subject: Re: [Ethics] Inquiry about Correctional Service Canada

Hello,

We also have students (in criminology) working in prisons. They had to
obtain CSC approval, after having received approval from the University REB,
before they could proceed with their research.

Catherine Paquet
Responsable de déontologie en recherche / Protocol Officer for Ethics in
Research
Université d'Ottawa / University of Ottawa

5. International Ethics Applications

From: "Joan Stevenson" <stevensj@post.queensu.ca>
Subject: [Ethics] International Ethics Applications

Dear Listserv Members,

As a General Research Ethics Board, we are planning to discuss the level of
scrutiny we should take for international applications. Should they
undergo a full review? Should they be expedited and treated identically to
other proposals of low minimal risk? Should there be some additional
procedure since there are complex cultural and political issues similar to
those of Aboriginal Peoples applications?

What does your institution have as a procedure for international applications?

Joan Stevenson, PhD
GREB Chair
Queen's University

From: "Michael Owen" <mowen@spartan.ac.brocku.ca>
Subject: Re: [Ethics] International Ethics Applications

Dear Dr. Stevenson
My question is why one would treat applications for studies with
human subjects in an international setting less stringently than you
would other applications. One question that rises, of course, is
whether the Canadian research has the appropriate permits (research
visas, etc.) to conduct the research and has obtained approval/review
from a board in the jurisdiction in which the research will occur.
The parallel to research with First Nations is appropriate,in some
instances, and inappropriate in others (e.g., research in schools in
the UK or France).
Michael
--
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: "Lindley, Pat" <plindley@kilcom1.ucis.dal.ca>
Subject: Re: [Ethics] International Ethics Applications

Perhaps it would be helpful to cite a few concrete examples of why scrutiny
is needed as intensely, if not more so, for international studies as for
'domestic' ones.

Recently we had a case of a student who wished to study AIDS in an
African Country. Her perspective was one which fell squarely on the
boundary of social science and medical science, and her supervisor was
from a non-medical department. Our Board found her proposed
methodology problematic on a number of fronts, and upon contacting
individuals in the medical fraternity in the study country, were told that local
approval would absolutely be needed, in addition to our approval. Our
consultation had included a precis of our Board's concerns and we were
assured that what was being proposed by the student would also be
objectionable in the local context. We were advised of who to approach
and we then advised the student to seek local approval, and offered our
support with the logistics. This of course came as a complete surprise to
the student and her supervisor. I include here a quote from the Chair of the
local Board, at the end of the review

"... the decision of your ethics committee to have us review the proposal
first is much appreciated. Will you please convey this to your committee.

Your realistic and sensitive stance is in contrast to the increasingly
common situation that we have of US-based researchers suddenly
appearing waving a US IRB approval that they regard as some sort of
universal passport - when we insist on local approval as well we get
reactions varying from surprise to anger."

Having gone through the process it should be noted that the proposal was
submitted to us in May and is now just finishing up approval. This process
takes time and international researchers need to be aware of it. It could
have been longer, except that the Chair of our Board had personal
contacts in Africa that streamlined the whole process.

There were also issues of safety that raised serious concerns for our
Board. The researcher was a young, blond female who proposed venturing
into neighbourhoods where she herself would be seriously at risk. This sort
of thing is not as infrequent in international research as one would hope.
Students, especially, frame their studies in an academic way, often with
little appreciation (or with a naive and optimistic one) of the local social /
political environment. They also frequently want to pursue projects in a way
that involves an element of political activism ('empowerment' is often one of
their study objectives), which is morally laudable, but which can have
horrific consequences if all that they succeed in doing is provoking
negative repercussions for their subjects. We have seen this potential in
several 'international' studies (eg. the use of blood diamonds in Sierra
Leone, prostitution in the Philippines, conflict in the Congo...)

Because assessing risk is what we are supposed to do, we require that as
part of the protocol (we don't use forms which can truncate a study
description so much that the details of methodology that reveal these
issues never appear), the researcher give us a description of the current
socio-political context for their study if they are going abroad. Our office
also is on the DFAIT travel advisory email circular. I do an informal tally of
countries that are dangerous and keep an eye out for protocols involving
travel to them. This allows us to assess whether or not the researcher has
been realistic in their study design... usually more of a problem with
students than faculty.

Having said all this the exhortation of the TCPS to get local ethics approval
is probably achievable for most medical research (you can't get access to
hospitals oversees without their being institutional approval of some sort),
but much more problematic for social science research. Although the
TCPS direction is for local review 'where required', making the
determination of whether there is such a requirement, or who to approach,
is certainly not easy. I would be interested to hear how others address this.

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: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Subject: Re: [Ethics] International Ethics Applications

I think this exanple is very telling and perhaps should be more widely distributed within the academic milieu. Once again this sort of process failure points to the responsibility of supervisors as much as students, something NCEHR has pointed out in the past.

However we have a slightly different twist. Our researchers did indeed seek and apparently receive approval in the host countries. Unfortunately we have been presented with a pile of documents purporting to be Research Ethics approvals in a multitude of foreign languages none of which are familiar to members of our REB. So how does one assess the documentation?

You could ask whether our internationally inclined investigators had thought of that in the first place.

6. Internet Research and Ethics

From: "Leslie_MacDonald-Hicks" <LeslieMacDonaldHicks@pigeon.carleton.ca>
Subject: [Ethics] Internet research & ethics

Hi folks,

I'm not certain if this one has already been asked or not. Does anyone out
there have some suggested readings on the matter of Internet research and
ethics?

Thanks,

Leslie J. MacDonald-Hicks

From: "Bill Marr" <bmarr@wlu.ca>
Subject: Re: [Ethics] Internet research & ethics

When I had the same question this summer I contacted Heather Kitchin in the
Department of Sociology at Acadia University (heather.kitchin@acadiau.ca). At
the end of her talk at the session that PRE organized at the Congress for the
Humanities and Social Sciences in June, she mentioned that she had a
bibliography relating to Internet research and ethics. She sent it to me and
the materials that are cited there are very useful.

There are also two chapters in Will van den Hoonaard's book entitled Walking
the Tightrope: Ethical Issues for Qualitative Researchers on that topic.

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
Subject: Re: [Ethics] Internet research & ethics

Although a little dated, this link may be of interest.

http://www.aaas.org/spp/sfrl/projects/intres/main.htm

From: "John Mueller" <mueller@ucalgary.ca>
Subject: Re: [Ethics] Internet research & ethics


http://basil.acs.bolton.ac.uk/~ch5/hews_psychol.pdf


-- 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)

7. Investigator Databases


Thus spake jjohnson@cato.com :

Are there any Canadian Legal issues for a company to set up an
investigator database for internal use?

The only issue I can think of is that if the database creator puts
personal opinions in the database as a basis for a decision and this
gets communicated outside of the company there could be defamation of
character issues. I don't believe it would fall under the privacy act,
because we would not be collecting personal information. Does REBs
keep such a database for their own use?

I am looking for any other type of legal or other restrictions on doing this.

Thanks in advance.

