Summary of NCEHR Listserv for January 2003


TOPICS

1. Anonyimity and Confidentiality

2. Ethics Grad Course at UBC

3. Jurisdication and Review

4. MRIs and Sedation of Children

5. Ogden Subpoenaed Again

6. Participatory Action Research and Consent

7. PRE Nominations to Social Science Working Group

8. Minor Changes and Reconsent

 

1. Anonyimity and Confidentiality

Subject: [Ethics] anonymity/confidentiality
Date: Fri, 10 Jan 2003 10:50:45 -0600
From: Katherine Arbuthnott <Katherine.Arbuthnott@uregina.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

Hello all

Do any of your REBs have a good description of the difference between
anonymity and confidentiality, and what is required for each?

----------------------------
Katherine Arbuthnott
Department of Psychology
University of Regina
Regina, SK, S4S 0A2
Canada

Subject: Re: [Ethics] anonymity/confidentiality
Date: Fri, 10 Jan 2003 13:36:01 AST
From: "Lindley, Pat" <plindley@Kilcom1.UCIS.Dal.Ca>
Reply-To: ethics@lists.ncehr-cnerh.org
Organization: Dalhousie University
To: ethics@lists.ncehr-cnerh.org

hi Katherine,
Our 'working definition' of anonymity would relate to all aspects of the study
whereby the subjects identity might be linked to the research. Anonymity
becomes a concern (even if data is kept confidential) where mere
association with a study might pose a risk to individuals (for example, a list
of research participants is generated as back-up for compensation claims
and is processed through the financial system of an institution where the
study is on alchohol or drug addiction, or of compulsive gambling). THe
data which relates to the individual may never be directly linked to them
through the reported results (ie. confidentiality is safeguarded), but the fact
that they are participating in the study is now known to others. A similar
situation may occur when the comings and goings of research participants
may be observed in some settings (eg. where subjects are interviewed at
the workplace, or at school), and it is likely that others in the research
setting will infer participation in the study by these individuals. This could
be anyone in the vicinity, or just other research subjects who know that the
study is being conducted in a particular venue.

With focus groups it is clear that anonymity cannot be offered to individuals
(even if pseudonyms are used, people can visually be identified by other
focus group participants), and we ask that researchers explicitly point this
out, along with the fact that while confidentiality may be requested of all
focus group participants, it cannot be guaranteed by the researcher. In
other words, not only the identity of participants in the study is known to
others, but also information that they contribute can be directly linked.
Where there is highly sensitive information being shared, we suggest that a
simple confidentiality agreement be used with participants to underscore
the seriousness of the request for confidentiality.

Confidentiality has to do with who has access to the data and the ability to
link data to individuals. There are times when the ability to protect
anonymity and confidentiality are congruent, and times when clearly there
are separate measures needed to deal with each.

Pat Lindley

 

2. Ethics Grad Course at UBC

From: james frankish <frankish@interchange.ubc.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org, ethics@lists.ncehr-cnerh.org
CC: ccole@interchange.ubc.ca, abest@vanhosp.bc.c, shirley.thompson@ors.ubc.ca,
annaleey@aol.com, vpr@interchange.ubc.ca

Hello
We are developing a graduate-level course on Human Ethics and
Community-Based Research. The course will be part of our CIHR-MSFHR funded,
research-training program on Community Partnership research. It will
provide one part of a larger University initiative around ethics training.

The initial course be limited to human subjects (nonclinical) research
issues. The ethics of community-based research will be a particular focus.

We would greatly appreciate receiving any course syllabi, reading lists,
readings or other curricular material. We will be pleased to share whatever
we compile and develop with other members of the Ethics Listserve.

Thank you in advance for any assistance. Please feel free to share this
message with other potential sources of information or resources.

Best regards

Jim Frankish
Chair, Behavioural Research Ethics Board - UBC
Dr. C. James Frankish
Senior Scholar, Michael Smith Foundation for Health Research
Associate Director, Institute of Health Promotion Research
Associate Professor, Graduate Studies & Health Care & Epidemiology
Room 425, Library Processing Centre, 2206 East Mall Vancouver BC V6T 1Z3
Office: 604-822-9205 Private fax: 604-822-9228
IHPR Office: 604-822-2258, 604-822-9210
frankish@interchg.ubc.ca Web Site http\\www.ihpr.ub

o: ethics@lists.ncehr-cnerh.org

This email came at an interesting time for me. I was just reading about the
Community Based research program in the Government Science journal and was
wondering how Community based researchers deal with ethics issues. I was
going to make contact to find out, but couldn't find a phone number. Anyhow,
I am a PhD psychologist heading the Human Computer Interaction program at
the NRC. Currently, part of my work involves MusicGrid - a
multi-stakeholder, multi-partner video-mediated communication project that
focuses on music education. I have also sat on a REB for three years and
written about ethics in software engineering research.

Part of what I am doing for MusicGrid is examining ethical issues wrt to
qualitative and action research in the context of these types of projects.
For instance, what does it mean to get consent? How do you arrive at a
consent process, etc?

I would very interested to learn more about research ethics in the context
of Community Based Research. Any pointers would be greatly appreciated.

Thank you in advance,

Janice Singer
On Thursday, January 23, 2003, at 10:44 AM, james frankish wrote:

HelloFrom: "Helen Gardiner" <helen@thegardiners.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
Organization: H. Gardiner & Associates Inc.
To: <ethics@lists.ncehr-cnerh.org>

Hi Jim:

A course focussed on research ethics, particularly community-based research,
is a wonderful idea. The university ethics courses I'm aware of focus on
clinical or biomedical ethics and tend to be too short and non-specific for
such an important area.

Research ethics outside of biomedical work (i.e. social sciences,
qualitative enquiry, program evaluation, etc.) is the focus of my Ph.D.
dissertation. Since I'm already 1.5 years into it, I have quite a library
of material that may be useful to you. Are you looking for publications
that apply to Canada only or internationally? For instance, as you
undoubtedly know, researchers who work with colleagues in the U.S. or carry
out part of their work in the U.S. would also need to know about the Code of
Federal Regulations, Title 45, Part 46. They probably also need to know
about the NBAC Ethical and Policy Issues in Research Involving Human
Participants and may want to keep up with the new Secretary's Advisory
Committee on Human Research Protection, even though it is likely to be
focussed on biomedical research.

I also have some articles which examine the grey area between work that
requires REB review and that which does not. For example, there have been a
number of "Quality Assurance" articles published recently. QA is usually
assumed to not need review although in the case of the published work I am
aware of, the methods are virtually indistinguishable from "research" and
the ethical considerations are parallel. If you can tell me more
specifically what you intend to cover in the course, I can send along a
reading list.

