Summary of NCEHR Listserv for April 2003

TOPICS

1. When is it Research, When Clinical Practice?

2. Dancing with Research Ethics Boards

3. Ojibwe Translator

4. Older Persons on REBs

5. REB Quorums in Times of Plague

6. When is a Person a Participant

7. Canadian HIPAA Authorizations

8. Hamilton NCEHR Workshop

9. PRE Nominations

10. Health Canada Div 5. 1 QI per Site

Files for Download

NEJM - Controlling Research Trials

NEJM - The Cost of HIPPA Compliance

MEJM - HIPPA Regulations: A New ERA of Medical-Record Privacy?

Patient Consent Preferences for research uses of information in electronic medical records: Interview and Survey Data

Readability Standards for Informed Consent Forms as Compared with Actual Readability

US HIPAA Authorization Forms & Consent

Schedule C Drug Stakeholders - Health Canada

HIPAA Implementation in the NSABP

HIPPA Implementation Sheet for IRBs (NSABP)

Overview of HIPPA/NSABP Privacy Rule Procedures

Allergen Patient Authorization for Use and Release of Health and Research Study Information

 

1. When is it Research, When Clinical Practice?


Subject: [Ethics] When is research research and when is it clinical practice?
Date: Thursday, April 10, 2003 6:54 PM

A physician gave a patient an off-label drug for a condition that is not only rare but untreatable. They had plausible biological rationale and the patient improved. That is publishable as a case report.

However it was then proposed to study 10 consecutive patients to see if this was a fluke. A protocol was writen and sent to their local REB as an unfunded study. When asked 'Where is Health Canada's letter of 'no objection' based on your CTA? the physician admitted to being unaware that all phase I,II and III trials, whether investigator or industry initiated, funded or unfunded, whether new drug or marketed drug, have to be filed with the Clinical Trials Programme of TPD for approval.

The REB provided details of who to contact in Ottawa. After talking to the Programme staff, the physician became aware of the regulatory burden involved, and withdrew the protocol from the REB.

The REB were very concerned that the individual would simply go and treat the next 10 patients who walked through the door, which turned out to be the intent. They consulted Health Canada and learnt that this will result in unpublishable data, and could be detected by one of Health Canada's inspectors now enforcing the new Clinical Trials Regulations.

The moral of the story is that you cannot submit a protocol and then withdraw it without arousing suspicion.

We have a lot of education to do. The good news is that Health Canada is actually prepared to help physicians like this with limited resources, so the story had a happy ending.

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] When is research research?
Date: Saturday, April 12, 2003 3:37 PM

1. Lawyers
My job (inter alia) , I think, is to prevent lawyers having field days (sorry anyone out there who is one, many of my best friends are) - and to protect our institutional legal counsel from going prematurely grey.

2. Research
We http://www.cdha.nshealth.ca/research/researchEthics/generalGuidelinesResearchEthics.html
have defined research according to CIOMS International Ethical Guidelines 1993
Which means we should update to the 2002 version!
http://www.cioms.ch/frame_guidelines_nov_2002.htm

The term "research" refers to a class of activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. In the present context "research" includes both medical and behavioural studies pertaining to human health. Usually "research" is modified by the adjective "biomedical" to indicate its relation to health.

Helen - does the CIOM website answer your question?

3. CTA
See attachment for upcoming workshop in Halifax.

4. Food and Drugs Act and Regulations
Let us see who in our midst has a more regulatory frame of mind and can answer Alison's question, because we do not want mis-information out there.

We could start with the Regulations, Part C (Drugs) (not the Act as some people seem to think)
http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/schedule/gazette.ii/sch-1024_e.pdf

DIVISION 5
DRUGS FOR CLINICAL TRIALS INVOLVING HUMAN SUBJECTS
Interpretation
C.05.001. The definitions in this section apply in this Division.

"clinical trial" means an investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug. (essai clinique)

Alison's point about sale and importation is an intriguing one (Dr Mithani please help us out!) which relates to the Constitution Act 1867-1982 which gives powers to the Federal Government over;

91 (2.) The Regulation of Trade and Commerce

but powers in the matter of 'health' to the Provinces;

92 (7.) The Establishement, Maintenance, and Management of Hospitals, Asylums....

which means the Federal Government has to frequently rely on tenuous grounds, particularly the preamble to Section 91, relating to

Laws for the Peace, Order, and good Government of Canada

and

in relation to all Matters not coming within the Classes od Subjects by this Act assigned exclusively to the Legislatures of the Provinces

Personally, in matters of interpretation I tend to go straight to the RIAS which you will find in the second part of the regulations, starting on page 22. This specifically excludes 'individual patient treatment' (N of 1) or phase IV trials. The intent to regulate clinical trials and to ensure their compliance with GCP is clear. The ability to control sale of drugs gives powers to prevent an investigator applying a drug, which technically would need to be 'sold' before application to the individual. The regulations also require sponsors to obtain REB approval prior to conducting clinical trials. A lot of the deabate as to meaning interpretation took place around the comment period provided between publication in the Canada Gazette Part I and Part II.

The statement also addresses the use of marketed drugs for new indications, and acknowledges that the 'sponsor' may in fact be a an independent investigator.

5. Who needs an REB anyway?
I detect a sense of frustration out there in terms of defining what should and what should not be referred to an REB. A little common sense sometimes helps in times like these. The issue is about oversight of human subject research, that is protection of human subjects. If human beings, individually or in aggregate, can be harmed physically, psychologically or socially through threats to their privacy, then it would be a matter of referral. The default for the protection of investigators should always be to refer or at least consult. Is that too simplistic?

From: "TASC - CMX Research Inc" <tasc@attcanada.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is research research and when is it clinical practice?
Date: Thursday, April 10, 2003 8:13 PM

I may be mistaken but understood a clinical trial only to require Health
Canada approval if the drug is to be sold or imported. If a physician would
like to use a licensed drug or use the drug off label with no intent to
market for that purpose it would seem they do not require the approval of
Health Canada (may required ICH, REB etc only). This is similar to the FDA
in that they only have jurisdiction over drugs that will be transported
cross state. Since all marketed drugs will be transported, then they need
to meet with FDA regs, but if you were not planning to market, then it would
not be required by law.

C.05.002. (1) Subject to subsection (2), this Division applies to the sale
or importation of drugs to be used for the purposes of clinical trials
involving human subjects.

Does anyone have further information on this?

Alison Orth
Research Coordinator


From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is research research and when is it clinicalpractice?
Date: Friday, April 11, 2003 9:00 AM

Well since Health Canada monitors this list you may get a reply. That is where the question - When is research research and when is it clinical practice comes in.

Our REB has definitions of research. If one were treating a patient as a one off, it could be justified on compassionate grounds. You could also probably publish a retrospective series of your experiences. But if you are treating patients with the intent to quantitate efficacy that is research, and a clinical trial and is filable.

From: "Jack Corman" <irbs@interlog.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is research research and when is it clinicalpractice?
Date: Friday, April 11, 2003 6:31 PM

I would refer you to the Belmont Report, which has a section on this
subject, and discusses both biomedical and behavioural research. Of course,
much of social science research is not behavioural in nature. Worth a look
if you haven't seen it lately.

Jack Corman
IRB Services

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is a person a participant?
Date: Friday, April 25, 2003 5:30 PM

To put this in perspective - are these research proposals that are coming to you to determine whether they require REB approval?

Without seeing the full protocol, and on the information provided I would stick my neck out and say 'no'


From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] When is research research and when is itclinicalpractice?
Date: Friday, April 18, 2003 12:57 PM

On a lighter note, someone once said that stealing ideas from someone is called Plagiarism, but if it is stealing from everybody it is called Research

2. Dancing with Research Ethics Boards

From: "Michael Owen" <mowen@spartan.ac.brocku.ca>
To: "Michael J. Wilson" <srebsec@mcmaster.ca>; <ethics@lists.ncehr-cnerh.org>
Cc: <regional-rebs-list@informer2.cis.McMaster.CA>
Subject: [Ethics] Re: [regional-rebs-list]June 1, 2003 meeting in Halifax
Date: Thursday, April 17, 2003 5:24 PM

Please find attached a pre-conference announcement. There is no
registration fee.

Please bring this to the attention of REB members or faculty who
might be attending the Congress of the Humanities and Social Sciences
(formerly The Learneds).

June 1, 2003, 11:30 AM -4:30 PM: Dancing with Research Ethics Boards
Location: Dalhousie University, Room 212, Henry Hicks Arts &
Administration Building

The Interagency Advisory Panel on Research Ethics (PRE) and the
Canadian Federation for the Humanities and Social Sciences (CFHSS)
are inviting researchers, REB members, and institutions to engage the
dialogue on research ethics issues in the SS&H. The program includes
updates on recent PRE and CFHSS research ethics initiatives in SS&H
research and discussion on some ethical issues of particular interest
to SS&H researchers, e.g. SS&H multi-centered research, on-line
research, oral history, and school boards.


1 juin, 2003, 11h30 -16h30: Une ronde avec les CÉR
Salle: Dalhousie University, Room 212, Henry Hicks Arts &
Administration Building

Le Groupe consultatif interagences en éthique de la recherche (GER)
et la Fédération canadienne des sciences humaines (FCSH) invitent les
chercheurs, les CER et les institutions à engager le dialogue sur
l'éthique de la recherche en sciences humaines. Le programme comprend
une mise à jour sur les activités du GER et de la FCSH ainsi que des
questions intéressant en particulier les sciences humaines,
notamment, la recherche en ligne,l'histoire orale, travailler avec
les conseils scolaires et la recherche multi-centre en sciences
humaines.