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
Subject: Re: [Ethics] Investigator Databases

The Privacy Act, Access to Information act and provincial equivalents
apply to information held by government institutions.

My understanding is that the database would fall under the Personal
Information Protection and Electronic Documents act if it contained
personal information.
http://www.privcom.gc.ca/legislation/02_06_01_e.asp

(I'm not a lawyer and have no expertise in privacy law)

Cheers

Cam

From: "Edith Deleury" <Edith.Deleury@fd.ulaval.ca>
Subject: Re: [Ethics] Investigator Databases

It is also my understanting
Édith Deleury

8. Must Consent Forms be Witnessed?

From: "philip hebert" <philiphebert@rogers.com>
Subject: [Ethics] [IRB Discussion] Must Consent Forms bewitnessed?

I agree with Francis -- the witness signature is not NB. At Sunnybrook &
some other U of T hospitals we are asking researchers to strike from the
consent form the witness line. The consent form is meaningful as a piece
of evidence about what the participant may have been told -- the latter
conversation is, ultimately, more NB than the dotted i's & crossed t's
in any form, no matter how many witnesses to the signature. What is more
important in my mind is that potential participants have time to
consider the proposal -- time that may be very short in some
circumstances -- & time to discusss it with others (GP, family etc.).
The coerciveness of some consent situations is that folks are expected
to sign along the dotted line without truly considering the proposal's
risks & benefits.

Philip

Philip C Hebert MD PhD FCFPC
Associate Professor of Family Medicine
University of Toronto
Bioethics Consultant
Joint Centre for Bioethics,
Chair, Research Ethics Board
Sunnybrook & Women's College Health Sciences Centre
Tel 416-480-4963
Pager 416-237-3424

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
Subject: Re: [Ethics] [IRB Discussion] Must Consent Forms bewitnessed?

This discussion looked familiar, so I looked back in the archives.
In June 2002, there was a reasonably extensive discussion on the
signatures required on a consent form. We had been asked by an
external REB to have the participant, the person getting informed
consent and the PI on the form. Maybe there's a distinction between
"witness" and "additional signatures"...

Cheers

Cam

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: "Michael J. Wilson" <srebsec@mcmaster.ca>
Cc: <ablake@ncehr-cnerh.org>
Subject: Re: [Ethics] [IRB Discussion] Must Consent Forms bewitnessed?
Date: Wednesday, September 03, 2003 11:48 AM

Hi Michael

There is a module replacement for Mailman that allows better
archiving features, including searching:
http://sourceforge.net/projects/smartarchiver/
It does look new, so I don't know how buggy/stable it may be.

There is a Unix based local solution:
http://www.htdig.org/

Not an option for us, unfortunately, so it would be nice if there was
a central search. I looked into archiving locally, but couldn't find
a decent search engine (and also got busy doing something else).

Cheers

Cam

Thus spake Michael J. Wilson :

> Cam,
>
> I did a search on our ATOMZ on "signed consent form" search engine on
> the NCEHR Listserv summary I prepare and found a link to this:
> http://www.mcmaster.ca/ors/ethics/ncehr/june2002.htm#3 The Google
> search engine just isn't working on this set yet.
>
> Our summary of the email is here:
> http://www.mcmaster.ca/ors/ethics/ncehr/summary.htm

> The recent issue of NCEHR's "Communique" mentioned that they are
> trying to put a search engine on the archived email. I am still
> trying to fine tune our search engines too, and might end this summary
> if NCEHR can make it work.
>
> All the best
>
> Michael

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
Subject: Re: [Ethics] [IRB Discussion] Must Consent Forms bewitnessed?

This discussion is familar on IRB Forum and NCEHR Lists, but its central
importance to REB work, requires repeating as often as questions arise.

The *use* of a witness signature is referred to at ICH GCP 4.8.9. I
believe an REB is wise to focus on the opening phrase that says, "If a
subject is unable to read". This can refer not only to a state of
literacy, but rather to any *transitory inability to comprehend*. REBs
need to consider temporary incapacity as requiring a witness when dealing
with studies in vulnerable populations such as stroke or persons requiring
emergency care.

This situation arose last week for us when dealing with a study collecting
data on a standard drug used in transplant whereby study participation
offerred no direct benefit to the subject. The legally authorized
representative was asked to sign as the patient/subject was not in a state
to contemplate choice.

To be entirely transparent on the issue we asked for the temporary
incapacity to be cited in the medical record, and a witness, not a member
of the research team, present during the study consent discussion was asked
to sign as per 4.8.9 that reads:

"By signing the consent form, the witness attests that the information in
the consent form and any other written information was accurately explained
to, and apparently understood by, the subject or the subject's legally
acceptable representative, and that informed consent was freely given by
the subject or the subject's legally acceptable representative".

As a witness signature is not required at our institution this line and
identifier was penciled and will be considered as an editorial correction
to the CF.

Useful in the routine design of CFs is the ICH GCP information at 4.8.8
that suggests a CF be signed "by the person who conducted the informed
consent discussion", with that designation appearing under the name line
... elisabeth

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Subject: Re: [Ethics] [IRB Discussion] Must Consent Forms bewitnessed?

We referred the issue to our Risk Management and Legal Services Dept. who have apparently been struggling with the issue all along, and are unsure where to go. What they would like to see is all consents in the institution having a consistency in terms of signing.

What is emerging in the correspondence is the need to think carefully about what is involved when people ask for a signature.

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
Subject: [Ethics] Consent forms as contracts

Something to consider (albeit US):

In the case of Dahl v. Hem Pharmaceuticals Corporation, 7 F.3d 1399 (9th
Cir. 1993), the U.S. Court of Appeals for the Ninth Circuit U.S. Court of
Appeals handed down a decision that an informed consent document was a
contract that required a sponsor to perform services for study subjects even
after the clinical trial ended. The case also recognized the right of study
subjects to bring suit against a sponsor to prevent the termination of their
participation in the study. The decision also is significant because it held
that under certain circumstances clinical investigators could be found to be
the agents of the sponsor.
Source: John M. Isidor, JD, Informed Consent as a Contract

Jack Corman
t

9. NCEHR Training in Research Ethics

From: "Blake, Andrea" <ablake@ncehr-cnerh.org>
Subject: [Ethics] NCEHR Training in Research Ethics - Biomedical

NCEHR Training in Research Ethics
Hamilton ON

BIOMEDICAL - Thursday November 6, 2003 (1 day program)

Conference Location
Conference Room: Albion AB

Hamilton Convention Centre
1 Summers Lane
Hamilton ON L8P 4Y2
Web Site: http://www.hecfi.on.ca
Telephone: 905-546-3012
Fax 905-540-5464

Registration

Registration Fee: $150.00
The fee includes continental breakfast, lunch, coffee breaks and a participant package.
ON-LINE registration (coming soon!) Confirmation of registration will be sent by e-mail.
NOTE: Registration fees are non-refundable, registrants are encouraged to
send a substitute if unable to attend. Those who register and do not attend will receive a participant package by mail.

