Summary of NCEHR Listserv for June 2003

TOPICS

1. When Does Student Research Require REB Review

2. Age of Consent and Passive Consent with Teenagers

3. Contacting Family Members

4. Control of Publication from Clinical Trial

5. Deadly Clinical Trial not Approved by Health Canada

6. External Institutional Approval

7. Investigator's Brochures

8. CAREB Membership

9. On Campus Outreach and Education Programs

10. Stem Cell Animal Research and REB Review

11. PRE Webpage

12. Privacy Commissioner's REB Speech

13. Storage of SAE's

14. Unused Study Drug

15. Volunteer Part-Time Physicians Research

Files for Download

Launch of PRE Website

 

 

 

1. When Does Student Research Require REB Review

From: "Lori Sheremeta" <lshereme@law.ualberta.ca>
To: <michael.Goodyear@cdha.nshealth.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research RequireREB - and canit be retroactive?
Date: Thursday, June 12, 2003 8:16 PM

Dear Listserve members:

I am interested in the discussion tha will ensue here. I am
not an expert in interpreting the TCPS by any means but this
does not appear, to me, to be "human subject research". Are
University Deans/Associate Deans vulnerable subjects or are
they simply answering questions pertaining to the operation
of their faculties? Where personal information is not sought
and the person holds on office of this nature, it seems to
me to be an absurd over-extension of the principles of the
TCPS to suggest that REB approval ought to have been
obtained.

I agree that many cases of resrearch of this nature may fall
into a grey area and that consultation is appropriate.
However, the grey zone needs to be clarified. In our
faculty, there were discussions wherein some people were of
the opinion that if a student were to call experts about a
particilar legal subject matter that that would be
considered research involving human subjects! We have to
reflect on what the purpose of the REB approval is and what
harm it is seeking to prevent.

There remains a lot of confusion over this.

Best,

Lori Sheremeta,
Research Associate, Health Law Institute, Faculty of Law,
University of Alberta


>>> michael.Goodyear@cdha.nshealth.ca 06/12/03 2:25 PM >>>
We think this is a first for us. I know what I think, but I
would feel happier knowing what you think.

The Scenario
A graduate student enrolls in a education degree course.

As part of that they decide to do a survey of Canadian
Universities and mail out a 2-page questionnaire to 16
Associate Deans of Education, of whom virtually all respond.

The questions are factual,

e.g. Does your institution have an Office of Student
Professional Development or equivalent (Y, N).

One question could be construed as asking for an opinion;
"Which of the following might be of assistance in
implementing a programme...."
Evaluation Methods Y N
Guest Speakers Y N
etc

The responses have been anonymised.

This survey tool has been used before and there is a
published study in a peer reviewed journal in 1999. Nowhere
in the article is informed consent or IRB oversight
mentioned.

Now the student has been told that since the survey was
conducted without informed consent (that is no consent forms
were provided to the subjects (Associate Deans), and there
was no human subjects protection oversight, that the data
must be destroyed, and that it cannot be either analysed or
published.

The student was intending to present the data at a
conference, and to prepare it for publication.

The student writes to an REB requesting approval to proceed.
Approval is witheld on the grounds that it is retrospective.
The fellow replies, pleading ignorance in a letter of abject
apology, and offers to destroy the data.

The REB chair arranges a meeting with the student's
Departmental Chair, who is (a) astounded, (b) confesses to
having done the same thing (c) asks the REB to help get the
student out of his predicament.

The Issues
1. Did this actually require REB oversight?

2. Who is at fault? The student, the supervisor, the thesis
committee, the system, all of the above?

3. Does a response by subject's who must be considered the
most informed subjects one could imagine on this particular
subject, constitute implicit unwritten consent, or at least
assent?

4. Were research subjects exposed to any appreciable risk?

5. Is it possible to issue a retrospective approval, or at
least a prospective approval of data analysis (which has not
yet been done) for presentation and publication?

The Analysis
The context: Surveys are done regularly in academic and
health care circles, to the extent of almost becoming a way
of life. Rarely do I see any request for signed consent, or
mention of REB approval. However this survey was done as
part of course work.

Research on human subjects (RHS): Surveys have been
considered contentious depending on the nature of the
information sought. Traditionally surveys considered to be
RHS have been identified by factors such as (a) is it purely
factual or are subjects being asked to state their opinions,
and therefore entailing some exposure to risk, and (b) is
the information personal or is it factual with regard to
whether a particular circumstance exists or not in that
person's environment.

The survey consists of about 10 questions. It is largely a
collection of facts that does not expose the subjects
(Associate Deans) to any risk, provided that confidentiality
is respected. Technically if the survey revealed a
deficiency at a particular university, the subject could
have been discomforted. On the other hand they could
benefit.

This survey collects no personal information, is anonymous,
and is factual. While there is a gray zone as to whether REB
approval is needed or not, a counsel of perfection is to at
least request an opinion from the REB.

Fault: NCEHR and others have commented on the lack of
adequate supervision of students with respect to Research
Ethics. It is interesting that the subject never appears to
have been discussed untill after the the data was collected.
It would appear from the literature that similar surveys
have been conducted without REB oversight.

Consent: The questionnaire's are unsigned. The covering
letter appears to provide the subjects with a clear picture
of the nature of the survey. Participation was clearly
voluntary. Interestingly not one of the Deans questioned the
need for consent or oversight. The high response rate
indicates a level of willingness. The subjects are not a
vulnerable population, and have no obligations to the
surveyor.

Risk and discomfort: All questionaires carry some degree of
risk and discomfort. This took 3-5 minutes, was closed ended
(all Y, N answers). The information is anonymous and
confidential. The risks do not appear to be appreciably
greater than those of every day life.

Retrospective Approval: While not to be reccommmended, we do
need to consider the relative merits of offering an opinion
as to whether the rights of the subjects were protected
versus leaving an ethical void. The rights of the subjects
could be considered to extend to the data they collected and
submitted, and to destroy it might raise questions as to
respect for the individual. Proportionality and common sense
need to be considered.

Disclaimer
Some details have been altered or concealed to preserve
confidentiality.

Ironically the subject of the survey dealt with issues which
could be construed as covering the situation described
above.

Now what do you think?


Dr Michael D E Goodyear FRACP FRCPC FACP
From: "Luc Simon" <Luc.Simon@vrr.ulaval.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research Require REB - and can it be retroactive?
Date: Thursday, June 12, 2003 10:02 PM

Michael,

The case can be made that under the TCPS, this type of inquiry does fall
under the article 1.1d exemption: Quality assurance studies, performance
reviews or testing within normal educational requirements should also not be
subject to REB review.

We are now developping policy at our institution to explicitly state
circumstances where some types of inquiry can proceed without REB oversight.
The example you give would qualify as ³no REB review required² status under
our proposal.

In a different jurisdiction, it seems that others also come to a similar
conclusion: The UPenn ³Report of the working group on human subjects
research in the sociobehavioral sciences² recommandation #4 reads:4. IRB
review in exemption category: We recommend that, by default, survey research
be considered exempt from IRB review if protection of the confidentially of
research subjects is adequately demonstrated (which does not necessarily
involve submitting the survey instrument to the IRB). In addition, all other
applicable criteria for exemption of IRB review must be fulfilled (e.g., the
research must not involve vulnerable populations). This recommendation is
consistent with the already existing regulation CFR 46.101.b (1--4), but we
wish to make it explicit that submitting the survey instrument should not be
necessary.
(http://www.upenn.edu/almanac/v49/n02/FC-human_subjects.html)

Regards,

Luc Simon

From: "Louise Dumas" <l.dumas@videotron.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research Require REB - andcan it be retroactive?
Date: Thursday, June 12, 2003 10:07 PM

Michael,
At our institution, all graduate or even undergraduate students who have a professional intervention or a research project must go through ethics approval from our university. In this case, my guess is that expedited review would have been done since, as you mentioned, this is very very very common (at least in nursing!), there is minimal risk, it is completely voluntary, and the data are anonymized.

So to answer your questions:
The Issues
1. Did this actually require REB oversight? yes at the university only

2. Who is at fault? The student, the supervisor, the thesis committee, the system, all of the above? I would say all of the above, starting with the thesis committee (however, I see this often...)

3. Does a response by subject's who must be considered the most informed subjects one could imagine on this particular subject, constitute implicit unwritten consent, or at least assent? I would think implicit unwritten consent since they were free to answer or not. In nursing, it is so common since we try not to reinvent the wheel and to get info on what is being done elsewhere in Canada.To my knowledge, it is common even if we intend to use this for publication.

4. Were research subjects exposed to any appreciable risk? No

5. Is it possible to issue a retrospective approval, or at least a prospective approval of data analysis (which has not yet been done) for presentation and publication? If I were at this university, I would try to get retrospective approval at least for publication purposes.

Hope this helps...Bye! Louise

Louise Dumas, RN, M.S.N., PhD

From: "Gabrielle Miller" <gmiller@nickel.laurentian.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research RequireREB - and canit be retroactive?
Date: Friday, June 13, 2003 8:32 AM

The Issues
1. Did this actually require REB oversight?

We have run into this several times. I would think that it would be exempt on the grounds that personal information wasn't being asked. For instance, we had the Director of a programme on language competence at the University asking faculty members what words were necessary for students to understand in their fields.

There are grey areas in questionnaires though, so I would think it prudent that the survey be sent to the REB and be formally declared exempt (on an expedited basis).

2. Who is at fault? The student, the supervisor, the thesis committee, the system, all of the above?

The system probably, for not making everyone aware of the rules. (and we have this problem too!)

3. Does a response by subject's who must be considered the most informed subjects one could imagine on this particular subject, constitute implicit unwritten consent, or at least assent?

For questionnaires which are sent in by mail, it makes sense to go by the second iteration of the TCP which said that returning the questionnaire was equivalent to consent. It has the advantage that the response is truly anonymous.

4. Were research subjects exposed to any appreciable risk?

No.

5. Is it possible to issue a retrospective approval, or at least a prospective approval of data analysis (which has not yet been done) for presentation and publication?

It is a bad idea to issue a retrospective approval, but in my opinion, the survey didn't require approval, so I wouldn't see that in this case there is a problem with publishing.

I would think that everyone involved should be more aware of the need for thinking about whether a survey might require ethics review, though.


Gaby Miller
Chair/Administrator, REB
Laurentian University

From: "Susan Hoddinott" <hoddinott@uwo.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research Require REB - and canit be retroactive?
Date: Friday, June 13, 2003 9:06 AM

We would not require REB review of such a project. No personal
information is being sought. I like to compare it to libraries - if I
want information on how the library runs or how to access government
documents I go to the Reference Librarian (this is not human subject
research) but if I go to Reference Librarians to ask how their job
impacts on their home life then it is human subject research. In this
instance I would see the Assoc Deans project as the former.

We NEVER give retrospective approval on anything. We may however (if
the project is in order) issue a letter indicating that had it come for
REB review it would likely have received ethics approval for the
following reasons.... This is not meant to be a back door for those
wishing to circumvent the system as we will only do this once for an
investigator (generally students) and only for those projects considered
minimal risk. All others have to "take their lumps".

cheers

Susan

From: "Laurel Evans" <levans@mcmaster.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research Require REB - and canit be retroactive?
Date: Friday, June 13, 2003 10:44 AM

1. While aspects of this survey might be considered "quality assurance",
as soon as the element of presentation at a conference and publication
of the data comes in, we would consider that it has an "element of
research" and therefore it would have required review.