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

Office of Research Services:
Tel: 905-688-5550, Ext 3127
Fax: 905-688-0748

CCOVI:
Tel: 905-688-5550, Ext 4716
Fax: 905-688-3104

Cell: 905-687-2383

email: mowen@brocku.ca

3. Ojibwe Translator

From: "John O'Meara" <jomeara@mail1.lakeheadu.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Translators - Ethic approval requirements?
Date: Friday, April 25, 2003 1:55 PM


A graduate student in the Faculty of Education is proposing a
research project which will involve interviewing a member of a
particular aboriginal community, as part of a life history project.
Although the interview will be conducted in English, the individual
being interviewed also speaks Ojibwe (an indigenous language), and it
is anticipated that she may speak in Ojibwe during the interview
periods.

To that end, the researcher proposes to have a translator present to
assist in the understanding of any Ojibwe language material.

The translator is not really a research subject but is not a researcher either.

In this type of case is it necessary to prepare a separate consent
form for the translator? How would some of the ethics provisions
apply to him? For example, anonymity / confidentiality? (The person
who is being interviewed will not be anonymous, at her request)

Thanks

--


**********************************************************
John O'Meara, Chair
Graduate Studies and Research in Education
Faculty of Education
Lakehead University
Thunder Bay ON P7B 5E1 CANADA
Phone: 807-343-8054 FAX: 807-346-7771 E-mail: jomeara@mail1.lakeheadu.ca
Web Page: http://www.lakeheadu.ca/~facedwww/pages/Programs/Graduate/index.htm
**********************************************************

From: "Gabrielle Miller" <gmiller@nickel.laurentian.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Translators - Ethic approval requirements?
Date: Friday, April 25, 2003 2:46 PM

John:

It seems to me that there are two things to consider:
1) The interviewee needs to be aware of and approve of the presence of the translator.
2) The translator should sign a confidentiality agreement. (Despite the waiver of anonymity, there may be some material which the interviewee may not want to be made public.)

I think the translator is more like a co-researcher than like a subject in this instance.


Gaby Miller, Chair/Administrator,
Laurentian University REB

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Translators - Ethic approval requirements?
Date: Friday, April 25, 2003 5:36 PM

My stab would be that the translator is an instrument. However in so much as the translator is potentially exposed to confidentail information, and is presumably a professional, normal rules surrounding confidentiality of personal information should apply, regardless of whether this is research or not.

Anyone preparing an examination in bioethics would find this listserve a goldmine

4. Older Persons on REBs

From: <skb@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] older persons on REBs
Date: Saturday, April 19, 2003 5:35 PM

Hi to all

A break from HIPAA.

I queried this one time before and I thank those that responded. But just
in case there are others who didn't see my first message I am interested in
whether your REB has 'older persons' as chair, co-chair, member and the
constituencies they represent (legal, non -clinician researcher, clinician
researcher, basic scientist, clinician, layperson, bioethicist, community
agency). Are they retired or not retired? Are they given/ do they take on
some of the extra tasks of an REB, particularly if they are retired? I won't
get into the definition thing again but I am thinking of 'older' as 50+
(although my work on the aging study would consider this older-middle).

I am gi ving a presentation in early May on the role of older persons on
REBs. (The theme of the forum is aging and research and there will also be
presentions on older people on peer review panels, etc.). Our committee has
two retired persons - one a non-clinician researcher and one layperson from
a community agency. I am one of them so I won't say anything about my
contribution; Margaret has put forward very useful questions and comments
from the potential participant perspective. Having to address questions
from laypersons has often brought us down to ground level.

Again, thanks to those of you who responded earlier - your emails are
archived - but...if you want to add or elaborate, please feel free to do so.


Many thanks for this.

Sharon Buehler
Co-chair
Human Investigation Committee
Memorial University of Newfoundland

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] older persons on REBs
Date: Monday, April 21, 2003 2:58 PM

I have no idea, I am far too polite to ask people their age when they come on board (OK I will save you asking, I am 56).

We do not go out of our way to find elders for the REB, any more than any other variable, otherwise it would get impossible. Perhaps you could survey all REB members in Canada and ask them to state their age anonymously.


From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] older persons on REBs
Date: Wednesday, April 23, 2003 9:25 AM

Older as 50+, humph! I protest! -- yep, that includes me, too! In Florida
that rates me a senior's discount.... But at 50, retirees would be unusual.
We have no such lucky folks on our REB -- nor have we ever had retirees. Our
REB is not age-restricted, but most of our members are not 'older' on this
definition. New REB members tend to be new members of staff & tend to be
younger.
Philip
Philip C Hebert MD PhD FCFPC
Associate Professor, Family Medicine
Chair, Research Ethics Board, 416-480-6100 ext. 4276
Clinical Ethicist ext. 4818
Family Physician: Room A100 ext. 4963
Pager 237-3424
Messages: 480-6100 X 5081
Alternate E-mail: philiphebert@rogers.com

5. REB Quorums in Times of Plague

From: "Williams, Robert" <RWilliams@tsh.to>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] REB Quorums in Times of Plague
Date: Tuesday, April 29, 2003 6:43 PM


Hello everyone,

Having the dubious distinction of being a SARS centre, not to mention being
much pilloried in the press as the SARS epicenter of the Western World, over
the past weeks we have had a number of researchers come to us with their
SARS studies. Each of these studies, we are assured, necessitates the
immediate and undivided attention of the REB in order that it can be
approved posthaste. The problem is that the REB, as a full, functioning
hospital board, has not been able to meet since this whole problem erupted.
To further complicate the matter, these studies do not meet our criteria for
expedited review.

In order to facilitate such studies in such times, we created a new category
of protocol review, which we call "crisis review." This allows for a
segment of the full REB to assess studies that would otherwise have been
assessed by the full Board in "normal times," but cannot now be so assessed
because of a widespread crisis. The quorum needed for a crisis review is
the minimum requirements for REBs as set down in GCP and TCPS. Even still,
we are finding that in the ongoing hurly-burly, even this minimal quorum is
hard to bring together quickly.

The question I would like to pose to the list serve members is what do you
do, or what do you think you would do, when you can't pull together the
minimum number and composition of REB members to review an urgent,
time-sensitive, situation-specific protocol within a critical window of
opportunity?

More and more REBs may be faced with similar situations now that the Special
Access Program is moving towards only releasing experimental drugs as part
of an ongoing study.

Thank you for your help with this.

Bob

Robert S. Williams
Bioethicist
The Scarborough Hospital
Toronto

From: "Richard Neuman" <rneuman@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] REB Quorums in Times of Plague
Date: Tuesday, April 29, 2003 7:44 PM

My first thought is that I would prevail on REBs in the area that might
be able to include a small number of outside protocols at their meeting
and ask for their help in the review process. I would want one or two
members of the home REB, including the chair or co-chair, to be in
attendance to deal with local ethics related to my institution. Most
REBs are over worked as it is, but I suspect in the face of a crisis
they may be willing to lend a hand.
Richard Neuman
Co-Chair, HIC
Memorial University

From: "JohnLast" <jmlast@uottawa.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] REB Quorums in Times of Plague
Date: Tuesday, April 29, 2003 7:50 PM

The answer to this question should be self-evident but of course it isn’t.
When a whole community is at risk, the needs of the community trump the
rights of individuals – a maxim that has been used to justify among other
things the edicts and actions of the homeland security officials in the USA.
One could debate the merits of various points of view on this, but when an
epidemic threatens the community, the niceties of ethical review have to be
modified. In the SARS epidemic, the question may be whether the community
at large was (or is) threatened.

At the discussions in Geneva in 1990 leading up to drafting of the CIOMS
Guidelines on Ethical Review of Epidemiological Studies, I managed to
persuade all present at a session I chaired, that urgent epidemic
investigation, though in a strictly technical sense might be ‘research’ and
therefore subject to ethical review, it is also routine (and emergency)
practice. I’ve not seen or read anything since then that would lead me to
change my mind.

For what my opinion may be worth, I think you have to assess each
SARS-related research proposal on its merits, and decide which justify
expedited review, and which do not – triage them, in other words

John Last

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] REB Quorums in Times of Plague
Date: Wednesday, April 30, 2003 8:12 AM

We sympathise - your dilemma is appreciated.

There are a number of possible approaches, most of which have been touched on either by yourself or others.

1. Clearly you need to be flexible, unless all of your REB are under quarantine, presumably you could meet somewhere else.
2. There is precedent and indeed regulatory allowance for pooling REBs in local areas
3. There is also provision for emergent situations
4. Administratively, REBS may need to create their own rules in terms of how often to meet and for how long, and in terms of priorities, when the situation is far from normal
5. In all things a sense of proportionality needs to be maintained. Societal risk vs the individual. The risks of doing the research vs the risks of not doing the research, and the relative merits of the proposals before you.
6. Despite all this, the usual guiding principles plus common sense should triumph over rules which do not serve a purpose under the specific circumstances.

References:
FDA Guidelines
Non-local IRB review
Multinstitutional IRB

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Sampson, Heather" <Heather.Sampson@rmp.uhn.on.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] REB Quorums in Times of Plague
Date: Wednesday, April 30, 2003 10:09 AM

Being in one of the other code orange sites in Toronto, we held one "common
sense prevails" REB meeting via conference call. It was ably chaired from
Montreal and deftly administered in Toronto.
We were also able to include folk who were out of the country, which of
course usually we would not be able to accommodate in the mandated
face-to-face meetings.

It is obviously not preferable to meet in this way on a regular basis; but
with apologies to the original expression -- "desperate times, sometimes
call for desperate measures".

cheers
Heather Sampson
(a member of REB)

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: Wednesday, April 30, 2003 11:58 AM

In the US, it is not uncommon for institutions to avail themselves of
independent ethics review services at crucial times, such as when Duke and
Johns Hopkins were shut down by the FDA/OHRP. The same option is available
to any Canadian institution through us or one of the other independent REBs
in Canada.