Is your course going to be open to community-based researchers? Are you
going to discuss the differences between research which requires REB review
and that which does not? If so, are you going to talk about gaining access
to REBs when none of the community based researches are affiliated with a
university? I would appreciate being kept up to date on your progress and
the final content.

Cheers!

Helen Gardiner, M.Sc., Ph.D. (candidate)
University of Calgary

From: "George, Anne" <ageorge@cw.bc.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: "'ethics@lists.ncehr-cnerh.org'" <ethics@lists.ncehr-cnerh.org>
CC: "'mvanbibber@telus.net'" <mvanbibber@telus.net>

Helen

We are currently working on a contract for a major non-profit organization
in BC that wants to set up an ethical review board for community based
reseearch. It is complex.

I would like to talk to you, but am going on holidays for a week now. If
that is possible for you, could you give me your phone number and some
suggested times/dates that would be convenient for you.

I would like to phone you early in February. Your work may be very valuable
for this project, which is coming to an end.

Thanks,
Anne George

3. Jurisdication and Review

From: Charmaine Kabatoff <Charmaine.Kabatoff@usask.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

Hello,

I have a question regarding the TCP requirement for jurisdictional review
(Article 1.14). Particularly, what are the criteria that determine whether
an institution or agency has jurisdiction over a population, especially when
the researcher does not have an affiliation with either? For example, we
have a researcher from our university who wants to conduct street gang
research both here and in Vancouver. Typically, our REB would want
assurance that the researcher had contacted and obtained approval from the
appropriate REB from that jurisdiction. Given that the researcher has no
affiliation with any institution in Vancouver, to whom should the researcher
apply for ethical approval? According to the TCP, ethical approval should
be sought from the REB, where such exists, with the legal responsibility and
equivalent ethical and procedural safeguards in the country or jurisdiction
where the research is to be conducted. I would appreciate hearing what
other REBs do in this situation.
Thank you,
Charmaine Kabatoff

Subject: Re: [Ethics] A Question of Jurisdiction
Date: Tue, 28 Jan 2003 10:15:16 -0500
From: Bill Marr <bmarr@wlu.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

Since the researcher is from your university, your REB would need to
review and approve the project. Whether other approvals are necessary
almost has to be determined on a case-by-case basis because there are
several different circumstances that could arise. I think that in many
cases we would not require any other approvals. In our situation,
researchers at Laurier carry out human-participant research in, say,
Hamilton or Toronto or Ottawa without seeking the approval of the REB at
McMaster or the University of Toronto or the University of Ottawa or
Carleton. Now if the researcher is specifically seeking participants
from those universities, then I would say that the approval of their REB
would be required. Many social agencies, school boards, etc. also have
their own ethics boards, and their approval would need to be sought in
research involving their potential participants.

Charmaine Kabatoff wrote:

Subject: Re: [Ethics] A Question of Jurisdiction
Date: Tue, 28 Jan 2003 10:41:03 -0500
From: Michael Owen <mowen@spartan.ac.brocku.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

Charmaine,

I am not sure that this requires the review/approval of another REB. The
research is not international (another country) and the population does not fall
under the rubric of a community.

My sense would be that the U of S REB has jurisdiction over the research in
the same way as if the researcher was studying street gangs in another town or city
in Saskatchewan.

Michael

Subject: Re: [Ethics] A Question of Jurisdiction
Date: Tue, 28 Jan 2003 12:00:56 AST
From: "Lindley, Pat" <plindley@Kilcom1.UCIS.Dal.Ca>
Reply-To: ethics@lists.ncehr-cnerh.org
Organization: Dalhousie University
To: ethics@lists.ncehr-cnerh.org

HI Charmaine.
>
> I have a question regarding the TCP requirement for jurisdictional
> review (Article 1.14). Particularly, what are the criteria that
> determine whether an institution or agency has jurisdiction over a
> population, especially when the researcher does not have an
> affiliation with either? For example, we have a researcher from our
> university who wants to conduct street gang research both here and in
> Vancouver. Typically, our REB would want assurance that the
> researcher had contacted and obtained approval from the appropriate
> REB from that jurisdiction. Given that the researcher has no
> affiliation with any institution in Vancouver, to whom should the
> researcher apply for ethical approval?

REB's do not have any jurisdiction over any population... they have
jurisdiction only over the researchers who are affiliated with the institution
that the REB serves.

We ask our researchers to explain to us in sufficient detail the cultural
context where they plan to carryout their work, and we require that they
show that they have the appropriate permissions (for example, to access
school children, or hospital patients, or approach people in aboriginal
communities) and 'REB' approvals from the local organization, if they are
customarily done. The latter would primarily be relevant where hospital
patients are being recruited. However, there is not always an institutional
'gatekeeper' involved in recruiting subjects, in which case there is no REB
to get approval from. We have no central governance of research ethics in
Canada. However since the TCPS is the closest thing to a national
standard that we have, I would think that the project that you are doing is
OK, based on your own review.

It is when researchers travel to other countries that things get tricky. In
these situations, when researchers request a waiver of what we would
normally consider appropriate practice (eg. oral consent instead of signed
consent form) we ask that they explain to us why this is necessary.
Something more than "signed consent would be culturally unacceptable" is
needed. We also have someone with extensive international development
research sitting on our Board. When a thorny issue comes up, we will
sometimes seek advice or further information from someone at the
University who has first-hand knowledge of the cultural context.

The main point is that your REB does not have 'jurisdiction' over any
subjects... only over your researchers. A hospital may require that all
researchers who wish to access patients via the hospital be reviewed by
the hospital's REB. However it cannot prevent patients from participating in
a study outside of the hospital, should they so choose.

Pat LIndley

Subject: Re: [Ethics] A Question of Jurisdiction
Date: Tue, 28 Jan 2003 11:28:46 -0500
From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

Although the issue being discussed is from a social science perspective,
this can ofcourse apply to biomedical research. Within the jurisdiction
issue what is inherent to the discussion is the issue of central REB
review. Hopefully, we will get some clarity on the appropriate role in
Canada of *central board review*, public or private, from those working
with the *governance dossier*.

While i agree with Pat that "REB's do not have any jurisdiction over any
population", i think the one population where additional review of the
study objectives and methods must be done in addition to the original
review, would be research among First nations people, or other communities
where strong community developed traditions are evident ... elisabeth

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

Subject: Re: [Ethics] A Question of Jurisdiction
Date: Tue, 28 Jan 2003 13:18:22 -0500
From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
Reply-To: ethics@lists.ncehr-cnerh.org
To: NCEHR <ethics@lists.ncehr-cnerh.org>

Seems to me we are in that zone where ethics and law intersect. For example,
US law concerning biomedical and behavioural research (including ethical
oversight) is clear. Federally funded US researchers who comply with 45CFR,
with ethical oversight by their institution's ethics boards, have no barrier
conducting research in other countries, unless that country or other
political entity with legislative authority makes it illegal. Interestingly
enough, there does not seem to be any barrier to non-US IRB/REB review of
research conducted in the US so long as it complies with US law. Hence, one
can argue that Canadian researchers conducting research abroad should comply
with and be judged by Canadian standards, i.e., TCPS, as well as any local
laws of which the Canadian REB should be familiar.