2. In terms of fault, I agree with the other responses that it is
basically a combination of all of the parties. I am sure that we have
lots of surveys of this nature that go under the radar.

3. We do have situations where a response / completion of the
questionnaire is deemed consent, but only if there is a prior
explanation either in the questionnaire or in a letter / e-mail of
information which includes the information that the survey is for
research purposes.

4. Clearly there is virtually no risk to the participants.

5. We would not grant "retrospective" approval per se, but in this
instance we would suggest that the student re-contact all of the
Associate Deans, explain the connundrum, (including mentioning that
there are grey areas concerning whether consent is / was actually
required), and see if he/she could get their "retroactive" consent. If
he managed that, plus completed an application, he/she would probably be
granted clearance on that basis. At least then, he/she could present
and publish the results.

Not a perfect answer but given the low risk and the principle of
proportionate review, that is how I believe our institution would
proceed.

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research Require REB - and can it be retroactive?
Date: Friday, June 13, 2003 11:16 AM

Hello all

I''ve been interested in reading the excellent responses and the
variety of the opinion in this thread.

Here's my analysis:

Using the algorithm of "is it research?" and "does it involve human
subjects?":

Is it research? It's not clear what the intent of the study is, but
I'd argue that it does not fall under the rubric of quality assurance
or performance studies because it doesn't deal with self-evaluation.
The questions have been directed to other university administrators.
Given that it was also intended to be presented (shared for
generalizable knowledge), in my opinion, yes, it's research.

Does it involve human subjects? Like Lori, I think that many of the
questions appear to be public domain and about an institution. There
are no personal questions per se apart from the opinion question and
even that appears to be about operations rather than a personal
question. A potential problem, and I'm not sure how to reconcile
this, is if questions were being asked about an organization that
were not public domain (e.g. fiscal situations) and if answering
these questions put someone at risk. Regardless, I'd argue that
human subjects are not involved.

Based on what I've seen and because it doesn't meet both criteria,
I'd say it's not "research" and doesn't fall under the auspices of
the REB, barring any specific institutional requirement.

Informed consent: I'd like to make a distinction between informed
consent and documentation of the informed consent process. Having a
signed consent form doesn't constitute informed consent, it's just
documentation that something happened. In this instance, it sounds
like covering letter provided the orientation to the study, subject
to its adequacy. Surveys often use completion of the survey as
documentation of consent. In surveys I've done, I usually say this
explicitly in the orientation letter. It prevents having a link to
the participants that wouldn't exist otherwise (the signed consent
form) and can actually better protect participants provide anonymity
as opposed to confidentiality.

Process: Ideally, the REB should decide if something is exempt, not
a researcher. However, communication and precedent being what they
are, this kind of scenario is probably pretty commmon.

Fault: I'd look at this as an opportunity for quality improvement
rather than an issue of fault. It's evident that a senior academic
wasn't aware of the process. I wouldn't necessarily expect a student
to be aware of the rules unless they're explictly told somehow.
Asking questions about how they could be better informed, what would
work for them, etc. may help improve the awareness of expectations.
I've found that situations like this are excellent seques for
learning.

Retrospective [retroactive] approval: We haven't been faced with a
decision for retro-active approval if the work is de novo. Usually
what happens is a work shifts from quality assurance to research, the
researcher wants it reviewed now because they're presenting it in a
month :-p The approval is then one of secondary access to existing
data. Others have cautioned against retro-active approval, which I
agree with. Similar issues come up for publication of works that may
not have undergone ethical review or may be of dubious ethical
quality.

That's my 0.02

Cheers

Cam


From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research Require REB - and can it be retroactive?
Date: Friday, June 13, 2003 4:43 PM

Hello Laurel

This is a good point and speaks to the interpretation of the concept
of research subject. The TCPS says 'the research must involve
humans as "research subjects"' . The CFR 45 46 is much more explicit
in the definition of subject: "a living individual about whom an
investigator obtains...". The "about whom" is the critical comment.

If a third party interview takes place about a person, that's human
subject research. This is regardless whether the means of
investigation is a direct interview, a health record, an employment
record or a third party interview. The key point is the research is
about a person, not an institution.

I remain unconvinced that the research Michael described is human
subject research. I think it was about an institution.

This does still raise the ethical dilemma if research about an
institution puts someone at risk.

Cheers

Cam

From: "Laurel Evans" <levans@mcmaster.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research Require REB - and can it be retroactive?
Date: Friday, June 13, 2003 5:31 PM

Good points Cam. My last words on the issue (promise) are that 1) I agree
with you that the research is about an institution. 2) The TCPS does say
"as research subjects" and by that I think that they mean "those about whom
or on whom the research is carried out". (See the discussion on choice of
participant / subject). I consider third parties as human subjects on whom
research is being carried out..whether the research is a qualitative survey
or administration of a new drug. If you accept this interpretation, then you
do not have the ethical dilemma that you refer to and that otherwise could
exist if research about an institution could put a research participant at
risk...and there are lots of cases where that could/does occur. I don't
dispute your interpretation of the US regs, but their rules aren't ours.
Cheers and have a good week-end!

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] A conundrum - When does Student Research Require REB - and can it be retroactive?
Date: Friday, June 13, 2003 6:09 PM

We'd review it at our REB if the research is being done by a staff / student
at our hospital & it broadly concerns humans; it would have gotten expedited
review & would have passed likely without comment. It is only now an issue
because the REB wasn't consulted. Although innocuous, it would be best if
consent is sought from those who filled out the questionnaires; if the
research were really striking &, let's say, the subjects involved couldn't
be contacted, would we retrospectively approve it? ...Maybe...We still would
want the involved institutions 1st notified & approve the use of 'their'
data.
Philip

PCHebert MD PhD FCFPC
Chair REB SWCHSC

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] A conundrum - When does Student Research RequireREB- and can it be retroactive?
Date: Friday, June 13, 2003 6:31 PM

This has been quite a lively discussion, and oes demonstrate very well the shades of meaning and intepretation. For those people at Sherbrooke who want to study what REBs do across the country with their series of mock protocols, they could note the variety of ways this real life example could be handled.

While it looks as if we are looking down the barrel of some sort of federal regulatory supervision here in Canada, I think we al need to keep clearly in mind what Research Ethics is all about, and why we got here in the first place. While it can be interesting to squeeze 30 meanings out of a clause in a guideline, what really matters is are we satisied that human beings who participate in research are being treated with honesty, disclosure and respect, and are their rights to privacy and confidentiality being respected, and not exposed unnecessarily to disproportionate risks.

Protection versus paternalism is always an interesting debate in research ethics.

Have a nice weekend everyone!

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Helen Gardiner VistaEvaluation" <helen.gardiner@vistaevaluation.com>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research Require REB - and can it be retroactive?
Date: Monday, June 16, 2003 9:23 AM

This conversation has been very interesting because I often run into the
issue of what projects require REB approval, and whether that approval can
be retroactive, in my work. Consequently I selected this issue for my Ph.D
dissertation. My topic revolves around the issue of when Health and Human
Service organizations need to apply for Research Ethics Board (REB or IRB)
approval before carrying out systematic data collection projects, including
applied research, quality assurance and program evaluation. I have
developed a preliminary "Ethics Decision Guide" based on an exhaustive
review of the academic and grey literature as well as interviews with ethics
experts, researchers, students, quality assurance professionals, program
evaluators and individuals who have participated in such projects. I am now
seeking to validate the instrument. This necessitates collecting
information from all relevant professional groups. I'm working with a few
groups in Canada and the U.S.A. as well as an international association to
validate the "guide". Given the current listserv discussion, I thought that
the listserv members might be interested in participating in the validation
process. If anyone is, please copy the following url and paste it into your
browser. It will take you to the online survey instrument.

http://websurveyor.net/wsb.dll/12838/Ethics_Decision_Guide_final.htm

The Ethics Decision Guide instrument will be a reliable and valid tool to
help Health and Human Service organizations, REBs, researchers, program
evaluators, and quality assurance professionals who undertake systematic
investigations, to make more consistent decisions regarding ethics review.
When it is completed it will be available in the public domain and therefore
accessible to all interested parties. If anyone is interested in a copy of
the final study results, please email me offline at
helen.gardiner@amhb.ab.ca.

Cheers and thanks.

Helen Gardiner, M.Sc., Ph.D. (candidate)
University of Calgary
Provincial Program Evaluation Manager
Alberta Mental Health Board

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research RequireREB -and can it be retroactive?
Date: Monday, June 16, 2003 9:28 AM

Agree - I hope all incidents can be used as learning exercises (as opposed to blame and and punitive meaasures) - and the list enables much larger numbers of people to learn.

>>> cnelson@mail1.lakeheadu.ca 06/12/03 05:48PM >>>
Michael,

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research Require REB-and can it be retroactive?
Date: Monday, June 23, 2003 3:30 PM

Points to consider:

1. Generalizability of Data: Definition of research includes the concept of
generalizability. Does the project pass the generalizability test?

2. Who is the subject: There is a difference between a research subject and
a survey where there is no information obtained about the respondent. If
the survey respondent is not the subject of the research, he/she is NOT a
research subject. For example, if one were to conduct a survey of executive
level compensation in the auto industry, would the HR person at General
Motors be the research subject? No. However, if the survey were to gather
and analyse data about HR administrator attitudes, behaviours, etc., that
would be different. The former survey would likely not require prior ethics
approval, the latter could very well.

3. Waiver of consent: The REB could decide that this survey does not
constitute research requiring prior ethics review, and/or does note require
prior consent, and waive the requirement. Hence, no transgression by the
student. For example, no doubt market research involving humans, e.g.,
focus groups, direct mail or telephone surveys, is undertaken by the
university's business school, foundation or other related entities. Such
decision could then be communicated to the editor in question.

4. Appeal: Appeal the decision - journal editors should be asked to justify
the decision and identify specifically the basis for it, including the
citation, to avoid arbitrary and unfair decisions. If there are no valid
grounds for the decision, then it should be overturned.


Jack Corman
President/Secretary
IRB Services
14845-6 Yonge Street
Suite 328
Aurora, ON, L4G 1H6
Phone: (905) 727-7989 ext. 25
Fax: (905) 727-7990

 

2. Age of Consent and Passive Consent with Teenagers

From: "Joan Stevenson" <stevensj@post.queensu.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Age of Consent and Passive Consent with Teenagers
Date: Friday, June 06, 2003 4:20 AM

RE: Age of Consent and Passive Consent with Teenagers

Our General REB (non-medical, minimal risk, low ethical concern) has been
asked to change our policy so that a researcher could have a younger age of
consent for teenagers without the requirement of parental approval (we
currently require both parent's/guardian's and teenager's signature up to
18 years). G-REB has also been asked if researchers working with teenagers
(ie 14-18 years) could use a 'passive' parental approval, meaning that,
unless the parent indicates otherwise (based on Letter of Information) the
decision to participate would be made by the teenager ( with all TCPS
applying).

Please identify
a) your current age of consent without parent/guardian approval.
b) do you have special procedures for teenager consent in low risk, low
ethical concern studies .
c) any other information that would help us decide the minimum age of
consent without parental approval.