Hotel Information
Sheraton Hamilton Hotel
http://www.starwood.com/sheraton/search/hotel_detail.html?propertyID=185
116 Kings Street West, Hamilton ON L8P 4V3
Phone: (905) 529-5515
Fax: (905) 529-8266
sheratonhamilton@sheraton.com
Room rate: $129 per night (single or double occupancy) - additional taxes apply
When booking do so under meeting code 6865 or National Council on Ethics in
Human Research ( NCEHR) to receive this room rate

You can make your own reservation from the Sheraton web site by following
these simple instructions:

* Click on MEETING PLANNERS at the bottom of the page
* Click on ATTEND A MEETING
* Enter Hamilton, Ontario as the destination
* Enter the meeting code: 6865
* Click CONTINUE
* Select the Sheraton Hamilton
* Proceed with reservation information and a confirmation will be sent
to via e-mail.

NOTE: Rooms will be released October 7, 2003

Travel
Jackie Fish Algonquin - MKI Conference Management
Ottawa, Ontario
Tel: (613) 244-5806; Toll Free: 1-800-387-6767 ext. 329; Fax: (613) 244-0413
E-mail: jackie.fish@mki.algonquintravel.com

For more information, please contact:
The National Council on Ethics In Human Research
Tel: (613) 730-6225, Fax: (613) 730-8251
office@ncehr-cnerh.org

From: "Blake, Andrea" <ablake@ncehr-cnerh.org>
To: "List Serv (E-mail)" <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] NCEHR Training in Research Ethics - Social and Behavioural Scienc es
Date: Monday, September 15, 2003 9:05 AM

NCEHR Training in Research Ethics
Hamilton ON
November 7, 2003 (1 day program)

Conference Location
Conference Room: Albion AB

Hamilton Convention Centre
1 Summers Lane
Hamilton ON L8P 4Y2
Web Site: http://www.hecfi.on.ca
Telephone: 905-546-3012
Fax 905-540-5464

Registration

Registration Fee: $150.00
The fee includes continental breakfast, lunch, coffee breaks and a participant package.
ON-LINE registration (coming soon!) Confirmation of registration will be sent by e-mail.
NOTE: Registration fees are non-refundable, registrants are encouraged to
send a substitute if unable to attend. Those who register and do not attend will receive a participant package by mail.

Hotel Information
Sheraton Hamilton Hotel
http://www.starwood.com/sheraton/search/hotel_detail.html?propertyID=185
116 Kings Street West, Hamilton ON L8P 4V3
Phone: (905) 529-5515
Fax: (905) 529-8266
sheratonhamilton@sheraton.com
Room rate: $129 per night (single or double occupancy) - additional taxes apply
When booking do so under meeting code 6865 or National Council on Ethics in
Human Research ( NCEHR) to receive this room rate

You can make your own reservation from the Sheraton web site by following
these simple instructions:

* Click on MEETING PLANNERS at the bottom of the page
* Click on ATTEND A MEETING
* Enter Hamilton, Ontario as the destination
* Enter the meeting code: 6865
* Click CONTINUE
* Select the Sheraton Hamilton
* Proceed with reservation information and a confirmation will be sent
to via e-mail.

NOTE: Rooms will be released October 7, 2003

Travel
Jackie Fish Algonquin - MKI Conference Management
Ottawa, Ontario
Tel: (613) 244-5806; Toll Free: 1-800-387-6767 ext. 329; Fax: (613) 244-0413
E-mail: jackie.fish@mki.algonquintravel.com

For more information, please contact:
The National Council on Ethics In Human Research
Tel: (613) 730-6225, Fax: (613) 730-8251
office@ncehr-cnerh.org

10. Non-compensable Research Injury

From: "H R Kloppenburg" <hrk@kloppenburg.ca>
Subject: [Ethics] Non compensable research injury?

I have for a long time wondered about the need to include in a consent to be a research subject a provision referring to non compensable research caused injury. I will explain that term as I proceed.

When a research subject suffers a research caused injury, the research subject has a claim in law against the person causing such injury e.g. investigator or clinician or research sponsor such as a pharmaceutical manufacturer or both where the research subject can show:

1. negligence on the part of the investigator or research sponsor (I will not define negligence here other than to say negligence means a failure to meet a standard of care which results in an injury or loss which ought to have been foreseeable and which a reasonable researcher clinician or research sponsor should have foreseen);

2. failing to perform a contract to provide care, e.g. where the a investigator / clinician administers a research drug or continues to do so when warning signs appear (this is practically the same as negligence but needs a separate characterisation.

These statements are another way of saying that compensation is available only when fault can be shown. A compensable research caused injury or loss results when fault can be shown. And I might add, if medical knowledge is to be expanded risks must be incurred and some of those risks will be realised despite no want of care.

The problem I see is this: in a small number of cases a research caused injury will occur without negligence though a cause and effect relation between the carrying out of the research protocol and the subject's injuries may appear, Alternatively in a small number of cases without the investigator / clinician having failed in his contractual duty of care to his / her patient may result in research caused injury without fault.

This is what I mean by non compensable research caused injury: injury without fault on the part of the research sponsor or investigator / clinician. In our society to be compensated for injury caused to a person by another it is necessary to prove fault, ordinarily negligence or breach of contract.

In a happily limited number of cases research caused injury may occur but it is impossible to prove negligence or breach of contract. When I say research caused I mean that participation in the research causing injury and typically economic loss can be shown to have had an cause and effect relation to the research undertaken. At the same time fault (negligence on the part of research sponsor or investigator or breach of a clinicians or researcher's duty of care) may not exist.

Where fault does not exist when research caused injury results the research subject bears the entire cost of participation in a research protocol because the research caused injury is not compensable. That research subject may loose his livelihood. We do not have no fault insurance in the medical / hospital sphere. Negligence or other form of fault has to be proved. What about the research subject who cannot prove fault in order to be compensated despite that fact that his / her loss was clearly research cause but without negligence or breach of contract?

This has lead me to two questions:

1. how do we (should we) deal with the question of non-compensable research caused injury in IRB processes?

2. should the existence of non-compensable research caused injury be put forward to and explained to a research subject as a risk of participation in research?


H R Kloppenburg

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Subject: Re: [Ethics] Non compensable research injury?

As you surmise, this is an issue that occupies far more of our time than I would care for.Perhaps the first necessity is to define research related injury, to make sure we are all on the same track.

If we define this loosely as harm or discomfort that occurs in a context of research that would not have occurred if the subject had not participated, then this is a common phenomenon, which we glibly refer to as AEs. Usually these are taken care of fairly easily, occasionally they are serious and lead to hospitalisation, serious injury, disability or death. In most cases the health care system picks up the tab. However if the subject then has longer term sequelae, needs expensive medications, is disabled, or off work with loss of remuneration, a situation exists which would not be covered by the health care system.

I would think that in many cases these are not due to 'negligence' or 'failure to provide care' but to the nature of the intervention and the underlying disorder. this I believe is what is being referred to here as non compensable research caused injury. This is a forseeable risk of participation in research, and has to be balanced against potential benefit (which may be slight to negligible).