Jack Corman
President/Secretary

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] REB Quorums in Times of Plague
Date: Wednesday, April 30, 2003 12:45 PM

An additional advantage to the teleconference is the ability to tap
specific distant expertise that would, I suspect, often be a very
helpful in crisis research. Deferring to other IRBs would also be
quite helpful if logistics is the major issue.

The TCG discusses emergency care almost entirely in the context of
the individual and requirements for conduct rather than in the
context of a public health crises and review process. Having
specific criteria for emergency review, not only for the process
itself but also for the elements that may be required or waived may
be helpful. Such criteria could include defining if a real and
present health crises actually exists (vis a vis the media's penchant
for titillation), the clear circumstance that the work can only be
conducted within the existing/projected window, a reasonable
expectation that the work will have real and immediate impact on the
crises, and a reasonable person standard for modifications for
conduct (like the need for individual informed consent). These are
not easy, I know.

I get concerned about utilitarian views on ethics, because we're not
only talking about the review process, but potentially about the
requirements for ethical conduct as well. I think John's comments
about the distinction between research and emergent public health
crisis care/management [my paraphrase] is an important one. Criteria
for distinguishing between the two, if possible, would also be
helpful.

Cheers

Cam

Thus spake Francis Rolleston :

> I very much appreciate this exchange and have asked that it be on the
> agenda of the next meeting of the REB that I chair.
>
> It raises the interpretation of face-to-face meetings. To my
> remembrance in developing the TCPS, face-to-face meetings were
> insisted upon because the Working Group knew of some REBs that never
> met, but worked entirely through faxes etc. I would believe that an
> REB that routinely meets face to face should be able to hold an
> occasional meeting for special reasons using teleconferencing.
>
> Thank you
>
> Francis
>
> Francis Rolleston
> 500 Denbury Avenue
> Ottawa, ON
> K2A 2N7
>
> frolleston@sympatico.ca
> 613 728-7163
>
> -----Original Message-----
> From: ethics-admin@lists.ncehr-cnerh.org
> [mailto:ethics-admin@lists.ncehr-cnerh.org]On Behalf Of Sampson,
> Heather Sent: April 30, 2003 10:03 AM To:
> 'ethics@lists.ncehr-cnerh.org' Subject: RE: [Ethics] REB Quorums in
> Times of Plague
>
> Being in one of the other code orange sites in Toronto, we held one
> "common sense prevails" REB meeting via conference call. It was ably
> chaired from Montreal and deftly administered in Toronto. We were
> also able to include folk who were out of the country, which of course
> usually we would not be able to accommodate in the mandated
> face-to-face meetings.
>
> It is obviously not preferable to meet in this way on a regular basis;
> but with apologies to the original expression -- "desperate times,
> sometimes call for desperate measures".
>
> cheers
> Heather Sampson
> (a member of REB)
>
> Heather A. Sampson,
> Director, Clinical Research Program
> Radiation Medicine, Princess Margaret Hospital, 5-972
> 610 University Ave., Toronto, Ontario, Canada M5G 2MB
> 416-946-4501 x 3392
> fax: 416-946-4442
>
> admin assistant: Laura Nash 416-946-4501 x 3975
>

6. When is a Person a Participant

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] When is a person a participant?
Date: Friday, April 25, 2003 12:55 PM

Hello all

I'm trying to get a clear definition for a research subject
(participant). This has come up with studies that evaluate the
performance of evaluative procedures like, for example, reliability
of an X-ray measurement technique. The question is are the examiners
who use the technique subjects or not? Another example could be the
evaluation of reliability of ICD coding of patient files. Are the
evaluators subjects? If people critically appraise a series of
articles using a quality rating tool, are they subjects?

These are some questions that are coming up and I'm not sure how to
respond. I've been erring on the side of saying yes, but I'm
starting to wonder if this is a bit overboard. 45 CFR 46 identifies
subjects as a living individual "about whom" data or identifiable
private information is obtained. TCG doesn't seem to have even that
specific a statement but Appendix 1 identifies works requiring review
"whether the focus of the research is the subject." which would seem
to suggest that the instances above may be subjects.

In the instances I've described above, an OHRP rep felt that many
would not constitute human research because the information was not
"about" the person themselves.

Any thoughts or clips from policy would be helpful.

Cheers

Cam
From: "Luc Simon" <Luc.Simon@vrr.ulaval.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is a person a participant?
Date: Friday, April 25, 2003 1:50 PM

Hello Cam,

Even before asking if they are research subjects, one could ask if such
activities should be considered "research" for REB review purposes !

We are now developping local policy to state our understanding of rule 1.1 d
of the TCPS.

=====
Quality assurance studies, performance reviews or testing within normal
educational requirements should also not be subject to REB review.
=====

We will thus consider "exempt from REB review":

- research about a living individual involved in the public arena, or about
an artist, based exclusively on publicly available information, documents,
records, works, performances, archival materials or third-party interviews.

- surveys or marketing studies where no personal data are gathered

- quality assurance studies

- performance reviews or testing within normal educational requirements or
related to standard educational practice

- public policy analyses, journalistic enquiries, litterary critics

- performance reviews conducted within an organization, in accordance with
its mandate, work conditions or training program (provided there is not a
distinct research component)

- research conducted using secondary analysis of denominalized datasets or
coded samples, provided the local research team cannot have access to the
identity of subjects


Regards,

Luc Simon

From: "Michael Owen" <mowen@spartan.ac.brocku.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is a person a participant?
Date: Saturday, April 26, 2003 10:09 AM

Luc

Does your list below mean that the researcher or study leader
determines if the study is exempt or, as is the case in the US, does
the REB make the determination of whether an individual study is
exempt? If the former, do you do any monitoring to assure that exempt
studies are indeed exempt?

Michael

From: "Lindley, Pat" <plindley@Kilcom1.UCIS.Dal.Ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is a person a participant?
Date: Monday, April 28, 2003 9:06 AM

Hi Luc et al.

One of the things we wrestle with is 'public policy research' where
interviews are being conducted. Often the interviewee is not a public figure
(i.e. a minister) but a lower level bureaucrat, and often it is the personal
(albeit professional) experience or opinions that are being sought. Given
that what is sometimes being sought is critical commentary from an
internal source ... something which is frowned upon by the Canadian
government... a blanket exclusion of 'public policy' research would seem to
me to exclude some research that arguably should be reviewed... i.e. does
present risks to subjects who are not otherwise protected. However, it is a
thorny issue and I would like to hear the arguments on both sides.

Patricia Lindley
Office of Human Research Ethics Administration

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is a person a participant?
Date: Monday, April 28, 2003 11:47 AM

Hello all

Pat and Gaby's examples are similar to the kinds of things we're
faced with occasionally. A person may be put at some kind of risk if
they take part in a work. These risks may be small compared to the
risks in other projects, but I have some problems with exempting
works from review based on risk rather than the nature of the
interaction. I'd much prefer to determine if a work is "about" a
person or not i.e. are they a participant?

One of our REB members felt that consent, in a specific instance that
looked at inter-rater reliability of ICD coding, was inappropriate as
the raters weren't subjects and including it actually denigrated the
concept of informed consent. The question then was were they
participants or not: if they weren't subjects, why were we reviewing
the project? Another member argued that they were subjects as their
abilities were being assessed using a specific tool (ICD coding)
regardless that personal information was not being sought. Another
asked if these people would be at risk if poor performance in the
study could endanger them somehow, considering that this study was
outside the purvue of a normal evaluative process. The latter
argument was based on the principle rather than any real likelihood
of risk.

I'm trying to push this back to a two criteria decision (a) is it
research? and (b) are human participants involved? Our policy covers
item a) fairly well. I'm still not sure how to consistently answer
b). The challenge with looking at the kinds of questions being asked
and deciding if a review is required (as per Gaby's example below) is
that doesn't really answer question (b).

By and large, it would probably be "safe" to exempt many such works
from review. However, it would be nice to apply a consistent
yardstick. At our institution, we don't allow investigators or any
third party to decide if a work is exempt from ethics review.


Cheers

Cam

From: "Bill Marr" <bmarr@wlu.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is a person a participant?
Date: Monday, April 28, 2003 12:23 PM

The REB at Laurier more or less takes the same approach as Gaby wrote
for Laurentian. We likely ere on the side of requiring an ethics review
for all so-called "public policy research" since the information
collection hardly ever just involves questions of policy statements or
regulations, which are in the public domain. Once I ask the researcher
a few questions about the topics of the interview, they usually deal
with opinions, applications, improvements, etc.

Gabrielle Miller wrote:

>We look at the kinds of questions being asked in that case-- whether they might pose a risk to the interviewee. When the questions are simply asking for the policy or regulations, we cconsider that they are "Public Policy Research" in the TCP sense, but when they ask for opinions on the effectiveness of the policy or whether/how the policy is really being applied-- we want to ensure that anonymity/confidentiality is in place to protect the interviewee.
>
>For instance, a few years ago we had a case that involved asking various municipal figures and union leaders and activists questions that went the full gamut-- we felt that it had to be reviewed to ensure protections were in place.
>
>Gaby Miller
>

From: "Lindley, Pat" <plindley@Kilcom1.UCIS.Dal.Ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is a person a participant?
Date: Monday, April 28, 2003 1:12 PM

Re:

The following analogy is what I use to make the distinction about whether or
not interviews/surveys of professionals are HS research:

If I were sent a survey about the ethics review process at Dalhousie, which
asked questions about the institution, process, roles responsibilities etc.
and I could hand this survey to my assistant to be completed, or to anyone
else familiar with the information requested, then clearly this is research
about Dalhousie, not me. The main caveat would be whether or not it was
considered by the institution to be confidential information.