Thank you

Joan Stevenson, PhD
Professor and GREB Chair

 

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Age of Consent and Passive Consent with Teenagers
Date: Friday, June 06, 2003 7:32 AM

1. First we have to operate within the law (which may vary from province to province)
2. Many institutions such as ourselves have a separate board dealing with paediatrics. It is important that the adult and paediatric boards are consistent and seamless. Adolescents are always in danger of being excluded from both adult and child studies, and inclusiveness is part of the giuding principles.
3. may protocols and submissions come to us with varying lower limits of age.
3. In practice (after much debate) we have reached a compromise, in which age per se is not the only principle. For 16 and under, we refer to the paediatric board for approval, in addition to our own if adults are also involved. For adolescents of 17 and above we use the principle of letting the investigator determine whether they are 'functional' adults. A 17 year old living away from home and making independant decisions, and not requring parental signatures for other aspects of their life, we deem a 'functional' adult to be consistent with society's perspective, and respectful. An adolescent living at home and deferring decisions to parents is not deemed an adult.

Obviously there is a fair amount of discretion involved here. If parental signatures are required, then approval by the paediatric board is required. We do not usually distinguish the level of risk in these determinations, but in practice I suspect it sways investigators.

However that is the opinion of an REB in an adult health care environment.

Dr Michael D E Goodyear FRACP FRCPC FACP

Joan,
Our age of consent is 19.

In low risk studies with teenagers we have allowed passive parental
approval. The studies typically involve surveys of high school students
where it is not practical or feasible to obtain parental consent. The
local school board and school principal must agree to allow the study to
proceed. An information sheet is sent home with the students for the
parents to read. Parents may exclude involvement of their children by
filling out a section of the information sheet and returning it to the
school. We have approved a number of these studies over the years and
have yet to receive a complaint.
Richard


Joan Stevenson wrote:

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Age of Consent and Passive Consent with Teenagers
Date: Friday, June 06, 2003 11:06 AM

Hello Joan

As Michael pointed out, age milestones vary from province to
province. A reference for some in Ontario can be found here:

http://www.jfcy.org/age/agebased.html

We use 18, which is age of majority in Ontario. At 16, one can
become an emancipated minor, but we settled on age of majority,
mostly because I was unable to find consistent practice to the
contrary. Health care is based on capacity, not age (excepting
refusal of emergency care which can occur at 16 with capacity).

I'm not a fan of passive consent. I feel at best its worthless, and
at worst harmful. There's no assurance that, in this example, the
parent even saw the form. And that's my general feeling on passive
consent (yes, I've accidentally subscribed to AOL).

So the real issue, as you've identified, is "When may an
adolescent/child be involved in research without parental approval or
knowledge". It would make sense to me that capacity is central,
rather than age. For example, using a cut-off level of, say, 14
above which, up to age of majority, investigators would have to
demonstrate that :

1. The research was below the threshold of minimal risk for that age
group.

2. That the age group would be able to understand the study and be
free to make an informed decision about whether or not to
participate.

3. That the work could not reasonably be carried out if obtaining
parental consent was a requirement.

This gets away from lowering age of consent and anchors it more as if
you were waiving an existing limit (like waiving the requirement for
signed informed consent) under specific circumstances. This is may
well be an oversimplification, given the feelings of parents on some
specific issues. I should also point out that I'm not a parent.
What may be worthwhile is soliciting input from a local parents
rights/advocacy group.

This is a critical topic. As can be seen from the link below, the
possibility for legislation is a real one.

http://www.apa.org/ppo/grassroots/swashtimes.1.29.html

Cheers

Cam

From: "Joanne Gallivan" <joanne_gallivan@uccb.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Age of Consent and Passive Consent with Teenagers
Date: Tuesday, June 10, 2003 10:50 AM

I puzzled at the statement by James Crombie:

>There is a tension, here, between the requirement for consent and the
>requirement for confidentiality. Nova Scotia, it would seem, has no
>statutory definition of age of majority...

According to both the lawyer on our REB and the Legal Information Society of
NS, the age of majority in NS is 19, although on consent issues,
specifically, there is a 'grey' area for the ages 14-18 which complicates
matters (of course!).

Regards,

Joanne Gallivan, Ph.D.
Professor of Psychology
Acting Dean, Research and Library Services
University College of Cape Breton
Sydney, N. S. B1P 6L2
902-563-1271

From: "Hal Weinberg" <hal_weinberg@sfu.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Age of Consent and Passive Consent with Teenagers
Date: Tuesday, June 10, 2003 10:50 AM

We use 14 for minimal risk applications and 19 for non-minimal risk
applications. If subjects are registered students at SFU then they are all
considered adults regardless of their age.

At 04:13 6/06/03 -0400, you wrote:
>RE: Age of Consent and Passive Consent with Teenagers
>
>Our General REB (non-medical, minimal risk, low ethical concern) has been
>asked to change our policy so that a researcher could have a younger age of
>consent for teenagers without the requirement of parental approval (we
>currently require both parent's/guardian's and teenager's signature up to
>18 years). G-REB has also been asked if researchers working with teenagers
>(ie 14-18 years) could use a 'passive' parental approval, meaning that,
>unless the parent indicates otherwise (based on Letter of Information) the
>decision to participate would be made by the teenager ( with all TCPS
>applying).
>
>Please identify
>a) your current age of consent without parent/guardian approval.
>b) do you have special procedures for teenager consent in low risk, low
>ethical concern studies .
>c) any other information that would help us decide the minimum age of
>consent without parental approval.
>
>Thank you
>
>Joan Stevenson, PhD
>Professor and GREB Chair
>
>___________________________

 

3. Contacting Family Members

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Cc: "Daniel Rayson" <daniel.rayson@cdha.nshealth.ca>; <charles.weijer@dal.ca>; <christy.simpson@dal.ca>; <Jeffrey.Kirby@dal.ca>
Subject: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 11:54 AM

1. The Problem: The researcher wants to call family members (siblings) to get them to come in for testing and information about the proband subject's condition. We said no, provide the subject with a letter to give/mail to their siblings, who can contact the researcher if interested.

It didn't work, they claim, very few family members called. Either they were not interested or the subject never passed on the information. We are being told we are out of step, other REBs allow the researchers to call family members directly. We have asked for documentation. We are also told that 'geneticists do this all the time' with the subject's permission.

2. The scenario: The researcher is studying thrombophilia by taking people who have blood clots and testing them for a predisposing thrombophilia. In some cases this may be genetic. They propose to test the siblings and if positive, warn them about the increased risks, especially if they need surgery. There is no intervention.

3. Position: This is an invasion of privacy. If siblings are not responding it is probably for a good reason. They may not be in a good relationship with the subject or they are scared. A direct contact by the researcher might be interpreted as harassment.

This would need to be balanced against the 'need to know', and the potential risks of not knowing and benefits of knowing, to the sibling.

4. Questions: Who has experience with this and how have they handled it? Even if you have not, what do you think? Does anyone else recall this protocol and what they did? Is there a 'workaround' solution. So far no one has come up with passive consent.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Masood Zangeneh" <Masood_Zangeneh@camh.net>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 12:37 PM


During my undergrad, I worked as a research assistant with a very
questionnable psychiatrist who made all the unethical decisions when it came
to recruitment. It was a genetic study and we were told to pursue patient's
family members to particiapte (no money was available to compensate them).
We were indirectly told to pressure them to participate. We were even told
to use things like "it is for the good of humanity" and for the good of
those suffering from so and so disorder. It is understanding that it is a
daunting task to continuously monitor what a PI is doing in the privacy of
his/her own research setting, but I think it is important to have such a
mechanism in place. If ERBs have shortage of manpower, universities should
come up with a plan to recruit and attract students to such a specialized
trainings.

my 1.5 cents.

masood

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 12:50 PM

For non-medical people who may not know what thrombophilia is, here is an
extract from the Thrombophilia Support Page:

Thrombophilia Support Page
Factor V Leiden
Prothrombin 20210 mutation
Activated Protein C resistance
Protein C & S Deficiency
Antithrombin Deficiency and other clotting disorders

------------------------------------------------------------------------
Factor V Leiden is the most common hereditary blood coagulation disorder in
the United States. It is present in 5% of the Caucasian population and 1.2%
of the Afro-American population.

Factor V Leiden increases the risk of venous thrombosis [clotting] 3-8 fold
for heterozygous (one bad gene inherited) and substantially more, 30-140
fold, for homozygous individuals (two genes inherited are bad).

The prothrombin 20210 mutation is the second most common inherited clotting
abnormality; more common than protein S and C deficiency and Antithrombin
deficiency combined. 2 % of the general population is heterozygous. It is
only a mild risk factor for clots, but together with other risk factors
(such as oral contraceptives, surgery, trauma, high blood pressure, obesity,
smoking, etc.) or combined with other clotting disorders (like factor V
Leiden), the risk of clotting increases dramatically.


How does the researcher get the names and telephone numbers of the siblings
in the first place? From the phone book by randomly calling all the people
in the area with the same surname (married and/or maiden) as his/her
thrombophilia patients? I think not. The family member has no right to
reveal details of his/her siblings without the siblings¹ prior consent,
despite the familial connection.

Let's broaden the scenario. Let¹s assume a researcher wishes to determine
the prevalence of Factor V Leiden and the prothrombin 20210 mutation in
siblings in the entire province. S/he proposes to do so by writing to all
the physicians in the province, asking them to provide the names of all
patients with bleeding disorders in their practice and the names of the
siblings. The researcher would then contact the patients and the siblings so
they can be genetically tested to determine if the disorder is thrombophilia
or not, and, if so, whether the siblings carry the mutation. No question
that the request to have the names released to the researcher by the MD
without prior consent from the potential subjects would be rejected by the
REB. privacy laws. The only difference here is that the patients are known
to the researcher because the researcher is the physician to whom they have
turned for help. If anything, this puts an even greater onus on the
researcher to act in accordance with the highest standards because of the
unequal and potentially coercive relationship that exists between the
patient and the physician. For example, it may be that a patient subject
does not want to provide the names and telephone numbers of his/her siblings
for whatever reason, but feels compelled to do so because s/he is afraid to
disappoint the treating physician.

Perhaps a more innovative way can be found to secure the siblings¹ prior
consent, short of an inducement to participate.

Jack Corman
IRB Services

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 1:14 PM

You obviously went to a good school to learn research ethics at first hand. For the sceptics who feel they need no oversight, such things do go on.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Mary Jane Salpeter" <salpeter@uhnres.utoronto.ca>
To: <ethics@lists.ncehr-cnerh.org>
Cc: "Daniel Rayson" <daniel.rayson@cdha.nshealth.ca>; <charles.weijer@dal.ca>; <christy.simpson@dal.ca>; <Jeffrey.Kirby@dal.ca>
Subject: Re: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 1:17 PM

Response:
1. a) Primary care giver (Hematologist or Genetic Counselor, if the Institution has a clinic for Genetic counseling) could meet with the subject and his or her family members to request their permission to receive a call from research staff to discuss a study about blood clots. (Thrombophilia) Cold calls are definitely out of the question at our Institution, we do
not allow telemarketing of research studies!
b) Post advertisements (approved by the REB) in thrombosis clinics or local health clinics.
c) 'geneticists do this all the time' with the subject's permission. Do they do this for Clinical or Research purposes?

2. There is no intervention. What does this mean? Researchers will document and inform study subjects of a clinical diagnosis and walk away! Is their not an obligation to treat or provide referrals to treat if they are the bearers of the bad news?
Patients should be informed of the potential medical diagnosis they may receive if they choose to consent and enroll in the study.
"testing them for a predisposing thrombophilia" Has the test been approved by Health Canada to make a diagnosis for thrombophilia. Is the test standard of care by clinicians at their institution?