At the end of the day, the objective is human research subject protection.
In Canada, the primary national guidance document to accomplish this goal is
the TCPS, and, for most biomedical research, certain federal legislation
(e.g., PIPEDA, Health Canada clinical trial regulations) govern, along with
provincial laws, e.g., age of majority variance, privacy legislation, etc.

Where the governance of research issue comes in is to verify that standards,
regulations and guidance for the ethical conduct of research are being
applied by everyone in the system, i.e., research funders, investigators and
ethics boards. Unfortunately, until there is an objective and independent
accreditation or verification body, there will be no good and transparent
way to know for sure which researchers/funders/REBs meet standards and which
don't, whether independent, publicly-funded community or institutionally
based.

Jack Corman
IRB Services
14845-6 Yonge St. #328
Aurora, ON L4G 6H8
Tel 905 727 7989 ext. 25 Fax 905 727 7990

Subject: Re: [Ethics] A Question of Jurisdiction
Date: Tue, 28 Jan 2003 14:32:41 -0800
From: <anderlam@telus.net>
Reply-To: ethics@lists.ncehr-cnerh.org
To: <ethics@lists.ncehr-cnerh.org>

I think you need to determine the capacity in which the researcher is acting
when planning to engage in the research. If the researcher is employed by
university AND is, for example, independently employed as in business such
as independent health consultant (sole proprietorship, etc) AND the
researcher is in no way using the university name (and is not getting
approval for the research due to affiliation with the university), then the
approval does not need to come through your particular university. Every
faculty member doing research involving human subjects must insure TCPS
guidelines are addressed and there are many avenues for doing so.
Sharon

Subject: Re: [Ethics] Research Outside the Institution
Date: Tue, 14 Jan 2003 10:45:21 -0500
From: Jack Corman <irbs@interlog.com>
Reply-To: ethics@lists.ncehr-cnerh.org
To: NCEHR <ethics@lists.ncehr-cnerh.org>

Michael,

Sorry for the delay in replying. Holiday season, etc., etc.

I would never argue that a university has no responsibility for, or is
incapable of, oversight of the activities of its staff, including research.
Nor would I argue that agents who are paid to perform a service are free of
potential COI. Like your institution’s external accounting firm. Internal
financial accounting expertise of a high order exists within the
institution, yet an external private company is always hired to check the
accounts in addition to any controls within the institution.

Oversight of research by employees of an entity that is the financial and
professional beneficiary of an affirmative decision by its employees, such
research to be conducted by colleagues who may hold power over those
employees or are otherwise closely ties, has inherent potential conflicts
that may be far more subtle and more powerful than a straight
fee-for-service arrangement with an external body whose personnel are
totally at arms length. I would be much happier, for example, if the
university or hospital REB were composed of a majority of non-affiliated
members, instead of a minimum of just one.

Potential for COI exists in both the public and private sectors, and steps
must be taken to minimize and control it everywhere, including where it is
most subtle and least obvious, not just where it is readily apparent. The
straw man cuts a wide swath.

Jack Corman

on 12/16/02 6:56 PM, Michael Owen at mowen@spartan.ac.brocku.ca wrote:

Jack

You are correct in stating that internal bodies do have a potential for COI.
Agents who are paid to provide a service also have the potential for COI.

This question arose, when at another institution, the REB required the
payment of a fee for non-University studies (i.e., studies that were not
conducted by a faculty member, including clinical appointments, at
the institution) in order to offset some, not all, of the costs
associated with the administration of the ethical review process. The issue was, if we
are paid, even partially, to conduct an review of a protocol, are we
somehow bound to provide a positive review? The answer, of course,
is no.

You have posed a number of straw person arguments below.

I would argue, strongly, that REBs at universities act
independently -- they make their decisions quite independently of any perceived
notion that a study must be approved because it has been funded by sponsor X or Y,
whether the sponsor is government, a granting council, an industry sponsor, or
a not-for-profit. It is the tradition of independent review in the university
system, I might argue, that is the strength of the REB system in universities.

I think that you have conflated much -- indirect costs, direct
costs of research, collaborative research, spin-off companies -- into a suggestion
that the process of ethical review of research protocols within the
university/university hospital system is, somehow, inadequate or inherently less than transparent. I
disagree very strongly with the proposition that you infer here -- the reviews by
university REBs are not of the same standard that might be obtained through a commercial
service.

Back to the original question -- research outside of the
institution. My argument is, if the research is being conducted by a member of the institution,
no matter where it is being conducted, as long as the research is part of the
researcher's institutional responsibilities and commitments -- i.e., not a consultancy for
company Y run through a non-affiliated agency -- then the institution has a
responsibility to ensure that the protocol is reviewed and meets the institution's
standards (in our case, the minimum standards of review are the TCPS). If there is a
disagreement in the outcome of two reviews, then it is the responsibility of the two REBs to
assess how the disagreement is to be resolved.

We have addressed this, in part, by requiring researchers whose
studies have been reviewed elsewhere, to submit the protocol submitted at the other
institution, information on the composition of the REB/IRB and its review processes, and a
copy of any letter of approval from that other institution. This is done on a
case-by-case basis.

The Brock REB retains the prerogative not to approve the protocol
as submitted to and approved by the other institution.

My experience suggests that it is not unusual for REBs/IRBs to
disagree with the review of another -- whether it be the content of consent forms or
the risks of particular interventions. These are most often resolved without jeopardizing
the study and usually make it stronger.

Michael

At 04:03 PM 16/12/2002 -0500, you wrote:

As is widely known, reviews by internal bodies have
inherent potential for serious conflicts of interest .
There is at least a theoretical danger that an audit
function and operations function within the same entity
can lead to a situation analogous to Arthur Andersen and
Enron (same accounting firm did the consulting as did
the auditing). Some examples:
Industrial sponsors donate millions to
universities/university hospitals. Acceptance of large
sums from industry, as everyone knows, can lead to at
least a public perception that institutional decisions
may be improperly influenced by the donations. Two
examples - Olivieri, Dr. David Leary hiring/dehiring.

