Summary of NCEHR Listserv for March 2003


TOPICS

1. Russel Ogden Letter

2. Ongoing Clinical Trial Safety Information

3. HIPAA

4. Evaluating the Morality of Research

5. Sergent-Suicide-Montreal-Gazette-Coverage

6. CAREB's New Webpage

7. Off Site Investigators

8. Wake Up Call - IRB Wrongdoing

Files for Download

HIPPA Guidelines

HC Schedule C(e)

OCSI Report

 

 

 

1. Russel Ogden Letter

OPEN LETTER: Protecting Research Participants From Harm
March 5, 2003

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

Dear Messieurs Renaud, Brzutowski, and Berstein,

I am following up on the open letters that Professors Ted Palys and John
Lowman sent to you on January 28th and February 6th. The supportive
response from academics across the country and also the USA was reassuring.
I was pleased to hear from many researchers who favour the idea that
Canada's three granting councils take the initiative to lobby for provisions
equivalent to the USA's confidentiality and privacy certificates. It
concerns me that the academic community has not yet heard your reply and I
worry that people may question the moral authority of the Tricouncil Policy
Statement if your statement is not forthcoming soon. In the role of
researcher, I need to know where the three councils stand on protecting
human research participants.

As you know, my research into assisted death has been the subject of two
court subpoenas in less than a decade. The most recent subpoena has had a
decidedly chilling effect on my research. In February, after the Crown
withdrew the subpoena, I requested an explanation for why it was issued in
the first place and why it was withdrawn. The response of the Crown led me
to conclude that the State was actually on a "fishing expedition," hoping
that I would yield information to assist in its prosecution. Additionally,
although the Prosecutor withdrew the subpoena, his response left the
possibility that he might subpoena me at a later stage. I did not feel that
I could safely resume my research, so I asked the Prosecutor for his
assurance that he would neither subpoena me nor exercise any powers of
search, specific to my research. This week, the Prosecutor refused to give
any such assurances. In addition to this continued threat to my research
and research participants, I recently learned that my data collection on
assisted death has made me a "person of interest" in an RCMP file.

It is discomforting to know that the state views me as a potential agent for
the prosecution. If I cannot freely engage in this sort of inquiry, then
society may never benefit from the knowledge that would otherwise be
acquired. Because the Prosecutor will not release me from the threat of
search or subpoena, at this time I can't think of any responsible way to
continue with the research, save for some type of formal confidentiality
protection. Therefore, I would like you to tell me what measures you are
taking to help promote statutory confidentiality protections so that human
research subjects may be protected from harm.

Your prompt reply is requested.

Yours,
Russel Ogden

Subject: re: [Ethics] Open Letter: Protecting Research Participants From Harm
Date: Thu, 06 Mar 2003 08:59:24 -0600
From: H R Kloppenburg <hrk@kloppenburg.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

One more time:

Should this listserv be used for advocacy of this kind?

The issues here are political, involving a change in the law.

This situation restates the proposition: the listserv ought to communicate
the terms of reference for its users or be actively managed.

Best regards,

HRK

Subject: RE: [Ethics] Open Letter: Protecting Research Participants From H arm
Date: Thu, 6 Mar 2003 11:45:20 AST
From: "Lindley, Pat" <plindley@Kilcom1.UCIS.Dal.Ca>

WIth respect, I disagree with Mr. Kloppenburg.

This is an issue that is of interest to research ethics people, and I do not
believe that members of the NCEHR listserve are being asked necessarily
to endorse this, or any other, position. I, for one, am glad to be informed of
what is happening with respect to this issue. The listserve is to share
information. It is not intended to be the 'mouthpiece' of those who
participate, nor do I think this is a case where that is being assumed. We
are merely being copied on a communication to the Granting Councils.
Those who operate on REB's often feel isolated within their institutions,
and it is only by sharing information and experiences, that we gain a sense
of what is of concern to the broader community... things that impact on the
ability of researchers to offer confidentiality, and the affect that that has on
research, should be of interest at least, if not concern, to REB's.

Pat Lindley

Patricia Lindley
Office of Human Research Ethics Administration
Room 321 Henry Hicks Arts and Administration Building
Dalhousie University
Halifax, Nova Scotia
B3H 4H6 ~~~~~~~~~~~~~~~~~~~
ph. (902) 494-1462
fax. (902) 494-1595
e-mail Patricia.Lindley@dal.ca

Subject: Re: [Ethics] Open Letter: Protecting Research Participants From H arm
Date: Thu, 06 Mar 2003 14:09:28 -0500
From: Cindy Riach <riachc@mcmaster.ca>

I agree with Pat Lindley,
Being familiar with Ogden's experiences is crucial to the conduct of research and understanding
the rights and vulnerabilities of participants. How else can REBs make decisions if this kind
of issue is not part of the discussion on the listserv?

Cindy Riach Ph.D.
Chair, McMaster Research Ethics Board

Subject: RE: [Ethics] Open Letter: Protecting Research Participants From H arm
Date: Thu, 6 Mar 2003 12:51:51 -0400
From: "Joanne Gallivan" <joanne_gallivan@uccb.ca>

I, too, found it useful to be made aware of the issue and the
correspondence.