3. Perhaps the family member with the diagnosis does not want to share his medical history with his family.(call the lawyers?!)

Passive consent? I am not familiar with this term, please define.


Mary Jane Salpeter <salpeter@uhnres.utoronto.ca>
Ethics Co-ordinator
University Health Network

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 1:20 PM

Dear Jack,

What a wonderful mine of information you are. I was trying not to burden people with too many details vs the principles!

We were told that the subject would provide a contact list of family members. At present the subject is supposed to do the contacting themselves.


Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 1:45 PM

No institution can ever be entirely free of researchers who lose sight of the means and the ends, which is why we are here. It is also why we need a concerted effort to reform the research ethos and it s relationship with REBs. The Royal College Report is a good start.

In a moment of weakness I brashly volunteered to take on the task!


Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 1:45 PM

Thanks for your helpful thoughts Mary Jane:

(1a,b) I will follow up on your suggestions re invitations and advertisements.
(1c) I suspect clinical, I copied this to my medical geneticist to check on that.

(2) An integral part of genetic testing is the counselling that comes with the results. We did approve the information given to the siblings. If you want details I can let you know. Clearly any discussion on risks in genetic testing has to include the social and psychological burden of the result (either way).

(3) I am not an expert in this field, but we were informed that the tests were standard, the research question is the genetic inheritance pattern. The sharing of medical information in families is a contentious one since there is a risk/benefit balance. Disclosure without consent would be very problematical. You are right, this does get into the legalities of privacy laws. We are consulting our lawyers.

Passive Consent: This was discussed on the list recently in relation to adolescents. It is supposed to be how cable companies operate. they add a new service, send you a letter, and if you do not write back and refuse, you have passively consented, and your next month's bill will reflect the increase.

In relation to adolescents, the idea was to send them home with a letter from their parents. If the parents don't object it is assumed they have consented (passively). how many adolescents give their parents notes from teachers?

We recently approved passive consent in a survey. The letter which provided the results of the survey said that the aggregate results including the subject's data would be published unless the subject objected. A consent form was not used. We had some discussion about those issues on the list too - if someone fills out a questionnaire, after reading the covering letter, is that implied consent?

In this case I was curious to see if anyone would raise the question, that unless family members objected, that they were consenting, which would also be problematic.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Richard Neuman" <rneuman@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 2:08 PM

Michael,
I believe our approval is different than yours in that the the proband
is asked to contact the relatives for verbal consent and the researcher
then contacts the proband again to determine if the relatives have given
their verbal consent. If the proband has received verbal consent the
researcher then contacts the relatives by phone. The contact is direct
or by phone, not the return of a letter. The return rate for letter
contact is very small.

Richard Neuman, Ph.D.
Co-Chair, human Investigation Committee

From: <skb@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 2:08 PM

Richard has already commented on our usual policy here but I thought I would
add what we are doing on a familial colorectal study that I am involved with
(with REB approval, of course). We contact patients with colorectal cancer
through their physician and then send questionnaires re family history, risk
factors, dietary intake. If the family history indicates the patient is
likely be part of a moderate or high risk family, the patient is sent a
letter to ask permission to contact family members with a form to list
family members and their contact information and a tick box to indicate the
proband has contacted them and they are willing for one of the research team
to call ( and a tick box to indicate 'do not contact').

Sharon Buehler

From: <skb@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 2:08 PM

I should have added that this 'permission to contact' likely elicits a
higher response rate than putting the burden of contacting the research team
on the family member.

Sharon

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 2:13 PM

At 13:10 7/3/2003 -0400, Mary Jane wrote:
Passive consent? I am not familiar with this term, please define.

Michael your're very fast, but i'll still give it a shot ...

Passive Consent - a mythical state of permission assumed to be in effect in
the absence of informed consent following discussion between the research
investigator and potential subject.

... also once described at an REB meeting by Benji Freedman as the Roger's
Cable authority to bill customers for unsolicited service ... elisabeth


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

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 2:19 PM

That seems similar to what we are doing - to a point. I gather you are relying on the proband to contact the family member and take their word for it and then call, as opposed to waiting for them to call you. Have you ever had a problem when people get a call?

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Contacting Family Members
Date: Thursday, July 03, 2003 2:26 PM

Thanks, that seems similar to Sharon's position too.

Dr Michael D E Goodyear FRACP FRCPC FACP

4. Control of Publication from Clinical Trial

From: "Richard Neuman" <rneuman@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] control of publication from clinical trial
Date: Friday, June 13, 2003 9:28 AM


With respect to clinical trials, our publication policy states that
investigators have the right to publish, but must allow the sponsor 90
days to a maximum of 180 days to review and comment on the manuscript
before it is submitted for publication. In negotiating a contract for a
new trial we were informed by the sponsor that all publications arising
from the trial were to be submitted to a publication committee,
consisting of six academics and four company sponsors, and that this
committee would determine whether a manuscript could be submitted for
publication. In other words the publication committee could suppress
publication of material arising from the trial. We were advised that
this part of the contract was non-negotiable.

Would your REB approve this trial?

Thanks,
Richard Neuman
Co-Chair, Human Investigation Committee

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] control of publication from clinical trial
Date: Friday, June 13, 2003 10:14 AM

I thjnk we would like to know a little more about the setup here. We have recently discussed the issue of what looks like an 'independant' publication committee, others have Sterring Committees. We felt that this was preferable to having the whole trial controlled by a commercial sponsor. Presumably this committee has some terms of reference. We would not be happy if we felt that the committee had the power to suppress all publications from the study, as opposed to monitoring their quality. Often what these committees are more concerned about is single institutios publishing their own experience within a trial. However after Olivieri, there has to be allowance for whistle blowing.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Richard Neuman" <rneuman@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] control of publication from clinical trial
Date: Friday, June 13, 2003 11:04 AM

Michael,
I believe your assumption is correct that the publication committee was
established to monitor quality and to limit publication on a small
number of cases from one site. Nevertheless, the publication committee
has the right to refuse publication and their decision is final. In the
face of the Olivieri case, it is hard to see how a REB in Canada could
approve this trial and yet we understand that 3 REBs in Canada have
given approval. According to the sponsor, we are the only REB to
express concern over publication control.

Cheers,
Richard

From: <aideen.moore@sickkids.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research Require REB - and can it be retroactive?
Date: Friday, June 13, 2003 11:25 AM


We would review this type of project at the outset, usually through an
expedited mechanism, although I often think it is not good use of an REB's
time.

The fact that it is a student researcher does not enter into it.
As the study is already completed, they cannot have retroactive approval,
but a letter saying that if submitted it would have been approved is
appropriate.

I was very interested to see the number of thoughtful responses saying that
they think it does not qualify for review.

This is an instance where the listserv could be very useful for dialogue
with other REB's, and feed back to the TCPS,

Regards,

AideenFrom: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] control of publication from clinical trial
Date: Friday, June 13, 2003 11:35 AM

Ouch! With all due respect to the industry members of this list, this is standard industry policy. You have been told that you are out of step. To which our usual response is to ask to see the reviews of the other REBs. I would think that the CAUT would be very interested to know th what extent REBs and institutions in Canada have implemented the Olivieri recommendations.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Lindley, Pat" <plindley@Kilcom1.UCIS.Dal.Ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research Require REB - and can it be retroactive?
Date: Friday, June 13, 2003 1:31 PM

Hi,
We review a lot of qualitative research, much of it survey research.

Here is my view:

Using the algorithm of "is it research?" and "does it involve human
subjects?":

>Is it research?
Yes it is. I agree with Cam, for the reasons he cites. Basically it is only QA
in our view when the application of the results is localized to improvement
of the intervention, program etc which is the subject of the evaluation. The
desire to publish the results implies that 'generalizability' is, to some
degree, the intent.


>Does it involve human subjects?
The reasoning that we use in these situations (and we see them fairly
often) is best illustrated as follows.... (I think I have quoted this before on the
listserve.) If a survey were to come to me, but the questions dealt with the
institution in which I worked... and anyone in the office who could access
the information could fill it out, and return it, then the subject of the survey is
clearly the institution. Not me. Certainly I shouldn't be handing out
information that is confidential, but it is my responsibility to ensure that I am
abiding by my institution's policy in this regard. If, on the other hand the
survey were directed to me, in my professional capacity, seeking answers
to questions which reflected my opinion, individual knowledge, or
experience, then it is my voice that is speaking in replying, and arguably it
is linked in an individual way to me (even if the information might not by
some be deemed 'personal', but rather professional). I would be the
subject of the research.

>Informed consent: I'd like to make a distinction between informed
>consent and documentation of the informed consent process. Having a
>signed consent form doesn't constitute informed consent, it's just
>documentation that something happened. In this instance, it sounds
>like covering letter provided the orientation to the study, subject to
>its adequacy. Surveys often use completion of the survey as
>documentation of consent. In surveys I've done, I usually say this
>explicitly in the orientation letter. It prevents having a link to
>the participants that wouldn't exist otherwise (the signed consent
>form) and can actually better protect participants provide anonymity
>as opposed to confidentiality.

I agree

>Process: Ideally, the REB should decide if something is exempt, not a
>researcher.

I also agree.

>Fault: I'd look at this as an opportunity for quality improvement
>rather than an issue of fault. It's evident that a senior academic
>wasn't aware of the process. I wouldn't necessarily expect a student
>t be aware of the rules unless they're explictly told somehow.
>Asking questions about how they could be better informed, what would
>work for them, etc. may help improve the awareness of expectations.
>I've found that situations like this are excellent seques for
>learning.

Also, we have expanded our guidelines to include discussions of these
sorts of things to provide guidance for our researchers.

>That's my 0.02

Make it 0.04

Pat

From: "Laurel Evans" <levans@mcmaster.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] A conundrum - When does Student Research Require REB - and can it be retroactive?
Date: Friday, June 13, 2003 3:41 PM

With all due respect it seems to me that there is some confusion between research which is
about human participants and research which involves human participants. The TCPS uses the
words involves human subjects, and references the case of research about a public figure etc.
where the information is publicly available or available from third party interviews, as not
requiring REB approval. However, if the research involves interaction with the research
subject, REB approval is required. The commentary goes on to say that for third party
interviews, (eg. interviews of employees about their company?) REBs should ensure that the
interviews are conducted according to a professional protocol and to article 2.1 (i.e. free and
informed consent). Ergo, they require review at least to that extent. At least, that's my
reading of it.

"Lindley, Pat" wrote:

> Hi,
> We review a lot of qualitative research, much of it survey research.
>
> Here is my view:

5. Deadly Clinical Trial not Approved by Health Canada

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Deadly clinical trial wasn't approved by Health Canada
Date: Friday, June 13, 2003 6:15 PM

Thus spake the CBC as in

http://ottawa.cbc.ca/regional/servlet/View?filename=ot_lucio20030612

and understandably have tied this in with every other negative thing one can think about with regards to clinical trials. We should be worried, even though it does not look as though this death was something that REBs could have prevented.

This raises the question yet again of the allegations made on March 18th by the CBC about trials with Gefitinib/ZD1839/Iressa (embedded in the above story), but worth listening to again to see what lessons we can learn.

I have tried to trace the paper trail. Cetainly I received a letter from Astra-Zeneca about the deaths on November 21st (because I had a patient who wanted the drug), but it is implied that many investigators did not for months. Is this true. Eventually I found an Action Letter (in a protected site) at the US NCI dated November 1st, although it is not clear as to who it exactly went to and dates on letters do not necessarily say anything about receipt. (attached).