If however I were sent a survey about the ethics review process at
Dalhousie which was seeking my opinions, my experiences, or my unique
professional attitudes about ethics review at Dalhousie -- the institution,
process, roles, responsibilities --- and it is clear that breaches of
confidentiality would reflect back on me individually--- then I would consider
myself to be a subject of the research.

Pat


Patricia Lindley
Office of Human Research Ethics Administration
Room 321 Henry Hicks Arts and Administration Building
Dalhousie University
Halifax, Nova Scotia
B3From: "Gabrielle Miller" <gmiller@nickel.laurentian.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is a person a participant?
Date: Monday, April 28, 2003 1:41 PM


To step back a bit, it seems to me that if personal information is involved, as it is when opinions, beliefs, etc. are being asked, (as opposed to facts: what is stated in policy) then the people giving that information ARE subjects. If it is merely facts, then the policies are the subject.

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
----------------------------------

H 4H6

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is a person a participant?
Date: Monday, April 28, 2003 4:15 PM

Hi Gaby

I agree with personal information defining a person as a participant.
I'm more interested in a situation in which someone is not disclosing
personal information and the subject of the research may not
explictly be the person. Here's a couple of examples.

1. I'm looking at the agreement of a new MRI technique compared to a
usual practice standard MRI for identifying MS plaques. Anonymous
MRI images are provided to four radiologists who rate the quality of
the modality on a scale of 0 (not readable) to 5 (high quality). Are
the radiologists subjects?

2. I do a systematic literature review that involves quality rating
of randomized controlled trials. Each reviewer rates the quality of
the paper using a validated tool. We use a Delphi process to come to
consensus on the quality score. Are the raters subjects?

3. I do a study that is assessing the ability of a history checklist
to identify predictors of suicide. Twenty mock histories are
distributed to four psychologists who are using the checklist of
previously validated predictors of suicidal behaviour. The histories
are conglomerates of cases that have been prepared to represent a
spectrum of patients from high risk to no risk. I'm interested in
assessing if the inter-rater reliability of the instrument is good
(ie. will all the assessors come to the same conclusions using this
tool). Are the assessors subjects?

Consider these instances. If the people are not participants, then
there is no reason for the REB to review the work and to protect
them. Consider what distinguishes the three instances above, if
anything. Is it the method of participation or the risk involved?

Scenario 1: All raters, except rater number 1, agree that the new
modality is inferior to the usual practice. Rater 1 does not
distinguish between modalities and often reads abnormal usual
practice MRI's as normal. Rater 2 is head of the radiology
department.

Scenario 2: Rater number 1 (poor guy) is at marked disagreement with
the others in the Delphi process, (which is essentially a group
consensus meeting).

Scenario 3: The results of the study are presented to the raters as a
group. All raters (except Rater 1 - surprise) show good agreement on
identifying the risk factors for suicide and were able to distinguish
between high risk and low risk histories with excellent accuracy.
Rater one was unable to distinguish between high risk and low risk
histories using this tool.

This is the last post I'll make in this thread, I promise :-)

Cheers

Cam

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] When is a person a participant?
Date: Tuesday, April 29, 2003 10:58 AM

Cam - comments as follows.
>
> I agree with personal information defining a person as a participant.
> I'm more interested in a situation in which someone is not disclosing
> personal information and the subject of the research may not
> explictly be the person. Here's a couple of examples.
>
> 1. I'm looking at the agreement of a new MRI technique compared to a
> usual practice standard MRI for identifying MS plaques. Anonymous
> MRI images are provided to four radiologists who rate the quality of
> the modality on a scale of 0 (not readable) to 5 (high quality). Are
> the radiologists subjects? No, but the research project is still subject to
ethics review to ensure, for example, that subject (i.e., MS patients whose MRIs
are being read) confidentiality protections are adequate. Also, if the new
technique is considered experimental, which it seems to be, then obviously
ethical review and oversight of the project are necessary. Sounds like
expedited would be OK.
>
> 2. I do a systematic literature review that involves quality rating
> of randomized controlled trials. Each reviewer rates the quality of
> the paper using a validated tool. We use a Delphi process to come to
> consensus on the quality score. Are the raters subjects? No, unless you
specifically have designed a project to study their behaviour.
>
> 3. I do a study that is assessing the ability of a history checklist
> to identify predictors of suicide. Twenty mock histories are
> distributed to four psychologists who are using the checklist of
> previously validated predictors of suicidal behaviour. The histories
> are conglomerates of cases that have been prepared to represent a
> spectrum of patients from high risk to no risk. I'm interested in
> assessing if the inter-rater reliability of the instrument is good
> (ie. will all the assessors come to the same conclusions using this
> tool). Are the assessors subjects? Almost certainly yes. You would need to
protect them from possible professional and/or personal consequences.
>
> Consider these instances. If the people are not participants, then
> there is no reason for the REB to review the work and to protect
> them. Still needs ethics review, it¹s research involving human subjects, in
the MRI case it¹s the MS patients. Consider what distinguishes the three
instances above, if
> anything. Is it the method of participation or the risk involved? >
> Scenario 1: All raters, except rater number 1, agree that the new
> modality is inferior to the usual practice. Rater 1 does not
> distinguish between modalities and often reads abnormal usual
> practice MRI's as normal. Rater 2 is head of the radiology
> department.
>
> Scenario 2: Rater number 1 (poor guy) is at marked disagreement with
> the others in the Delphi process, (which is essentially a group
> consensus meeting).
>
> Scenario 3: The results of the study are presented to the raters as a
> group. All raters (except Rater 1 - surprise) show good agreement on
> identifying the risk factors for suicide and were able to distinguish
> between high risk and low risk histories with excellent accuracy.
> Rater one was unable to distinguish between high risk and low risk
> histories using this tool.
>
> This is the last post I'll make in this thread, I promise :-)
>
> Cheers
>
> Cam
>
>
>

7. Canadian HIPAA Authorizations

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 17, 2003 1:51 PM

Dear all;
One sponsor stills wants us to proceed with agreeing to HIPAA -- how would
you respond? Allergan, by the way, has authorized that this letter to me be
sent out on the list-serv. I suspect others will hear from US sponsors

Philip Hebert MD PhD CCFP FCFPC
Associate Professor, Family Medcine,
Room A 100 Tel 480-4963
REB Chair S&W; Ethics: E228b Tel 48

From: "Marleen Van Laethem" <vanlaethemm@smh.toronto.on.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 17, 2003 3:54 PM

Philip,
Thank you for putting this on the listserv. We are all looking for a definitive answer on this, and I look forward to reading more opinions on HIPAA in the Canadian context.


Marleen.


From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 17, 2003 3:54 PM

Interesting. The tone of the letter seems to suggest that a subject
agreeing to the terms of a "Patient Authorization (PA)" is a benign
exercise, without future privacy ramification. Indeed, in every example of
PA i've read, a patient is excluded from study participation if unwilling
to sign a PA. This seems a rather high price to pay to relieve anxiety,
particularly inlight of the US federal determination clearly stated in the
letter

Philip, why not ask your source for the names of the "officials with the US
Department of Health and Human Services (DHHS) who have opined that HIPAA
will be enforced ... regardless whether the study subject resides in the US
or not." It would be helpful for this List to understand how enforcement
of extra-territorial law would be achieved.

I will re-contact the person in HHS Division of Policy, Planning and
Special Projects who so far has written that, "Your question about HIPAA's
impact with research conducted aboard is more complex, and will be
case-specific." Presumably, when/if HIPAA would apply in a special case,
HHS will specify the need.

In response to a recent posting on IRB Forum discussing HIPAA, i received
the following response from a US researcher:

"As to why sponsors want to do anything with HIPAA is beyond me. Most are
not covered entities and, as such, should have no say as to the content or
use of a freestanding authorization. We have an authorization that sponsors
may view, but we consider that document to be our exclusive domain (we're
on the hook, not the sponsor) and as such don't let the sponsor make
changes to the document. That said, we do allow sponsors to have input when
the HIPAA authorization is combined with the consent form for the study."

At some point reason and the law of the land must prevail. Laws exist to
provide protection for citizens.

Any comments from Heath Canada would likely be appreciated by everyone.

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

tel: 514-934-1934 x-34720

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Wednesday, April 23, 2003 7:43 PM

Sharon, it sounds like you are prepared to go further than many of us on this. I notice that you repeatedly talk about good trials being withdrawn from your site. I think you might try calling some bluff. Because it sounds as if they would have to pull the trial from all sites in Canada the way I am reading this list.

I am being increasingly drawn to the idea that this group should think about starting to use this exchange of ideas to draft some policies. And no I am not suggesting usurping CAREB or NCEHR but as being complementary. At this point I would see such poicies as guidances rather than binding. We would probably need some website space too.

Grade 9-9.5 well that is very honest of you. I think we should have a contest to see who can come up with a grade 3 consent that isn't horribly patronising. I could give you some hints as to where to start looking for ideas, buit I won't just yet.

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>; <Philip.Hebert@sw.ca>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Friday, April 18, 2003 2:02 PM

Thanks for the tip, good question.

So far to the best of my knowledge Allergan is unique (other companies have backed off - one in an attached thread to their reply referred to 'more HIPAA madness'). They appear to be acting on their own, and they admit to this in their letter. Health Canada tell me that HIPAA does not apply, therefore you could tell them to tell DHHS to take it up with the Government of Canada, and we will be guided by the latter. Maybe Health Canada should issue a directive (Hullo Siddika).