However the question is does a reasonable person, "fully informed", actually realise this? - and how can it best be explained.

As in the previous correspondence, some sponsors offer "compensation" under these circumstances (Which I think I am hearing may be a misnomer). Whether they actually pay up, and how they determine the amount of redress without litigation is a mystery.

So, yes, we may have underplayed the financial risks to participants.

From: "H R Kloppenburg" <hrk@kloppenburg.ca>
Subject: [Ethics] Non compensable research injury?

This responds top Dr Goodyear's Reponse to my comments Non compensable research injury

TO avoid the discussion getting off the track, I refer to my email 2003-09-04 which defined functionally compensable research caused injury. I use the word caused because the law and legal liability uses the language of cause.

I quite deliberately did not use the language research related. . I am concerned about the very real scenario wherein a research subject suffers significant or trivial research caused injury without legal fault on the part of investigator, clinician, or research sponsor (i.e. without provable negligence or breach of professional duty)

Should the research subject have to bear the cost of having participated in the research protocol throughout the rest of his / her life because the subject cannot prove fault or liability liability despite the fact that the injury and loss have a cause and effect relation to participating in the research protocol? And if so, should the subject be warned?

Research caused injury where a sustainable and successful claim in law exists is a subset of the larger set of research caused injury. Thus:
When a research subject suffers a research caused injury, the research subject has a claim in law against the person causing such injury e.g. investigator or clinician or research sponsor such as a pharmaceutical manufacturer or both where the research subject can show:

1. negligence on the part of the investigator or research sponsor (I will not define negligence here other than to say negligence means a failure to meet a standard of care which results in an injury or loss which ought to have been foreseeable and which a reasonable researcher clinician or research sponsor should have foreseen);

2. failing to perform a contract to provide care, e.g. where the a investigator / clinician administers a research drug or continues to do so when warning signs appear (this is practically the same as negligence but needs a separate characterisation.
These statements are another way of saying that compensation is available only when fault can be shown. A compensable research caused injury or loss results when fault can be shown

H R Kloppenburg.

On September 4, 2003 11:14 AM, Michael Goodyear wrote:

Date: Thu, 04 Sep 2003 14:14:36 -0300
From: Michael Goodyear
To: ethics@lists.ncehr-cnerh.org
Subject: Re: [Ethics] Non compensable research injury?

As you surmise, this is an issue that occupies far more of our time than I would care for.

Perhaps the first necessity is to define research related injury, to make sure we are all on the same track.

If we define this loosely as harm or discomfort that occurs in a context of research that would not have occurred if the subject had not participated, then this is a common phenomenon, which we glibly refer to as AEs. Usually these are taken care of fairly easily, occasionally they are serious and lead to hospitalisation, serious injury, disability or death. In most cases the health care system picks up the tab. However if the subject then has longer term sequelae, needs expensive medications, is disabled, or off work with loss of remuneration, a situation exists which would not be covered by the health care system.

I would think that in many cases these are not due to 'negligence' or 'failure to provide care' but to the nature of the intervention and the underlying disorder. this I believe is what is being referred to here as non compensable research caused injury. This is a forseeable risk of participation in research, and has to be balanced against potential benefit (which may be slight to negligible).

However the question is does a reasonable person, "fully informed", actually realise this? - and how can it best be explained.

As in the previous correspondence, some sponsors offer "compensation" under these circumstances (Which I think I am hearing may be a misnomer). Whether they actually pay up, and how they determine the amount of redress without litigation is a mystery.

So, yes, we may have underplayed the financial risks to participants.


>>> hrk@kloppenburg.ca 09/04/03 01:30PM >>>
I have for a long time wondered about the need to include in a consent to be a research subject a provision referring to non compensable research caused injury. I will explain that term as I proceed.

When a research subject suffers a research caused injury, the research subject has a claim in law against the person causing such injury e.g. investigator or clinician or research sponsor such as a pharmaceutical manufacturer or both where the research subject can show:

1. negligence on the part of the investigator or research sponsor (I will not define negligence here other than to say negligence means a failure to meet a standard of care which results in an injury or loss which ought to have been foreseeable and which a reasonable researcher clinician or research sponsor should have foreseen);

2. failing to perform a contract to provide care, e.g. where the a investigator / clinician administers a research drug or continues to do so when warning signs appear (this is practically the same as negligence but needs a separate characterisation.

These statements are another way of saying that compensation is available only when fault can be shown. A compensable research caused injury or loss results when fault can be shown. And I might add, if medical knowledge is to be expanded risks must be incurred and some of those risks will be realised despite no want of care.

The problem I see is this: in a small number of cases a research caused injury will occur without negligence though a cause and effect relation between the carrying out of the research protocol and the subject's injuries may appear, Alternatively in a small number of cases without the investigator / clinician having failed in his contractual duty of care to his / her patient may result in research caused injury without fault.

This is what I mean by non compensable research caused injury: injury without fault on the part of the research sponsor or investigator / clinician. In our society to be compensated for injury caused to a person by another it is necessary to prove fault, ordinarily negligence or breach of contract.

In a happily limited number of cases research caused injury may occur but it is impossible to prove negligence or breach of contract. When I say research caused I mean that participation in the research causing injury and typically economic loss can be shown to have had an cause and effect relation to the research undertaken. At the same time fault (negligence on the part of research sponsor or investigator or breach of a clinicians or researcher's duty of care) may not exist.

Where fault does not exist when research caused injury results the research subject bears the entire cost of participation in a research protocol because the research caused injury is not compensable. That research subject may loose his livelihood. We do not have no fault insurance in the medical / hospital sphere. Negligence or other form of fault has to be proved. What about the research subject who cannot prove fault in order to be compensated despite that fact that his / her loss was clearly research cause but without negligence or breach of contract?

This has lead me to two questions:

1. how do we (should we) deal with the question of non-compensable research caused injury in IRB processes?

2. should the existence of non-compensable research caused injury be put forward to and explained to a research subject as a risk of participation in research?


H R Kloppenburg

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From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Subject: Re: [Ethics] Non compensable research injury?

That might be an important distinction which some have overlooked (caused vs related). However it would seem to me that that in itself gets into the question of criteria for causality and on whom the onus is placed for demonstrating this.

As far as I know, the phrase 'related' is the one most commonly used in consent forms. It is certainly helpful to be reminded of the legal phraseology.

If I understand correctly, subjects who find themselves in this position, and for whom the sponsor does not specifically provide for compensation, may sustain considerable economic harm. Should they be aware of this - yes. Can we predict the likelihood - probably not very well or we wouldn't be asking the research question.

From: "H R Kloppenburg" <hrk@kloppenburg.ca>
Subject: Re: [Ethics] Non compensable research injury?


It has been long established that a person who alleges s/he is victim and invokes the courts to get compensation bears the onus of proving it i.e. that negligence has occurred causing injury / loss loss or a breach of duty of care causing injury / loss has occurred.

