Summary of NCEHR Listserv for May 2003


TOPICS

 

1.Canadian HIPAA Authorizations

2. Assent Policy UBC Clinical REB

3. Call for Nominations from CIHR

4. Categories of Approval

5. Compensation Clause Post-NOC

6. Incarcerated Youth and Consent

7. NCEHR-CAREB Discussion Lists for REB Admin

8. Human to Animal Stem Cell Research & REB Review

9. REB Quorum in Times of Plague

10. REB Remuneration

11. Relationship of DSMBs and Sponsors

12. Research and Art

13. Studies Placed on Hold

Files for Download

HIPPA Privacy - Standards for Privacy of Individually Identifiable Health Information

General Overview for Standards for Privacy of Individually Idenfiable Health Information

PRE - CFHSS Session in Halifax June 2003

CFR (The Common Rule US Regulations) and HIPPA

UBC REB HIPPAA Guidance

Action to Control Cardiovascular Risk in Diabetes (ACCORD)Authorization for Use and Disclosure of Health Information for Research Purposes - HIPPA Sample Consent Form

1.Canadian HIPAA Authorizations

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] HIPAA
Date: Monday, March 31, 2003 10:27 AM

Is anyone having problems with Sponsors/Investigators expanding confidentiality clauses on the basis of the new HIPAA regulations due on April 14th?

Dr Michael D E Goodyear FRACP FRCPC FACP

From: <skb@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, May 01, 2003 1:33 PM

Hi all.

We have got permission from the sponsor of the ACCORD study to post both
their originally submitted HIPAA authorization and our revision which was
approved by the study center this week. It seemed simplest to integrate it
into our standard confidentiality section (which normally would include FDA,
etc. etc.) so that is where we have put it. We limited the research to
diabetes research and added in the section which notes that no identifiable
data will leave the institution.

This is only one sponsor but it is a small step forward. We haven't got it
down to grade 9 level yet (it is 9.3) but we will work on the next one.

Sharon Buehler
Co-Chair, Memorial University

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, May 01, 2003 3:50 PM

Sharon -- I read the model documents that you provided.

Why was it necessary to include HIPAA language in your version of the
consent document? Was the confidentiality language in your previously
REB-approved no longer acceptable?

I agree the fact that no identifiable information will leave you
institution seems to protect, but the exclusionary nature of the patient's
choice not to sign creates a coercive burden not previously present.

My understanding of HIPAA is rudimentary, but compliance with 45 CFR 160
has an institutional impact. The other requirement, separate from the
Patient Authorization (PA) issue, is your institution's agreement to
provide the person releasing PHI, with a Notice of Privacy Practices (NPP).
This seems to require someone to look at MUN's applicable disclosure laws.

I question whether to declare compliance opens the gate for sponsors, and
others to access other institutionally safe-guarded information, such as
billing-practices, length of stay (LOS) and resource utilization data for
starters that may be accessed legally (??). PA has no expiry date. HIPAA
was put in place to outline rules to access the records of the institution
as a covered entity (CE), not simply research records of a subject.

Putting aside the issue of US enforcement of extra-territorial law, HIPAA
compliance seems to creates obligations that suggest it to be in the best
interest of the institution to focus on the *big picture* ... elisabeth

From: <skb@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, May 01, 2003 5:58 PM

Thanks, Elisabeth, for your comments. We were sent the authorization for
this study by the site research nurse who sent accompanying information from
the sponsor that we did not have to approve it. She was expected to
implement the authorization for the patients they were then accruing into
the study. She regularly sends any material that has to be sent to patients
and sent the authorization. At that point the dialogue began. The sponsor
would not allow patients to be accrued without the authorization and we
would not allow patients to be accrued with it. Perhaps we acted too
hastily and should have stuck to our original position and simply not
approved the authorization and stopped accrual and waited longer to see if
the sponsor would back down.

I'm looking forward to the discussion at CAREB.

Sharon

P.S. The sponsor was fine with our usual confidentiality statement (they
just wanted the authorization as well). We just picked that section to try
to integrate the authorization language.

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, May 01, 2003 7:07 PM

Jack ... i agree that's true for private IRBs, but the HIPAA legal
requirement is tied to the institution with responsible for research acting
as a covered entity (CE), i.e. the holder of the protected health
information (PHI). Even private medical offices are CEs. The institution
must authorize either separate Patient Authorization (PA), or PA
confidentiality language within a consent document. Both type of
authorizations are HIPAA compliant. Institutions follow written SOPS to
govern which IRB conducts ethics review on its behalf.

So if an institution accepts status as a *CE* it's the institution's
responsibility as a CE to have the PA language approved either by an IRB or
by a Privacy Board The instance where an IRB *must* approve the PA is when
the language is *included within the CF*.

I think in Canada, or anywhere outside the US, the first step to determine
any HIPAA obligation is to decide whether the institution is a CE that is
subject to US law, and being subject to US law is not obvious to many
non-US parties ... elisabeth


At 05:23 PM 01-05-03 -0400, you wrote:
>The president of a well known and long-established US IRB, who is widely
>consulted on HIPAA asserts there is no requirement for an ethics board, even
>a US one, to look at, sign off, or even accept authorizations. Their ethics
>board doesn't, and is still in compliance with US law.
>
>Jack Corman
>President/Secretary
>

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Friday, May 02, 2003 9:58 AM

You are right, Elisabeth. However, no institutions or investigators in
Canada are covered entities. We are back to the debate of
extraterritoriality of US law, as we were for compliance with FDA. A
compounding problem with HIPAA is the fact that not even the Americans
understand it well.

For those who may not have it, attached is part of the US HIPAA Guidance
Document that was published on Dec. 3, 2002. Covered entities are:

* Health Plans
* Health Care Clearinghouses
* Health care providers who conduct certain financial and administrative
transactions electronically. These electronic transactions are those for
which standards have been adopted by the Secretary under HIPAA, such as
electronic billing and funds transfer.

Presumably, Canadian institutions and health care providers, who generally
function in a single-payer i.e., government system (sometimes insurance
companies for supplementary health insurance).

It would be interesting to know the positions of Canadian health plans such
as Liberty/Blue Cross, Great West Life, Sun Life, etc., are abiding by
HIPAA, let¹s say for insured persons travelling in the US who may need US
health care services. Or our governments who send patients to the US
because of excessive waiting lists for cardiac surgery or cancer treatment
in some Canadian provinces. In both situations, personal identifiable health
information is provided to US covered entities. Presumably, neither the
Canadian insurance industry or provincial governments are HIPAA compliant.

Jack Corman

> From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
> Reply-To: ethics@lists.ncehr-cnerh.org
> Date: Thu, 01 May 2003 19:02:13 -0400
> To: ethics@lists.ncehr-cnerh.org
> Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
>
> Jack ... i agree that's true for private IRBs, but the HIPAA legal
> requirement is tied to the institution with responsible for research acting
> as a covered entity (CE), i.e. the holder of the protected health
> information (PHI). Even private medical offices are CEs. The institution
> must authorize either separate Patient Authorization (PA), or PA
> confident

2. Assent Policy UBC Clinical REB

From: "J.S. Russell" <jsrussell@shaw.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Assent Policy -- UBC Clinical REB
Date: Thursday, May 15, 2003 2:18 PM

NCEHR Ethics List Members,

The UBC Clinical REB has recently adopted a comprehensive policy for
dealing with incompetent subjects who are capable of assent. You can find
it at:

http://www.orsil.ubc.ca/ethics/forms/GNinitialapp07May03.htm#Policy17

The policy gives practical effect to TCPS Article 2.7 which requires
researchers to seek assent from assent-capable but legally incompetent
subjects.