You cannot have HIPAA disclosure authorisation at your site for Allergan and no -one else. Either we adopt it as an across the board policy or not at all. We should all be resisting a divide-and-conquer approach by sponsors.

I think it is interesting to hear who they disclose personal information to! I do not think that any of us authorised such release of data. I suggest that that is their problem and that they should take action with regards to their own procedures and training. My understanding is that most if not all corporate and public US healthcare and research organisations have taken considerable pains to establish policies and training for the protection of PHI and who has access to what. Beware of companies passing off their responsibilities on to us.

With regards to investigators use of data, as an investigator and as an agent of granting agencies I have had access to such data for a long time and no US granting organisation has raised it as a problem to date (but may have applied for some sort of exemption). What I do know as that they have all sent out letters to us stating that they are NOT 'covered entities' or for that matter 'business associates' to whom HIPAA applies, and that "Participants from non-US and HIPAA-exempt institutions are NOT required to sign an authorisation". Note that data collected prior to April 14th is also exempt.

Allergan obviously needs to re-examine the relationship between itself and those entities it contracts out to conduct its studies, in terms of their eligibility to be a 'coverered entity'.

We only sent out anonymous data, and our patients have already signed consent forms allowing disclosure to manufacturers, sponsors and regulatory authorities in the US, and unlike US sites we do not disclose SINs. That should suffice.

The principle, however, is not without merit, namely that a distinction should be drawn as to the risks to privacy compared to the risks of study treatments, so an argument for separate (but linked) forms could be made as long as they were not duplicative. Most research subjects in health care should already have the expectation that their privacy rights will be respected.

Note that US authorities have deemed that the HIPAA authorisation is NOT subject to IRB (REB) approval unless combined with the consent form (which as even Allergan states) would be a very bad idea for many reasons, including possible coercion.

I think that the idea that data for the means of determining eligibility (ie before signing a consent) should be equally protected is intriguing, and deserves some thought.

Our job is to respect and maintain our subjects' privacy and to minimise the burdens on them (not to advise Corporate America about the nuances of their own laws) and any attempt to do otherwise should be firmly resisted.

While there is a continually irritating trend for the US to attempt to extend its legislation extra-jurisdictionally, remember they need us more than we need them.

Is that any help Phillip?

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] Canadian HIPAA authorizations --oops + extra
Date: Friday, April 18, 2003 2:24 PM

This looks pretty standard compared to what I have seen.

Please everyone - refrain from referring to these as Consents, as opposed to Authorisations - it really muddies the waters.


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] FW: Canadian HIPAA authorizations
Date: Friday, April 18, 2003 2:28 PM

Good points, as usual, Elizabeth.

I am reminded of the feeling I get when watching a US video, and the first message is one that the FBI reserves the right to break down your living room door to ensure you are not violating applicable legislation.

We have enough problems trying to deal with the evolving field of federal and provincial privacy regulations, and their impact on research. Take on this elephant and we have the capacity to get ourselves in a real mess.

Lets focus on what Research Ethics is all about, and not get bogged down in privacy legislation!


HAPPY HIPAA EVERYONE

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
To: "'Clark, Elisabeth '" <clarke@muhchem.mcgill.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Monday, April 21, 2003 8:32 AM


Dear Elisabeth;
Thanks for your response:
1. as I understand it, it's not that the long arm of US law will reach into
Canada, but rather that US authorities, failing to have evidence of
Authorisation, may decide to not allow the patient's data into the study
results. The sponsor I spoke to had no evidence that this would happen, but
was trying to avoid that possibility. Rightly, they don't want to support a
research venue that may be deemed later ineligible.
2. Note another consent form acceptable to them (I amended it) that
explicitly says this agreement cannot abrogate Canadian Laws...I have
attached it with my edits.
3. Quite frankly, when you look at the content of the form, it simply tells
participants how widely their data may be used. This is an honest
declaration; poeple who don't like that whole idea can elect not to
participate. Coercive or realistic?
Philip

From: "Saginur MD, Raphael" <rsaginur@ohri.ca>
To: <ethics@lists.ncehr-cnerh.org>; <Philip.Hebert@sw.ca>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Monday, April 21, 2003 8:43 AM

To follow up on Michael's excellent discussion, there appears to be
something missing in the Canadian HIPAA debate, namely a coherent Canadian
response to discuss HIPAA with the relevant US authority, HHS, and come to
some agreement.
It was my reading that HIPAA should be irrelevant to studies involving
Canadian patients, and there is some consensus of opinion that that is the
case. OHRP will not address HIPAA, since it is not their jurisdiction. The
HIPAA people do not accept direct questions, and an attempt to post the
following question on the HIPAA FAQ list over a month ago was unsuccessful:
I am Chair of a major teaching hospital research ethics board (IRB) in
Canada. Does HIPAA apply to clinical research performed in Canada? Does it
apply to Canadian sites in studies which are performed on both sides of the
U.S.-Canada border?

I am sympathetic to the Allergan position, but I take issue with it.

Who should carry the ball? Industry would be well advised to respond. It
would be appropriate for Rx&D, which represents the sponsors of the vast
majority of the implicated studies, to address HIPAA. If the pharmaceutical
industry does have an interest in doing business in Canada, it should
articulate a clear and accurate position. However, Rx&D represents
industry, and not a broader Canadian interest.

The buck stops at the Government of Canada. HIPAA relevance to Canada is a
privacy issue, and a governance/jurisdiction issue, and a health issue, and
an economic issue, and thereby relates potentially to a number of government
departments. Perhaps Health Canada would include external relations as part
of its governance mandate, and tackle the HIPAA issue on behalf of all
Canadians.

Ray

From: "Laurel Evans" <levans@mcmaster.ca>
To: <ethics@lists.ncehr-cnerh.org>
Cc: "'Clark, Elisabeth '" <clarke@muhchem.mcgill.ca>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Monday, April 21, 2003 10:07 AM

Philip, you are correct respecting the legalities of the situation. HIPAA does
not apply to Canadians and Canadian research studies. However, once PHI gets
into the hands of a US "covered entity", it doesn't matter whether the
information derives from a Canadian or from an American, the American entity
must comply with the US legislation. The question then becomes, how often does
personal health information which is identifiable to the subject come into the
hands of a US covered entity? Your sponsor has given a few examples of
possible situations. What must be asked is whether or not it is worth having
every Canadian research participant sign an authorisation because of the slight
likeliehood that this may occur, or is it, as others have suggested, up to the
covered entity to set up practices to ensure that if / when Canadian PHI comes
into their possession, that they either exclude it, or obtain the necessary
authorisations at that time. Presumably if the information is identifiable,
they would have some means of contacting the participants if necessary. Since
my experience to date comes primarily from the social sciences side, I don't
know how to answer the question, but perhaps you or the others would have a
better perspective. Laurel Evans.
From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Monday, April 21, 2003 3:02 PM

Again I would think that that is Allergan's problem, to clarify their own position vis a vis their regulators. We do not need any more bits of paper in the office or more things for patient's to have to sign, if we can avoid it.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Wednesday, April 23, 2003 9:16 AM

Michael and all:
Thankyou for your input. I have nixed Allergan's request -- I will be
interested in hearing from any of you if you get similar
requests...Unfortunately, once a participant's data leaves Canada we really
have no idea who sees it, do we? At least their consent form was hnoest and
up-front about how much data-sharing goes on.
Philip
Philip C Hebert MD PhD FCFPC
Associate Professor, Family Medicine
Chair, Research Ethics Board, 416-480-6100 ext. 4276
Clinical Ethicist ext. 4818
Family Physician: Room A100 ext. 4963
Pager 237-3424

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Wednesday, April 23, 2003 10:37 AM

I am sure the issue will not go away - but we should consider Philip's point pro-actively
Some of you may have seen the attached article

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Wednesday, April 23, 2003 11:11 AM

The MUHC received the same Patient Authorization document that Philip
posted. To date Allergan is the only industry sponsor to send us sample
documentation on HIPAA.

As i mentioned last week i followed up with HHS, OHRP, Division of Policy,
Planning and Special Projects, and received the following information that
may permit others among us to follow up as needed, because the HIPAA thing,
as Michael suggests will not go away ... elisabeth

begin forward --
"I would suggest you contact Marilou King, who is legal counsel for the HHS
Office for Civil Rights on the Privacy Rule. You can reach her by e-mail
at marilou.king@hhs.gov. To my knowledge, HHS has not yet issued guidance
on the extra-territorial implications of HIPAA, but I know Marilou has
onsidered this issue. I should note that HHS is planning to issue guidance
on this topic sometime in the near future.

Here's what I understand Marilou concluded for another research study
conducted abroad ... :

If there are no US-owned or related facilities in a foreign country that
could implicate them as covered entities under the Privacy Rule, the HIPAA
Privacy Rule would not apply to these foreign sites. But as you noted,
their own country may have relevant privacy laws or rules that would need
to be followed.

However, if a facility is US-owned or if the treating physician is acting in
the capacity of a workforce member of a US covered entity, then the HIPAA
Privacy Rule may apply based on facts and circumstances of the particular
situation.

I hope this is helpful. Best of luck.

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Wednesday, April 23, 2003 2:39 PM

Perhaps the following just in from Abbott a few minutes ago might help:

Thank you for your IRB comments and feedback regarding the Abbott M00-244/M00-258 Informed Consents. Abbott, however, has some concerns regarding the language proposed. We understand that Canadian sites do not need to include HIPAA language, and perhaps there has been some confusion between the terms "privacy language" and "HIPAA language". I hope I can clarify: While HIPAA language needed to be incorporated into all Informed Consents within the United States by 14 April 2003 to be compliant with United States Federal Law, Abbott also took the opportunity to implement updated privacy language to all Informed Consents for studies being conducted worldwide. The updated privacy language is intended to better provide patients with complete disclosure of what happens to their personal health information, protecting the patient, institution, IRB and sponsor. While Canadian sites do not need to include the "US only" HIPAA statements from the Abbott Informed Consent template provided to all sites, Abbott requests that all sites include the other elements of the privacy language. Abbott is flexible and very willing to work with sites who find the language unacceptable.


