Summary of NCEHR Listserv for November 2003


TOPICS

1. Where Should Signed Consent Forms be Stored?

2. University Fails Researcher: Academic Integrity and Freedom

3. Democratic Participation in Research Ethics

4. Liability for Lay Members

5. The Placebo Initiative Report

6. "Mini Olivieri Symposium" on the Journal of Medical Ethics website

7. PRE: Consultation: TCPS Implementation Feedback Framework

8. CALL FOR PROPOSALS FOR CASE VIGNETTES for NCEHR Communiqué

9. Frontline: Dangerous Prescription

 

Files for Download

Announcement PRO-Group - PRE

PRE - TIFF Consultation 2003 WORD

 

1. Where Should Signed Consent Forms be Stored?

From: "Kathy Reed" <reedk@post.queensu.ca>

A recent question has arisen with our REB office and we have been surprised
by the results of our seeking an answer on standard practise. We were
asked where signed consent forms should be kept. We were assuming that
they were being kept in locked research files. However, we have found that
for some drug trials, they are being put in the medical charts because they
involve treatment. We are thinking that a copy could be kept in the
medical chart but the original should be in the research files. We were
however surprised by the variation in practise among our clinical
departments. What happens at other institutions? Do you have a stated
policy?

Kathy Reed
Ethics Coordinator
Health Sciences Research Ethics Board
Office of Research Services
Room 307 Fleming-Jemmett
Queen's University
Tel: 613-533-6000 ext. 77000
Fax: 613-533-6806

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>

Always interesting when question of day to day SOPS does not reveal
standard operating procedures across jurisdictions. In our institution we
require "a subject's participation in research be documented in the
hospital file(s) by including a copy of the signed consent document, study
summary and emergency contact phone numbers in the medical record of the
hospital."

My question is to those who keep the 'signed original CF' in a research
file.

Original CF is a confidential study source document that in a medical
setting depicts the decision leading to experimental treatment. At study
termination when research files revert to the sponsor what happens to the
original CF?
... elisabeth

From: "April Hughes" <AHUGHES@sbgh.mb.ca>

I am unfamiliar with "research files revert to the sponsor" at the end of a study. The contracts we sign with Sponsors do not allow for original documents to leave our facility and our SOPs require that we must retain all study documents for 25 years as per Health Canada and GCP ...on the rare instance when a contract states that documents be returned to the Sponsor (I had one of those rare ones just in the last month) we requested that the wording be changed to allow us to retain the documents... and it was. I am curious to see what other groups are doing as there seems to be a system out there where files are returned as opposed to being retained?

April Hughes
Senior Administrator, Office of Clinical Research
Associate Director, Clinical Trials and Regulatory Affairs
St. Boniface General Hospital
N1002-409 Tache Avenue
Winnipeg, MB R2H 2A6
Tel: (204) 235-3819
Fax: (204) 237-9860
ahughes@sbgh.mb.ca

From: "H R Kloppenburg" <hrk@kloppenburg.ca>


Records retention is always lively issue. Quite frankly, for reasons you will see, I consider that institutions have a profound duty to their patients and research subject which can only be fulfilled if records are retained for a reasonable time, reasonable here being determined by the circumstances.

It seems to me that in considering this issue reference ought to be had to health care standards legislation and professional governance rules.

In the former case, provincial law typically lays down standards as to the required record of all treatment had by a patient. If research has a treatment component, I don't readily see how the provincial law could be avoided i.e. the institution is bound to keep the record, or a least a record of all treatment having a research component. If any provincial health care legislation does not dictate a particular standards of records retention it would be worth noting.

In the latter case, most if not all professional governing bodies have standards for record of activity by their members. Thus if research has a treatment component, so that the rules and regulations of governing bodies without argument apply, resort must be had, so it seems to me, to those regulations to know whether the researcher has a duty to retain the record (or a record) of his / her research efforts. Do the professional regulations of a professional association overrule or supercede the the demands of a research sponsor.

It may also be the case that institutions should insist on record retention. Moreover, how could patients' interests be protected later in the event of misconduct or wrongdoing by a researcher if the record were not available to health care providers attempting to rectify the situation.

At the risk of opening up old wounds and figuratively pouring gasoline on old fires, how would researchers protect themselves against manipulative patients in a worst case scenario if records were not retained. Again at the risk of opening old wounds how could institutions protect themselves against manipulative patients who fall into the hands of lawyers?

I am so bold as to say that IRBs have to have a balanced approach.



Best regards,

HRK

From: <jjohnson@cato.com>


The research files should not be sent back to the sponsor at the end of the
study unless the investigator has no means of keeping these files secure.
The original CFs should be maintained with the investigator study files for
that particular study and would accompany those files wherever they end up.
The decision to put a copy ( the original should always be kept in the
investigator study files) in the medical chart is a hospital/clinic/doctor
decision and not a regulatory one.