All ethics reviews at universities are conducted by committees
that are comprised almost exclusively of employees of the
institutions that conduct and/or fund the research being reviewed,
and may have a number of members as investigators for the projects
under review.
The institution is paid millions annually in either direct grants
or payments by private research funders for contract research.
University researchers spin off companies in which the university
has a vested interest, e.g., shares or royalty agreements, that
the university hospitals REBs review.
REB members at universities may be paid consultants for industrial
sponsors whose research they review. Do they always declare the
COI and recuse themselves accordingly?
Many of the reviewers are colleagues/co-workers of the
investigators and possibly in competition with them for funds,
academic advancement, promotion, etc.
As may have been the case with Johns Hopkins, close familiarity
with and trust in one or more of the investigators by the
reviewers may lead to superficial ethical and scientific reviews.
Most institutions charge about 40% of the research grant for
overheads and so there is a potentially strong financial incentive
to grant approvals.

A properly constituted and structured IRB/IEC/REB independent from
the university/university hospital has very few of the potentials
for conflict of interest enumerated above. We are simply paid a
fee for the review service, which is becoming widespread in the
public sector, too (how much does the REB at your institution
charge for a review?). Both models have their pros and cons.

Jack Corman
IRB Services

4. MRIs and Sedation of Children

Subject: [Ethics] MRIs on normal healthy children (controls)
Date: Fri, 31 Jan 2003 09:29:16 -0500
From: Susan Hoddinott <hoddinott@uwo.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
Organization: University of Western Ontario
To: NCEHR Listerver <ethics@lists.ncehr-cnerh.org>,
MCWIRB Listserver <irbforum@irbforum.org>

Our Health Sciences REB is now reviewing 3 separate requests to subject
normal healthy children (controls) ages 3 to 18 to MRIs of the brain (3
and 4 Tesla).

Among the many issues with these protocols there are three significant
areas of concern for the REB.
1. the use of sedation
2. safety, in particular the unknown long term effects of MRIs on
developing brains
3. informed consent from the child’s perspective

Regarding the use of sedation. The REB has very strong reservations
about sedation of children for non-therapeutic purposes. We do however
have evidence that the older children very rarely require this and one
of the investigators is very willing to exclude anyone that requires
sedation. It is likely we will make this one of our recommendations.
Have other REB’s allowed sedation for controls?

Regarding long term safety. Do you consider these types of MRIs to be
minimal risk? We have been told that It is the position of the FDA and
the IEC that MRI up to 4.1 T constitutes "insignificant risk" to all age
groups and all sexes. Do you agree?

Regarding Informed consent: It is obvious that younger children cannot
appreciate possible long term consequences of participation but what is
an appropriate ‘cut off’ age for such understanding? In addition we are
concerned about the possible (subtle) coercive effects of parents asking
their children to participate. Children are not going to find out about
these studies on the play ground and run home and ask their parents to
enroll them! In fact, most children will be identified as possible
candidates because of their or their family’s involvement with some kind
of clinic or treatment facility.

We would find it very helpful to hear of your experiences with similar
protocols and what decisions you finally reached.

Please feel free to respond to me off-line at hoddinott@uwo.ca.

Thank you all.

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/

Subject: Re: [Ethics] MRIs on normal healthy children (controls)
Date: Fri, 31 Jan 2003 11:58:49 -0500
From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

At 09:29 AM 31-01-03 -0500, Susan wrote:
>Our Health Sciences REB is now reviewing 3 separate requests to subject
>normal healthy children (controls) ages 3 to 18 to MRIs of the brain (3
>and 4 Tesla).
>
>Among the many issues with these protocols there are three significant
>areas of concern for the REB.
>1. the use of sedation
>2. safety, in particular the unknown long term effects of MRIs on
>developing brains
>3. informed consent from the child’s perspective

I consider Susan's discussion extremely important, so i'm cross-posting
from the IRB FORUM, Dr. Bob Nelson's view on the issue, in the hope that
our discussion will take place online ... elisabeth

begin forward --

"The Children's Hospital of Philidelphia (CHOP) IRB does not considser the
use of sedation as "minimal risk" and thus would not approve of its use for
healthy children undser any circumstances. There is an NIH sponsored study
using MRI scans in healthy children down to below one year of age that does
not use any sedation. They use a "mock scanner" to teach the children how
to hold still by watching a television that turns off when they move their
head.

The above MRI scan study is using the clinical MRI scan TESLA, which I
believe is about 1.5. I would need to review any available data before
commenting. Others?

Finally, I would honor dissent (even behaviorally expressed) at any age.
When you can obtain assent is more controversial."

Robert "Skip" Nelson MD PhD
nelsonro@email.chop.edu

_________________________________________

Subject: Re: [Ethics] MRIs on normal healthy children (controls)
Date: Sun, 02 Feb 2003 20:30:04 -0500
From: Gordon Crelinsten <gcrelinsten@qc.aibn.com>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

What about the information which may be gained such as a potentially serious
or dangerous asymptomatic malformation or the early detection of asymptomatic
serious illness such as tumour or cerebral aneurysm. How would news be
transmitted and what would be subsequent follow up and treatment??
Gordon Crelinsten

Cam McDermaid wrote:

> HSubject: Re: [Ethics] MRIs on normal healthy children (controls)
Date: Mon, 03 Feb 2003 09:37:06 -0500
From: Susan Hoddinott <hoddinott@uwo.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
Organization: University of Western Ontario
To: ethics@lists.ncehr-cnerh.org

The question regarding diagnosis has been raised by our REB before. From what we
understand, the "information" provided by the research MRI is not conducive to
diagnosing serious problems nor are the researchers trained in this kind of
interpretation. However if an anomoly is noted the PI will usually discuss the
matter with appropriate personnel in the clinical setting and will notify the
participant that subsequent tests should be considered and direct them to
appropriate resources.

All the points raised by Cam are good ones and ones that we have wrestled with.
Because 3 and 4 tesla MRIs are not used for diagnostic purposes and the settings
on lower tesla machines are not calibrated the same, the use of retrospective
clinical MRIs is not usually appropriate.

I have done some further reading and had a number of responses. It would appear
that MRIs (up to 4 tesla) are considered to be minimal risk, it is the sedation
that is of more concern and most REBs will not allow sedation on normal health
controls. Even though MRI are considered to be minimal risk I think we will
likely continue to require a warning statment in the Letter of Information about
unknown risks.

There are the usual risks with implanted metal etc. It would also appear that
'flying metal objects' that come loose in the room and enter the MRI are also a
concern (though I think most MRI units are now much more conscious of this
problem since the death of that young boy).