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: Wednesday, April 23, 2003 3:09 PM

Hi all.

I'm trying to get permission to share the information we have been working
on. We have gone back and forth with one sponsor and are now trying to
incorporate the HIPAA authorization content into the consent but with the
modifications to the authorization we received which would make it
acceptable to our committee - restriction on the blanket permission for
future research, inclusion of language which would preclude identifiable
information from leaving our site, specification of the agencies/people for
whom authorization and disclosure are authorized (fudging a bit by noting
the 60 site research teams, etc.), trying to explain more clearly the right
of access to information but not during the blinded portion of the trial and
getting it down to our required grade 9 (well, really 9.5) grade reading
level. We have spent a goodly number of hours thus far knowing that if we
cannot find a solution, the trial will be stopped.

I know that one person has indicated the insistence of a signed document
separate to the consent but we thought this was worth a try. Otherwise, a
very good trial will disappear from this site.

I wish I had time to read more carefully because there has been some very
interesting discussion. Maybe we should try to work out a breakfast meeting
or an after meeting beer discussion at the CAREB meeting.

Sharon Buehler

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
To: "'Michael Goodyear '" <michael.Goodyear@cdha.nshealth.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Wednesday, April 23, 2003 10:07 PM

I, too, commend Sharon & her committee's work -- & would love to see what
you come up with. 2 caveats:
1. it's a bit of a hornet's nest of agencies, people, etc who can access
almost all info about subjects
2. whatever you put in your consent form, how do we really know who accesses
this information?
Philip

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
To: "'swarden '" <swarden@uhnres.utoronto.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Wednesday, April 23, 2003 10:25 PM

Sarah;
thanks -- the price of such vigilence may be a lot more work on our part! Do
we exclude language because it sounds HIPPA-oid? (sorry)
Philip

From: "swarden" <swarden@uhnres.utoronto.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 10:23 AM

Philip,

You're right - some of the changes are not bad and probably do give useful
information to the patient. I guess we're all trying to draw a line as to how
many extra words the patient is bogged down by in the consent form - we feel
that our confidentiality section suffices which says (among other things) that
'no identifying information will leave our institution', but sometimes it is
easier to allow some benign extra language in than fighting every word. It's
where the line is drawn that is the slippery slope, I suppose! Is it the
enforcement of a foreign law on us that we're opposing or the content itself?

Sarah

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 11:14 AM

If it comes to a fight, then I will usualy go with language that is in the spirit of our consent, or will draft compromising language that does not viloate the guiding principles or our policies. It might be seen to be parochial fighting 'foreign' legislation, but if we do not need it we do not need it, and minimising the burden on the subject is a high priority.

Therefore anything that can be ssaid more simply should be. In general patients do not mind what happens to their data as long as they paid the respect of being asked. In general we should stick to the principle of keeping consents reasonably uniform within our institutions.

From: "Agnes V. Klein" <Agnes_V_Klein@hc-sc.gc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 12:31 PM


Excellent idea Francis!
The issue is that there is also privacy legislation in Canada that covers
many of the HIPAA points. So that needs some analysis before anyone jumps
into doing up any guidelines.



"Francis Rolleston"

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 1:33 PM

Thanks. That is a very real concern. I know granting agencies have spent a lot of time and money in evolving common policies on this.

I should be more careful about sending out e-mails with Abbott in the subject matter, Judith.


>>> judith.abbott@ualberta.ca 04/24/03 12:38PM >>>

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
To: "'Michael Goodyear '" <michael.Goodyear@cdha.nshealth.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 2:10 PM

Here is Allergan's response in part:

"there is nothing remote about the possibility of patient information coming
into the hands of a US covered entity. As I explained in my last letter,
Allergan and other companies are in the process of complying with the Pharma
guidelines by establishing databases containing study data for the use of
all study investigators, which means that US investigators will (not "may")
have access to Canadian patient data during the course of a study, assuming
work is being done in both countries.

"Allergan's position is admittedly protective of its US investigators and
of other covered entities that will use PHI. I am also frankly
astounded that the request that a patient sign an authorization, which
informs them of exactly what uses will be put to their identifiable data
and provides some measure of protection to their data once it enters the
US, would be an issue inciting such controversy.

"I suppose I can understand that some other sponsors are not as concerned
as Allergan has been about the legal welfare of their investigators,
since they have concluded that they themselves are not covered entities
and therefore not exposed. And, of course, there is the completely
unknown question of enforcement - perhaps DHHS will not enforce
violations of HIPAA against investigators in such circumstances.
However, I would submit that the answer to this latter question is much
less certain than the answer to to the question whether Canadian patient
data will end up in the hands of US physician covered entities."

Oughtn't trial participants know all this? = "abandon all hope of privacy
yee who enter here"?
Philip

From: "Michael Owen" <mowen@spartan.ac.brocku.ca>
To: <ethics@lists.ncehr-cnerh.org>; <CAURA-NET@listserv.uoguelph.ca>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 2:49 PM

>My suggestion would be the following:


With CAREB and CAURA holding a meeting next week, why not have the
first of a series of meetings of HIPPA for Canadian research
institutes and REBs, jointly sponsored by CAURA, NCEHR and CAREB?

While it may not be possible to invite any American experts, it might
be useful for a one day/one half day session on HIPPA for Canadians:
What it means to you as a researcher, as a REB, and as a research
administrator?

Michael

From: <skb@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 4:44 PM

Absolutely right, Philip - the hornet's nest and the documentation of
access. I gather this is one of the nightmares of the hospitals...with the
patient's right to see and amend records ("I think I will white-out my
'obsessive-compulsive' disorder" on that last visit") they have to have IT
systems that track and identify every record change. Most small hospitals
would not have that capability.

I'm waiting to see Michael's reference to the resource for grade 3 language.
Bet you can't get a drug name in there.

Sharon

From: "Nestor Nituch" <nestor.nituch@bms.com>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 4:45 PM

Hi Agnes & Francis:

My US contacts have told me that HIPAA does not apply ex-US. I have asked for written confirmation from a gov't
guru and should have that in a few days. A GCP newsletter that I receive had some other interesting info that
may interest the readership on this forum:

"HHS TO IRBS: NOT REQUIRED TO REVIEW HIPAA FORMS

Institutional review boards (IRBs) do not have to review materials and
authorizations under the Health Insurance Portability and
Accountability
Act of 1996 (HIPAA) privacy rule, according to the Department of Health
and Human Services' Office for Civil Rights (OCR).

The OCR noted that many IRBs believe they are required to review all
written materials or information provided to subjects, including HIPAA
authorizations, due in part to International Conference on
Harmonisation
(ICH) Good Clinical Practice guidelines that state: "before initiating
a
trial, the investigator/institution should have written and dated
approval/favorable opinion from the IRB for the trial protocol, written
informed consent form, consent form updates, subject recruitment
procedures and any other written information to be provided to
subjects."

"This misinterpretation is apparently leading some IRBs to refuse to
allow continued enrollment of subjects in ongoing studies without first
reviewing and approving stand-alone HIPAA authorizations," the OCR
stated in an April 15 letter to Stan Crosley, chief privacy officer for
Eli Lilly & Co., who asked the agency for clarification as chair of the
International Pharmaceutical Privacy Consortium.

The OCR letter stated the FDA's position that the ICH "guidelines are
guidance and as such are not legal requirements subject to enforcement
by U.S. authorities." In addition, the "FDA advises that because IRB
review and approval of a stand-alone HIPAA authorization is not
required
under the Privacy Rule, use of a stand-alone HIPAA authorization
reviewed and approved by another entity, such as an investigator or
sponsor, is an acceptable alternative approach."

Nestor Nituch
Clinical Research BMS Canada

From: <skb@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 5:07 PM

The documentation that came with the authorization we were sent also said
that REBs were not required to review. However, the authorization changes
substantially what we would normally allow in a consent. We would not have
approved the consent with the inclusion of the authorization language as we
got it. So I would not like our committee to be circumvented by the
investigator.

Sharon Buehler
From: "TASC - CMX Research Inc" <tasc@attcanada.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 6:25 PM

It is worthwhile to note that the statement from the US HHS said that they
do not require an REB to review the authorization as the US groups are not
required to comply with ICH.

In Canada we are required to comply and therefore the authorization would be
subject to REB review.

Is this what others gleaned also?

Alison Orth
Research Coordinator

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 8:44 PM

That was my understanding too - the separation of privacy legislation from treatment and research consent.

>>> nestor.nituch@bms.com 04/24/03 05:40PM >>>
Hi Agnes & Francis:

My US contacts have told me that HIPAA does not apply ex-US. I have asked for written confirmation from a gov't
guru and should have that in a few days. A GCP newsletter that I receive had some other interesting info that
may interest the readership on this forum:

"HHS TO IRBS: NOT REQUIRED TO REVIEW HIPAA FORMS

Institutional review boards (IRBs) do not have to review materials and
authorizations under the Health Insurance Portability and
Accountability
Act of 1996 (HIPAA) privacy rule, according to the Department of Health
and Human Services' Office for Civil Rights (OCR).

The OCR noted that many IRBs believe they are required to review all
written materials or information provided to subjects, including HIPAA
authorizations, due in part to International Conference on
Harmonisation
(ICH) Good Clinical Practice guidelines that state: "before initiating
a
trial, the investigator/institution should have written and dated
approval/favorable opinion from the IRB for the trial protocol, written
informed consent form, consent form updates, subject recruitment
procedures and any other written information to be provided to
subjects."