What struck me was that the letter refers to amending consent forms and notifying IRBs/REBs (which could take months) but does not adress the need to notify participating patients. Therefore it is quite possible that the CBC's allegations have some truth in them, namely that as a system we failed because process came before outcome, and that REBs did in fact insist on approving all information being provided to patients, causing unacceptable delays.

If this is true, we have some serious house keeping to do.

6. External Institutional Approval

From: "Laurel Evans" <levans@mcmaster.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] External institutional approval
Date: Monday, June 09, 2003 2:26 PM

We have had a policy that if research is to take place at an institution
outside of the University, that approval for the research should be
obtained from the outside institution. If the other institution has a
research ethics board, then the approval of the external Board would be
obtained. If there is no Research Ethics Board, we still take the
position that the institution should be made aware that our researchers
are doing research involving their employees/students/patients etc.
This has been our "default" policy, there can be exceptions, for example
if the research would be compromised by obtaining the approval of the
outside institution then the researcher would be able to apply to the
Board to explain why the external approval should not be required, and
to explain what the persons being surveyed/interviewed will be told
about "risks", etc. Some of our researchers have objected to this
default policy...they are arguing that our policy protects the
"institution" not the research subjects, and that it may impinge on
academic freedom etc. particularly if the research is being done
off-site and in the employee's/students/patients own time. Could anyone
please respond with whether or not their institution has a similar
policy and the rationale for it? Many thanks.

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Monday, June 09, 2003 2:49 PM

Your position would seem to be in line with TCPS. Where there is no REB in the external institution we have asked for authority from the Governing body of that institution to subsume that role for them (also in TCPS) and to provide a letter of agreement and support for the research.

We do not see how you can really separate the various entities involved - it is for everyone's protection and demonstrates accountability to society.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Laurel Evans" <levans@mcmaster.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Monday, June 09, 2003 3:06 PM

Thanks Michael. It seems to be just common sense to me too, and in
accordance with the TCPS, but I have been requested to canvass the list
to determine the policy of other institutions. Regards. Laurel Evans.

Michael Goodyear wrote:

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Monday, June 09, 2003 3:26 PM

that's the way it works - or why we need national policies

>>> levans@mcmaster.ca 06/09/03 03:59PM >>>


Thanks Michael. It seems to be just common sense to me too, and in accordance with the TCPS, but I have been requested to canvass the list to determine the policy of other institutions. Regards. Laurel Evans.

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Monday, June 09, 2003 4:24 PM

Hi Laurel

How're things?

We've modeled our practice for local review for external research
along the policy lines of OHRP.

http://ohrp.osophs.dhhs.gov/humansubjects/assurance/engage.htm

The TCPS states that "principles of institutional accountability
require each local REB to be responsible for the ethical
acceptability of research undertaken within its institution."

IMO the critical question, left unanswered, is when do you consider
work to be "undertaken within an institution"? Perhaps the question
could be better framed as "when is an institution engaged in research
and local review required"? The OHRP policy addresses that issue in
what I think is a sensible way.

Our policy is fairly broad and not as explicit as I'd like, but in
practice, we generally require local review if:

1. An agent of the college is involved in the work;
2. The risk is below the threshold of minimal risk for the group
being accessed;
3. A vulnerable population is being accessed (e.g patients); or
4. There has been no other review.

This is a practice leading from the broad policy and we can default
to full review in any instance. For other works, we require a
current certificate for the work to be conducted from the
institutions whose researchers are conducting the work, an abstract
of the work, and copies of the consent documentation and any
instruments and advertising to be administered. In a practical
sense, one could construe this as an expedited review of sorts, but I
wouldn't call it a review. In a couple of instances, we've found our
name on advertising even though none of our agents were involved in
the work.

As a matter of interest, this topic has come up at least once before:

http://lists.ncehr-cnerh.org/mailman/private/ethics/2001- August/thread.html
(note that the above link may be split in your email program).

Requirement for local review in all instances presents the following
conundrums:

How low do you go? The requirement for local review could
conceivably include every advertisement on a premises or every
service provision for research related services regardless of the
actual site of the work or the state of the data (e.g. blood samples
being analysed on a fee-for-service basis).

It adds a layer of redundancy that may not be required. If I do a
study looking at perception of services provided by student loan
agencies across Canada, does that mean I'd have to get ethics
approval at every institution if I recruited their students using
advertisements on their premises or by having a member of our
research team at a career fair or orientation? There may be
considerations of culture etc. for the study, but ideally this should
be taken care of at the primary review stage by the institution whose
faculty are conducting the work. Communication between REB's can
probably flag such instances where special consideration is required.

Who has jurisdiction? If an external agent decides to access our,
say, student population, what jurisdiction does our REB have to
monitor work, inspect files off site etc. etc? Who undertakes the
monitoring role? Do we undertake that role for "our" particants, REB
X looks after theirs etc. etc. Undertaking a review also undertakes
an obligation for monitoring.

What's the burden on the local REB? Some works, even if minimal
risk, may present a significant burden to REB's to review,
particularly if they lack the expertise in the area of research or
requests are made frequently. Following a rule of local review for
everything, they may simply deny access.

We've run across a number of different policies in practice. At one
university, for a minimal risk study (an attitude survey of a student
sub-population) we were required to undergo local review *and* have a
local investigator who would be the local agent/contact for the
review. At another, we are being allowed access given a local
departmental REB review.

Institutions are obliged to review the work of their agents. I'm
taking as a given in Laurel's example that the researcher's
institution would review the work, regardless of where it was
conducted. I also agree with Michaels statements about
accountability and obligations to society.

What I'm not convinced of, in line with a principle of proportionate
review, is that all instances of research require local review.

Cheers

Cam

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Monday, June 09, 2003 4:44 PM

Now with those conditions, do they have to meet any or all?

We have been struggling with this for some time and eventually came up with an 'oversight of oversight' approach between the two extreme positions being put to us. This still reserves the right for more stringent review if the risk dictates.

For the record this is what we have come up with


Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Monday, June 09, 2003 4:44 PM

Now with those conditions, do they have to meet any or all?

We have been struggling with this for some time and eventually came up with an 'oversight of oversight' approach between the two extreme positions being put to us. Thi still reserves the right for more stringent review if the risk dictates.

For the record this is what we have come up with


Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Laurel Evans" <levans@mcmaster.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Monday, June 09, 2003 4:52 PM

Thanks Cam. My question is really more-or-less the opposite to that of the
situation which you have addressed. The researchers clearly require
"local" review...the question is, when they go off-site to do their
research, are we being unfair/overly strict in requiring that in most cases
they also let the off-site institution (eg. employer, hospital, school)
know that they are conducting research on their employees/patients/students
and get the off-site institution's approval? (Either by formal review or by
senior management permission) I don't think so but our researchers are
arguing that our policy is impinging upon academic freedom and is designed
to protect "institutions" rather than participants.

Cam McDermaid wrote:

> Hi Laurel
>

From: "Jack Corman" <irbs@interlog.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Monday, June 09, 2003 5:14 PM


At least for most biomedical research, in addition to the TCPS, there is a
national policy with teeth - sponsors who fail to observe the regulations
may be subject to criminal prosecution. In addition to stipulating that
ethics reviews are legally required for studies involving products it
regulates, Division 5 of the Canadian Food and Drug Regulations (Clinical
trials) also require ICH Good Clinical Practice Guidelines to be observed
for Phase IV research. Most industry sponsors in fact have changed their
SOPs to ensure ethics reviews are conducted for all research they sponsor,
not just those studies covered by the regulations. This commitment is
confirmed by the RX & D (Canada¹s Research Based Pharma Companies) Code.

While the requirement for the REB to be unaffiliated with the sponsor is
well understood by industry, it may not have been fully appreciated by
non-commercial, i.e., public sector sponsors. How this legal requirement
for an REB to be unaffiliated with the sponsor squares with research
sponsored by universities, hospitals or research groups would be an
interesting study.

Jack Corman
IRB Services
905 727 7989 ext 25
Fax 905 727 7990

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Tuesday, June 10, 2003 10:10 AM

Hi Laurel

Sorry, I misconstrued your note.

The question if requirement for external approval really protects
participants is an interesting one. Overtly, it would appear that it
is there to protect the institution. There may be other elements,
though. Some institutions may have custodial obligations, have
insight into ethical dilemmas not apparent to investigators or may be
so hostile to some research that accessing participants on their
premises puts them at risk. It would seem only common sense to ask
for permission to enter or access their premises or facilities.
Asking for this kind of permission may be a civic responsibility,
rather than a frankly ethical one.

It would seem to me that the proviso for waiving that permission
given justification vis a vis the impact on the research protects the
academic freedom of researchers.

Cheers

Cam

From: "Gabrielle Miller" <gmiller@nickel.laurentian.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Tuesday, June 10, 2003 10:51 AM

Another wrinkle:

We have required that off-site institutions where research is conducted also review the research, but we did run into one situation a long while ago, where it was not appropriate.

The institution was a company, and the subjects were former employees... and the research was historical with a labour context. Of course, in this situation, the company did not have an Ethics Committee, but we did ask that they approve the project, and were (appropriately, I think, in hindsight) shot down for it by the research team.

This was several years before the TCP came in and clarified things. I think they deal with this adequately in saying that "Consent is not required from organizations such as corporations or governments for research about their institutions." and "However, such organizations need not be approached for consent, and REBs should not require such an approach." (Section 2.1 d)

Gaby Miller

Gaby Miller
Research Officer/Agente de recherche
L-335a
Laurentian University/Université L

From: "Laurel Evans" <levans@mcmaster.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Tuesday, June 10, 2003 11:16 AM

Thanks Gaby, I hadn't adverted to the commentary under informed consent. Does that mean that you don't ask your researchers to get company/hospital/school "permission" to access their premises/speak to their employees/patients/students, as a general rule?

Gabrielle Miller wrote:

From: "Michael Owen" <mowen@spartan.ac.brocku.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Tuesday, June 10, 2003 1:29 PM

Hi Gaby

In the cases that you identified I would think that neither the
company's or the union's permission would be required. However, I do
think that if one was doing research in the organization, with
employees or students or patients that one would require ethical
reviews by both the institution and the organization (and in some
cases the organization's employees' association), although there
might be, in some instances, arguments for incomplete disclosure if,
say, one was conducting research on glass ceilings or other sensitive
topics within the organization or association.

Access to premises, identified below by Laurel, is I think a
different issue and does not relate solely to the ethics of the
research (e.g., issues of liability related to injury, etc.)

Michael
From: "Lindley, Pat" <plindley@kilcom1.ucis.dal.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Tuesday, June 10, 2003 4:02 PM

Re: institutional permission versus Institutional ethics review.

We make the distinction as follows:

If a researcher wishes to seek the assistance of an institution in the
conduct of research involving its staff, patients etc. then it must abide by
the policies of that institution. 'Assistance' can be anything from posting a
sign on an institutional bulletin Board, to circulating recruitment materials,
to allowing use of employee time or company facilities. This is
professional courtesy. Also, not to do so could put participants at risk (i.e.
to try and recruit in a clandestine fashion while infringing on the rights or
jurisdiction of the institution).

However if the researcher wishes to recruit staff, for example nurses, who
happen to work at an particular institution (in this case a hospital) by
going through the Professional Nurses Association, and mailing letter to
their homes, then we would not require ethics approval nor permission
from the hospital. The hospital employs the nurses... it does not control
every aspect of their lives. Otherwise you are granting the institution veto
power over research participation by its staff. This would be an
unreasonable limitation on the individual rights of the nurses to choose to
participate in a study outside their workplace.