Joanne Gallivan, Ph.D.
Professor of Psychology
Acting Dean, Research and Library Services
University College of Cape Breton

Subject: re: [Ethics] Open Letter: Protecting Research Participants From Harm
Date: Thu, 6 Mar 2003 16:52:03 -0500
From: "Cam McDermaid" <cmcdermaid@cmcc.ca>

Hello all

I went to the NCEHR site to look at the terms of reference for the
listserve

1. The goal of the REB LISTSERV is to promote exchange of
information about ethical concerns with human subjects research.

2. All participants in this forum should consider the discussion
that pertain to issues of common concern.

Given that these terms are fairly broad and its explicit that the
list is unmoderated, I think we generally do fairly well.

Whether this issue is implictly one of ethical concerns with human
subjects research is debatable, but I'm not so insular that I
disregard everything on the list that doesn't meet that criteria.
It's certainly one that research administrators would want to be
aware of whenever researchers are dealing with issues that may have
legal implications.

Regardless, if I do want to disregard something, I just drop the
header into a killfile and hope no one starts a more interesting
topic under the same subject name. :-)

Cheers

Cam

Date: Fri, 7 Mar 2003 08:23:28 -0700 (MST)
From: John Mueller <mueller@ucalgary.ca>

Yes, a wake up call indeed. Another case that should chill you is
at
http://www.csicop.org/si/2002-07/high-cost.html

-- John.
.................................................................
John Mueller http://mueller.educ.ucalgary.ca
Division of Applied Psychology 403-220-5664 (work)
University of Calgary 403-282-9244 (FAX)
Calgary, Alberta T2N-1N4 403-288-7342 (home)
.................................................................
Seldom is any liberty lost all at once (D. Hume)
.................................................................

Subject: Re: [Ethics] Open Letter: Protecting Research Participants From Harm
Date: Fri, 07 Mar 2003 12:21:02 -0800
From: Julie Charlebois <julie-is@theedge.ca>

I have not the letters behind my name yet as most of you do and I did not
think that I would truly ever add to this listserv but indeed I feel
compelled.
Mr. Ogden's message is the one email I have kept in my file folder simply
because it has sparked a keen interest within me and I was hoping to see
some positive dialogue generated from its content. This listserv, from my
understanding of the messages I have been reading and as is indicated from
its email address, is based on ethics, ethical conduct, standards,
procedures...
Is anyone actually going to respond to his inquiries or are you just
going to pontificate as to its appropriateness on the listserv? Surely one
person, perhaps from a Faculty of Criminology or Law, must have found his
email thought provoking.

Respectfully,

Julie Charlebois

Subject: Re: [Ethics] -- John.
Date: Sun, 09 Mar 2003 20:52:11 -0500
From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>

Research that involves subjects those who may have engaged in illegal
activity is high-risk behaviour. Whether or not one agrees with the law in
questions, is it any wonder the authorities, whose responsibility it is to
bring such persons to justice, would seek to acquire information from anyone
with the potential to aid them in their quest to uphold the law. No
reasonable person would argue that the justice system should abrogate its
responsibilities by knowingly refusing to pursue any

Investigators who knowingly seek to conduct such research also knowingly
place their persons at risk of being caught up in the judicial process
designed to apprehend those suspected of illegal acts.

Subject: Re: [Ethics] Open Letter: ....
Date: Mon, 10 Mar 2003 07:39:59 -0700 (MST)
From: John Mueller <mueller@ucalgary.ca>

"... MAY have engaged ...." Yes, at some level, this is what the
legal system is for. And it is NOT what the IRB/REB process is
for. Courts at least give lip service to innocent until proven
otherwise, whereas, in pursuit of zero risk, REBs typically seem
to decide that if it MAY be illegal it is and thus ban it a
priori.

"... would seek to acquire information ..." Oh yes indeed, the
authorities will seek to acquire information. But that's why
there are protective limits, such as search warrants.

The question is what the limits are here. If researchers don't
have SOME protection, whereas journalists and other investigators
do (even though they bypass the REB), one wonders just what the
benefits of the REB process might be from the researcher's
perspective (a perspective that seems neglected, even ignored).

The invasion for behaviors that MAY (or may not) be illegal
becomes a very powerful subterfuge to circumvent historical
protections, one that allows harassment and censorship of
researchers for other alleged "problems". For example, the case
described by Tavris at
http://www.csicop.org/si/2002-07/high-cost.html involved
perfectly legal activities but the research conclusions just
didn't please some people.

The various institutions and IRBs were simply useless, in fact
actually accomplices to the harassment. Nothing to do with harm
to subjects, nothing to do with legality, everything to do with
ideology. Then there are the cases that involve simple human
pettiness, as in the attached case involving Sergent at McGill.

Whatever it may (or may not) accomplish re protecting subjects,
the IRB/REB process provides a tailor-made mechanism for
harassment and censorship, and that opportunity seems to be
increasing too tempting for some to resist. It seems disingenuous
to protest that the ethics industry's hands are clean in these
matters, it has provided the loaded weapon.

One person's opinions,

-- John.