When a is before the courts or is in litigation (that is the situation I was dealing with) legal standards of proof (preponderance of evidence) supecede all other standards that researchers may apply or want to apply.

Thus let us come back to my point: is a research subject entitled to be told in order to obtain informed consent that s/he may suffer a research caused injury which is non negligent and not a breach of contract and thus serious injury / loss may be non compensable.

I still don't have anyone responding to this very real question: should the research subject have to bear the cost (whether loss of income, or physical or mental impairment) of having participated in the research protocol throughout the rest of his / her life because the subject cannot prove fault or liability liability despite the fact that the injury and loss have a cause and effect relation to participating in the research protocol?

HRK

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Subject: Re: [Ethics] Non compensable research injury?

It is really time someone else had a go at this! Thank you for the clarification for the burden of proof. As I mentioned earlier that is in itself a burden to place on the injured volunteer.

The answer to the question of whether subjects should be told - the principles of fully informed consent would dictate yes. How to explain it elegantly, truthfully and in a comprehensible manner is another matter.

The second question would appear to be an ethical as well as a legal one in terms of the investigators, sponsor's and institution's responsibilities to the research subject. Whereas the part of the question dealing with cost is addressable, the part dealing with loss of capacity is more difficult, other than the normal duty to care.

I think you appear to have raised a real question about the liabilities of research, and who should shoulder the burden in the event of harm. In terms of institutional and sponsor's insurance which would seem to be the obvious starting point, the question that needs to be addressed is whether misadventure should be treated differently for research subjects than non-research subjects. Does volunteering raise the moral responsibility of those involved as opposed to the forseeable risks of standard clinical intervention?

From: "H R Kloppenburg" <hrk@kloppenburg.ca>
Subject: Re: [Ethics] Non compensable research injury?

Sadly, insurers only pay for legal liability of their insureds. They don't make payments on a social policy basis. That is a reason for my frustration. The solution to the problem is either legislation or finding an appropriate means of putting to the research subject the risk of non compensable research caused injury.

Best regards,

HRK

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Subject: Re: [Ethics] Non compensable research injury?

It might be worthwhile to see to what extent this has been addressed.

TCPS and division C5 are silent.

GCP (5.8) appears to hide behind the regulator in terms of the responsibilities of the sponsor:

5.8 Compensation to Subjects and Investigators

5.8.1 If required by the applicable regulatory requirement(s), the sponsor should
provide insurance or should indemnify (legal and financial coverage) the
investigator/the institution against claims arising from the trial, except for claims
that arise from malpractice and/or negligence.
5.8.2 The sponsor's policies and procedures should address the costs of treatment
of trial subjects in the event of trial-related injuries in accordance with the
applicable regulatory requirement(s).
5.8.3 When trial subjects receive compensation, the method and manner of
compensation should comply with applicable regulatory requirement(s).

As far as consent goes, we have:

(g) The reasonably foreseeable risks or inconveniences to the subject and,
when applicable, to an embryo, fetus, or nursing infant.

(j) The compensation and/or treatment available to the subject in the event
of trial-related injury.

(l) The anticipated expenses, if any, to the subject for participating in the
trial.

The FDA as a regulator is more explicit:

(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
Informed consent documents should describe any compensation or medical treatments that will be provided if injury occurs. If specific statements cannot be made (e.g., each case is likely to require a different response), the subjects should be informed where further information may be obtained. The consent should also indicate whether subjects will be billed for the cost of such medical treatments. When costs will be billed, statements such as "will be billed to you or your insurer in the ordinary manner," "the sponsor has set some funds aside for medical costs related to.... Here's how to apply for reimbursement if you think you might be eligible" or "no funds have been set aside..." are preferred. Statements such as: "will be the responsibility of you or your insurance company" or "compensation is not available," could appear to relieve the sponsor or investigator of liability for negligence, see 21 CFR 50.20.
Compensation v. Waiver of Subject's Rights
The consent document must explain whether there is compensation available in case of injury but must not waive or appear to waive the rights of the subject or release or appear to release those conducting the study from liability for negligence. When no system has been set up to provide funds, the preferred wording is: "no funds have been set aside for" "[the cost] will be billed to you or your insurance," or similar wording that explains the provisions or the process. Wording such as: "will be your responsibility or that of your third-party payor" has been erroneously interpreted by some subjects to mean the insurance company is required to pay.


OHRP echoes this by pointing to the to applicable Federal Regulation (46.116) from which the FDA (6) is taken verbatim

CIOMS says 5(23ff):


the extent of the investigator's responsibility to provide medical services to the participant;


that treatment will be provided free of charge for specified types of research-related injury or for complications associated with the research, the nature and duration of such care, the name of the organization or individual that will provide the treatment, and whether there is any uncertainty regarding funding of such treatment.


in what way, and by what organization, the subject or the subject`s family or dependants will be compensated for disability or death resulting from such injury (or, when indicated, that there are no plans to provide such compensation);


whether or not, in the country in which the prospective subject is invited to participate in research, the right to compensation is legally guaranteed;

From: "H R Kloppenburg" <hrk@kloppenburg.ca>
Subject: Re: [Ethics] Non compensable research injury?

I will reply to your citation of references by interlineation in Times Roman Font in red and indented.

Since the discussion has now gone to regulations, I feel constrained to respond. The relationship between regulations and the law generally has to be discussed. The usual rule is that regulations do not create substantive law liabilities or rules creating such liabilities. The civil law of Canada and the provinces provides for liability.

HRK

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Non compensable research injury?
Date: Friday, September 05, 2003 8:02 AM

I am not sure how much further we can take this. A search of the NCEHR list (courtesy of Michael Wilson at McMaster) shows that his has been extensively deabated since the inception of this list, and probably is the commonest cause of disagreement between our REB and sponsors. Others appear strangely quiet on the issue.

I will observe that as far as as REBs go, in Canada there is not much Regulation per se, but more of the nature of guidance.

The point about regulation vs Law is well taken.

I think that what REBs need to consider in this light is:

The need to minimise risk
The need to ensure that subjects are fully informed about risks, and likely to comprehend

Exactly how we can ensure people comprehend noncompnable risk is challenging

>From an ethical perspective, I think the most important question is whether institutions should be held to a higher standard in the presence of misadventure to a subject engaged in research, than they are to any other person receiving care at that institution.

Here we are in the realm of Justice, ethically speaking, in terms of the distribution of burdens .

>From the REBs point of view, the duty is to ensure that the burdens of research do not fall unevenly on any sector of society.

>>> hrk@kloppenburg.ca 09/04/03 08:14PM >>>

I will reply to your citation of references by interlineation in Times Roman Font in red and indented.

Since the discussion has now gone to regulations, I feel constrained to respond. The relationship between regulations and the law generally has to be discussed. The usual rule is that regulations do not create substantive law liabilities or rules creating such liabilities. The civil law of Canada and the provinces provides for liability.

HRK
On September 4, 2003 4:15 PM, Michael Goodyear wrote:

Date: Thu, 04 Sep 2003 19:15:07 -0300
From: Michael Goodyear
To: ethics@lists.ncehr-cnerh.org
Subject: Re: [Ethics] Non compensable research injury?