It gets more complicated in studies, which we have seen, where there is
an element of political activisim (eg. empowerment of non-unionized
workers in developing country sweatshops) in the research. It is often
unrealistic to think that the research can actually go on without the
company knowing and anonymous participation may be very difficult to
achieve. There are real risks (spousal anger, managerial retaliation) for
participants when the objective of the research is counter to the interests
of the company. However, there are ethical arguments that would also
counter allowing a company to veto the research. The researcher has to
demonstrate in considerable detail how subjects will be protected from
retaliation in these situations. Unfortunately it is often graduate students
(with the least practical experience) who want to do this kind of research.

Pat Lindley

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] External institutional approval
Date: Wednesday, June 11, 2003 8:43 AM

I think that there are so many potential scenarios that each case needs to be assessed on its merits. In addition to 'research ethics' there also needs to be consideration of what is a a professional courtesy, and what is politically wise if the project is to succeed.

I can well understand the confusion as to whether 'home' REBs are protecting institutions or individual subjects. Hopefully these are not in conflict. If not the answer is usually both. The REBs prime duty is to ensure that research subjects are being dealth with honestly and fairly and with respect, are adequately informed in terms meaningful to them, and that the risks are not excessively disproportionate to the possible benefits (which are often negligible). At the same time the institution which appoints an REB has a reasonable expectation that it is making the institution compliant with the guiding principles and regulations, and therefore the REB is to some extent 'protecting' the institution.

With regards to external institutions, those potential research subjects who are approached because of their relationship to that institution have a reasoanable expectation that the institution, or legal entity, has exercised some degree of oversight of their rights.


Dr Michael D E Goodyear FRACP FRCPC FACP

7. Investigator's Brochures

From: "Hollinshead, Wendy" <whollin@mcmaster.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Investigator' Brochures
Date: Wednesday, June 25, 2003 3:52 PM

This is a question concerning Investigator's Brochures (IB) for clinical trials. Section 7.1 of the ICH GCP states that "the sponsor is responsible for ensuring that an up-to-date IB is made available to the investigator(s) and the investigators are responsible for providing the up-to-date IB to the responsible IRBs/IECs."

Our REBs are struggling with limited storage space and wondering whether we need to retain all versions of the IB in our files until the study is completed and for the required number of years thereafter until the file can be destroyed. The IB can be quite a lengthy document.

When an updated IB is submitted to the REB, can we destroy previous versions and simply retain the current IB? I can understand the investigator needing to keep older IBs on file as proof of previous instructions, but does the REB need to store older versions as long as the REB ensures it has a record (noted within the study file correspondence, or in the REB dbase for example) of the previous version(s) being received? I'd like to know what other REBs out there do with the IBs?

With thanks,
Wendy.

From: "Melony Frei" <mfrei@cpsa.ab.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Investigator' Brochures
Date: Wednesday, June 25, 2003 4:07 PM

We only keep the most current investigator brochure on file. The other
copies received are noted in the study file.

Sincerely,

Melony Frei
RERC Coordinator
College of Physicians & Surgeons of Alberta
780-970-6236
mfrei@cpsa.ab.ca

From: "Shelly Rempel Rossum" <remross@Ms.UManitoba.CA>
To: <Ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] IB's
Date: Wednesday, June 25, 2003 5:34 PM

Dear List serve
We have kept all copies of the IB's in the file to date. If two sites are
using the same IB our study files will reference the exact location of the one
IB. Over the past couple of months I have seriously considered revising our
procedures such that we keep a copy of the cover page of the outdated IB for
our files and confidentially destroy the older version. I suspect this would
be acceptable as often the letter from the sponsoring company will direct the
site to destroy the old copies in a confidential manner. I'm very interested
in the response of other REB's to this issue.

sincerely,

Shelly Rempel-Rossum RN, BN
Research Ethics Board Coordinator
University of Manitoba Research Eth

From: "swarden" <swarden@uhnres.utoronto.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Investigator' Brochures
Date: Wednesday, June 25, 2003 5:36 PM

Hi Wendy

We do exactly what you outlined in your last sentence, as the newest version contains all the information contained in the previous versions. We only keep the letter of submission of the previous version as well as the cover page of the previous version. We write on this letter "superceded by Version __, dated ___", then only keep the newest version in its entirety.

Sarah

rom: "Bonnie Korthuis" <Bonnie.Korthuis@usask.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] IB's
Date: Wednesday, June 25, 2003 7:25 PM

Good Afternoon:

We have just recently moved to the system that you are considering(that is
keeping a copy of the cover page of the outdated IB for our files and
confidentially destroying the older version) and I am happy to read that
others are doing the same.

Sincerely,

Bonnie Korthuis
Ethics Administrative Assistant (Biomedical)
Research Services, Room 3403
Office of the Vice-President Research
University of Saskatchewan
Box 5000 RPO University
110 Gymnasium Place

8. CAREB Membership

Hello to all,

Each year, we must sort through the CAREB member*s directory in order to
ensure that only members are listed and have access to this useful tool: the
website. Although the CAREB membership year ends on March 31st of every
year, this process is usually undertaken after the Annual Conference (around
mid-May), to allow members attending the Conference to renew their
membership at the same time.

As mentioned in the Secretary-Treasurer's reminder, those not having renewed
their membership will soon be deleted from the directory. It seems that
this message was overlooked by many. If you have received this message, it
is because we have not as of yet received an indication that you wished to
remain a member and therefore, unless we are informed otherwise, your access
to the secure portion of the Website would be removed by the end of the
week.

Receipt of a renewal form showing intent to remain a member will suffice; it
is not necessary that we receive the payment of your membership fees right
away for you to remain a member. The membership renewal form can be found
at the following address http://careb-accer.ca/fr/members.html and either
submitted by mail or faxed to (902) 470-6767, to the attention of Diann
Nicholson.

Should you wish to not renew your membership, simply ignore this message,
and the appropriate accesses will be removed accordingly.

Should you have any questions, please feel free to contact me.

Thank you for your cooperation.

Diann Nicholson
CAREB


Diann Nicholson
Director, Research and
Research Ethics Administration
IWK Health Centre
5850 University Avenue
Halifax, Nova Scotia
B3J 3G9
(902) 470-8765 (Phone)
(902) 470-6767 (Fax)
diann.nicholson@iwk.nshealth.ca

9. On Campus Outreach and Education Programs

From: "Tim Richards" <trichard@uvic.ca>
To: <ethics@lists.ncehr-cnerh.org>; <trichard@uvic.ca>
Subject: [Ethics] Re: On Campus Outreach and Education Programs
Date: Thursday, June 19, 2003 4:25 PM


Re: On Campus Outreach and Education Programs

This is not a question on an ethics issue, but rather a request for
information on whether other universities have on campus outreach and
education programs regarding research ethics.

Our Office of the Vice-President Research has been able to hire me in a part
time summer position to develop education workshops and materials for
research involving human participants. We are also planning to consult with
researchers to receive their feedback for suggestions to improve the ethics
review and approval process. Has anyone undertaken such efforts? If so,
what sort of outreach and education has been tried, how has it been done and
with whom, and are there suggestions as to what has been most successful?

Thanks in advance for any input.

Tim Richards
Research Ethics Educator
Office of the Vice-President Research
University of Victoria
trichard@uvic.ca
Ph. 250-472-5202

From: "Leslie_MacDonald-Hicks" <LeslieMacDonaldHicks@pigeon.carleton.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Re: On Campus Outreach and Education Programs
Date: Thursday, June 19, 2003 4:37 PM

The most successful event I have with folks on campus is the seminar
sessions. These are usually in-class presentations with Q & A's. I've done
these with undergrads and graduate students. I've also had meetings with
faculty members - sometimes on very specific issues. I've created a "Brown
Bag Lunch" series for the new academic year around how to apply and what is
generally involved. I've also designed some special events - example - the
local school board as an ethics process that most people do not know about.
I've invited them to present their policy and discuss how to put together an
application to the school board ethics committee.

Generally, people like to see you and ask specific questions. In terms of
feedback - you would be surprised what comes up. My experience so far is
that if you listen well and work with the researcher to find solutions to
their concerns you can have a very positive working relationship that
beenfits everyone.

Leslie J. MacDonald-Hicks

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Re: On Campus Outreach and Education Programs
Date: Thursday, June 19, 2003 4:43 PM

That is encouraging. We provide in-house education for REB members. There is a monthly 'Ethics Update' for research coordinators. The University Department of Bioethics provides a one day course 'Researcgh Ethics 101' once or twice a year. We need to do a lot more. i would like to see most investigators complete the NIH on-line certification.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Re: On Campus Outreach and Education Programs
Date: Thursday, June 19, 2003 4:43 PM

Leslie I wholeheatedly support your last statement, otherwise we are merely seen as getting in the way of research!

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Leslie_MacDonald-Hicks" <LeslieMacDonaldHicks@pigeon.carleton.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Re: On Campus Outreach and Education Programs
Date: Friday, June 20, 2003 9:03 AM

I am attaching the application guidelines from the Ottawa-Carleton District
School Board & The Ottawa Carleton Catholic School Board. While separate
school boards they collaborate in terms of the research ethics process and
contribute members to from each board to it. They are impressed by the TCPS
and were pleased to know that our faculty and students go through the
process with us before they even see anything. In fact we have not had a
single application rejected by them since they've learned about our process
and the standards of TCPS.

If you are unable to open the document I can arrange to send a hardcopy.

<<OCo Catholic & Public School Ethics Guidelines>>

Leslie J. MacDonald-Hicks

From: "Lindley, Pat" <plindley@Kilcom1.UCIS.Dal.Ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Re: On Campus Outreach and Education Programs
Date: Friday, June 20, 2003 10:27 AM

Re: On Campus Outreach and Education Programs

In the past we have held an annual REB 101 on the basics of ethics
review. This year we held an RER 101 - it was available to more than
ethics Board members, but still dealt with the basics of research ethics
(the TCPS, Consent, Risk, Justice and a case study). It was 1/2 day and
there was a very mixed crowd. The reviews were enthusiastic and,
although some had misgivings prior to the event, the joint learning
experience of REB members and those who are often tasked with
preparing ethics submissions was very positive. We had a lot of nurse
coordinators from the local affiliated hospitals... apparently no one ever
talks to them and they are the ones often doing the submissions or
recruiting and consenting participants.

Pat

From: <will@unb.ca>
To: <ethics@lists.ncehr-cnerh.org>; <trichard@uvic.ca>
Subject: Re: [Ethics] Re: On Campus Outreach and Education Programs
Date: Friday, June 20, 2003 12:41 PM

Here is a "contribution" to the listserv, after all. Dr.
Richard at U. Vic. asked whether anyone is doing research on the
research-ethics process. Recently, I received a SSHRCC grant to
see whether research-ethics review is changing the methodology
and/or the topics of social-science research. I am at the
documentary-data analysis stage, but hope to move into focus
groups and interviews later next Summer (in 2004).
If anyone can point me to published materials on this topic, I
would be pleased to hear from you. There is not much, but one
never knows.
Will C. van den Hoonaard


Will C. van den Hoonaard
Sociology Book-Review Editor,
Canadian Review of Sociology and Anthropology
Department of Sociology
POB 4400, Fredericton, N.B. Canada E3B 5A3
Tel (506) 453-4849; Fax (506) 453-4659

From: "Gabrielle Miller" <gmiller@nickel.laurentian.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Re: On Campus Outreach and Education Programs
Date: Friday, June 20, 2003 2:06 PM

I've done some courses for graduate students at the request of their programs, with mostly good results.