Subject: Re: [Ethics] Open Letter: ....
Date: Mon, 10 Mar 2003 11:35:22 -0500
From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>

My posting went out incomplete - I meant to file it as a draft and complete
it first. There should have been further comments on the limitations on
authorities to pursue their obligations, and a defence of some form of
protection to researchers who involve themselves in risky research because
they know the research is needed, have a social conscience strong enough to
put themselves at risk, the guts to go through with it and to take the flak
to protect their research subjects.

on 3/10/03 9:39 AM, John Mueller at mueller@ucalgary.ca wrote:

> "... MAY have engaged ...." Yes, at some level, this is what the
> legal system is for. And it is NOT what the IRB/REB process is
> for. Courts at least give lip service to innocent until proven
> otherwise, whereas, in pursuit of zero risk, REBs typically seem
> to decide that if it MAY be illegal it is and thus ban it a
> priori. Not necessarily. IRB/REB should refuse to approve clearly illegal
research. A small example in biomedical is research that requires the
provincial health plan to pay the costs – that’s not legal and should not be
approved. The issues are far more complex in social science research,
obviously. Hence, the role of the lawyer on the panel is crucial both in the
protection of human research subjects rights, and to help ensure that no
illegal research projects are knowingly sanctioned by the IRB/REB. I have a
problem with IRB/REB decisions that are based on self-protection of the
institution or the IRB/REB – the decision to approve-disapprove a research
project should be based on its merits, and not whether there is legal
exposure to the institution or IRB/REB and its members. That decision
should be one of institutional policy, divorced from the IRB/REB process.
>
> "... would seek to acquire information ..." Oh yes indeed, the
> authorities will seek to acquire information. But that's why
> there are protective limits, such as search warrants. Complete agreement.
>
> The question is what the limits are here. If researchers don't
> have SOME protection, whereas journalists and other investigators
> do (even though they bypass the REB), one wonders just what the
> benefits of the REB process might be from the researcher's
> perspective (a perspective that seems neglected, even ignored).
>
> The invasion for behaviors that MAY (or may not) be illegal
> becomes a very powerful subterfuge to circumvent historical
> protections, one that allows harassment and censorship of
> researchers for other alleged "problems". For example, the case
> described by Tavris at
> http://www.csicop.org/si/2002-07/high-cost.html involved
> perfectly legal activities but the research conclusions just
> didn't please some people.
>
> The various institutions and IRBs were simply useless, in fact
> actually accomplices to the harassment. Nothing to do with harm
> to subjects, nothing to do with legality, everything to do with
> ideology. Then there are the cases that involve simple human
> pettiness, as in the attached case involving Sergent at McGill.
>
> Whatever it may (or may not) accomplish re protecting subjects,
> the IRB/REB process provides a tailor-made mechanism for
> harassment and censorship, and that opportunity seems to be
> increasing too tempting for some to resist. It seems disingenuous
> to protest that the ethics industry's hands are clean in these
> matters, it has provided the loaded weapon. Who amongst us will ever admit
to lacking the courage of their convictions to stand up for what is right
when it may cost us our jobs, standing in the community, professional
advancement, etc., except perhaps in a very quiet moment? However, I would
also argue that, like any imperfect system, much good has been accomplished
by men and women of good will and determination who devote their lives (or
at least a significant portion thereof) to research ethics. Not that there
is no room for improvement, by a long shot.

However, that does not mean that researchers should be allowed a free hand
and total immunity if they learn important information in the course of
their research that could be instrumental in the prevention of a serious
crime, or in the apprehension of a perpetrator of a serious crime. Of
course, by not guaranteeing complete confidentiality to research subjects,
the research itself is hampered, and, like in Russell Ogden’s case, can put
a chill on the whole field.

The foregoing does not, in my opinion, relieve citizens in a democratic
society of their obligations to work towards a change in law to achieve
greater justice and protection from arbitrary actions of the authorities.
Presumably, those in the Research Ethics Community would at least be
supportive if not actually in the vanguard of any such initiative. As to
the role of the NCEHR list serve, alerting the members to issues is great,
but using it as a platform for any particular political purposes is not a
good idea. >
> One person's opinions, Also just one person’s opinions.
Jack

2. Ongoing Clinical Trial Safety Information

Subject: [Ethics] Management of adverse events in clinical trials
Date: Sun, 2 Mar 2003 16:00:16 -0500
From: "Francis Rolleston" <frolleston@sympatico.ca>

Dear Colleagues:

Ray Saginur and I invite advice from listserv participants on the management
of ongoing clinical safety information (OCSI, adverse event reports) in
clinical trials. This is in the context of our contract (signed Feb 14 and
due for completion March 31) with Health Canada to identify the major issues
and then develop policy options on:

The roles and responsibilities of sponsors, REBs, Health Canada, qualified
investigators and institutions;

Mechanisms that help protect research subjects and also respect the needs of
the various players;

Mechanisms for open and continuing dialogue and interaction between Health
Canada and REBs / qualified investigators / institutions.

We understand that Health Canada hopes to be able to use the results of this
work in consultation around possible new policy or guidance.

We invite input from any who are interested. I would be happy to send our
very initial draft report (Table of Contents below) and subsequent drafts to
any who express interest in offering their ideas on this work. Our short
time lines force us to seek rapid responses.