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Non compensable research injury?
Date: Friday, September 05, 2003 6:11 PM

While people are thinking carefully about the questions raised by my learned colleague I thought I would add this contribution, which in essence raises the question as to just how much of a hurdle do the courts present to the establishment of negligence? I suspect that this is not an entirely impartial view.


Inadequate justice when medical negligence is alleged

Sir--The English legal system came to Australia with the First Fleet in 1788, and with it the two distinctly different levels of proof that are used in the civil and criminal jurisdictions.
For two decades professional liability premiums for doctors have increased exponentially in Australia, and yet the standards of practice have, if anything, steadily improved. The average life expectancy has risen greatly, for the most part as a result of doctors doing a better rather than a worse job, using numerous technical advances in pharmacology and surgery.
One has to ask, why are the insurance premiums rising so fast when the insurance companies are not seemingly making vast profits?
Plaintiff lawyers are certainly vigorous in Australia, especially with the no-win-no-fee arrangements permitted by our laws. But plaintiff lawyers have to fight cases on behalf of their clients (our patients) within the legal system. So what is wrong with the tort law system?
There is an inherent defect, inherited from the British system, and it lies in the absurdly low level of proof to be hurdled by plaintiffs in civil courts, where negligence cases are fought.
In civil courts, the level of proof is "on the balance of probabilities". Such proof amounts to barely more than the toss of a coin. Judges and juries are constantly being confronted by plaintiffs who have had misfortunes, often serious misfortunes, with respect to medical outcomes. In a courtroom, it is well known that the defendant doctor will be insured (it is a legal prerequisite for medical registration in New South Wales), insurance companies have money to be disbursed, and the government is unlikely to help the plaintiff if the court does not.
That instances of bad luck and instances of errors of judgement made in good faith are both commonly found to be instances of negligence in our courts, when in fact neither amounts to negligence, is not therefore too surprising.
But, how unfair is this for the defendants? The loss of self-esteem, the loss of reputation, the waste of time in insurers' offices, in barristers' chambers, in courtrooms, the loss of earnings, the out of pocket legal expenses, etc, all add up to a more severe punishment than a common felon might face for robbing a bank. The common felon also gets more justice from our legal system, since in a criminal court, the level of proof is "beyond reasonable doubt".
There is only one answer to the rise in insurance premiums and that is to restore justice to the consideration of any allegations of negligence by replacing the civil court proof level with the criminal court proof level. Once done, not only will ridiculous claims fail when they get to court, but the much greater number of claims that are settled out of court for expedience and other reasons will also cease to benefit plaintiff lawyers and disgruntled plaintiffs who want financial recompense for bad luck.
In Australia there is a growing call for the more rigorous level of proof. Hopefully, this change will become a worldwide one, so that doctors can stop practising defensive medicine and get back to simply practising good medicine.
John R Graham

From: "Luc Simon" <Luc.Simon@vrr.ulaval.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Non compensable research injury?
Date: Saturday, September 06, 2003 12:10 AM

It is my understanding that, given our public health system¹s universal
coverage, any medical treatment that is needed will be provided to the
subjects. I was told, albeit unofficially, that in Quebec (and probably in
the ROC)
health authorities did realize that they were in effect ³subsidizing the
sponsors² by having the public health system cover these costs, but that it
was 1) probably cost effective and respectful of the subjects and 2) almost
negligible compared to the other ³tax breaks and other financial incentives²
that are generally available to research sponsors.

Moreover, many researchers strongly believe that given the shortcomings of
our public health system, research subjects actually receive better medical
care than the general population, at least in term of access to medical
resources, and some would even like to say so in the recruitment process...

LS

From: "H R Kloppenburg" <hrk@kloppenburg.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Non compensable research injury?
Date: Saturday, September 06, 2003 1:07 PM

M Simon:

I will respond to you useful discuss here by interlination in bold font like this. I am delighted to participate in this to and froing about an important question the answer to which can affect research subject profoundly.

On September 5, 2003 9:59 PM, Luc Simon wrote:

Date: Fri, 05 Sep 2003 23:59:56 -0400
From: Luc Simon
To: ethics@lists.ncehr-cnerh.org
Subject: Re: [Ethics] Non compensable research injury?

It is my understanding that, given our public health system’s universal coverage, any medical treatment that is needed will be provided to the subjects. I was told, albeit unofficially, that in Quebec (and probably in the ROC)
health authorities did realize that they were in effect “subsidizing the sponsors” by having the public health system cover these costs, but that it was 1) probably cost effective and respectful of the subjects and 2) almost negligible compared to the other “tax breaks and other financial incentives” that are generally available to research sponsors.

I suspect you are right. I doubt this is empirically demonstrable. However, this is only part of the question. Who covers the economic loss and extra-hospital cost of care for a research subject subject who suffers a catastrophic loss? Have we (meaning QC and the other provinces of Canada) developed a social policy and remedial law to deal with economic loss and extra-hospital cost of care for a research subject subject who suffers a catastrophic loss as a result of an unforeseen and unforeseeable risk. In making these comments I do not want to be seen as hostile to research based pharaceutical manufacturers ( I own shares in several of them without considering I have a conflict of interest in making these observations). I believe a social policy reflected in law which assigns costs to the person who stands to benefit economically from the carrying out of research is to be preferred to one that mades research subjects pay. Where a research mishap has occurred, a priori the research subject has not benefitted. HRK 2003-09-06

Moreover, many researchers strongly believe that given the shortcomings of our public health system, research subjects actually receive better medical care than the general population, at least in term of access to medical resources, and some would even like to say so in the recruitment process...
I suspect you are right. I doubt this is empirically demonstrable. If that is so, is that a good basis for the social policy now reflected in the substantive law which allocates the cost of a medical mishap to the person who volunteers to participate in research protocol where the risk of injury and loss realized is unforeseen and unforeseeable? HRK 2003-09-06


HRK
LS

(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. Informed consent documents should describe any compensation or medical treatments that will be provided if injury occurs. If specific statements cannot be made (e.g., each case is likely to require a different response), the subjects should be informed where further information may be obtained. The consent should also indicate whether subjects will be billed for the cost of such medical treatments. When costs will be billed, statements such as "will be billed to you or your insurer in the ordinary manner," "the sponsor has set some funds aside for medical costs related to.... Here's how to apply for reimbursement if you think you might be eligible" or "no funds have been set aside..." are preferred. Statements such as: "will be the responsibility of you or your insurance company" or "compensation is not available," could appear to relieve the sponsor or investigator of liability for negligence, see 21 CFR 50.20.

I am curious as to whether any readers of this list have seen a diclosure in a pharmaceutical manfacturer acceptable informed consent form that the research sponsor does not provide compensation for realizaton of unforeseen risks in carrying out a research protocol. HRK

========

I still don't have anyone responding to this very real question: should the research subject have to bear the cost (whether loss of income, or physical or mental impairment) of having participated in the research protocol throughout the rest of his / her life because the subject cannot prove fault or liability liability despite the fact that the injury and loss have a cause and effect relation to participating in the research protocol?