"This misinterpretation is apparently leading some IRBs to refuse to
allow continued enrollment of subjects in ongoing studies without first
reviewing and approving stand-alone HIPAA authorizations," the OCR
stated in an April 15 letter to Stan Crosley, chief privacy officer for
Eli Lilly & Co., who asked the agency for clarification as chair of the
International Pharmaceutical Privacy Consortium.

The OCR letter stated the FDA's position that the ICH "guidelines are
guidance and as such are not legal requirements subject to enforcement
by U.S. authorities." In addition, the "FDA advises that because IRB
review and approval of a stand-alone HIPAA authorization is not
required
under the Privacy Rule, use of a stand-alone HIPAA authorization
reviewed and approved by another entity, such as an investigator or
sponsor, is an acceptable alternative approach."

Nestor Nituch
Clinical Research BMS Canada

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 8:45 PM

OK I give in - and I am sorry, it was grade 4 not 3, the reference is attached as a PDF file. see page 723.

I do not think you can avoid technical terms, you just have to explain them when you use them. I recommend the use of an attached glossary (but don't call it that) to our coordinators).


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] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 8:55 PM

OK Someone explain what ICH has to do with HIPAA or HIPAA with ICH? Obviously neither refers to the other. ICH of course says 'comply with the applicable regulatory requirements' (4.8.1). I really do not think it refers to the REB's responsibilities here 3.12 deals with the documentation the REB reviews, and i really cannot see where Authorisation would fit in there either.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "TASC - CMX Research Inc" <tasc@attcanada.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 9:28 PM

Michael

The ICH guideline mentioned by the OCR was 4.4.1.

Alison

----- Original Message -----
From: Michael Goodyear
To: ethics@lists.ncehr-cnerh.org
Sent: Thursday, April 24, 2003 5:48 PM
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations


OK Someone explain what ICH has to do with HIPAA or HIPAA with ICH? Obviously neither refers to the other. ICH of course says 'comply with the applicable regulatory requirements' (4.8.1). I really do not think it refers to the REB's responsibilities here 3.12 deals with the documentation the REB reviews, and i really cannot see where Authorisation would fit in there either.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "TASC - CMX Research Inc" <tasc@attcanada.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 9:30 PM

Hi Michael

I think the association between ICH and HIPAA relates to the ICH requirement for REB's to review all written information given to subjects. If the authorization form is a written form given to research subjects for the purposes of approval to collect research data, then the REB would need to review it.

This first became raised because of a letter to Stan Crosley of HHS from the Richard Campanelli of OCR in the US. The concern was that REB's would be bogged down with review of these authorizations and the OCR said because we they not ruled by ICH that guideline is not enforceable and therefore REB review not required. In Canada this is different.

This is the concern - would like to know how REB members see that issue.

Alison

From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>
To: "'TASC - CMX Research Inc '" <tasc@attcanada.ca>; <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] FW: Canadian HIPAA authorizations
Date: Thursday, April 24, 2003 9:55 PM

ICH, HIPAA, consent, authorizations, information sheets -- call them what
you will...we need to see them all -- whatever documents go into enticing
patients into a trial -- all are relevant to our work, folks.
philip

-----Original Message-----
From: TASC - CMX Research Inc
To: ethics@lists.ncehr-cnerh.org
Sent: 24/04/03 9:29 PM
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations

Michael

The ICH guideline mentioned by the OCR was 4.4.1.

Alison

From: "swarden" <swarden@uhnres.utoronto.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Monday, April 28, 2003 10:38 AM

Hello all,

What I gleaned from this was not that our patients are not required to sign the
authorization, but rather that we do not have to review it before they do so.
Our REB had discussed this and as we consider it our responsibility to review
anything that goes to a patient regarding a research study (including an
additional authorization on top of what they already have to read and
understand), regardless of the ICH guidelines, our concern was not whether we
had to review it but rather what our patients had to review and sign.

Sarah

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Monday, April 28, 2003 11:47 AM

Let's not forget that, in addition to federal and provincial laws, this
country has a strong tradition of common law. Common law is not codified
as are statutes and regulations passed by the federal or provincial
governments and may be excluded if the text of the authorized is too
specific.


Jack Corman
President/Secretary

From: "Jack Corman" <irbs@interlog.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Monday, April 28, 2003 2:46 PM

Seems to me that you have it exactly right, Sarah. Nothing written (or even
verbal sometimes such as script for central telephone recruiting) should get
to the research subject without prior ethics review and approval. The REB
is within its legal rights to dismiss HIPAA authorizations, too, or to allow
for a waiver if you want to comply. No Canadian researcher is a 'covered
entity' under US law. Ask to speak to their legal department to show the
pertinent statute, i.e., that HIPAA specifically applies outside the
country.

Seems to me that Rx & D should take this matter up for the sake of their
members, as it is a common issue for all. CAREB and Rx & D working out a
common position would be useful.

Jack Corman

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] FW: Canadian HIPAA authorizations
Date: Tuesday, April 29, 2003 7:38 AM

That seems to make sense - I noticed more HIPAA like material appearing at this week's Board meeting, but we held the line - will see what sponors say - to date it has just been the pharmacy industry - but now we are getting it from NIH - it may just be an understanding - we asked the coordinator and PI to 'de-americanise' all of the materials before resubmitting .

However as many have observed to date, controlling what happens to data once it has left our door is problematic, no matter what the paper work might say.


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] FW: Canadian HIPAA authorizations
Date: Friday, April 25, 2003 11:26 AM

I think that is 3.1.2 'should obtain the following documents:...written information to be provided to subjects....
Interestingly it does not say 'review' but then it continues ...the investigator's currnt curriculum vitae and/or other documentation evidencing qualifications....(who is doing that)

Next question: the sponsor may be operating under ICH/GCP but is the REB? - as opposed to TCPS


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] FW: Canadian HIPAA authorizations
Date: Friday, April 25, 2003 11:26 AM

i.e IRB/IEC approval for 'wriiten information to be provided'

Some would argue that HIPAA is supposed to be complied with in the screening, before the patient is approached about consent, and therefore falls outside of this requirement


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

I came across a written statement, the first i've seen in circulation
*exempting non-US institutions from HIPAA provisions*.

NSABP is a cooperative research group with programs funded through the NCI
of the NIH, and therefore subject to US federal regulations. In an April
2, 2003 memo entitled "HIPAA Implementation in the NSABP", addressed to
NSABP PIs and Program Coordinators, from NSABP Operations and
Biostatistical Centres, we note the following:

"[Exceptation: Patients from non-US and HIPAA-exempt institutions are
_not_ required to sign an authorization]".

So i suggest the issue becomes one whereby our industry sponsors of
research must provide the US federal interpretaion, if a claim is made that
the (US) Standards for Privacy of Individually Identifiable Health
Information (the Privacy Rule) under the Health Insurance Portability and
Accountability Act (HIPAA) applies to the exchange of research data from
Canada.


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

tel: 514-934-1934 x-34720
fax: 514-843-1486
clarke@muhchem.mcgill.ca

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] HIPAA and NSABP
Date: Saturday, April 05, 2003 3:24 PM

these are the documents Elizabeth Clark is referring to

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Jack Corman" <irbs@interlog.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] HIPAA Encore un fois
Date: Friday, April 11, 2003 10:08 AM

I have been informed by a senior person at one of the top 5 pharma companies
that their legal department has obtained an official opinion that HIPAA does
not apply outside the US. However, once personal health information is
submitted to a US covered entity, the US covered entity must comply.

This is confirmatory to what an NIH person said in an unofficial email some
months ago.

Jack Corman
IRB Services

From: "Susan Hoddinott" <hoddinott@uwo.ca>
To: "NCEHR Listerver" <ethics@lists.ncehr-cnerh.org>; "CAURA Listerver" <caura-net@listserv.uoguelph.ca>
Subject: [Ethics] HIPAA Working Group
Date: Thursday, April 24, 2003 3:01 PM

Hello All

Because of the significant interest generated by the new HIPAA
legislation CAREB is proposing the creation of a Canadian working group
to address this issue. We would like to suggest that in light of the
pending CAREB conference on May 3rd in Ottawa CAREB will make available
a venue at that meeting in which those interested in such an activity
may meet and identify some preliminary steps. If you inteested in such
a session please reply to me offline and we will co-ordinate logistics.

Susan
VP CAREB

--
**********************************************************************
Susan Hoddinott, M.Sc., Director, Office of Research Ethics

From: "Agnes Nemet" <anemet@Vasogen.com>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] RE: HIPAA
Date: Tuesday, April 29, 2003 12:37 PM

I apologize if this has been circulated before; I thought that some of the
members might be interested in joining this audioconference...

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To register: Phone: toll-free (888) 838-5578 (inside the U.S.) or +1 (703)
538-7600
Web: http://www.fdanews.com/calendar/16064.html.

Payment: Payment is required by the date of the audioconference.
We accept the following credit cards: American Express,
MasterCard and Visa.