Perhaps you could reply directly to me at frolleston@sympatico.ca

Thank you for your interest.

Francis Rolleston

DRAFT TABLE OF CONTENTS
1. INTRODUCTION

WHERE WE ARE NOW
2.1 THE REGULATORY ENVIRONMENT
Current regulations: Overview of Canada, Europe, USA, ICH.
Definitions: AE, ADR, SADR, SUADR; Commentary

2.2 VIEWS FROM THE FIELD
Literature survey and summary of opinions about issues related to AERs

2.3 ISSUES AND OPPORTUNITIES
Identify the central issues through a "life cycle" from initial observation
to actions taken.

LOOKING FORWARD
3.1 PRINCIPLES AND OBJECTIVES FOR AN OCSI SYSTEM

3.2 OPTIONS
Headings such as:
Stakeholder responsibilities and accountabilities
Managing ongoing clinical safety information
Ensuring dialogue and operational interactions between stakeholders

4 CONCLUSIONS AND RECOMMENDATIONS

Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2A 2N7

frolleston@sympatico.ca
613 728-7163

Subject: RE: [Ethics] Management of adverse events in clinical trials
Date: Mon, 3 Mar 2003 10:18:52 -0500
From: "Francis Rolleston" <frolleston@sympatico.ca>

Dear Joe:

Good to hear from you. Attached the first early draft report, really little
more than a dump of thoughts. It needs much more substance, and any
comments that you might have would be very helpful

Thanks

Francis

Francis Rolleston
500 Denbury Avenue
Ottawa, ON
K2ASubject: Re: [Ethics] Management of adverse events in clinical trials
Date: Mon, 03 Mar 2003 11:07:02 -0400
From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Reply-To: ethics@lists.ncehr-cnerh.org

Frankly for multicentre trials I feel we have no way of interpreting AE data that comes in. We look at it and sign it and issue a receipt, but without a denominator it is impossible to know what it means, particularly when one may be receiving reports about a drug from multiple trials around the world using that drug, not just the trial one is overseeing.

Dr Michael D E Goodyear FRACP FRCPC FACP

Subject: Re: [Ethics] Management of adverse events in clinical trials
Date: Mon, 3 Mar 2003 10:38:44 -0500
From: "Tom Ekers" <tekers@cmxres.com>
Reply-To: ethics@lists.ncehr-cnerh.org

Francis,

This is a very important project to be addressed.

Our ethics board has had a difficult time dealing with the SAE's without
being provided a broader context when dealing with multicentered studies.
SAEs, when received from investigators in an intermittent fashion , over
some time, has created a need to organize these in a form that provides some
context for review which the board insists upon.

We believe that the sponsors should provide both a better context to boards
and we also wonder whether the silent DSMB's (or the sponsors who stike the
boards)shouldn't have some responsibility on the dissemination of their
findings to the involved ethics boards on studies where safety issues have
arisen.

We would be pleased to work with you on this project.

Tom Ekers
Trafalgar Ethics Board

Subject: RE: [Ethics] Management of adverse events in clinical trials
Date: Tue, 04 Mar 2003 10:04:28 -0400
From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>

Thank you for reminding us that these adverse events are very drug orintated, which raises interesting questions about research with devices or or other interventional medicine including surgery.

There has also been some interesting discussion over whether operative and postoperative deaths in an ovarian cancer trial should be reported or not, since the trial question was about the timing of the chemotherapy in relation to surgery. The 'operative' question being is there any reasonable way that the trial question could influence the incidence of the events.

I think that one of the issues that should really be concerning REBs is that of responsiibility. Inundated with bits of paper, are they going to be held responsible for something that is implicit in those documents that should have led to some action? I would argue not.

On the other hand we need to break down not only the significance of the event, but also the context in which it occurs in relation to the individual REBs relative responsibilities. Obviously 'in house' trials or trials that are being run from the host oganisation are the local REBs primary responsibility and should be scrutinised in a very different way than international trials with hundreds of patients of which the local organisation submits say 4 or 5.

Events by themselves are meaningless, and could be submitted en masse say, at Annual Approval. The only things that a local REB can meaningfully take responsibility for are events accompanied by requests for action, which may just be simply heightened awareness, reports from sponsors or regulators and DMSC reports. It would be more meaningful if tabulated toxicity data, such as that submitted to investigators at regular group meetings, and eventually published, were presented than individual case reports.

What is evident is that the current situation cannot continue. The workload is enormous, there is no structure for action, and the whole process creates a false sense of security that things are being monitored and regulated, which they are not.

One solution is for the events in multicentre trials to go only to the regulator who in turn decides what to inform the REB.