HRK

A couple of thoughts:

Can we translate “a research mishap that is unforeseeable and therefore non-negligent” to “an accident” ? Accidents do happen. Should research subjects be treated any differently than other patients ? Accidents do happen during regular care, and we are generally satisfied that the patients are “informed” of the possible outcomes and of the nature of the risks associated with various medical procedures. We also want research subjects to be even “better informed”, but we can presume that they are willing to assume at least the level of risk associated with the normal care of other patients.
The law is clear. Research subjects are entitled to a higher level of disclosure of the risk to be run in participating as a human subject in medical research. Presuming that [research subjects] are willing to assume at lease the level of risk associated with the normal care of other patients is not in my view permissible having regard to judicial statements as to the standard of disclosure required to obtain informed consent in a research context. Courts will not allow researchers / investigators to make assumptions about willingness to assume research risks. HRK 2003-09-06

Les us consider other areas of activity in our society. Every province has workers' compensation laws which provide compensation regardless of fault for accidents in the course of employment. Everyone who works know there are foreseen and unforeseeable accidents and risks of personal injury with economic consequences in everyworkplace. For example, carcinogens may appear in an industrial workplace as a byproduct of industrial processes. I believe there have been notable examples in QC. Denying compensation to victims of unforeseen and foreseeable medical research accidents is quite like denying worker's compensation benefits to a worker has been exposed to a carcinogen in the workplace and has suffered the consequence. HRK 2003-09-06

Every province that I know of including QC has motor vehicle insurance legislation which provides economic benefits for catastrophically injured persons regardless of fault. Motor vehicle insurance regimes across Canada including QC insure without regard to fault persons who are injured in motor vehicle accidents. While politicians may offer many reasons for this one reason I suggest that one reason for allocating the cost of care of catastrophically injured motor vehicle accident victims is that other drivers through their insurance should bear this cost as opposed to putting in on taxpayers generally through social assistance programs. HRK 2003-09-06

If it was decided that some sort of “compensation mechanism” should be put in place to lighten the burden of an accident for research subjects, where should the line be drawn ? Should a car accident on the way to the clinic be compensated ? Does it matter if this particular visit to the clinic was a requirement of the research protocol (cause and effect relation to participating in the research protocol, other patients would not have been followed so frequently) ? Would it be fair to provide compensation only to research subjects, if the more frequent visits to the clinic were already construed as a “benefit” for the research subjects ?

It is certainly possible to engage in an analysis of the difficulties inherent in devising a plan which will compensate individuals who suffer the sad consequences of unforeseen and unforeseeable risks of medical research. However, these problems have been dealt with successfully, more or less, without causing social unrest in the context of workers' compensation laws and automobile insurance (and I am sure many other contexts too). Difficulty in attacking this problem should not be allowed as a reason for shirking an attempt to resolve it especially where catastrophic injury is concerned. HRK 2003-09-06

=========
Luc Simon

Conseiller en gestion de la recherche
Vice-rectorat a la recherche
Université Laval
Telephone: (418) 656-2131 - poste 5301
Telecopieur: (418) 656-2506
Email: Luc.Simon@vrr.ulaval.ca

11. Records Retention Schedule

From: "Paul Hebbard" <pgh@sfu.ca>
Subject: [Ethics] Records Retention Schedules

Hi all,

Several months ago I solicited advice on this listserv regarding the
retention of records related to the administration of the Tri-Council's
ethics review process at universities. I received several emails
expressing interest in this subject. I have now drafted seven Records
Retention Schedules and Disposal Authorities (RRSDAs) that delineate
how long records need to be kept by Simon Fraser University's Office of
Research Ethics and its Research Ethics Board. I would like to thank
everyone who responded to my query. For those of you who are still
interested in this subject, please see the links below. Thanks again.

http://www.sfu.ca/archives/dur-rrsdas/2003-001.html
http://www.sfu.ca/archives/dur-rrsdas/2003-002.html
http://www.sfu.ca/archives/dur-rrsdas/2003-003.html
http://www.sfu.ca/archives/dur-rrsdas/2003-004.html
http://www.sfu.ca/archives/dur-rrsdas/2003-005.html
http://www.sfu.ca/archives/dur-rrsdas/2003-006.html
http://www.sfu.ca/archives/dur-rrsdas/2003-007.html
________________________________________________________
Paul Hebbard, M.A.S., M.L.I.S.
Records Management Archivist
Archives and Records Management Department
Simon Fraser University
8888 University Drive
Burnaby, BC V5A 1S6

BUS: (604) 291-4321
FAX: (604) 291-4047
E-MAIL: hebbard@sfu.ca
WEBSITE: http://www.sfu.ca/archives/
_________________________________________________

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
Subject: Re: [Ethics] Records Retention Schedules

Hello Paul ... iappreciate the sharing of your excellent work that carries
a quality of a "best practice" about it.

I remember the List discussion surrounding records retention also revealed
uncertainity over the length of time investigators conducting clinical
trials on behalf of sponsors, are required to keep the study documentation
on-site.

Also at the CAREB AGM there was a view expressed that investigators need to
retain the study records for 25 years. I'm not convinced that the Food and
Drugs Act requirement for sponsors to retain CT records for 25 years
applies to investigators. I've heard some sponsors insist this is the
case, and thus investigators are sending these CT files to Archivex at
additional cost to the study or the institution.

Since hospital records are retained for 10 years at our place, this is the
benchmark we think we'll base our policy on.

Do you or others have an opinion on this?

Elisabeth Clark
Research Ethics Officer/Human Protections Administrator
McGill University Health Center

 

From: "Jack Corman" <irbs@interlog.com>
Subject: Re: [Ethics] Records Retention Schedules

1. The Food and Drug Act itself is silent on the record storage question as
far as I know, it is the Clinical Trials regulations that specify that
sponsors are to retain trial related records for 25 years. The Inspectorate
has determined that sponsors should encourage stakeholders to also retain
study related documents for 25 years. Some companies have accepted the
Inspectorate¹s determination and are asking investigators to comply (even
paying for storage), others have not.
2. There is no specific mention of study record retention requirements for
REBs in the regulations. Our standard is to exceed the ICH GCP E6
requirement of retention for 3 years after the completion of the trial.
3. Clinical Trial Regulations do not apply to every clinical trial. The
regulations do state that GCP should be observed even where they do not
specifically apply, e.g., phase IV study. Presumably, this means that
record retention for those kind of studies could be what ICH GCP requires,
i.e., 3 years post study completion. Alternatively, for clinical research
where no drug or device is used and hence the regulations have no
application, e.g., cognitive therapy, surgical intervention, nursing care
models, etc., etc., the regulations are silent. Presumably, one will choose
to be consistent to avoid the need to differentiate clinical trials that are
covered by the regulations and those that are not.

Jack Corman

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Subject: Re: [Ethics] Records Retention Schedules

I would love to see how easy it will be to retrieve this material in 25 years and what shape it will be in.