Susan

Subject: Re: [Ethics] MRIs on normal healthy children (controls)
Date: Mon, 03 Feb 2003 19:08:06 -0500
From: Gordon Crelinsten <gcrelinsten@qc.aibn.com>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

Are the participents aware that important health information may available in the
test results that the researchers may not be able to recognize because of lack of
training?? Should not they be aware of this before consent can be truly informed?? Is
discussing cases with clinical personnel part of the deal?? Would the clinical
personnel now have an obligation to the subect now that they have been involved in a
diagnosis and a potential treatment plan??
Gordon Crelinsten

Susan Hoddinott wrote:

> The question regarding diagnosis has been raised by our REB before. From what we
> understand, the "information" provided by the research MRI is not conducive to
> diagnosing serious problems nor are the researchers trained in this kind of
> interpretation. However if an anomoly is noted the PI will usually discuss the
> matter with appropriate personnel in the clinical setting and will notify the
> participant that subsequent tests

Subject: Re: [Ethics] MRIs on normal healthy children (controls)
Date: Tue, 04 Feb 2003 19:10:59 -0500
From: Gordon Crelinsten <gcrelinsten@qc.aibn.com>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

I guess then what I am missing is the question the research is addressing What is the
research hypothesis and what part does the MRI play in addressing it? The explanation that
you gave to my initial concerns is perfect as long as the reseach participants are aware of
what you actually explained. That is the question.
Gordon Crelinsten

Susan Hoddinott wrote:

> Hello Gordon
>
> You have raised some good points, I will try to address them as best I can,
> 1. in no way do the study investigators promote participation as a way to assess health
> and diagnose problems. T

Subject: RE: [Ethics] MRIs on normal healthy children (controls)
Date: Wed, 5 Feb 2003 13:46:44 -0600
From: "Strevens, Valerie" <Valerie.Strevens@nrc-cnrc.gc.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: "'ethics@lists.ncehr-cnerh.org'" <ethics@lists.ncehr-cnerh.org>

The National Research Council Winnipeg REB has approved a protocol that
involves functional brain MRI at 1.5 tesla of a control group of healthy
children aged 6 to 12 (as a control group for the patient group in the
study). After extended discussion, the REB agreed that MRI at 1.5 tesla
could be deemed to be no more than minimal risk for this age group, provided
that a stringent screening process is in place, to ensure eligibility for
MRI, and that an age-appropriate familiarization process is used. The NRC
Institute for Biodiagnostics has many years of experience in performing
studies involving MRI and has developed appropriate procedures for the safe
participation of research subjects in MRI experiments. We do include a
standard wording on all MRI protocols, "No long-term adverse effects of MRI
have been reported. We would contact you if any new risks are discovered."
I should point out that this protocol did not involve sedation, injections
or any other invasive procedures.

With regard to the question about the procedure for informing patients if an
abnormality is suspected, we ask subjects in all MRI studies to provide us
with the name of their family physician. The information for the subject
reads: "Although this is not a diagnostic scan and any images obtained are
for research purposes only, it is possible that the MR scan may disclose an
unknown abnormality. In this event, a medical imaging specialist will
review the images and we would send a report to your doctor." If the
researcher suspects an abnormality, a medical imaging specialist reviews the
image and provides us with a report. We phone the family physician, forward
the report and ask him/her to follow up with the patient. Many of our
studies on healthy subjects are run by scientists and not by physicians, so
it is not considered appropriate for the researchers to tell a participant
that a possible abnormality has been found. Of course, in a patient study,
if the P.I. or a member of the research team is directly involved with the
care of the patient, this may be the best route for follow-up of
abnormalities. We stress to all participants that the research MRI is
different from a diagnostic scan and would not normally show an abnormality,
even if one were present.

My apologies for this late response to your original posting, but I hope
this information may be of use to you. Please contact me directly if you
would like any further details of our procedures.

Valerie

Valerie Strevens, PhD
Human Studies Co-ordinator
National Research Council Institute for Biodiagnostics
435 Ellice Avenue
Winnipeg, MB R3B 1Y6

Subject: Re: [Ethics] MRIs on normal healthy children (controls)
Date: Thu, 06 Feb 2003 17:43:07 -0500
From: Gordon Crelinsten <gcrelinsten@qc.aibn.com>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

Valerie:
Your response goes a long way in dealing with my concerns. I hope that other
centres doing similar work will incorporate your solution to inform patients
that abnormalities may be picked up and that there is a formal mechanism to deal
with the eventuality.
Gordon Crelinsten

"Strevens, Valerie" wrote:

> The National Research Council Winnipeg REB has approved a protocol that
> involves functional brain MRI at 1.5 tesla of a control group of healthy
> children aged 6 to 12 (as a control group for the patient group in the
> study). After extended discussion, the REB agreed that MRI at 1.5 tesla
> could be deemed to be no more than minimal risk for this

5. Ogden Subpoenaed Again

Subject: [Ethics] Déjà Vu: Ogden Subpoenaed Again
Date: Tue, 28 Jan 2003 15:20:46 -0800
From: palys@sfu.ca
Reply-To: ethics@lists.ncehr-cnerh.org
To: marc.renaud@sshrc.ca, tom.brzustowski@nserc.ca, abernstein@cihr.ca
CC: booth@ccu.manitoba.ca, president@aucc.ca, jstorch@uvic.ca, hms@sfu.ca,
ethics@lists.ncehr-cnerh.org, sfufa-and-admin@sfu.ca,
administrators-group@sfu.ca, apsa-forum@sfu.ca, apex-sfu@sfu.ca,
tssu@sfu.ca, poly-forum@sfu.ca, sfss-forum@sfu.ca, peak@sfu.ca

An Open Letter To:
Marc Renaud, President, Social Sciences and Humanities Research Council
Tom Brzustowski, President, National Science and Engineering Research
Council Alan Bernstein, President, Canadian Institutes for Health Research

From: Ted Palys & John Lowman
Subject: Déjà Vu: Ogden Subpoenaed Again

Russel Ogden, an internationally renowned expert on assisted suicide, has
been subpoenaed again. He was first subpoenaed in 1994 to appear before a
Coroner’s Court. He successfully defended academic freedom from the Court’s
threat using the common law “Wigmore test” to assert research-participant
privilege. The second subpoena arrived at his home on January 8th this year
and calls on him to appear on March 19th “to give material evidence for the
prosecution” in the preliminary hearing of 72 year old Evelyn Martens on
charges of counselling a person to commit suicide and aiding/abetting a
person to commit suicide. Today’s Vancouver Sun reports that other charges
are pending.

Ogden was attending Marten’s hearing as part of his research but now, as a
prospective material witness, he can no longer continue his court
observations. Worse, participants in his longitudinal research may withdraw
as they wait to see how the case unfolds. Others may decline to provide
information for fear that association with him will make them objects of the
prosecutor’s attention. In fact, Ogden’s entire research program is in
jeopardy now that he is squarely in the prosecutor’s sights as a prospective
witness in this and who knows what other cases.