Dr Michael D E Goodyear FRACP FRCPC FACP
Assistant Professor, Division of Medical Oncology, Department of Medicine, Dalhousie University
Room 456, Bethune Building, Queen Elizabeth II Health Sciences Centre

Subject: RE: [Ethics] Management of adverse events in clinical trials
Date: Mon, 3 Mar 2003 16:01:54 -0500
From: "Hebert, Dr. Philip" <Philip.Hebert@sw.ca>

I agree -- REB's cannot be & should not be DSMB's -- we need to receive
reports from DSMB's & could provide advice to researchers re-the study /
consent process, but it is hubris to think we could seriously look into
SAE's...
Philip

Philip Hebert MD PhD CCFP FCFPC
Associate Professor, Family Medicine,
Chair REB, SWCHSC
Room A 100 Tel 480-4963
Ethics: E228b Tel 480-4818

Subject: Re: [Ethics] Management of adverse events in clinical trials
Date: Sun, 02 Mar 2003 16:07:57 -0500
From: "Joe Gilbert" <Joe.Gilbert@lhsc.on.ca>

Hello Francis,
i would be pleased to review and give comment.
The Lawson Health Research Institute now has 950 active clinical trials and is most interested in contributing to the discussion re patient/voluteer safety.
Regards,
Joe Gilbert

3. HIPAA

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

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

Dr Michael D E Goodyear FRACP FRCPC FACP
Assistant Professor, Division of Medical Oncology, Department of Medicine, Dalhousie University
Room 456, Bethune Building, Queen Elizabeth II Health Sciences Centre

From: "Jack Corman (IRB Services)" <jcorman@irbservices.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] HIPAA
Date: Monday, March 31, 2003 1:10 PM

Two thoughts:

1. Is it wrong to agree to work with a sponsor that seeks to improve
privacy protections for research subjects, no matter the genesis?

2. Having stated point one, if the specifics are such that they are
inappropriate to Canada or your institution, you can/must modify them to
meet your requirements. If the sponsor will not work with you, then the
offending specifics are simply not approvable.


Jack Corman
President/Secretary

IRB Services
14845-6 Yonge Street
Suite 328
Aurora, ON, L4G 1H6
CANADA.

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] HIPAA
Date: Monday, March 31, 2003 2:01 PM

Michael --
Could you provide to the List in a general way some of the issues you've
encountered with sponsors in response to HIPAA. if any?

I'm not yet aware that a US or Canadian regulator has "definitively"
identified any direct impact internationally, on research data
collection/confidentiality issues. One obvious area to be certain about
concerns research conducted in Canada on limited data sets originating with
US registries.

The following from the HIPAA website is an excerpted response from the
American Hospital Association (AHA).

<http://www.hipaadvisory.com/views/archives/Provider/ahacomment21700.htm>

"The AHA is gravely concerned that the Secretary has greatly exceeded her
authority in promulgating this proposed rule. To attempt to protect the
privacy of all individually identifiable health information, rather than
the information transmitted electronically among providers and payers in
certain enumerated transactions, is not only beyond the scope of the HIPAA
mandate, but also requires the Secretary to reach into the organization and
delivery of health care by hundreds of thousands of caregivers in thousands
of locations. Because hospitals already have in place many safeguards to
protect confidentiality of patient information, the proposed requirements
are often redundant. But the prescriptive nature of the proposed standards
will require hospitals to rewrite policies, retrain staff, re-negotiate
contracts, and put in place comprehensive systems to track all uses and
disclosures of information.

... The fact that the underlying statute does not fully preempt state law,
would be less significant if providers only had to determine whether state
or federal rules applied to the administrative transactions specified in
HIPAA. The Secretary leaves individual providers exposed to significant
potential liability for violations by overreaching the statutory authority
and attempting to govern virtually all uses and disclosures of identifiable
health information."

I think we're involved with *watchful waiting* on this issue.

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>; <clarke@muhchem.mcgill.ca>
Subject: Re: [Ethics] HIPAA
Date: Monday, March 31, 2003 5:54 PM

General

We have our template consent form with which we have had considerable experience. However we find ourselves constantly battling sponsors who insist on adding all sorts of additional material, so that if we give in we very rapidly no longer have a consistent consent form format across the Health Authority. Furthermore these 'new growths' are usually inconsistent with each other and keep changing from protocol to protocol. Usually we end up staring down the industry, after wethering the usual 'well then we will just have to take our business elsewhere'.

This week a drug company came up with a Confidentiality section that ran to over a page in length and insisted that these were new regulations (HIPAA) they now had to abide by. While we are all for improving the information provided to subjects, and all for protecting privacy, consent forms continue to grow in length and complexity and are in danger of being burdensome to subjects, if not so already. We could not find anything in the 6 additional paragraphs that in anyway differed from the spirit of our original consent. Nor have we seen anything in HIPAA that is really any different from what we preach already.

Perhaps one new thing was the assurance that the subject could have access to their recorda and make corrections, more specifically addressing the subject's right to withdraw their data,

Our limited inquiries to date suggest that we (Canada) are not affected by these new rules. Put quite simply personal information with identifiers should not be transmitted to outside bodies. My understanding is that at least US sponsors receiving such CRFs or test results will simply return them with a request they be anonymised or coded.

To answer Jack Corman's specific comments. No it is not wrong to work with anyone who seeks to improve privacy protection, it just isn't necessary to do so in the consent form.

For the record here is our suggested Confidentiality clause (and we are not saying it is perfect), but is not over one page in length either!