The nature and status of assent and how to go about obtaining it in
different subject groups raise complicated practical, moral, and legal
issues. The UBC Clinical REB's assent policy appears to be the first
attempt by an REB in Canada to work out systematically a set of procedures
for implementing TCPS Article 2.7 for clinical research settings. As well,
the approach to assent adopted in Canada by the TCPS represents an
interesting and distinctive contribution to this topic in comparison to
other jurisdictions, notably the US.

It seems appropriate, then, for Canadian REBs to share experiences and
policies and, where possible, to develop common approaches related to this
issue. This document can be one starting point for such a dialogue.
Although the UBC Clinical REB's policy is framed in the context of BC law,
this will not significantly limit its relevance for other researchers in
Canada. We invite comment on this policy and hope that it will be of use to
other REBs.

John Russell, Ph.D.
Ethics Member
UBC Clinical REB

3. Call for Nominations from CIHR

From: "Blake, Andrea" <ablake@ncehr-cnerh.org>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] CALL FOR NOMINATIONS FROM CIHR-APPEL DE CANDIDATURES DES IRSC
Date: Wednesday, May 14, 2003 3:38 PM

ENGLISH

http://www.cihr-irsc.gc.ca/about_cihr/organization/ethics/stem_cell/call_for_members_e.shtml

CALL FOR NOMINATIONS FROM CIHR - THE STEM CELL OVERSIGHT COMMITTEEE (SCOC).

The human pluripotent stem cell research guidelines announced by the
Canadian Institutes of Health Research (CIHR) on March 4th 2002 include a
commitment to set up a Stem Cell Oversight Committee. This committee will
review grant applications in this area from researchers at institutions
funded by CIHR, NSERC and SSHRC in accordance with the guidelines.
Applications/nominations are now being sought for SCOC. Members will have a
variety of backgrounds and expertise. They will include professionals in
biology, health care, ethics, law, social sciences, the assisted human
reproduction community, and members of the general public with an interest
in health research.

For information on criteria for membership, how to apply and details on how
the Committee will operate, please visit

http://www.cihr-irsc.gc.ca/about_cihr/organization/ethics/stem_cell/committee_operation_e.shtml

The deadline for receiving applications is June 2nd 2003.

Please direct questions to:
Stem Cell Oversight Committee
Canadian Institutes of Health Research
9th Floor, Postal Locator 4209A
410 Laurier Ave. W.
Ottawa, Ontario ON K1A 0W9
Phone: (613) 941-2672 or 1-888-603-4178
Fax: (613) 954-1800
Email: stemcell@cihr-irsc.gc.ca

4. Categories of Approval

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Categories of Approval
Date: Friday, May 02, 2003 5:01 PM

Can I get some answers to this question posed by our Board today?

In what categories do other REBs rate submissions, and do they have criteria for each category?
(see our website: http://development/capitalhealth/research/researchEthics/index.html )

We have: Approved, Conditional, Not Approved

Today someone wanted to rate a submission as deferred - I said that is OK by TCPS.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Catherine Paquet" <cpaquet@uottawa.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Categories of Approval
Date: Monday, May 05, 2003 10:22 AM

Hello,

Here are the categories for the University of Ottawa (non-medical REBs):
I.a) Approval.

I.b) Approval for initial stage only. (Normally this refers (i) to the stage (within a research grant application)
during which the research instruments are to be developed, with re-evaluation necessary before they are taken into the field or used on human participants, or (ii) to the first stage of a multi-phase project in which the research instruments which will be used in later phases are dependent on the results of the initial phase.)

II.Delayed approval. (Some concerns must be addressed before approval is given. The REB could mandate its Chair or the Protocol officer, with or without other members, to grant ethics approval when the concerns have been satisfactorily addressed.)

III.Decision deferred. (Based on the documentation provided, the REB is unable to make a decision.
The decision is deferred pending receipt of supplementary information or documentation as specified by the REB. The ethics application needs to be submitted again for a complete evaluation by the REB.)

IV.Not approved. (The reasons will be provided. )

Catherine Paquet
Responsable de déontologie en recherche / Protocol Officer for Ethics in Research
Université d'Ottawa / University of Ottawa
Pavillon Tabaret Hall, salle/room 159A
Tél : (613) 562-5800 ext 1787
Fax: (613) 562-5318


From: Michael Goodyear
To: ethics@lists.ncehr-cnerh.org
Sent: 2 mai, 2003 16:52
Subject: [Ethics] Categories of Approval


Can I get some answers to this question posed by our Board today?

In what categories do other REBs rate submissions, and do they have criteria for each category?
(see our website: http://development/capitalhealth/research/researchEthics/index.html )

We have: Approved, Conditional, Not Approved

Today someone wanted to rate a submission as deferred - I said that is OK by TCPS.

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Categories of Approval
Date: Monday, May 05, 2003 4:55 PM

MUHC decisions arising from REB deliberation for a proposal are: Approved;
Decision pending (appropriate responses to REB recommendations); Proposal
tabled (comes back for Full Board review); or Disallowed.

We avoid the category of Conditional Approval (unless unavoidable) i.e.,
approval for medical device studies whereby HC will not release their No
Objection Notice *without REB approval* (HC drug and device rules are not
harmonized on this point). We are aware of instances in some jurisdictions
where providing "conditional approval" was misconstrued by investigators as
*sort of approved* and studies were begun in the absence of REB final
approval.

"Conditional approval" doesn't permit a study to start as it's not a final
approval, so there seems to be no benefit to generating "conditional
approval" correspondence. When a special condition is attached, and
required to approve the study, then it's defined within the REB approval
correspondence.


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

tel: 514-934-1934 x-34720

From: "Marleen Van Laethem" <vanlaethemm@smh.toronto.on.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Categories of Approval
Date: Tuesday, May 06, 2003 9:47 AM

Our procedures at St. Michael's Hospital are similar to MUHC. We do not use wording such as 'conditional approval' since it has been misinterpretted in the past. Deferring a decision until you have the information you need, is prudent.
Marleen.

Marleen Van Laethem
Research Ethics Monitor
St. Michael's Hospital
Room 4052, Queen wing
30 Bond Street
Toronto, Ontario, M5B 1W8
phone: 416.864.6060 x6308
fax: 416.864.6043
email: vanlaethemm@smh.toronto.on.ca

5. Compensation Clause Post-NOC

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Compensation clause post-NOC
Date: Tuesday, May 13, 2003 12:19 PM

One of our sponsors is trying to claim (divide and conquer?) that we are totally out of step with the rest of the country on an issue - prove me wrong!

The issue refers to the compensation clause, where the sponsor's position is that will provide compensation pre-NOC but not post-NOC, and says every REB in the country bar one in the West, has a separate pre-NOC and post-NOC consent form - first we have heard of it - and as usual this is the only company that has brought it up.

Our position was research is research - ie investigaion in an atmosphere of uncertainty and we didn't see what the NOC status of any drug had to do with it.

We also stated that if they wanted to provide compensation, that was fine, if they did not, that was up to them. Our standard wording does not mention compensation by sponsor, only that necessary medical treatment will always be made available at no extra cost whether or not you are in a study, and that the subject's legal rights are in no way waived. Some grant sponsors want us to include a statement that no compensation will be offered.