12. Third Party Insurance

From: "Henry Monks" <monks_henry@yahoo.com>
Subject: [Ethics] Third Party Insurance

Perhaps this is not the right forum to address my query. Does anyone consider it counterintuitive to allow a Sponsor to require that all of the insurance available to Study Subjects - ie. OHIP and Private Third Party Providers - be accessed prior to compensation by Sponsor?

From: <skb@mun.ca>
Subject: RE: [Ethics] Third Party Insurance

Our compensation statement does not allow mention of provincial health
insurance, etc. - only that the sponsor will pay for injury as a direct
result of taking part in the research if they have followed the directions
of the research staff (it is worded a bit more elegantly than this).
Richard has checked with a couple of sponsors who say they have never paid
out which makes you wonder whether the province and third parties are.

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: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Subject: Re: [Ethics] Third Party Insurance

This or related issues come up quite a bit. In some ways it is a storm in a teacup since it is very unlikely that the issues will even arise. We tend to steer such discussions as to who will pay for what away from consent forms to contracts. All subjects need to be aware of is that they will be taken care of. The issue really relates to liability for lost wages, long term disability etc. Acute medical care would normally be taken care of in Canada. However I think Nova Scotia is the only province where the there is a formal agreement between the Health Insurance scheme and us to do so.

Some people take the attitude that the sponsor should pay for everything, which would mean that provincial insurance schemes would then need to cost out the exercise and go after the sponsor for reimbursement, which is not very practical.

We take the attitude that many sponsors (eg CIHR, NCIC) do not have the resources anyway, s o this only applies to industry studies. In which case we see it as an optional offer, and therefore they can define the conditions to some extent provide it is not seen in way as limiting liability (exculpatory). I suspect that the sponsors main concerns are always to protect themselves. Anyone know how often one has actually paid out?

In the last resort the subject always has the legal system to seek redress, but none of us would like to see subjects shouldering that burden as a result of participating in research.

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Subject: RE: [Ethics] Third Party Insurance

We have accepted 'direct' but draw the line at phrases like 'following directions'. However in either case the sponsor gets considerable 'wriggle room' and can can probably argue their way out of paying anything. How do you prove any of these conditions. To us it smacks of limiting liability. Stop burdening subjects with these legal niceties - tel them that their medical needs will be taken care of.

Recently we have accepted NCIC's insistence that we say there is no compensation, but it is difficult to word this gently.

From: "H R Kloppenburg" <hrk@kloppenburg.ca>
Subject: [Ethics] Third Party Insurance


I have served on an IRB and have recognized the attempts of research sponsors to avoid having to meet their legal liabilities to cover cost of care caused by culpable research caused injury.

I am not sure whether counterintuitive is the right word here. It seems to me to be a clear question of economics. It is question of research sponsors wanting to shift the cost of a mishap onto the research subject, i.e. by requiring the research subject to rely upon his or her personal insurance whether public or private until it runs out and at that point only having the research subject who has a research caused injury look to the research sponsor for insurance benefit / indemnity. The research subject by his/her taxes or personal income covers the cost of public or private health insurance by his / her premiums or taxes. Thus the research sponsor wants a free ride if a mishap occurs until the public and private insurance run out. Is this sound social and research policy? I this an ethical issue or is it just economics?

If a research caused injury ends up in litigation based on an allegation of fault against the research sponsor or investigator, it matters not which, in several provinces the research subject is bound to include in his / her action a claim for the amount of money which provincial health insurance has had to pay out to provide care for the research caused injury. When I researched this some years ago I was told that this provision went back to the Federal Provincial agreements of the mid fifities on cost sharing for hospital insurance. I have not looked at the primary documentary sources. When one sees a provision in a research consent form wherein the research subject agrees not to look to the research sponsor or investigator for compensation until his / her private or publicly funded health insurance has run out, this is typically an attempt to have the research subject contract out of the provincial law requiring subrogation for the provincial health plan. And private premium health plans and income loss insurance have the same subrogation features now too. This is also an attempt to make the terms of an informed consent have contractual effect.

H R Kloppenburg QC BCL (Oxford).

13. Truth or Fiction - Tales from the Trenches

From: "Laurel Evans" <levans@mcmaster.ca>
Subject: [Ethics] Truth or Fiction: Tales from the Trenches

I am hoping to obtain some assistance from those of you who are involved
in Social Sciences/ Behavioural research. In preparation for an
upcoming presentation, NCEHR and McMaster are seeking examples of
situations where input from the Social/Behavioural REB has been
effective in forestalling possible "problematical" situations in
research. We are looking for both "silly" situations (i.e. researchers
propose the silliest things) and for "serious" situations, i.e.
situations where even though the research is behavioural / non-medical,
the potential risks / harms to participants have been potentially
"significant" and REB intervention has been important. If you could
respond off-list to levans@mcmaster.ca, or even telephone me at (905)
525-9140 ext. 26117 to discuss, that would be wonderful. Any eventual
use of the scenarios will be disguised to ensure researcher/institution
confidentiality. Thanks in advance for your anticipated assistance.

From: <will@unb.ca>
Subject: Re: [Ethics] Truth or Fiction: Tales from the Trenches

Dear Laurel:
One of the best pieces on ethics in "behavioral" research is
by Elizabeth Murphy and Robert Dingwall, "The Ethics of
Ethnography" which is found on pp. 339-351 in Paul
Atkinson et al, eds. (2002) Handbook of Ethnography.
London and Thousand Oaks, CA: Sage. They give many
interesting examples about unintended risks, etc.

I am hoping you will have an opportunity to delve into the
subtleties of e.g. ethnographic research: "silly" research may
abound everywhere, not just in "behavioral" research and
that ritualistic observation of codes may actually increase
the risk of harm by blunting ethnographers' sensitivities.
Research participants can exercise enormous power over
the researcher and that, too, pits a particular glow on what
constitutes risk. Risks or dangers can come from quite
unexpected [sic] quarters. It's a complex research world
and I hope you have a chance to demonstrate that so that
we all can approach the subject with a great deal more
understanding.
With kind regards, Will C. van den Hoonaard (UNB)
--
"... 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

14. Update OHRP Guidelines on Expedited Review

From: "Marie Buy" <mbuy@cyberus.ca>
Subject: [Ethics] Fw: Updated OHRP Guidance on Expedited Review Procedures
Date: Wednesday, September 24, 2003 11:33 AM

I believe the following information might be of interest to our ethics community:

Subject: Updated OHRP Guidance on Expedited Review Procedures


The Office for Human Research Protections (OHRP) has updated its guidance on Expedited Review Procedures. You can find the revised guidance document, Guidance on the Use of Expedited Review Procedures, at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/exprev.htm The revised document consolidates guidance regarding expedited review found in two earlier guidance documents: (1) Expedited Review of Certain Research by Institutional Review Boards (OPRR Reports, January 6, 1999) and (2) Exempt Research and Research That May Undergo Expedited Review (OPRR REPORTS, May 5, 1995).

Bien à vous,

Marie Buy