You will not be identified as a study participant in any reports or publications of this research. Your records will be kept in a secure area such as a locked file cabinet. Only the staff involved in the research study will see them.Because this is a study of a new drug (or device), the drug company (identify), or its monitoring agents, the Research Ethics Board, the Therapeutics Products Directorate of Health Canada, (the Food and Drug Administration of the U.S.), may look at the records to make sure that the information is correct. With your permission, your family doctor will also be informed of your participation in this research study. This consent form will be placed on your Health Chart.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <clarke@muhchem.mcgill.ca>
Cc: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] More on the Privacy Act (HIPAA)
Date: Tuesday, April 01, 2003 9:01 AM

What I cannot figure out is how this affects those north of the parallel!

Dr Michael D E Goodyear FRACP FRCPC FACP

From: <swarden@uhnres.utoronto.ca>
To: <ethics@lists.ncehr-cnerh.org>; <ethics@lists.ncehr-cnerh.org>; <clarke@muhchem.mcgill.ca>
Subject: Re: [Ethics] HIPAA
Date: Tuesday, April 01, 2003 10:33 AM

Thank you for this Michael,

I am also very interested in this as we are starting to see requests to comply with
HIPAA at our site, and most of these are from oncology intergroup trials. I have been
in touch with two of them (NCIC and ACOSOG) and the initial responses seem to be
"I don't think HIPAA applies to Canadian sites, but we'll check with the DHHS".
So far I haven't received a conclusive answer. I think we need to get this resolved
quickly (i.e. before April 14!) so we can know whether or not we have to deal with
all the consent changes.

Thanks
Sarah

From: "Susan Hoddinott" <hoddinott@uwo.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] HIPAA
Date: Tuesday, April 01, 2003 1:40 PM

Hello All
I too have been trying to get a definitive answer from OHRP, FDA, HHS - CIvil Rights Office etc regarding HIPAA and Canada. No luck so far - I am now
waiting for a response from the Civil Rights Office as they are responsible for the HIPAA legislation. If anyone is interested attached is a guideline
that we have issued regarding the HIPAA stuff.

In short, it is my interpretation that the HIPAA legislation establishes the conditions under which protected health information may be used or
disclosed by covered entities for research purposes. Canadian entities (e.g. hospitals, health insurers etc) and research participants located in
Canada are subject to Canadian federal and provincial legislation and should not fall under the jurisdiction of the US Federal government or the US
HIPAA legislation. Canadian federal privacy legislation and pending Ontario privacy legislation should be consulted when a Canadian institution creates
data release forms for their institution. Researchers are encouraged work together with their institution’s legal advisors to determine what, if any,
documentation is required for release of information for research purposes.

If data is transferred to a "covered entity" in the US then THAT institutution may require a HIPAA release depending on the circumstances. I don't
think pharma sponsors fall under the 'covered entity' umbrella.

cheers

Susan

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] HIPAA
Date: Tuesday, April 01, 2003 4:03 PM

Clarity of interpretation is not the strong suit for appropriate responses
to HIPAA in US or Canada. In keeping with the emerging tone of this
discussion, i view this as another example of research sponsors' requests
to apply extra-territorial law in Canada, similar to the habit of requiring
*sign off* by Investigators on an FDA 1572, creating linkage to 21 CFR
regulations for the REB, and the institution.

Susan importantly points out that all privacy legislation, federal and
provincial, are in play with the decision-making. I suggest we consider
responses describing that our regulatory system affords protections that
are at least equivalent to those provided by US federal law, which is the
case at my institution.

To this discussion i'm adding an example, received today, of language
provided by a sponsor within the model Patient Authorization to Use or
Disclose (Release) Identifiable Health Information for Research:

"By signing this Authorization you agree to permit the disclosure of your
confidential health and research study information including without
limitation, your [INSERT ALL APPLICABLE TERMS: name, age, sex,
race/ethnicity, medical diagnosis, sexual life, physical or mental health,
study data, address, and name of your medical provider, etc.]"

Given the federal nature of this issue, i think we should expect HC to
provide regulatory guidance to enable a unified interpretation to address
HIPAA issues, so that individually we cannot be accused of "stirring the
pot".

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: "Jack Corman" <irbs@interlog.com>
To: "NCEHR" <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] HIPAA
Date: Tuesday, April 01, 2003 1:10 PM

Here is something from a person at the NIH, who declined to be named because
the opinion is not official NIH policy.

>> According to HHS, "A Canadian company likely has no independent requirements
>> under our privacy rule."
>>
>> For example, if a Canadian company is sending individually identifiable
>> health information to a U.S. covered entity, the U.S. covered entity will
>> need to protect that information as it would any protected health information
>> under the Privacy Rule. The rule does not make distinctions as to the source
>> of the information. I am unable to discern (and really cannot make the
>> determination) if the U.S. affiliate you mention below is a covered entity.
>>
>> Now, once the Canadian PHI is in the hands of the U.S. covered entity, the
>> covered entity can only use and disclose that PHI in accordance with the
>> Privacy Rule. That may mean that the covered entity needs an Authorization
>> from the subject of the PHI, a waiver of the Authorization requirement, or
>> other representations and documents to use and disclose the information.