As far as we are concerned our standard clause covers all eventualities - why would they want us to change it?

Anyone else had this experience - and just to lever it a bit further - the sponsor points out we are losing thousands of dollars of research money due to our out of step policy.

To us there really is not an issue.

Here is the text extract:

"X will cover the cost of medical care that a participant needs (over and
above the medical care provided by the provincial insurance) if they are
injured as a direct result of their participation in a PRE-NOC study.

If the compound has already received Health Canada's approval for the
indication for which it is being used, then we will not cover the costs of
medical care. If we did, it would be opening up a "Pandora's Box" as Health
Canada has already approved the compound for the indication and so by X
putting this compensation clause in the consent form we are essentially
providing an advantage to the participants taking part in the study that
they would not be eligible for had their doctor prescribed the medication
for them without the study - we cannot treat the participants any different
than the public with a POST-NOC drug as it is an unfair practice.

The standard post-Noc compensation clause as provided in the original consent
is used by most institutions who do research with us across Canada. I had
sought to provide you with several other suggested post-Noc compensation
clauses but was only able to find the clause forwarded as the other
institutions use our standard clause.

The timelines were very tight for that study and we missed the deadline for study participation.
It is causing the QEII to miss research opportunities. "

We could not see there was an issue here.


Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Tom Ekers" <tekers@cmxres.com>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Compensation clause post-NOC
Date: Tuesday, May 13, 2003 2:14 PM

Michael,

Never seen this before. It's not fair nor right and would be a terrible precedent.

Tom Ekers
Trafalgar Ethics Boar

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <tekers@cmxres.com>; <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Compensation clause post-NOC
Date: Tuesday, May 13, 2003 3:22 PM

Well after a long conference call with our lawyer and the company regulatory people, it appears that they read our clause:

If you become ill or injured as a direct result of participating in this study, necessary medical treatment will be available at no additional cost to you.

as unacceptable, because 'direct' and 'no additional cost' means the company is liable for everything - we mean your Provincial health insurance! they argue the drug is available commercially so they have no liability, they just want to compare it to someone else's drug in an add-on fashion, all patients having failed standard first line care.

All clauses submitted by the company were rejected by us as failing to provide the assurance that is surely at the root of the clause - that they will be looked after just as well in a research study as if they were not. Finessing who pays for what is for the Letter of Agreement, not for cluttering the subject's mind.

It will come as no surprise that the word 'direct' was forced on us by companies claiming that without it they were liable for everything that happened to the patient while they were in the study.

We have to get away from the consent form as a legal contract - it isn't.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Jack Corman" <irbs@interlog.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Compensation clause post-NOC
Date: Wednesday, May 14, 2003 9:52 AM

It is illegal in most if not all provinces for the public health plan to pay
for services due to third parties, e.g., insurance physicals, extra labs,
visits, tests, due to study requirements. It gets tricky when someone needs
care because of an injury or side effect due to clinical trial
participation.

A special visit to the study doctor to look at a rash that might be an ADR
is one thing (peanuts) vs. crisis requiring hospitalization, e.g., MI, CA,
GI bleed, etc. Often the relationship of the event to the study drug or
procedures is uncertain or unproven. Even if the hospitals identify to the
provincial health plan which of their patients were in clinical trials, it
is doubtful that they could recover costs, unless a clear link is proven.
So it may not be worth the effort. However, there are likely little data to
determine cost/benefit of keeping track of patients in studies who require
care for injuries, what it costs the system, and what is the likelihood of
recouping the cost. (Not every pharma will be willing to pay, certainly not
without a fight). May be a worthy area of research for a public health
policy person. Also, it is probable that commercial sponsors will
substantially reduce their funding of clinical trials in Canada if they are
billed for every hospital visit/health care utilization cost due to a
possible injury in a clinical trial.

The other issue is confidentiality ­ the patient will almost certainly be
identified to the drug company. Do we want that?

Jack Corman
IRB Services
>
> From: "Saginur MD, Raphael" <rsaginur@ohri.ca>
> Reply-To: ethics@lists.ncehr-cnerh.org
> Date: Tue, 13 May 2003 17:31:24 -0400
> To: "'ethics@lists.ncehr-cnerh.org'" <ethics@lists.ncehr-cnerh.org>
> Subject: RE: [Ethics] Compensation clause post-NOC
>

> Michael,
>
> We have had one sponsor's lawyer who raised the issue that she would demand a
> different compensation clause for a Phase IV trial because the company's
> potential liability would be reduced in that Health Canada had approved the
> drug. We agreed t

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Compensation clause post-NOC
Date: Tuesday, May 13, 2003 5:30 PM

Samuel Beckett, where are you when we need you? No REB with which I am
familiar makes a specific distinction in the compensation clause between
investigational drug studies and those with NOC.

Let¹s say the study (blinded double dummy) involves an investigational COX2
NSAID vs. naproxen, which is approved for the indication under study. A
subject on blinded meds suffers a serious GI bleed and is admitted to
hospital for several days, etc., etc. Does that mean that the sponsor will
only pay for medical care above the provincial plan if it turns out that the
GI bleed was due to the investigational drug and not the naproxen
comparator? I hardly think so. So they would already be agreeing to pay
for care due to injury suffered from a drug with an NOC, and it¹s not even
their own.

In real life, even if someone is hurt in a study, the probability is high
that there will not be a claim for medical expenses because everyone in
Canada has access to no-cost medically necessary medical care (at least in
theory, ragged edges notwithstanding). So the risk to the sponsor is much
more theoretical. An aggrieved subject can always launch a lawsuit against
the MD and the sponsor for compensation for pain and suffering, lost wages,
etc. I don¹t think that I¹d want to be the lawyer for the defence - my
advice would be to settle.

It also reminds me of Francis Rolleston¹s attempt at one time to forge a
consensus compensation clause for national use. Any chance of revival of
the idea?


Jack Corman
President/Secretary

IRB Services

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Compensation clause post-NOC
Date: Tuesday, May 13, 2003 6:14 PM

I think it is worth looking at again - it would appear that we are being misled once again. I agree completely with the view point that you make. Those were the points we made to the sponsor.

The sponsor called this a 'Pandora's Box' that is is if one person was compensated in a study a precedent has been created for all patients using their product. we are dealing with a very defensive industry here.

Eventually we removed the 'offending' words, since I am all for simplified consents, leaving us with:

If you become ill or injured while participating in this study, all necessary medical treatment will be available to you.

I suggested that discussion of costs be left to the letter of agreement (and hence the lawyers), something I am doing more and more with anything that smacks of 'contract' , this is not an issue to burden subjects with despite protestations from sponsors about the need for full disclosure which presumably would rapidly grow into a 100 page document.

We will see what the reaction is.


From: "Dr. Peter Loewen" <ploewen@interchange.ubc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Compensation clause post-NOC
Date: Tuesday, May 13, 2003 7:20 PM

Michael...

The UBC Research Ethics Boards have ONE policy regarding compensation for
study-related injury. We make no distinction between pre and post-NOC, nor
do I see any reason to, nor has any sponsor presented this as an important
issue.