This year we (thanks to a student we had in the Office) developed a booklet for graduate students, including the most pertinent parts of the Tri-Council Policy, our policy, the application form (which they can also download from the web) a description of the way the system works, etc.

We also set up a binder for new Ethics Board members, with the basic ethics policies other than the TCP, and some case studies and articles that semed pertinent-- vulnerable subjects, qualitative research issues, that sort of thing. I haven't had much feedback on that yet: hoping they eventually read it...

We should do more: the feedback is mostly positive whwn you do things, and I can see it helps in terms of the quality of what cmes in. It's just hard doing everything...

Gaby Miller


Gaby Miller
Research Officer/Agente de recherche
L-335a
Laurentian University/Université Laurentienne
(705) 675-1151, ext/poste 3213
Fax: (705) 671-3840
gmiller@laurentian.ca
Web page: http://www.laurentian.ca/grad_study/research/research.html
or
http://www.laurentian.ca/admn/grad_study/research/recherch.html
--------------------------------------------

From: "Masood Zangeneh" <Masood_Zangeneh@camh.net>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Re: On Campus Outreach and Education Programs
Date: Friday, June 20, 2003 2:46 PM


Dear Gaby and other list members

As a new member allow me to take this opportunity and thank you all for your
thoughtful posts. We are at COSTI Immigrant Services currently developing
our own organizational ethics board structure. As part of this project, we
are developing what is going to be called "client's rights" (a first of its
kind) in Canada (I think?). COSTI is a community social service agency that
serves multi-ethnic comunities in the Greater Toronto Area and to some
extent (depending on the nature of its service) the province of Ontario. We
are currently one stage behind what Gaby described below. We would be very
interested if anyone could share his/her resources with us and we would be
more than happy to do the same.

Regards,

***********************************************************************
Masood Zangeneh, B.Sc. (UofT), M.Ed. (MSVU), M.A. (Unisa- candidate)

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Re: On Campus Outreach and Education Programs
Date: Friday, June 20, 2003 3:18 PM

Your pont is taken completely. We do guide people to our website, which is public.

http://development/capitalhealth/research/researchEthics/index.html

- and it has fairly good links. The problem is people knowing where to look for the iformation they need. We encourage researchers and/or their staff to drop by the office for a pre-submission consultation.


Dr Michael D E Goodyear FRACP FRCPC FACP
Assistant Professor, Division of Medical Onco

From: "Hal Weinberg" <hal_weinberg@sfu.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Re: On Campus Outreach and Education Programs
Date: Tuesday, June 24, 2003 6:26 PM

We send out newsletters regularly, have discs to distribute, talk to
classes and conduct forums for the public, faculty and students.

At 13:18 6/19/03 -0700, you wrote:

>Re: On Campus Outreach and Education Programs
>
>This is not a question on an ethics issue, but rather a request for
>information on whether other universities have on campus outreach and
>education programs regarding research ethics.
>

From: "Jaro Kotalik" <jkotalik@tbaytel.net>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Re: On Campus Outreach and Education Programs
Date: Thursday, June 26, 2003 9:15 AM

We organise once a year a 1-1.5 day workshop on research ethics for REB members, administrators, researchers and students. Topics are chosen based on survey of REB chairs. Each topic is given a 2 hr block to allow for group work, discussions and sharing of experiences.
Jaro Kotalik, MD, MA, FRCPC
Director, Centre for Health Care Ethics, Lakehead University
955 Oliver Rd., Thunder Bay, ON P7B 5E1
Phone/fax (807) 343-8126 E-mail: Jaro.Kotalik@lakeheadu.ca

10. Stem Cell Animal Research and REB Review

"Dr. Peter Loewen" wrote:

Your opinion would be valued:

I have been asked by a stem cell researcher (using approved,
registered, CIHR compliantî human cell lines purchased from the U.S.)
whether ethical review is required for their projects in which the
cells will be injected into animals.

My initial impression was ìno ethical review required unless they are
studied in a human subject, including cadavers, as per TCPS 1.1(b).

Upon re-reading TCPS 1.1(b), I am reminded that it says research
involving ìhuman remains, cadavers, tissues, biological fluids,
embryos, or foetuses shall be ethically reviewed by the REBs. We do
insist on cadaver and human research being reviewed.

I'd imagine this type of research is already going on at our
university, but our boards has never been asked to review a proposal,
nor have I been asked outright whether they need to seek ethical
review. We have reviewed stem cell experiments involving human
subjects.

I'm reluctant to interpret TCPS 1.1(b) as requiring review, since I
doubt our board is properly constituted to review this sort of animal
research.

Your advice would be appreciated.


Peter Loewen, B.Sc.(Pharm), Pharm.D.
Pharmacotherapeutic Specialist - Internal Medicine
Vancouver Hospital & Health Sciences Center - UBCH
Clinical Assistant Professor

Subject: Re: [Ethics] Opinion Requested: Stem Cell Animal research & REB
Review
Copies to: tdg@pre.ethics.gc.ca
Send reply to: ethics@lists.ncehr-cnerh.org
Date sent: Mon, 2 Jun 2003 18:47:56 -0400

I do not think that we can avoid responsibility to provide ethical oversight for a
project such as you describe because it does involve human tissue, albeit in the
form of cell lines. However, I think that this could be done by having a stated
policy governing this type of research which would be available on the CREB/ORS
website and could be distributed to any researcher making an inquiry. Such a
policy could state that the cell lines must themselves be compliant with
relevant regulations of Health Canada and CIHR, the uses to which they will
be put must be within any guidelines of those same organizations and the actual
animal research must be compliant with UBC rules and guidelines for animal
research. With some thought we may want to indicate some additional
conditions. Any investigator who felt he or she was comfortably within those
guidelines could proceed with the blessing of the REB. Any in doubt could ask
for guidance.

Joseph M Connors, MD Chair, Lymphoma Tumor Group, BC
Cancer Agency jconnors@bccancer.bc.caphone: 604-877-6000 x 2746 fax: 604-877-0585 600 West 10th Ave, Vancouver, BC V5Z 4E6


Peter
I believe this in fact requires ethical review for the reasons you
state, but the issue is thornier than portrayed with the CIHR plowing
aheand in the absence of legislative decree, out of frustration with the
pace of action. I had written to Pat when I saw the announcement, but
don't think I've had a response. She is our national expert on this, we
should hear from her, but I caution against exactly this sort of "just
slip it in there" approach, and am surprised to see how fast it has come
on the heels of the announcement just this week. We probably need a
university-wide policy, not an institution by institution one, and there
will be all sorts of allegations about preventing/disabling competetive
research if we don't get it right. Besides hearing from Pat, I think
Indira should be directly involved in this one - this will be setting
significant policy. Katherine

 

My first inclination would be to contact the UBC Committee for Animal Care
to see if they are reviewing such proposals. Either way, they might be
aware of federal policy that more specfically tackles this type of issue.

I would not be comfortable having the Providence REB review this type of
research.

Steve

-----Original Message-----
From: Dr. Peter Loewen [mailto:ploewen@interchange.ubc.ca]
Sent: Friday, May 30, 2003 2:13 PM
To: ethics@lists.ncehr-cnerh.org; Barbara McGillivray; Ian Franks; Jim
Frankish; Joseph Connors; Katherine Paton; Margaret Shotter; Patricia Baird;
Steve Shalansky
Subject: Opinion Requested: Stem Cell Animal research & REB Review


Your opinion would be valued:

Hi All.

My REB has been asked to review a protocol that uses an immortalized
embryonic stem cell line for in vitro work. My feeling was that such a
protocol does not warrant review, as it does not fall into article
1.1b), and is more similar to other in vitro work involving
commercialized human cell lines (e.g. breast cancer cell lines), which
does not undergo review, than work using tissues or embryos.

Upon communicating with CIHR, I've been told that in fact this work does
require ethics review. My problem is that it seems that this review is
more geared to bioethics (i.e. the ethics of using embryonic stem
cells), not ethics review (i.e. what is going to be done).

Rachel

james frankish wrote:
>
> Hi
>
> My view is that if it involves human tissue it should get ethics approval.
> But, I am a complete neophyte in this area. Jim
>
> PS: I enjoyed the REPAB meeting.
>

Hi Peter,
Re: Human stem cells used in animals and ethical review
It depends what they are doing with the stem cells in animals. For example,
are human stem cells being put in animal embryos? Are they being put in
brain? I would think a query to the CIHR Stem Cell Oversight Committee that
is being formed would be in order. This is a more complicated topic than it
looks on surface. Bill C-13 would provide legislation overseeing this area.
It is still before the Commons, supposed to have its 3rd and final reading
this month.
The CIHR Stem Cell Oversight Committee is said to be going to have
guidelines that are congruent with C-13 legislation. This is a topic we
ought to discuss.
(I'm off out of the country at end of the week).
Cheers,
Patricia

Patricia...

Thank you for this opinion. We should discuss it at REPAB. I will try to
contact the CIHR Oversight Ctte to see what today's guidance is, and will
also be talking to the Animal Care Committee to see what the components of
their review of such projects includes, since there are already 7 projects
ongoing at UBC involving stem cells in animals. None underwent REB review,
all underwent Animal Care Cttee review.

PL

I concur with Katherine that due process is primordial here. The same way
that under our system of human subject protection, agencies, institutions
and REBs all expect that researchers will comply with the TCPS and other
rules and regulations, it is also important that REBs apply the rules as
they are written !!

For now, and until new regulation or legislation is enacted, the TCPS
clearly says that REB have oversight on HUMAN SUBJECT RESEARCH. Research
using anonymized tissues, which is what approved, registered,
CIHR compliant human cell lines purchased from the U.S are, is NOT human
subject research, and thus not a matter for REB, unless of course this
situation is already addressed in a local institutional policy.

In the example given, the involvement of animals makes it subject to review
by the local Animal Care Committee.

Regards,

Luc Simon

11. PRE Webpage

From: <Secretariat@pre.ethics.gc.ca>
Subject: [Ethics] Launch of Interagency Advisory Panel on Research Ethics Web Site / Lancement du site Web du Groupe consultatif interagences en éthique de la recherche
Date: Monday, June 23, 2003 9:20 AM


To: Research Ethics Community

From: Interagency Advisory Panel on Research Ethics (PRE)

Date: June 20, 2003

Subject: Launch of Interagency Advisory Panel on Research Ethics Web
Site


The Interagency Advisory Panel on Research Ethics (PRE) is pleased to
announce the launch of their new web site. The site can be viewed at
www.pre.ethics.gc.ca

PRE’s new web site will play an important role in further assisting PRE in
carrying out its mandate: to promote high ethical standards of conduct in
research involving humans through the development, evolution,
interpretation, and implementation of the Tri-Council Policy Statement:
Ethical Conduct for Research Involving Humans (TCPS). It has been designed
as a resource for those conducting, participating in or reviewing research
involving human subjects to access information on research ethics standards
and policies relevant to the TCPS.

The site offers a wide variety of information about PRE, including its
mandate, policy initiatives, meetings, partners, publications, reports and
the official version of the TCPS. Updates to the TCPS in May 2000 and
technical amendments to the English version of the TCPS in September 2002
are posted.