My interpretation is that we in Canada are not bound by HIPAA, but if we
send personal health information to a US covered entity, then the US entity
must be HIPAA compliant. If we send any identifiable personal health
information to the US, and the entity wishes to transmit or otherwise use
the identifiable health information, it may need the subject's consent or an
IRB waiver, etc.

However, since the data from Canadian investigators will presumably be from
non-US residents or citizens, collected ex-US, I don't see how US law,
specifically HIPAA, can legally apply to these Canadian research subjects.

Henry Kloppenburg, where are you?

Jack Corman
IRB Services
From: "Joe Pater" <jpater@ctg.queensu.ca>
To: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
Subject: Re: HIPAA
Date: Wednesday, April 02, 2003 9:06 AM

At the conference call yesterday, it was decided/recognized that US groups do not have to get HIPAA authorization from Canadian centres. You should be hearing from them.

Michael Goodyear wrote:

From: <swarden@uhnres.utoronto.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] HIPAA
Date: Thursday, April 03, 2003 9:55 AM

Thank you all...

This raises an interesting question.

An earlier email of Jack Corman's has the DHHS suggesting that if a US covered entity
wished to use identifiable data originating in Canada, then that data would have to
be consented to under HIPAA regulations. Our REB does not permit any data that we
would consider "identifiable" - name, address, SIN - to be released to anyone outside
our institution. So this would indicate that the sponsor might be covered. But
according to this email, it sounds like the definition of 'identifiable information'
could include any study data?

Sarah Warden
Research Ethics Coordinator

4. Evaluating the Morality of Research

List Members:

I have been asked by a REB member if the REB can reject an application
for ethics review on the grounds that the research is immoral. As it
was put to me: "What do we do as a REB or as REB members when we
believe that the whole project or the topic being investigated is
morally questionable? For example, what would be my responsibility if I
were a faithful Catholic - who believed that life begins at conception
- and was on an REB asked to review a project which included harvesting
cells from fertilized human embryos? Is this strictly a question of
personal morality or is it also a question of research ethics?" Or I
might believe that abortion is morally wrong and, therefore, could not
approve a research project that asked teenagers, who had recently had an
abortion: How can such-and-such a social agency meet your immediate needs?

Perhaps the TCPS speaks to this and I just missed it. But I am
interested in any comments, including those from the Tri-Councils and
the Inter-Agency Panel.

--
Bill Marr, PhD
Department of Economics
and
Chair, Research Ethics Board
Wilfrid Laurier University
75 University Ave., West
Waterloo, Ontario, Canada
N2L 3C5

Hi Bill,
As a brief response to a tough issue, I would refer you to the discussion
relating to Article 1.5 of the TCPS.

"In evaluating the merit and the scholarly standards of a research proposal
the REB should be concerned with a global assessment of the degree to
which the research might further the understanding of a phenomenon, and
not be driven by factors such as personal biases, or preferences. REBs
should not reject research proposals because they are controversial,
challenge mainstream thought, or offend powerful or vocal interest groups.
The primary tests to be used by the REBs should be ethical probity and
high scientific and scholarly standards."

Where the research is offensive to a particular Board member's personal
beliefs, a partial solution might be for that individual to recuse themselves
from that discussion. It is my interpretation that the 'ethical probity' that
concerns the REB is that which applies to the conduct of the research itself
in relation to how research subjects are treated, not to the research topic
per se. I don't think that the TCPS instructs us to restrict research to only
those topics that deal with morally acceptable behaviour. This would
eliminate many aspects of human activity from the benefits of research,
arguably those which need it the most, which would itself be unethical.

Pat Lindley
Patricia Lindley
Office of Human Research Ethics Administration
Room 321 Henry Hicks Arts and Administration Building
Dalhousie University
Halifax, Nova Scotia
B3H 4H6 ~~~~~~~~~~~~~~~~~~~
ph. (902) 494-1462
fax. (902) 494-1595
e-mail Patricia.Lindley@dal.ca

Yes, thank you for clarifying for those who think they can impose their
moral beliefs into the research approvals process. My understanding is that
an REB member who feels in conflict on moral grounds always has the
opportunity to decline to be part of the review of such research.
Sharon
----- Original Message -----
From: "Andrée Bertrand" <abertran@uottawa.ca>
To: <ethics@lists.ncehr-cnerh.org>
Sent: Thursday, March 13, 2003 1:04 PM
Subject: Re: [Ethics] morality of a research project


> Exactly !! Thank you Pat.
>
> Andrée Bertrand
> Protocol officer for ethics in research
> University of Ottawa
>
> "Lindley, Pat" wrote:
>
The situation gets complicated when the institution (e.g., hospital) is part
of an organization with strict codes, like the Catholic church and fetal
tissue research. It then is taken out of the REBs hands, since it is a
matter of institutional policy. Is there not a moral conflict for REB
members if they do not agree morally with institutional policy? What should
the REB member do?

Jack

What Jack is referring to is also dealt with, very briefly, in the TCPS. Under
Article 1.2, which deals with the jurisdictional and authority relationship
between the Institution and its REB, the following text is found:

"Institutions must respect the authority delegated to the REB. The institution
may not override negative REB decisions reached on the grounds of
ethics, without a formal appeal mechanism as set out below. Institutions
may refuse to allow certain research within its jurisdiction even though the
REB has found it ethically acceptable."