Ogden’s second case dramatically illustrates the threat that the courts pose
to academic freedom in Canada. The mere fact of the subpoena will have a
chilling effect on Ogden’s research regardless of how the court ultimately
deals with it.

The scene is reminiscent of the United States in the 1970s during the Nixon
years when grand juries and other legal authorities first tried to co-opt
researchers as witnesses for the prosecution. U.S. researchers resisted and
they, their universities, their disciplinary associations and federal
funding agencies campaigned for statutory protections for research
confidentiality. Federal authorities understood that certain kinds of
sensitive research on important social issues could never be done with
researchers and their participants wondering when the next subpoena would
arrive. They understood that the justice system itself would lose out
because it would lose the potential for the expert testimony that is the
essential foundation of legal decisions and social policies.

The U.S. government responded by creating statutory protections in the form
of “confidentiality” and “privacy certificates” making certain kinds of
sensitive health and criminal justice research immune to the courts.
Statistics Canada researchers enjoy the same kinds of protections under the
Statistics Act.

Have Canadian academics learned anything in light of the U.S. experience?
Apparently not. The SFU Research Ethics Policy Review Task Force, Chaired by
the late Ellen Gee, recommended that SFU initiate a campaign for
confidentiality certificates here in Canada. What has SFU done? So far,
nothing, but we hope that will change. And, of course, SFU should not have
to bear this burden alone.

In 1998 the three granting councils saw fit to impose the Tri-Council Policy
Statement on Canadian universities in the name of protecting research
subjects. The Policy Statement recognises that “legal and ethical approaches
to issues may lead to different conclusions” and says that “though ethical
approaches cannot pre-empt the application of the law, they may well affect
its future development.” The question now is: how much are the granting
councils prepared to walk their talk? Where is their responsibility in
ensuring that the law develops in such a way that conflicts between ethics
and law are minimised?

Three years ago we published an article on the ethics and law of research
confidentiality in the Canadian Journal of Law and Society (URL) that ended
by urging the councils to pick up the baton and press for research
confidentiality certificate legislation in Canada based on the U.S. model.
As far as we know, they have done nothing to this end. Perhaps Ogden’s
latest subpoena will convince them to chart a different course.

Ogden’s first subpoena might have been written off as a fluke. But this
second one shows that Ogden’s research is a target. Now is the time for
every member of the academic research community to do what they can to
support Ogden’s fight to prevent the courts and the state from co-opting
researchers as agents of law enforcement and witnesses for the prosecution.
This open letter is a formal request to the three granting councils to
provide the requisite funds for a lawyer so that Russel Ogden is not left on
his own once again to defend academic freedom and the integrity of the
research enterprise.

 

Subject: [Ethics] Re: [Ethics] Déjà Vu: Ogden Subpoenaed Again
Date: Tue, 28 Jan 2003 17:25:58 -0700
From: "Helen Gardiner" <helen@thegardiners.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
Organization: H. Gardiner & Associates Inc.
To: <ethics@lists.ncehr-cnerh.org>

The research community has spent a lot of time considering how to protect
the rights of research participants. This is as it should be. However, we
must also consider how to protect the fragile flower that is known as
research. If legitimate researchers can be compelled to be witnesses in
criminal cases simply because of their research, it is likely that those
research topics will be avoided. Where will that leave topics such as
suicide prevention, or diversion of mental health clients from the criminal
justice system or other topics where research brushes up against legal
boundaries? Where does it leave academic freedom, or , for that matter, the
value of REB approval (which I believe Mr. Ogden had for his work)?

Ted and John, can you please provide information about how to best support
your appeal? Would a letter to the Presidents of SSHRC, NSERC and CIHR
help? If so, would you care to provide a template outlining the key issues
(for those of us who are pressed for time)? Is there any other organization
that can be appealed to as far as funds are concerned for Mr. Ogden's
defense? If not, perhaps such a fund can be established by the academic
community since this court case concerns all Canadian researchers.

Cheers!

Helen Gardiner, M.Sc., Ph.D. (candidate)
University of Calgary

Subject: Re: [Ethics] Déjà Vu: Ogden Subpoenaed Again
Date: Thu, 30 Jan 2003 15:35:39 -0800
From: palys@sfu.ca
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org
CC: marc.renaud@sshrc.ca, tom.brzustowski@nserc.ca, abernstein@cihr.ca,
booth@ccu.manitoba.ca, president@aucc.ca, jstorch@uvic.ca, hms@sfu.ca,
ethics@lists.ncehr-cnerh.org, sfufa-and-admin@sfu.ca,
administrators-group@sfu.ca, apsa-forum@sfu.ca, apex-sfu@sfu.ca,
tssu@sfu.ca, poly-forum@sfu.ca, sfss-forum@sfu.ca, peak@sfu.ca

Thanks to Helen Gardiner and the many others from the listserve, SFU, and
elsewhere who contacted us asking how they can help Russel Ogden. Your
expressions of support are much appreciated; we have taken the liberty of
forwarding these to Russel, who also expresses his appreciation.

We suggest that researchers and others who would like to support Russel
forward this email to the Presidents of the three granting councils urging
them to take two actions.

1. Provide whatever funds are necessary to defend Russel Ogden’s research
subjects from the threat of the courts; and

2. Initiate a campaign for legislation to create “confidentiality
certificates” in Canada.

We would note that we addressed our plea for legal help to the Presidents of
the three granting councils for two reasons. First, the subpoena Russel just
received concerns his work as an independent researcher. Because he did not
hold a University or College post when he started his current research on
assisted suicide, it is conducted under the auspices of a Community Based
Research Council ethics certificate. CBRC has no funds for mounting a legal
defence. Second, our article in the Canadian Journal of Law and Society
(http://www.sfu.ca/~palys/Strategies-CJLS.pdf) alerted the three granting
councils to the problem Russel is now facing and asked them to resolve
potential conflicts between ethics and law by securing confidentiality
certificate legislation in Canada. If the granting councils are not prepared
to champion this cause, who will? Also, we note that if the granting
councils had acted three years ago, their resolve to protect research
participants from the courts could have been used now as evidence to defend
Ogden's research subjects against the subpoena.

The names of the three granting council presidents are:

Marc Renaud, President, Social Sciences and Humanities Research Council
Tom Brzustowski, President, National Science and Engineering Research
Council Alan Bernstein, President, Canadian Institutes for Health Research

Their respective email addresses are: marc.renaud@sshrc.ca,
tom.brzustowski@nserc.ca, abernstein@cihr.ca

Thanks again for your support. We will keep you posted as to progress on
this situation, and may establish a formal legal defence fund depending on
the response of the granting councils.