A section dedicated to “Public Participation” details the various ways in
which the research community and the public can become involved in advancing
research ethics standards and practices in Canada. An extensive “Links” page
offers both national and international research ethics documentation and
organizations. Users are also provided with the opportunity to “Subscribe”
to receive future updates to the TCPS.


More information, including a “Frequently Asked Questions” section, along
with new features to enhance the interactivity of the site, are currently
under development. In the fall of 2003, an “On-line Tutorial” to facilitate
the use, interpretation and implementation of the TCPS in the Canadian
research community will also be available.

The Interagency Advisory Panel on Research Ethics (PRE) is a body of
external experts established in November 2001 by Canada’s three Federal
Granting Agencies (the Canadian Institutes of Health Research, the Natural
Sciences and Engineering Research Council and the Social Sciences and
Humanities Research Council) to support the development and evolution of
their joint research ethics policy the Tri-Council Policy Statement: Ethical
Conduct for Research Involving Humans (TCPS).

The Agencies adopted the TCPS in August, 1998 as a common statement of
research ethics policy in institutions funded by CIHR, NSERC and SSHRC. PRE
is mandated to advise the Agencies on the evolution, interpretation,
implementation and educational needs of the policy.

For further information please contact:

Secretariat on Research Ethics
350 Albert Street

Ottawa ON

K1A 1H5
Tel: (613) 996-0072
Fax: (613) 996-7117
secretariat@pre.ethics.gc.ca

12. Privacy Commissioner's REB Speech

FYI
With all of our discussions recently about HIPAA, I thought I'd forward a link to the Privacy Commissioner's May 7, 2003 Speech on Research Ethics Boards

http://www.privcom.gc.ca/speech/2003/02_05_a_030507_e.asp

Joe Irvine
VP Medical Affairs
& Business Development
University of Ottawa Heart Institute
and

13. Storage of SAE's

From: "Susan Blum" <susan.blum@usask.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Storage of SAE's
Date: Friday, June 27, 2003 2:46 PM

Dear Listserve members,

As a follow up to the IB inquiry, I would like some input on:
a) how other institutions store SAE's after acknowledgment by the Chair
(REB), and
b) at what point is this information discarded?

At present, our process is as follows:
SAEs are signed off by the Chair and are filed and stored until the
study is closed. Once the study is closed the SAE's are destroyed
(confidentially) and the remaining file is archived.

Thank you for your responses.

Susan

Susan C. P. Blum, Ph.D.
Ethics Officer
Office of Research Services (VP Research)
University of Saskatchewan
110 Gymnasium Place, Room 3402
Box 5000 RPO University
Saskatoon, SK S7N 4J8
Phone: 306-966-8585 Fax: 306-966-2069
Email: susan.blum@usask.ca
http://www.usask.ca/research

From: "Judith Abbott" <judith.abbott@ualberta.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Storage of SAE's
Date: Friday, June 27, 2003 5:03 PM

About a year or two ago we made a decision that external SAEs would be
destroyed when the study was closed. We retain the letter of notification,
any summary list that's provided, and our acknowledgement, but the MedWatch
reports, etc. go in the shredder. Reports of local SAEs are retained with
the rest of the file, which is archived 2-3 years post-closure at our site.

This decision was made basically as a space-saving measure, when we realized
we would be archiving files with huge stacks of SAE reports. These reports
are retained in the PIs files, and can be retrieved by us if necessary. I
have never, in 8+ years, been asked to go back and review one.

Judith Abbott

From: "Susan Blum" <susan.blum@usask.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Storage of SAE's
Date: Friday, June 27, 2003 5:18 PM

Dear Sarah,
Thank you for your response. We just destroy the external SAEs to cut
down on storage space. SAEs from our own site are archived with the
file for 100 years.

Susan

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Storage of SAE's
Date: Monday, June 30, 2003 8:50 AM

I think that the distinction between external SAES that are not directly pertinent to the study, and those from the site, is an important one.

100 years must be a record. Anyone top that?

Dr Michael D E Goodyear FRACP FRCPC FACP

 

14. Unused Study Drug

In our institution typically speaking, the study participant would
return
all unused drugs to the study coordinator, however when participants are not
local, they have the option of bringing the study drugs to their local
pharmacists to be destroyed. How do other REBs handle the issue of
returning or destroying a drug at the end of a study?
It has been suggested that we include statements regarding the
disposition
of study drugs on the consent form. Do other REBs currently do this or are
you aware of other ways of raising this discussion with study participants?

Linda Frid
Coordinator, General Research Ethics Board
Office of Research Services
Room 301 Fleming-Jemmett
Queen's University
Kingston, Ontario, Canada
K7L 3N6
Tel: 613-533-6000 ext. 78281
Fax: 613-533-6806
http://www.queensu.ca/vpr/

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Unused Study Drug
Date: Thursday, June 19, 2003 4:09 PM

I cannot say that I am in favour of adding further to the burgeoning consent form. I cannot really recall the issue ever coming up at the REB. However in my own research the issues that you discuss are certainly discussed with the patients. However usually they bring the drug with them on their next visit.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Judith Abbott" <judith.abbott@ualberta.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Unused Study Drug
Date: Thursday, June 19, 2003 4:49 PM

The request to 'return unused study drug or empty containers' at each, including the last, visit is a routine part of many consent forms. (We've seen - and rejected - the wording "return used or unused medication".) The question about having the drug destroyed elsewhere has, in my experience, never come up. Perhaps Michael is right - exceptions to the rule can be dealt with on a patient-by-patient basis. Don't clutter up the information sheets with possibilities, especially when it's usually in the patient's best interests to return for the final visit.

Judith

---- Original Message -----
From: Michael Goodyear
To: ethics@lists.ncehr-cnerh.org
Sent: Thursday, June 19, 2003 2:03 PM
Subject: Re: [Ethics] Unused Study Drug


I cannot say that I am in favour of adding further to the burgeoning consent form. I cannot really recall the issue ever coming up at the REB. However in my own research the issues that you discuss are certainly discussed with the patients. However usually they bring the drug with them on their next visit.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Jack Corman" <irbs@interlog.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Unused Study Drug
Date: Thursday, June 19, 2003 6:01 PM

By involving the local pharmacist, it makes him/her party to a clinical
trial with an investigational drug likely without knowing all the legal
implications. For example, does the pharmacist destroy medication under GMP?
Document fully the date, amount, method (and validate the method) of
destruction? Comply with Hazardous Materials regulations? What about
possible environmental contamination with experimental drug substances - can
the pharmacist guarantee there is no chance of same? Has the pharmacist been
identified as a member of the study team, thus entitled to handle the
investigational drug as per the CTA? Etc., etc. It is the investigator
responsibility, and should not be shifted to the patient and a retail
pharmacist.

Consent forms are more than long enough already, but often there is a
patient instruction sheet on how to take the study medication. Instructions
on what to do with extra medication could be included there without
cluttering up the consent document further.

Jack Corman
IRB Services

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Unused Study Drug
Date: Thursday, June 19, 2003 7:01 PM

Point taken - but I would have thought the sponsor ordinarily would want to maintain drug accountability especially for INDs.

Jack has hit on another point, namely that traditionally REBs are supposed to review ALL written material given to patients. My guess is that this is not observed, especially for all of these diffferent instructions. The practical question being what is really directly part of the experimental manoeuver which ought to be ocupying REBs, not necessarily every detail of its execution?

Dr Michael D E Goodyear FRACP FRCPC FACP

From: " Nancy Ondrusek" <nondrusek@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Unused Study Drug
Date: Friday, June 20, 2003 9:50 AM

I would also add that in some cases details that from the instructions would
belong in the consent form, if they may affect a person's decision about
taking part. For example I hate swallowing pills, and would think twice
about a study which required me to take 10 capsules, 3 times a day.

Nancy Ondrusek

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Unused Study Drug
Date: Friday, June 20, 2003 11:27 AM

That i agree would normally be under 'Procedures'

Dr Michael D E Goodyear FRACP FRCPC FACP

15. Volunteer Part-Time Physicians Research

From: "Laviolette, Mary-Ann" <mlaviolette@ohri.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Volunteer Part-time Physicians Research
Date: Wednesday, June 25, 2003 11:33 AM

Good Morning:

All research involving human subjects at our institution or conducted by
members of the professional staff of our institution requires review by our
REB. This includes all Geographical Full-Time Physicians (GFTs).

Could anyone tell me if the same is demanded for Volunteer Part-time
Physicians (VPTs) at your institution?

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
Website: http://www.ohri.ca/ohreb/

From: "Cowan, Jane" <jcowan@mtsinai.on.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Volunteer Part-time Physicians Research
Date: Wednesday, June 25, 2003 12:21 PM

We don't know of any volunteer part time physicians at our hospital. We are
surprised to know that such a person exists!

Jane Cowan, RN CON
__________________________
Research Ethics Board Coordinator
Mount Sinai Hospital
600 University Avenue,
Room 1003B
Toronto, Ontario. M5G 1X5
phone: 416-586-4687
fax: 416-586-4715
email: jcowan@mtsinai.on.ca
MSH Intranet: http://info/reb
SLRI Intranet: http://invivo.mshri.on.ca/ethics

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Volunteer Part-time Physicians Research
Date: Wednesday, June 25, 2003 12:52 PM

We all use different terminolgy - could you define this term? If you mean people with part time appointments, and a private practice, we include them too, whether their work is outside the institution or not.

Dr Michael D E Goodyear FRACP FRCPC FACP
Assistant Professor, Division of Medical Oncology, Department of Medicine, Dalhousie University
Executive Chair, Research Ethics Board, Capital District Health Authority
Chairman, Canadian Brain Tumour Consortium, Credentials Committee
Spokesperson on Tobacco or Health: Canadian Oncology Societies
Porte-parole pour tabac ou sante: Societes d'oncologie du Canada
Chair, RTOG Medical Oncology Quality Control

From: "Saginur MD, Raphael" <rsaginur@ohri.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Volunteer Part-time Physicians Research
Date: Thursday, June 26, 2003 9:14 AM

The question relates to physicians whose offices are outside the hospital,
and who participate in teaching in the hospital. They may be surgeons, who
operate in the hospital, internists, psychiatrists, or family physicians.
Members of the medical staff may be voluntary part-time or geographic
full-time.

Their clinical research may be entirely outside the hospital, including both
clinical and laboratory elements.

The hospital may incur a liability position in case of misadventure.

Our REB terms of reference do not distinguish between different kinds of
hospital affiliation. We believe that there is incomplete compliance with
our rules, and wonder if our rules are consistent with conventional practice
around the country.

Raphael Saginur

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Volunteer Part-time Physicians Research
Date: Thursday, June 26, 2003 10:04 AM

It seems to me that they have hospital appointments and therfore fall under the hospital's jurisdiction, and certainly, as you comment, liability. I am assuming that they are currently using an independant central IRB? Some institutions will demand their own independant review. We are feeling our way on this. At present we ask for all the documentation, and review it to make sure it is in order (TCPS compliant etc), and issue a letter of compliance, with continuing oversight, usually an annual renewal contingent on approval by the primary IRB. On occasion we have considered the risk sufficient to warrant full review.

We also ask them to sign an assurance that they will maintain complete separation of their research from any hospital activity or affiliation. Of course they may still be using that affiliation to attract research contracts, which is a trickier question.

Do these people also have university appointments?


Dr Michael D E Goodyear FRACP FRCPC FACP