I interpret this to mean that the REB operates within the mandate of the
institution it serves, but that it is supposed to be independent in terms of
rendering its decisions. WHile it is probably unlikely that a Board, derived
largely from within the institution would be at odds with the moral stance of
that institution, it is not inconceivable, as Jack suggests. Where this were
the case, the Board would be free to state its opinions, approve the
research, but not force its acceptance upon the Institution. However, I would
interpret the TCPS to mean that an institution should not seek to use the
REB to enforce its moral code.

Pat

Re: [Ethics] morality of a research project
From:
Michael Coughlin <coughlin@mcmaster.ca>
Date:
Fri, 14 Mar 2003 16:17:05 -0500
To:
ethics@lists.ncehr-cnerh.org

I appreciate the reflection that has gone on around this issue of the relationship between the
REB, the beliefs of individual members and the moral stance of an institution. One of the
assumptions I seem to see in the discussion is that the REB achieves "ethical probity" by
operating within some moral code or an ethic that is somehow separate from and easily
distinguishable from that of the individuals and institutions with which it is in
relationship. The TCPS and the GCP and Declaration of Helsinki and US Federal Law and Health
Canada Regulations and a long history of ethical reflection all contribute to forming some kind
of general consensus around what is an ethically justifiable way to do research, but it is
always open to interpretation and change. The consensus ethic for Canada is in the TCPS, but
it is just that, a consensus document. It provides a generally agreed on minimal ethic. That
is why the institutions may not override a negative decision by the REB but they may veto or
overrule a positive decision. Moreover, different REBs decide differently on the same project
(e.g. certain placebo-control trials), and REBs tend to have a voting mechanism because people
do differ in their judgments of the application of the TCPS and other sources of ethics to a
particular project. I would hope that unless there were an actual conflict of interest,
individuals with strong beliefs would not "recuse" themselves from the REB. Let them argue
their point, and then let the vote carry the decision. That is what voting is for.

In fact, sometimes the issue in question is precisely the research topic itself. The TCPS
itself has had to come down on one side or other of debated issues. As a final point, using
the TCPS comment on Article 9.5 on cloning as an example:
"Article 9.5 recognizes that while some research involving human reproduction is
inherently objectionable to some schools of ethical and religious thought, it may not be so for
others. Such techniques have provoked vigorous debates arising from conflicts in values, and
such discussion and reflection need to continue. In the meantime, the intrinsic ills,
potential harm, and the scientific and ethical uncertainty weigh in favour of not approving
such research."

For many things, "discussion and reflection need to continue."

Michael

5. Sergent-Suicide-Montreal-Gazette-Coverage

The text from the Montreal Gazette about a researcher who committed suicide. Somehow, the research ethics board that reviewed the research is held up for blame and responsibility by the researchers who took their lives.

6. CAREB's New Webpage

Hello Everyone:

I invite you to check out the new CAREB website http://careb-accer.ca/en/index.html
for information about the Canadian Association of Research Ethics Boards
(CAREB) Annual General Meeting to be held in Ottawa at the Marriott Hotel on
Saturday May 3, 2003.

Please note that this year's CAREB meeting will take place the day prior
to the start of the Canadian Association of University Research Administrators (CAURA)
meeting which is being held at the same venue May 4 to 6.

You may also want to take some time to explore our new website.

Hope to see you in Ottawa!

Susan

CAREB Vice President
Chair CAREB 2003 AGM Committee

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


7. Off Site Investigators

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] Off site investigators
Date: Monday, March 31, 2003 10:32 AM

Is anyone noticing a trend to investigators moving their research off site to take advantage of central REB/IRBs, and if so how have you dealt with it. How have you defined their role as 'personnel' in terms of hospital or university appointments even if they are not using any staff or resources from those institutions (or paying fee for service) but maintain their appointments at those institutions.

Dr Michael D E Goodyear FRACP FRCPC FACP

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>
To: <ethics@lists.ncehr-cnerh.org>
Subject: Re: [Ethics] Off site investigators
Date: Monday, March 31, 2003 11:13 AM

Hello Michael

We define the requirement for local review based on whether the
faculty member is acting in an institutionally delegated role,
regardless of access to services or the location of the work.
Ideally this role is described in terms of employment but can also be
inferred from release time to do the work, claiming it as scholarly
activity as part of an institutional performance review etc. A
consideration that may be neglected and I've been thinking about
lately is who is providing protection to an investigator in the event
of a mishap. If a person elects not to act in an institutional role
and undergo local review, I wonder if that institution would extend
liability protection to that individual.

Jurisdiction of review is a recurrent theme on the list, and one that
probably won't be solved unless there are specific additions to the
TCG or like document to define institutional engagement more clearly.

Cheers

Cam

8. Wake Up Call - IRB Wrongdoing


Date: Fri, 07 Mar 2003 16:41:06 -0800
From: John Lowman <lowman@sfu.ca>
Reply-To: ethics@lists.ncehr-cnerh.org
To: ethics@lists.ncehr-cnerh.org

And another:

http://www.philly.com/mld/inquirer/living/health/5301924.htm