Our policy on this issue is available at:
http://www.ors.ubc.ca/ethics/Forms/guidance.html

Peter

--
Peter Loewen, B.Sc.(Pharm), Pharm.D.
Pharmacotherapeutic Specialist - Internal Medicine

From: "Francis Rolleston" <frolleston@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Compensation clause post-NOC
Date: Tuesday, May 13, 2003 7:33 PM

This correspondence raises yet again what I perceive to be a need for us in
Canada to act together on such issues. The REB that I chair for NRC has
been going over this area again, in terms of being a mixture of a research
sponsor, a funder, a partner and also a performer. Rather than fighting
these battles site by site, sponsor by sponsor, why not just agree on
wording that Canada will use?

An opportunity for CAREB leadership.


Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

frolleston@sympatico.ca

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Compensation clause post-NOC
Date: Wednesday, May 14, 2003 8:45 AM

Absolutely. What I have concluded is that REBs with 'standard templates' probably need sepaarate clauses for those trials in whch their are provisions for compensation and those that do not, except that with the latter NCIC insists we say there is no compensation available. It is all rather moot in Canada - can anyone actually recall any patient being compensated?

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Saginur MD, Raphael" <rsaginur@ohri.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Compensation clause post-NOC
Date: Wednesday, May 14, 2003 9:02 AM

Michael,
We have had one sponsor's lawyer who raised the issue that she would demand
a different compensation clause for a Phase IV trial because the company's
potential liability would be reduced in that Health Canada had approved the
drug. We agreed to disagree, but the issue was moot, because we didn't see
Phase IV company-sponsored studies at our REB, and the Phase IV discussion
was peripheral to our discussion of compensation clauses. Perhaps it was
the same sponsor as yours.
Clearly, the issue of compensation clauses is a national issue. It has
arisen before on this listserv. It dovetails with our uncertainty of the
role of medicare in paying for adverse events in clinical trials. Is it de
facto national policy that provincial health insurance should pay; i.e., a
competitive advantage in attracting studies to Canada? Or, as more than one
sponsor has told me, are we remiss in not demanding that sponsors pay for
adverse events attributable to their drugs?
It is my impression that counsel to every pharmaceutical house in Canada has
parsed GCP somewhat differently, that when last this arose none had talked
to any other, that it was a chaotic situation. I agree with Jack Corman's
suggestion of an attempt at national consensus, which requires political
will of the participants.
On another note, although the consent form is not a contract, it does
provide evidence of what agreement it can be claimed the patient agreed to,
and puts the onus on a plaintiff to prove otherwise.
Ray



-----Original Message-----
From: Michael Goodyear [mailto:michael.Goodyear@cdha.nshealth.ca]
Sent: May 13, 2003 3:14 PM
To: tekers@cmxres.com; ethics@lists.ncehr

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Compensation clause post-NOC
Date: Wednesday, May 14, 2003 11:21 AM

Ray,

I was aware you had an interest in this issue. It is not only REBs that need concensus but sponsors. As far as I know neither we nor Health Canada can force a sponsor to provide compensation, which is rather a moot issue anyway. We have a letter from our provincial health insurance but frankly we are not sure how much we can rely on it.

Even when sponsors do offer to pay, the policy often has a lot of holes in it - how do you prove it was a direct effect what about drug interactions - and what if the patient was in the control arm - none of these subtleties are in the consent form - best leave it out! There is no doubt what the motivation is for the way GCP is parsed.

It is not so much the concept of contract in consent that bothers me - consent is a social contract - but treating the document like a contract in terms of wording - definitely not user friendly - we need a consent form revolution. If you like the consent form is strictly the signaure page.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Jack Corman" <irbs@interlog.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Compensation clause post-NOC
Date: Wednesday, May 14, 2003 12:14 PM

Exactly.

Jack Corman
>
> From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
> Reply-To: ethics@lists.ncehr-cnerh.org
> Date: Wed, 14 May 2003 12:19:34 -0300
> To: <ethics@lists.ncehr-cnerh.org>
> Subject: Re: [Ethics] Compensation clause post-NOC
>

> In short - it is a mess
>
> Dr Michael D E Goodyear FRACP FRCPC

 

Re: [Ethics] Compensation clause post-NOCResearch budgets should include =
funds for expected side effects that require care such as =
hospitalization or extra tests. For injuries caused by negligence, as in =
any other case, the provincial health plans pay for care research =
induced injuries but retain the right of subrogation, through which they =
may make a legal claim against the negligent party for eimbursed for =
their costs. As far as I know, none of them have done this.

I believe US law requires sponsors to declare whether or not they have =
established an injury compensation fund. They are not required to =
establish a fund, but if they do not, they must declare the fact, which =
seems fair. This does not affect any participant's legal rights to =
compensation. It just means that they may have to sue to collect if =
there is no fund.

Kathleen Glass

6. Incarcerated Youth and Consent

Date: Wed, 14 May 2003 11:17:16 -0400
From: Leslie_MacDonald-Hicks
To: "'ethics@lists.ncehr-cnerh.org'" <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Incarcerate youth and consent

I have two researchers who are participating in a multi-centred study on
youths and auto theft. The subjects will range from age 12-17 and reside in
both closed and open custody settings.

I have instructed the researchers to design consent forms for parents and
legal guardians. The concern is around subjects who are crown wards. Can
someone representing the state give consent when the study is federally
funded? Also, how do the researchers avoid any perception of coercion when
the subjects are crown wards?

Leslie J. MacDonald-Hicks
Research Ethics Coordinator
Office of Research Services
Room 511A Tory Building
Carleton University
1125 Colonel By Drive
Ottawa, ON K1S 5B2
Tel: 613.520.2517
Fax: 613.520.2521

From: "H R Kloppenburg" <hrk@kloppenburg.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: re: [Ethics] Incarcerate youth and consent
Date: Wednesday, May 14, 2003 12:07 PM

The answer to this question is province specific. When a person under a
specified age becomes a public ward (either of the Crown or the Minister
of the Crown responsible) that Minister or officer of the Crown assigned
responsibility becomes guardian in law of the ward. The powers of the
guardian are contained in the enabling legislation as might be
supplemented by common law principles governing guardian and ward.

Best regards,

HRK

2003-05-14

7. NCERH-CAREB Discussion Lists for REB Admin

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] NCEHR/CAREB re: REB admin issues
Date: Friday, May 02, 2003 3:44 PM

Suggestion: Would it make sense for CAREB to develop a parallel discussion
group for operational/administrative issues related to running REBs, while
NCEHR listserve forum focuses more on policy matters?

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

From: "Susan Blum" <susan.blum@usask.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] NCEHR/CAREB re: REB admin issues
Date: Friday, May 02, 2003 4:13 PM

Dear Jack,

I think this is a wonderful idea and would strongly support this initiative.

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

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] NCEHR/CAREB re: REB admin issues
Date: Friday, May 02, 2003 6:25 PM

Actually I am not so sure - I think CAREB should be involved but do we need twice as much mail - and there is already a list in place - and woudn't we be trying to decide all the time - is this policy or operations?

Dear Jack,

I think this is a wonderful idea and would strongly support this initiative.

Susan C. P. Blum, Ph.D.
Ethics Officer

From: "Francis Rolleston" <frolleston@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] NCEHR/CAREB re: REB admin issues
Date: Saturday, May 03, 2003 4:43 PM

I would prefer a different approach. We have this listserv, which has done
great work but is also capable of improvement, and which can meet all the
needs, especially if it could be moderated. I know that NCEHER does not
have resources to moderate, but the REB community as a whole does. Could we
not explore the possibility of NCEHR and CAREB, and perhaps other
organizations such as the PRE, pooling resources to provide expertise for
discussion leaders, and also the moderation that I believe is needed, to
give us nationally a really useful discussion system that might also be a
means of sharing best practices etc, such as was discussed today by the
excellent PRE presentation to the excellent CAREB AGM.

Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

From: "Bruce P. Clayman" <clayman@sfu.ca>
To: <ethics@lists.ncehr-cnerh.org>; <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] NCEHR/CAREB re: REB admin issues
Date: Saturday, May 03, 2003 5:42 PM

At 05:48 PM 5/3/2003 -0300, Michael Goodyear wrote:
>I would strongly support Francis' position
>
>Dr Michael D E Goodyear

As do I.....having just attended the annual CAREB Conference and seeing the
vitality and professionalism of the members.

Bruce Clayman

From: <mowen@spartan.ac.brocku.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] NCEHR/CAREB re: REB admin issues
Date: Sunday, May 04, 2003 6:25 PM

FRancis.
I think one list serve is best. WHile not moederated, I think that the
current list serve can support both the discussion of broader ethical issues
related to human subject research and the more focused discussion of
administrative issues. Like yourself and Bruce, I think the discussion at
CAREB and the program were just excellent.

Michael

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
To: "'Francis Rolleston '" <frolleston@sympatico.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] NCEHR/CAREB re: REB admin issues
Date: Sunday, May 04, 2003 10:21 PM

I agree with Francis. One listserv for all!
Philip

Philip Hebert MD PhD FC

From: "Leslie_MacDonald-Hicks" <LeslieMacDonaldHicks@pigeon.carleton.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] NCEHR/CAREB re: REB admin issues
Date: Monday, May 05, 2003 8:39 AM

Yes. I could not agree more. While the policy discussions are interesting
and helpful they do not always suit the situation we find ourselves in as an
institution without a medical component. Operational issues are important
and a single place to discuss them or make inquiries would be very helpful.

Leslie J. MacDonald-Hicks
From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] NCEHR/CAREB re: REB admin issues
Date: Monday, May 05, 2003 9:43 AM

I'm more in line with Michael's position. I feel that operational
and policy issues are often intertwined. While that is certainly not
always the case, mixing the two doesn't present an overwhelming
volume of mail on the current list serve.

As far as moderation, I think we do a good job at self-moderation in
terms of content. IMO, moderation is problematic on a list serve.
Volume can quickly become overwhelming, even with the most simple of
filtering algorithms.

If anything, I'd suggest that NCEHR consider moving to a bulletin
board system, which presents a lot of advantages. It would allow
different posting areas so that explicit policy and operational
issues could be kept separate, allow easy searching of past topics,
better ease of following threads (lines of discussion), peoples email
would be less affected, etc. etc. Given the high quality of the
group and using a registration system, the only moderation required
would be relocating the occasional topic.

Cheers

Cam
From: "Susan Pilon" <Susan_Pilon@camh.net>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] NCEHR/CAREB re: REB admin issues
Date: Monday, May 05, 2003 10:43 AM

I think that having more than 1 list serve would be a disaster! Susan

-----Original Message-----
From: Hebert, Dr. Philip [mailto:Philip.Hebert@sw.ca]
Sent: May 4, 2003 10:15 PM
To: 'Francis Rolleston '; 'ethics@lists.ncehr-cnerh.org '
Subject: RE: [Ethics] NCEHR/CAREB re: REB admin issues

rom: "Yvette Parent" <Yvette_Parent@hc-sc.gc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] NCEHR/CAREB re: REB admin issues
Date: Monday, May 05, 2003 11:01 AM

Hi everyone,

I agree, just simply too complicated to have more than one listserver, a
single avenue for discussion purposes and/or making any inquiries, would be
more appropriate.


Yvette Parent
Senior REB Administrator
Office of the Chief Scientist
Health Canada
(613) 941-5199
Cell: 371-8369

8. Human to Animal Stem Cell Research & REB Review

Your opinion would be valued:

I have been asked by a stem cell researcher (using =approved, registered,
CIHR compliant 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 no 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
human remains, cadavers, tissues, biological fluids, embryos, or foetuses
shall be ethically reviewed by the REB's . We do insist on cadaver and human
research being reviewed.

I'd imagine this type of research is already going on at our university, bu t
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
Faculty of Pharmaceutical Sciences, University of BC
Chair, UBC Clinical Research Ethics Board
Coordinator, Advanced Pharmacotherapeutics, UBC Pharm.D. Program
Publishing Editor, The Journal of Informed Pharmacotherapy
Phone: 604-822-7985 Fax: 604-822-9742
www.vhpharmsci.com
www.informedpharmacotherapy.com
www.ubcpharmacy.org

Opinion Requested: Stem Cell Animal research & REB Review

Peter, for your (bio)ethical dilemma you may be interested to check the link by Novo Nordisk in
Denmark (a health care company mostly working on stem cells in diabetes research). Part of the Novo's text reads:

Ethical spotlight on animal experiments

In 2002, Novo Nordisk implemented a new policy of performing internal ethical reviews of all present and future types of experiment on living animals. Two Ethical Review Committees (ERCs), in development and in research, meet monthly to review applications for animal experiments. No type of
animal experiment at Novo Nordisk can be conducted without a review by the relevant ERC. Such review committees are not yet required by law in Denmark, but we feel this oversight is important to ensure high ethica standards.

Each committee is chaired by an experienced animal scientist and has members who are directly involved in animal experimentation and others who are not. The goal is to review current animal experiments in light of stress levels, housing conditions, how well the experiments meet the three Rs (reduce, refine and replace animal experiments wherever possible), and by cost-benefit analyses to
determine whether the gain for humanity outweighs the possible suffering of the nimals.

For the rest look at "http://www.novonordisk.com/sustainability/soc_responsibility/res pect_life.asp">

http://www.novonordisk.com/sustainability/soc_responsibility/respect_life.asp

Since, we have a UBC committee on animal care,maybe they should get involved with reviewing this project?

Valia S. Lestou, PhD Research Scientist, Dept. of Pathology,  BC Cancer Agency Honorary Member, Dept. of Pathology, Scientific Reviewer, UBC Clinical Research Ethics Office: 604.877.6000 Ext.=20
2087      FAX: 604.877.6178

I would think that your revised opinion is the correct one. Questions of
source, and method of acquisition of the human stem cells would need to
be addressed. This work should be reviewed.

However, you should consult the CIHR guidelines on stem cell research
for additional guidance.

Pat Lindley

9. REB Quorum in Times of Plague

From: "Marleen Van Laethem" <vanlaethemm@smh.toronto.on.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] REB Quorums in Times of Plague
Date: Thursday, May 01, 2003 5:43 PM

Dear Bob,
First of all, my sympathies; these are indeed, very trying times.

Now I know it's an occupational hazard and a trait of my personality, but I'm always worried about anything done too hastily. These protocols may be drafted very quickly - the investigators might not be thinking about every angle, and the REB review is happening very quickly, also potentially overlooking some aspects. (However, this is not to say that the protocol preparation and the REB review might be as good a quality as when it is done with more time.)

Your question specifically addresses how to arrive at a valid review and approval. I commend you for your work on the new category of 'crisis review'. Additional measures could also include granting approval for a shorter length of time, such as 3 months or 6 months, to give you time to have another review at the level of the full board.