Agnes

Agnes Nemet, M.D.
Associate Medical Director

Vasogen Inc.
2155 Dunwin Drive, Unit 10
Mississauga, ON L5L 4M1

Tel: (905) 569-2265 ext. 257
Fax: (905) 820-0800
E-mail: anemet@vasogen.com

8. Hamilton NCEHR Workshop

From: "Verdon, Natalie" <nverdon@ncehr-cnerh.org>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] List serv announcement / Annonce Listserv
Date: Tuesday, April 08, 2003 9:30 AM

NCEHR is pleased to announce the Training In Research Ethics - Social and
Behavioural Sciences and Humanities and Biomedical programs will be held on
May 12-13, 2003. The workshops are sponsored by the National Council on
Ethics in Human Research and Co-Sponsored by McMaster University.
Information concerning the two workshops have been posted on our website at
<<<http://ncehr-cnerh.org>>>. We have reserved a block of rooms at the
Admiral Inn in Hamilton. Space being limited, we urge you to register as
soon as possible. Should you encounter problems or need additional
information, please contact our office at 613-730-6225. We are presently
working on our secure online registration and should be available by the end
of the week. Please note that upon our receiving new information, we will
accordingly update our website. Thank you for your understanding and we look
forward to seeing you in Hamilton.

Thank you,

Natalie Verdon
Website/Office Assistant
_____________________________________________________________

Le CNERH a le plaisir d'annoncer un atelier de Formation en éthique de la
recherche pour les sciences sociales et un atelier de Formation en éthique
de la recherche biomédical les 12 et 13 mai 2003. Les ateliers sont
parrainés par le Conseil national d'éthique en recherche chez l'humain et
co-parrainés par l'Université McMaster. L'information requise pour ces
ateliers est affichée sur notre site web<<<http://ncehr-cnerh.org>>>. Nous
avons réservé un bloc de chambres à l'Admiral Inn de Hamilton. Comme les
places sont limitées, nous vous prions de vous inscrire dès que possible. En
cas de difficulté ou si vous désirez de plus amples renseignements, veuillez
nous contacter au 613-730-6225. En se moment, nous travaillons à notre
processus d'enregistrement électronique. Dès que le processus
d'enregistrement électronique sera disponible, une mise à jour sera faite
sur notre site web. Merci et au plaisir de vous rencontrer à Hamilton.

Merci,

Natalie Verdon
Website/Office Assistant


_______________________________________________

9. PRE Nominations

From: <Hanan.Abdel-Akher@pre.ethics.gc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Call for Nominations: Interagency Advisory Panel on Research Ethics / Appel de candidatures: le Groupe consultatif interagences en éthique de la recherche
Date: Tuesday, April 08, 2003 10:19 AM

Please see the correct website links in the message below


> (le français suit)
>
> Call for Nominations:
> Interagency Advisory Panel on Research Ethics (PRE)
>
> The Federal Granting Agencies - Canadian Institutes of Health Research
> (CIHR), Natural Sciences and Engineering Research Council (NSERC), and
> Social Sciences and Humanities Research Council (SSHRC) - are pleased to
> announce a public call for nominations for membership on the Interagency
> Advisory Panel on Research Ethics.
>
> For further details, please consult the following website:
>
http://www.nserc.ca/programs/ethics/english/call_nom_e.htm
<http://www.nserc.ca/programs/ethics/english/call_nom_e.htm>

> The federal granting agencies thank you in advance for your support in
> ensuring that this call for nominations benefits from as broad an outreach
> as possible.
>
>
> ********
>
> Appel de candidatures:
> le Groupe consultatif interagences en éthique de la recherche
>
> Les organismes subventionnaires - les Instituts de recherche en santé du
> Canada (IRSC), le Conseil de recherches en sciences naturelles et en génie
> du Canada (CRSNG) et le Conseil de recherches en sciences humaines du
> Canada (CRSH) ont le plaisir d'annoncer un appel public de candidatures
> pour le Groupe consultatif interagences en éthique de la recherche.
> Pour de plus amples renseignements, veuillez consulter le site suivant:
>
http://www.nserc.ca/programs/ethics/francais/call_nom_f.htm
<http://www.nserc.ca/programs/ethics/francais/call_nom_f.htm>

> Les organismes subventionnaires vous remercient d'avance de votre soutien,
> qui sera essentiel pour assurer une large diffusion de cet appel de
> candidatures.
>
>
> Hanan Abdel-Akher
> Policy Analyst/Analyste des politiques
> Secretariat on Research Ethics
> Secrétariat en éthique de la recherche
> Tel: (613)996-2564
> Fax:(613)996-7117
> Hanan.Abdel-Akher@pre.ethics.gc.ca
>
10. Health Canada Div 5. 1 QI per Site

From: <skb@mun.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Div 5 - one QI per site
Date: Tuesday, April 15, 2003 6:15 PM

I'm afraid we have not been paying attention to this. My first reaction was
that it was a totally unreal expectation. I certainly would not want to
treat multiple 'sites' of the same study as separate REB files. We have
enough trouble keeping track of the big interdisciplinary studies with their
offspring.

I will be interested in how others are doing this.

Sharon Buehler

-----Original Message-----
From: ethics-admin@lists.ncehr-cnerh.org
[mailto:ethics-admin@lists.ncehr-cnerh.org]On Behalf Of Marleen Van
Laethem
Sent: April 15, 2003 1:11 PM
To: ethics@lists.ncehr-cnerh.org
Subject: [Ethics] Div 5 - one QI per site


Hello All,
We're looking for examples of how people are interpretting the Health Canada
Food & Drug Regulations Division 5 statement that a sponsor must ensure that
at each clinical trial site, there is no more than one qualified
investigator. (C.05.010(e))

How does one define 'clinical trial site'? What are the potential
ramifications if an REB accepts more than one 'site' within an institution?
Have other institutions had more than one study going on, in parallel, under
different Qualified Investigators? If so, what were the circumstances that
warranted that decision? Does the REB treat these as separate REB files,
with each QI submitting SAE reports and annual renewals, etc?

We're also interested in Health Canada's interpretation, or the intent
behind including this in the Division 5 regs, and how sponsors are
interpretting this.

I have consulted the archives of this listserv and I don't see previous
discussions on this topic - my apologies if I missed it.

Regards,
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

From: "Melony Frei" <mfrei@cpsa.ab.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: RE: [Ethics] Div 5 - one QI per site
Date: Wednesday, April 16, 2003 10:42 AM

The College of Physicians and Surgeons of Alberta Research Ethics Review
Committee is somewhat different from most ethics boards in that we approve
individual physicians in the community for research. Therefore, in
multi-centre studies, we often have anywhere from 2 to 40 physicians doing
the same study at different sites. We register and keep track of each site.
Each site must submit documentation of their qualifications, they all must
be using the same consent form, each site must submit annual reports, each
site submits adverse events, amendments, etc. Yes, it is onerous.

For more information on our process, visit the College web site at
www.cpsa.ab.ca (Click on College Programs, then Research Ethics Review. Go
to the section titled "Information" and click on "Review Types". Scroll
down to "Multiple Principal Investigator Review". Also under "Information",
click on "Items Required for Review. Each site is required to submit the
items listed.).

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

This communication, including any attached documentation, is intended only
for the use of the recipient(s) to whom it is addressed, and may contain
confidential, personal and/or privileged information. Any unauthorized
disclosure, copying, or taking action on the contents is strictly
prohibited. If you received this communication in error, please contact the
sender immediately so we may correct our records. Any communications,
including all attachments, received in error, should be destroyed by
shredding.

-----Original Message-----

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Div 5 - one QI per site
Date: Wednesday, April 16, 2003 11:01 AM

We have interpreted this as one QI per REB.

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

From: "swarden" <swarden@uhnres.utoronto.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Div 5 - one QI per site
Date: Wednesday, April 16, 2003 11:50 AM

Hi Marleen,

In general, we insist on one Qualified (although we call them Principal)
Investigator for each study at our site (UHN). This is for accountability and
correspondence - we want to be able to have just one person that is responsible
for each study that we can direct inquiries to. Having said that, we do have a
few problematic investigators that want to do the same study, but conduct it
separately in terms of enrollment and correspondence with us. So in the past we
have included both investigators as PIs with the same file number. As you can
imagine, this has made it very difficult as often we will receive SAE
notifications from one and not the other, or both of them will submit an annual
renewal form and if one is late and one is on time, that affects the renewal
date and the status of the study, etc. In short, it's a regulatory nightmare!

So recently we considered our two options: 1) we enter the same protocol twice,
with two separate file numbers under two separate PIs and treated them as
different studies, or 2) we insist that they choose one PI/QI for the study and
only that person corresponds for us and sends us information pertaining to both
investigator's patients. In short, the other "PI" becomes a co-investigator.

Due to both Division 5 and our own reasons, we decided to push for option 2, and
I believe we are having success enforcing this thus far.

Thanks!
Sarah Warden, M.Sc.
UHN REB Coordinator

skb@mun.ca wrote:

> I'm afraid we have not been paying attention to this. My first reaction was
> that it was a totally unreal expectation. I certainly would not want to
> treat multiple 'sites' of the same study as separate REB files. We have
> enough trouble keeping track of the big interdisciplinary studies with their
> offspring.
>
> I will be interested in how others are doing this.
>
> Sharon Buehler
>

From: "Nancy Ondrusek" <nondrusek@sympatico.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Div 5 - one QI per site
Date: Wednesday, April 16, 2003 2:47 PM

Thinking about this from the perspective of patient safety, rather than administration, it was my interpretation that the role of the Qualified Investigator is to take ultimate responsibility for the medical decisions regarding subjects participating in a particular study. Therefore you would want one individual identified to take that responsibility. I would think "site" would be defined by the relationship between patients and
investigators. If two investigators were doing the same study in the same institution, whether or not one QI could suffice would depend on whether it was possible for one QI to take responsibility for the medical decisions for both patient groups.

Nancy Ondrusek


Marleen Van Laethem wrote:

> Hello All,
> We're looking for examples of how people are interpretting the Health Canada Food & Drug Regulations Division 5 statement that a sponsor must ensure that at each clinical trial site, there is no more than one qualified investigator. (C.05.010(e))
>