Ted Palys & John Lowman

 

6. Participatory Action Research and Consent

Subject: [Ethics] participatory action research consents
Date: Fri, 10 Jan 2003 11:07:44 -0800
From: <anderlam@telus.net>
Reply-To: ethics@lists.ncehr-cnerh.org
To: <Ethics@lists.ncehr-cnerh.org>

I am seeking information concerning the wording of consent in participatory
action research (PAR). I am planning a project which has set objectives and
involves the use of focus groups for information on women's health. In PAR,
the focus remains clear, yet community participants may choose how they wish
to identify and make public their health concerns (by poster, written
report, videotaping, etc). Is it sufficient, in terms of the protection of
participants, to address the nature of PAR in the consent form by explaining
that the data collection may be by one or all of the following. . .(written
report, . . .) and that the choice will be made by the group? How have
people addressed the nature of evolving methods, as in PAR and some types of
qualitative research, in regard to obtaining consent? If you have addressed
this concern, would you be willing to share examples of your policies
regarding this, and any consent forms that clarify the wording for evolving
methods in feminist research, for example?
Thanks.
Sharon Andersen
Subject: Re: [Ethics] participatory action research consents
Date: Mon, 13 Jan 2003 10:07:42 -0500
From: "Gabrielle Miller" <gmiller@nickel.laurentian.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: <ethics@lists.ncehr-cnerh.org>

Sharon:

It seems to me that the point of informed consent is to make the
participants aware of the process and the risks, so basically you need
to tell them the general subject that the groups will tackle, how the
focus groups will work, point out that confidentiality is subject to the
members of the group keeping the information confidential, since they
will all know the identity of the other members and what they say,
asking them to please do that, but pointing out that you cannot
guarantee that everyone will do it.

I am less certain that it is essential to let them know that the data
will be collected in a format which they in the group will choose
(though it might be good, and certainly wouldn't do any harm) .

Does that help?

Gaby Miller

Gaby Miller
Research Officer/Agente de recherche
L-335a
Laurentian University/Université Laurentienne
(705) 675-1151, ext/poste 3213
FaxSubject: Re: [Ethics] participatory action research consents
Date: Mon, 13 Jan 2003 10:41:08 -0500
From: Michael Owen <mowen@spartan.ac.brocku.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org, <ethics@lists.ncehr-cnerh.org>

Sharon

While I agree with Gaby's intervention, I think that the issue with
participatory and action research is one of adequate information to
potential participants, especially when videotaping and focus groups
are involved. Related, of course, is the issue of assent/consent of
individuals who may be minors (in the case of schools) and the need
to also obtain approval of parents/guardians.

Michael

Subject: Re: [Ethics] participatory action research consents
Date: Mon, 13 Jan 2003 11:07:45 -0500
From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: <ethics@lists.ncehr-cnerh.org>

Hi Sharon

I have a couple of suggestions:

1. I think that for the initial consent process could outline the
means by which participants may take part more or less as you've
outlined.

2. I think the consent process should follow an emergent model as
well, so meaningful opportunities to reconsider willingness to
participate are provided as the process develops; for instance at
major milestones. The extent to which this would be done would depend
on the risks to the participants.

Cheers

Cam

7. PRE Nominations to Social Science Working Group

http://www.nserc.ca/programs/ethics/english/nomination_e.htm

Call for Nominations from the Interagency Advisory Panel on Research Ethics to Establish a
Social Sciences and Humanities Research Ethics Special Working Committee
The Interagency Advisory Panel on Research Ethics (PRE) is pleased to announce a public call for nominations for the creation of a Social Sciences and Humanities Research Ethics Special Working Committee.

Background
The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) seeks to address “the interdependent duties to research subjects, which are shared by researchers, institutions and Research Ethics Boards (REBs). By addressing common issues and needs, the TCPS seeks to articulate ethical norms that transcend disciplinary boundaries.”* Effective application of such norms means responding to a breadth of research disciplines, methods, and environments, as well as diverse perspectives and philosophical approaches to research ethics dilemmas.

In this context, in the autumn of 2001, the Social Sciences and Humanities Research Council (SSHRC) Standing Committee on Ethics and Integrity (CEI) provided the newly created Interagency Advisory Panel on Research Ethics (PRE) with a brief that identified gaps, ambiguities of language, and inadequate treatment of social sciences and humanities research ethics issues in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). The SSHRC CEI urged the Panel “to give priority attention to these matters in setting its agenda.”

Subsequent discussions with the Canadian Federation for the Humanities and Social Sciences (CFHSS), as well as recent exchanges with such communities as qualitative researchers, and anthropologists, have reinforced the need for the TCPS to address more effectively the research ethics issues and contexts in social sciences and humanities disciplines.

This led to the recommendation – which was adopted by the Panel at its June 2002 meeting – for the Panel to establish a special working committee on social sciences and humanities ethics.

Terms of Reference
(November 2002)
Objective
To provide the Panel with advice and recommendations on strategic approaches for addressing priority issues in social sciences and humanities research ethics for the TCPS.

Role of the Special Working Committee
To provide advice and recommendations on social sciences and humanities priorities for the TCPS based on activities such as:

Reviewing recent documents, reports or analyses;
Soliciting further insight on issues if necessary;
Consulting with research participants;
Advising on priorities issues and on how they might be addressed;
Identifying relevant resources or expert groups to further develop identified issues;
Proposing strategies and options for coherently addressing priority issues (e.g. commissioned papers, workshops, meetings, consultations, etc.).
Responsibilities
Chair of the Special Working Committee: A member of the Panel’s Task Force on Evolution shall chair the Social Sciences and Humanities Research Ethics Special Working Committee.
Reporting: The Special Working Committee shall submit its reports and recommendations to PRE as a first phase of this initiative.
Follow-up: PRE will consider the report and refer appropriate follow-up to the PRE Task Force on Evolution, as a second phase of the initiative.
Term
The Working Committee shall have an initial mandate with a duration of one year, with the possibility of renewal.

Meetings
It is anticipated that there will be two meetings in Ottawa as well as teleconferences and e-mail exchanges. A delegation of the Special Working Group will be encouraged to present preliminary findings and recommendations at a special session of the PRE at the Congress of the Social Sciences and Humanities on June 1, 2003.

Draft Calendar
The Social Sciences and Humanities Research Ethics Special Working Committee is a work-intensive committee. It is expected that it will submit a draft report within four months of its first meeting and a final report within six months. Further consultation with the Special Working Committee may continue upon submission of the final report, as required until the end of its term.