Of course, I also have to give a plug for internal monitoring or auditing programs. These studies, being higher risk, would qualify for increased level of monitoring activity, and therefore could be on the list for an internal audit. This could assure the REB, that although the initial approval wasn't arrived at in the usual manner, due to crisis, the study is being conducted appropriately.

In fact these various aspects could be combined. Initial review occurs through the abbreviated 'crisis review', or at another REB. Approval is only granted for 6 months, initially. An internal audit occurs, and by the time that the full REB considers it at the 6-month mark, they have the audit report to guide them in their decision.

Further questions on a similar note ... how are affected REBs/hospitals/institutions coping through the SARS precautions? Are you able to hold your regular meetings? Are community members allowed to attend? What do you do if your community members are not allowed to attend?

I support the face-to-face meeting requirement of TCPS Article 1.9; I agree with discouraging regular REB meetings through conference calls, or by e-mail. Thanks to Francis for confirming this. I think discussions about the ethics of research are enhanced through non-verbal communication that may occur, i.e. body language. Again, a skilled Chair is important. However, in these extraordinary times, I think that we all do the best that we can, and I'm glad to hear from Heather that their conference call went so well.

Regards,
Marleen.

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] REB Quorums in Times of Plague
Date: Friday, May 02, 2003 10:39 AM

Marleen brings up a very important point. All of us familiar with the TCPS
are aware that it calls for a convened REB meeting with a quorum present.
All institutions that receive funding from any of the granting councils are
contractually bound to respect the TCPS as a condition of receiving the
grants. REB meetings conducted by teleconference are in contravention of
the TCPS and hence in violation of commitments to CIHR, NSSHRC or NSERC.

The obvious questions this prompts are, when can institutions decide not to
observe the TCPS, and what is the process for them to be relieved of their
obligations to do so? If the granting councils did not expressly waive the
requirement to observe TCPS Article 1.9, then those institutions technically
are in breach of contract.

Changing modus operandi for the REB may also be in violation of Health
Canada regulations and GCP where they apply, e.g., Do the participating
institutions have Standard Operating Procedures in place for this
eventuality, and, if not, were new ones drafted and approved by the
institutions in accordance with established written procedures? Also, the
REBs on the clinical trial documents filed to TPD must be in compliance
with GCP. Have they followed their written SOPs? Is the composition of the
REB in these circumstances the same as the REB noted on reg docs? If not,
then documentation is deficient, and would presumably be a negative audit
finding in the event of an HPFB Inspection.

Another ethics board that meets TPD and TCPS requirements could have been
approached to take over; the May, 2000 TCPS clarification allows for this to
occur. Following on Marleen¹s comment about monitoring, the hospital can
still take on this function irrespective of the board that conducted the
review. After all, isn¹t this about protecting human research subjects, not
turf?

Jack Corman
President/Secretary
IRB Services

From: "Susan Pilon" <Susan_Pilon@camh.net>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] REB Quorums in Times of Plague
Date: Friday, May 02, 2003 4:25 PM

Marleen, an excellent response. In regard to your question about what other
REBs are doing, we had to cancel our April REB meeting but have just
finished a "catch up" meeting held with internal and external members, off
site. We hope to then resume our usual schedule with our regular May
meeting on site. If this is possible, it will mean that our internal and
external members will need to be screened for SARS. In future, it would be
helpful to have a system of secure electronic distribution of protocols in
place to ease some of the burden of review meetings under these difficult
conditions. Susan

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] REB Quorums in Times of Plague
Date: Friday, May 02, 2003 6:25 PM

Which is a very good point - how many sites are runningtheir operations electronically - ie online submissions consents etc emailed to reviewers - protocols might be tougher but some of them are now being sent to sites in electronic form

Dr Michael D E Goodyear FRACP FRCPC FACP

10. REB Remuneration

From: "Leslie_MacDonald-Hicks" <LeslieMacDonaldHicks@pigeon.carleton.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] REB remuneration
Date: Thursday, May 22, 2003 10:23 AM

Dear List members,

I am in need of some information on how you remunerate REB members. At
present our REB members are not compensated and we would like to end this
practice. Our REB would like a sense of what others do. Therefore, I would
like to know if you compensate and how - work release, financial, or even by
some others means. For the sake of confidentiality you may contact me
directly at Leslie_MacDonald-Hicks@carleton.ca

I appreciate your time and effort in this matter.

Leslie J. MacDonald-Hicks

Research Ethics Coordinator
Office of Research Services
Room 511A Tory Building
Carleton University
1125 Colonel By Drive
Ottawa, ON K1S 5B2
Tel: 613.520.2517
Fax: 613.520.2521

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] REB remuneration
Date: Thursday, May 22, 2003 12:40 PM

we do -- in recognition of significant time spent by each member on REB
reviews. Why not?
Philip

PhilipHebert MD PhD FCFPC
Chair REB, SWCHSC
Toronto

From: "Louise Dumas" <l.dumas@videotron.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] REB remuneration
Date: Friday, May 23, 2003 9:58 AM

We are not compensated either...To my knowledge, no member of research ethics committees or clinical ethics committees in Quebec are receiving any financial compensation. We call it "human or social service to our community".

Louise Dumas, R.N., M.S.N., PhD
Professor and researcher at the Université du Q

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] REB remuneration
Date: Friday, May 23, 2003 11:02 AM

Leslie and the List --
At the MUHC we remunerate the Chairs of our REBs a symbolic amount annually
to recognise their contribution to the increasingly demanding workload.

A couple of years ago the FRSQ, had been considering a mechanism to assist
institutions with providing annual sum to remunerate the complete
membership of Quebec's REBs, but i am not aware of any concrete
recommendation to emerge on this issue.

The MUHC is not the only research institution in Quebec that offers some
remuneration.

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] REB remuneration
Date: Thursday, May 22, 2003 11:30 AM

We do not - should we?

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] REB remuneration
Date: Friday, May 23, 2003 1:44 PM

Where is remuneration coming from now - and the larger question - how many REBs are completely self sufficient as opposed to being supported by their institutions. And ( I apologise - je suis désolé ) what is FRSQ?

Dr Michael D E Goodyear FRACP FRCPC FACP

From: <anolet.crir@ssss.gouv.qc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Réf. : Re: [Ethics] REB remuneration
Date: Friday, May 23, 2003 1:56 PM

Good afternoon,

I would like to mention that we do compensate our members.

Me Anik Nolet
Coordonnatrice à l'éthique de la recherche
des établissements du CRIR
6300 avenue Darlington
Montréal (Québec)
H3J 2J4
Tel: (514) 340-2085 poste 2233
Fax: (514) 340-2154
Courriel: anolet.crir@ssss.gouv.qc.ca

From: "Laura Sokal" <l.sokal@uwinnipeg.ca>
To: <ethics@lists.ncehr-cnerh.org>; <lchamber@mail1.lakeheadu.ca>
Subject: Re: [Ethics] REB remuneration
Date: Friday, May 23, 2003 2:01 PM

Hello,
We allow the chair a teaching release of one course. Our external members also receive a small financial honorarium.
Laura

 

Laura Sokal, Ph.D.
Bachelor of Education Program
University of Winnipeg
515 Portage Avenue
Winnipeg, Manitoba
R3B 2E9

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] REB remuneration
Date: Friday, May 23, 2003 2:28 PM

The remuneration is considered as an institutional expense paid from the
budget of the Research Institute (RI). I am not aware of institutional
REBs that are self-financing.

Sorry Michael, i was speaking for the benefit of the initiated ... Fonds de
la recherche en santé du Québec (FRSQ) is the provincial agency that
supports RIs, and individual investigators conducting health research in
Quebec through a system of grants and awards ... elisabeth


At 14:32 5/23/2003 -0300, you wrote:

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] REB remuneration
Date: Friday, May 23, 2003 5:06 PM

this is the view that ethics is free -- a service to the community... nice
sentiment, but ethics is work, too, & ought to be remunerated...
Philip
Philip C Hebert MD PhD FCFPC

From: "Louise Dumas" <l.dumas@videotron.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Re: [Ethics] Réf. : Re: [Ethics] REB remuneration
Date: Friday, May 23, 2003 5:17 PM

Please tell me what is CRIR???? so I know who compensates their members in
Quebec?
Thank you. Louise

Louise Dumas, R.N., M.S.N., PhD
Professor and researcher, Université du Québec en Outaouais
Secretary, REB Centre Hospitalier des Vallées de l'Outaouais


----- Original Message -----
From: <anolet.crir@ssss.gouv.qc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Sent: Friday, May 23, 2003 1:47 PM
Subject: [Ethics] Réf. : Re: [Ethics] REB remuneration


>
>
> Good afternoon,
>
> I would like to mention that we do compensate our members.
>
>
>
> Me Anik Nolet
> Coordonnatrice à l'éthique de la recherche
> des établissements du CRIR
> 6300 avenue Darlington
> Montréal (Québec)
> H3J 2J4
> Tel: (514) 340-2085 poste 2233
> Fax: (514) 340-2154
> Courriel: anolet.crir@ssss.gouv.qc.ca
>
>

From: <skb@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] REB remuneration
Date: Friday, May 23, 2003 6:07 PM

I think Richard may also have responded for our committee, We do not pay our
members. The faculty sitting on our committee do not get release from other
duties. Laymembers get parking permits for the Health Sciences Centre
parking area(a big deal). We all get pizza or some such during the three
hour meeting (4-7 every other week). Chair/co-chairs get an honorarium
which goes into one of their research accounts. We plan one
reception/gathering a year to thank members stepping down etc.

Serving on the REB is considered one of many faculty administrative
functions - admissions committee and curriculum committees are the other
heavy duty commiittees. As we move to a provincial board we are considering
some kind of small honorarium for our laymembers to defray travel to and
from meetings but iwe have not seriously considered paying faculty members.


This has worked well for us.

Sharon Buehler
Memorial University

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] REB remuneration
Date: Monday, May 26, 2003 8:26 AM

Obviously people are interpreting "renumeration" in a number of different ways.

However 'recognition' or release or credits are equally important subjects to consider in terms of a national policy. Our Executive Chair is considered to be 0.4 FTE and an Associate Executive Chair 0.2 FTE if the duties are split. This is all part of what has been alluded to as the 'professionalisation' of REBs.


Dr Michael D E Goodyear FRACP FRCPC FACP

 

11. Relationship of DSMBs and Sponsors

From: "Judith Abbott" <judith.abbott@ualberta.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Relationship of DSMBs and sponsors
Date: Thursday, May 22, 2003 4:46 PM

Our biomedical REB has recently seen a couple of clinical trial protocols
which state "The sponsor has the right to reject or modify decisions of the
DSMB."

When we questioned it, we received this response: "The DSMB is an advisory
body, not a ruling body. The ultimate responsibility is with <the sponsor>,
not the DSMB. Therefore, any decision .... is with <the sponsor>. ... It
is possible, but unlikely that <the sponsor>, would reject or modify the
DSMB's recommendations".

Has anyone else seen this in protocols - and have you accepted it? Isn't
the whole point of DSMBs that they monitor the trial and recommend as they
see fit? As an REB we have always assumed that DSMB recommendations will be
followed, but I don't recall ever seeing any that were negative. Does the
sponsor have the right to decide who receives a copy?

The issue is coming up again at tomorrow afternoon's meeting.

Judith
********************

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Relationship of DSMBs and sponsors
Date: Thursday, May 22, 2003 5:37 PM

Have never seen it - DSMBs are supposed to be independant - but it is true they are advisory - I cannot recall an instance where they have been overuled

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Ken Uffen" <kuffen@nygh.on.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Relationship of DSMBs and sponsors
Date: Thursday, May 22, 2003 6:20 PM

Unbelievable. Never seen this. We would not accept such a clause.
Ken Uffen
Chair REB NYGH

Judith Abbott wrote:

From: "Francis Rolleston" <frolleston@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Relationship of DSMBs and sponsors
Date: Thursday, May 22, 2003 7:18 PM

I would suggest that the sponsor has the right to make its own decisions and
interpretations on the reports of the DSMB, but also that that the sponsor
has an ethical duty to inform the trial sites (REBs) about the views of the
DSMB, without alteration, even if the sponsor also attaches its own
interpretations. The independence of the DSMB is critical.

The report that Ray Saginur and I are now submitting to Health Canada on
management of adverse event reports regards the opinions of an independent
data monitoring committee (or DSMB) as one mechanism for developing
recommendations to local REBs on the significance of adverse event reports.

Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

From: "Louise Dumas" <l.dumas@videotron.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Relationship of DSMBs and sponsors
Date: Friday, May 23, 2003 10:06 AM

I am interested in reading more about this part of your message since we
have a problem with the amount and quality of those reports...
"The report that Ray Saginur and I are now submitting to Health Canada on
management of adverse event reports regards the opinions of an independent
data monitoring committee (or DSMB) as one mechanism for developing
recommendations to local REBs on the significance of adverse event reports."
Louise

Louise Dumas, R.N., M.S.N., PhD
Professor and researcher, Université du Québec en Outaouais
Secretary, Research ethics committee, Centre Hospitalier des Vallées de
l'Outaouais

From: "Agnes V. Klein" <Agnes_V_Klein@hc-sc.gc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Relationship of DSMBs and sponsors
Date: Friday, May 23, 2003 10:17 AM

I agree! Indeed it would be sad if they were to be overruled. From the
point of view of Health Canada, the overruling is problematic in the
extreme



"Michael Goodyear"

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Relationship of DSMBs and sponsors
Date: Friday, May 23, 2003 12:20 PM

I agree with Francis, fortunately there is a growing trend to making DSMB reports freely available to investigators, and obviously they should be filed with REBs. It would be quite wrong to edit them, but perfectly acceptable to editorialise them.

However a sponsor that acts contrary to their DSMB's advice is opening up a huge liability issue. This is where steering committees are important.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Jack Corman" <irbs@interlog.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Relationship of DSMBs and sponsors
Date: Friday, May 23, 2003 12:38 PM

Michael are Francis are right. It would be interesting to see what a
sponsor would say if asked to stipulate under what circumstances might the
DSMB decision be overruled. I suspect that it¹s the company lawyers not
wanting to tie corporate hands in case of a wacky or vindictive DSMB
decision, like advising clients to sue everyone. If the sponsor cannot
describe an acceptable example of where the DSMB might be overruled (and
they probably can¹t), then why have the statement ­ out it should go.