Membership
The Special Working Committee shall be comprised of at least five appointed members and four ex officio members, in addition of the Chair of the Special Working Committee who will be a member of the Panel. Total membership will not exceed 10 members.

The combined expertise on the Special Working Committee shall include expertise and the representation from groups such as:

Social Sciences community;
Humanities community;
Relevant social sciences and humanities professional societies;
Ethics community, particularly those familiar with social sciences and humanities research ethics;
Representation from all levels of the research community including students.
Members with expertise in social sciences and humanities research ethics from the following entities will be invited to serve as ex officio members:

The Canadian Federation for the Humanities and Social Sciences (CFHSS) Sub-committee on Ethics and Integrity;
The SSHRC Standing Committee on Ethics and Integrity;
The Canadian Institutes of Health Research (CIHR) Standing Committee on Ethics; and
A Council member of the National Council on Ethics in Human Research (NCEHR).
Selection Criteria for Appointed Members
Appointed members will be selected to provide broad coverage of research ethics issues relevant to the social sciences and humanities community, for their research expertise, and experience as members of a Research Ethics Board. Gender, language, and regional representation will be taken into consideration.

A statement of interest of no more than 1,000 words should address the following:

Experience with and expertise in human research ethics and the TCPS (e.g. REB membership, research involving humans, etc.);
Involvement with disciplinary-focused organizations (e.g. professional organizations or scholarly societies); and
A statement of why you are interested in serving on this committee and what you believe you would contribute to its work.
Selection Committee
A selection committee composed of members of the PRE, the SSHRC CEI and HSSFC will select the membership based on the selection criteria. The Chair of the selection committee will be a PRE member other than the PRE member who will chair the Special Working Committee. The final list of appointees will be approved by PRE membership.

Submission of Applications
Please send your curriculum vitae and statement of interest by
e-mail, letter, or fax by February 5, 2003 to:

Call for Nominations
Social Sciences and Humanities Research Ethics Special Working Committee
Secretariat on Research Ethics
350 Albert Street
Ottawa, Ontario
K1A 1H5

Tel.: (613) 996-0072
Fax: (613) 996-7117
E-mail: secretariat@pre.ethics.gc.ca
Web Site: http://pre.ethics.gc.ca

All information and documents received will be kept confidential and are protected under the federal Privacy Act and Access to Information Act. The Secretariat will retain the submitted information and documents for three years, for consideration for future Panel initiatives.

We ask all who receive this call for nominations to help us to distribute it as widely as possible. Please forward the call for nominations to institutions, organizations and individuals who might be interested in posting and/or responding to it.

The PRE thanks you in advance for your support in ensuring that this important initiative benefits from as broad an outreach as possible.

* Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 1998.


8. Minor Changes and Reconsent

Subject: [Ethics] Re-consent of Patients
Date: Tue, 7 Jan 2003 11:20:49 -0500
From: "Laviolette, Mary-Ann" <mlaviolette@ohri.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: "'ethics@lists.ncehr-cnerh.org'" <ethics@lists.ncehr-cnerh.org>

Good Morning to all and 'Happy New Year':

Does the ethics board at your institution insist that investigators
reconsent all patients involved in their studies when there are minor
changes made to the consent document that would not impact the patient's
decision to stay in the study?

One of our investigators is being pressured by the sponsor to re-consent all
patients even though the changes made were strictly administrative. We
normally only ask the investigators to re-consent patients if new
information becomes available which might impact a patient's decision to
remain in a study.

I would appreciate any advice or comments you might have on this topic.

Thank you.

Mary Ann Laviolette
Ethics Co-ordinator
Ottawa Hospital Research Ethics Board
Telephone: (613) 761-5072
Fax: (613) 761-4311
Email: mlaviolette@ohri.ca

Subject: Re: [Ethics] Re-consent of Patients
Date: Tue, 07 Jan 2003 11:46:36 -0500
From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

Hi Mary Ann --
We would never routinely *re-consent* subjects of research. The rules seem
pretty much silent about this, however i believe most REBs would err on the
side of not burdening the subject with further signatures on paper, unless
as you point out required by a major study modification. I suspect most
studies go forward with a presumption of continuing consent of a study
subject that can be affirmed at scheduled visits, but that doesn't make the
case for formal re-documentation of consent.

Continuing consent, ofcourse turns on the assumption that there takes place
adequate ongoing dialogue including new information freely provided by the
investigator to the subject, that can be put into a personal context by the
physician for the patient ... elisabeth

Elisabeth Clark
Research Ethics Officer
McGill University Health Centre

Subject: Re: [Ethics] Re-consent of Patients
Date: Tue, 07 Jan 2003 13:39:11 -0330
From: Richard Neuman <rneuman@mun.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

Hi,
Only in the case of a major change in the protocol or new information about
the drug or procedure that might influence participation would our REB
require a new consent form. Minor administrative changes might require a
modified consent form for new participants, but existing participants would
not be reconsented.
Cheers,
Richard Neuman
Co-Chair, Human Investigation Committee

Clark, Elisabeth wrote:

Subject: Re: [Ethics] Re-consent of Patients
Date: Tue, 7 Jan 2003 09:43:38 -0800
From: "TASC - CMX Research Inc" <tasc@attcanada.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: <ethics@lists.ncehr-cnerh.org>

Mary-Ann

We have always re-consented ongoing subjects at the next visit but by the
use of a Consent Addendum (usually one page) that explains only the changes
that were made.

Other times if it does not require their agreement to continue participation
we have made sure that the information is relayed (verbally or written
material) and this is communication is documented as per ICH 4.8.2.

New enrolees are consented with the revised consent form. Our ethics
committee will advise if they wish us to re-consent completed subjects.

I hope this is of help to you.
Alison Orth, BBA, CCRC
TASC - CMX Research Services
Surrey, BC

Subject: Re: [Ethics] Re-consent of Patients
Date: Tue, 07 Jan 2003 13:29:50 -0500
From: Jack Corman <irbs@interlog.com>
Reply-To: ethics@lists.ncehr-cnerh.org
To: NCEHR <ethics@lists.ncehr-cnerh.org>

Are there any necessary (i.e., substantive) changes to the consent form due
to the administrative changes? If not, it makes no sense to require
subjects to re-consent. Why does the sponsor think it’s important?

Consent forms typically promise that subjects will be promptly informed of
any new information that might affect their willingness to continue. Minor
administrative protocol changes, one would think, don’t fall into this
category (see attached IRB/IEC major/minor amendment decision grid based on
ICH GCP developed by Pfizer’s GCP Manager, Marianne Vanderwel). On the
other hand, isn’t it presumptive to decide what will or will not influence a
subject’s decision to continue participating?

Jack Corman
IRB Services