Jack Corman
IRB Services

From: "Saginur MD, Raphael" <rsaginur@ohri.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Relationship of DSMBs and sponsors
Date: Friday, May 23, 2003 1:51 PM

Judith,
Your sponsor is correct. According to GCP 1.25, the sponsor may establish a
DSMB, and the DSMB recommends action to the sponsor.
That said, the sponsor is wise to follow the recommendation of the DSMB, or
have a well argued rationale why not. There would be hell to pay to
disregard a DSMB.
I believe there is an obligation under FDA rules to communicate DMC(DSMB)
opinions to REBs.
Ray

12. Research and Art

I guess that if feedback was being collected, then you would have to warn people of that before they entered the exhibit. I would see that "social facilitation" might be a problem though-- would people be willing to be the only one of their group to drop out? i.e. Would this put pressure on them to participate?

The other alternative would be to have some way for the potential subject to turn off the collection if they wanted to, or to erase it afterwards if they decided they didn't want to have the data used. It gets pretty complicated, technically, but could be done.

Gaby Miller

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

From: "Alex Karabanow" <akaraban@ryerson.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Research and Art
Date: Friday, May 30, 2003 2:01 PM

Certain artistic installations or performances include the observation
and documentation of the reaction of people. In some cases, the feedback
is videotaped or stored in a database. The Ryerson REB has sometimes run
across such projects that involve feedback on sensitive subjects
(sometimes described as "virtual storytelling") or in media where
subjects may be identifiable.

How do other REBs attempt in drawing the line between art and research?
In light of the upcoming SSHRC competition for artist researchers, this
issue may be of interest to others on the listserv.

Sincerely,
_______________________________________________________________
Alexander Karabanow, Grants/Contracts Officer
Office of Research Services, Eric Palin Hall, Room T400N
Ryerson University, 350 Victoria St., Toronto, Canada M5B 2K3
Phone: (416) 979-5000 Ext. 7112, Fax: (416) 979-5336
Email: akaraban@ryerson.ca, Web: http://www.research.ryerson.ca
_______________________________________________________________

13. Studies Placed on Hold

From: "Melony Frei" <mfrei@cpsa.ab.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Studies Placed on Hold
Date: Wednesday, May 21, 2003 3:33 PM

I am hoping to gain some information as to how other ethics
boards/committees handle the following situation:

A protocol was reviewed by the ethics committee at a meeting 1 year ago
and the concerns regarding the study were sent to the investigator
within two working days of that meeting. The Committee was subsequently
advised by the investigator that the sponsor had put the study on hold
and it remains on hold to this day. The concerns have not been
addressed to date.

How do other boards/committees handle this? Must the study be
re-reviewed? Is it simply left on hold until the investigator advises
otherwise?

Thank you in advance for your input.

Sincerely,

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

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Studies Placed on Hold
Date: Wednesday, May 21, 2003 3:57 PM

Hello Melony -- at the MUHC we would have followed up with the Investigator
sooner than one year post-review.

Your answer is more simple than you think. Since the study has passed its
one year anniversary of the REB initial review, that initial review has
expired, and would no longer be valid with respect to the regulation that
requires a study to be reviewed "at least once per year". We would require
the study to be reviewed as a new submission and assign a new Study #
referenced to the first study for which time ran out. Since the sponsor
has placed the study On Hold there would seem to be no new submission given
your example. Should the study ever re-appear it would likely be modified
in a major way ... 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] Studies Placed on Hold
Date: Wednesday, May 21, 2003 6:06 PM

We have a 6 month dead wood policy - after that it is a new study - other REBs in our Health Science network have 3 months - you don't need studies like this clogging your office - chances are if ever revitalised it will be a new study - chances are also that there are major problems with the study anyway

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Yvette Parent" <Yvette_Parent@hc-sc.gc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Studies Placed on Hold
Date: Thursday, May 22, 2003 8:37 AM


Hi Melony,

Please note that in Health Canada, it is the responsibility of the
Principal Investigator to get back to the REB via the REB Secretariat,
however, if the Secretariat has not had any communication from them after 4
months since the issuance of the note requesting modification and/or
additional information, the file will be closed and a new application will
be required whenever they resubmit.

Take care,

Yvette Parent
Senior REB Administrator
Administratrice principale du CER
Office of the Chief Scientist
Bureau de l'Expert scientifique en chef
(613) 941-5199
Cell: 371-8369

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Uncoded data
Date: Friday, May 16, 2003 12:02 PM

We recently became aware of uncoded data with identifiers being sent to a coordinating centre in another province. It turns out that neither centre has a policy on incoming data. In the US now any data with identifiers would be returned immediately.

I suggest we adopt a collective default policy - no identifiers going out or coming in. Add to CAREB policy portfolio if all agreed!

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] data
Date: Friday, May 16, 2003 2:24 PM

Coming from a university that does not have a medical component we are
grappling with the same problem with social science and humanities. At
present I go along with the data being the student's unless the student is
working on a specific project related to the professor's work and it is
clearly stated that the data will be retained by the professor.

In terms of retaining data for future research I have students include a
statement about retaining the data for future research purposes. But this
raises another concern: who is responsible for the storage and security of
the data? Students are mobile, so who is responsible for the data in the
long term?

Another point: if a student should discover something in the data and wants
to pursue it as an individual project then things change. While each case is
different depending on the methodology and other factors I presently advise
students to submit a separate proposal and seek the permission of the
professor from the original project.

Now for an actual case: we have recently seen the firing of a RA for
pursuing personal research interests on a PI's project. The RA went so far
as to add questions that had not been reviewed by the PI or the ethics
committee. The RA also used the demographic information from the project
without permission. Once caught the RA was ordered to hand over all the
research data (it was destroyed). The PI contacted the participants to
explain what had happened and gave them they opportunity to withdraw from
the study (in this case no one withdrew). And, as I have already stated the
RA was dismissed from the project.

Leslie J. MacDonald-Hicks

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] data
Date: Friday, May 16, 2003 4:41 PM

Well two points here -

Reuse of data - technically should be in a consent form either a specific secondary use or an open ended agreement. In practice we are all aware that data gets used for all sorts of purposes, and it is probably reasonable to use a dataset for hypothesis generation. It gets trickier if it is merged with something else or traced back to other information. Obviously anonymised data is more protected.

As to who owns data - that should be decided when a project starts - like a pre-nuptial - it also depends on whether an individual's data is completely independent or part of a larger set, and what it's intended use is - going off to a rival lab and setting up in competition with data (and ideas) would raise a lot of eyebrows to say the least.

Sorry - no easier answers - 'it depends' as we used to say at McMaster - here I say 'context specific'.

From: "Luc Simon" <Luc.Simon@vrr.ulaval.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] data
Date: Friday, May 16, 2003 4:43 PM

Extrait de la Déclaration des droits des étudiants et des étudiantes de
l'Université Laval
http://www.ulaval.ca/sg/reg/declaration.html

1.5
les étudiants et les étudiantes ont droit, dans la mesure de leur
contribution à ces ouvrages, à la propriété intellectuelle de leurs travaux
d'études, essais, mémoires et thèses;

This means that unless a contractual agreement is in place between the
student and the university (MOU when starting work in a lab, hiring contract
for research assistantship, etc...), the student "owns" the intellectual
property he develops himself.

If a question arises, there should be a case by case determination of the
extent of the contribution of the student, how much institutional resources
were used to conduct the work, etc...

My understanding is that the usual practice is that the student who whishes
to do so can leave with a copy of the data he generated, and the original
data is left in the custody of the institution.

Of course, this does not apply if there is a clear understanding that the
data was collected under a specific protocol, approved by some institutional
authority (REB, research office), where data retention/ownership issues were
already addressed, and that this was known and accepted by the student.

Regards,

Luc Simon