From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>

April, i'm referring to study data rigorously monitored by sponsor
throughout the study as being the information that "reverts to sponsor" at
each site's study close-out. Included with these research files are as
'near to source' as law allows "source documentation" described at ICH GCP
Section 8 that describes who is responsible for what document at each stage
of the research.

We are in contact with Health Products and Food Branch Inspectorate
requesting clarification of the "25 years" retention clause. Confusion
arises in trying to determine which party to the agreement does the
obligation to store information for 25 years lie. Federal law and
accompanying forms filed by sponsor all state the responsibility is 'of the
sponsor'. Inspectorate told us to combine federal law with ICH Section 8
to understand what's what. CF

Taking the Inspectorate advice the research documents an investigator
institution could be required to maintain are minimal (ICH Section 8) and
clearly not the study data collected during the reseach that reverts to the
sponsor that would amopunt to storing duplicated data We are waiting for
the Inspectorate's written policy statement before drafting an SOP.

... elisabeth

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>

At 12:45 11/3/2003 -0500, jjohnson wrote:
>The research files should not be sent back to the sponsor at the end of the
>study unless the investigator has no means of keeping these files secure.
>The original CFs should be maintained with the investigator study files for
>that particular study and would accompany those files wherever they end up.
>The decision to put a copy ( the original should always be kept in the
>investigator study files) in the medical chart is a hospital/clinic/doctor
>decision and not a regulatory one.


Clearly principal source documents in a treatment study are the hospital
medical records that record the clinical findings involved with the
experiment. The medical records are photocopied and become the research
data that are reported on CRFs. CF is never the propriety of the sponsor,
even in copy.

The following 2 clauses appear in the Health Canada form entitled "CLINICAL
TRIAL SITE INFORMATION FORM":

"Qualified Investigator
A Qualified Investigator Undertaking must be completed by the qualified
investigator responsible for the conduct of the clinical trial at the site
specified above. The completed undertaking must be retained by the
clinical trial sponsor for a period of 25 years."

"Research Ethics Board Approval
A Research Ethics Board Attestation must be completed by the Research
Ethics Board that reviewed and approved the protocol and informed consent
form for this clinical trial at the site specified above. The completed
attestation must be retained by the clinical trial sponsor for a period of
25 years."

i don't see any requirement that the investigator must store the files for
25 years... elisabeth

From: "April Hughes" <AHUGHES@sbgh.mb.ca>

While I agree in general with you Elizabeth, there is an important distinction here.....the Sponsor monitors CRF data against source data and takes back the "original" CRF top copy..... but this is not source data it is transcribed data from other original documents......CRFs are not source documents. Consent forms are source documents as are all original records, notes, films, etc .... we retain the site copy of the CRF for 25years regardless, but source documents do not leave the facility.... As we are the Institution, our SOPs have the Hospital take over care of the Investigator files when the Investigator moves, retires, etc. In that case the Hospital, as per the contracts with the Sponsors, retains the research files...... we do not send anything to the Sponsor for storage.

April Hughes
Senior Administrator, Office of Clinical Research
Associate Director, Clinical Trials and Regulatory Affairs
St. Boniface General Hospital
N1002-409 Tache Avenue
Winnipeg, MB R2H 2A6
Tel: (204) 235-3819
Fax: (204) 237-9860
ahughes@sbgh.mb.ca

From: "GLADYS RANGARATNAM" <gvrangaratna@cambrianc.on.ca>

Thanks, Ibrahim.

Gladys Rangaratnam
Director, Research & Development
Cambrian College
Tel:705-566-8101, ext. 7888
Fax:705-524-7312
gvrangaratna@cambrianc.on.ca

Knowledge is experience.
All else is information.
Albert Einstein

>>> H R Kloppenburg <hrk@kloppenburg.ca> 11/03/03 12:40PM >>>

Records retention is always lively issue. Quite frankly, for reasons
you will see, I consider that institutions have a profound duty to their
patients and research subject which can only be fulfilled if records are
retained for a reasonable time, reasonable here being determined by the
circumstances.

It seems to me that in considering this issue reference ought to be had
to health care standards legislation and professional governance rules.


In the former case, provincial law typically lays down standards as to
the required record of all treatment had by a patient. If research has a
treatment component, I don't readily see how the provincial law could be
avoided i.e. the institution is bound to keep the record, or a least a
record of all treatment having a research component. If any provincial
health care legislation does not dictate a particular standards of
records retention it would be worth noting.

In the latter case, most if not all professional governing bodies have
standards for record of activity by their members. Thus if research has
a treatment component, so that the rules and regulations of governing
bodies without argument apply, resort must be had, so it seems to me, to
those regulations to know whether the researcher has a duty to retain
the record (or a record) of his / her research efforts. Do the
professional regulations of a professional association overrule or
supercede the the demands of a research sponsor.

It may also be the case that institutions should insist on record
retention. Moreover, how could patients' interests be protected later in
the event of misconduct or wrongdoing by a researcher if the record were
not available to health care providers attempting to rectify the
situation.

At the risk of opening up old wounds and figuratively pouring gasoline
on old fires, how would researchers protect themselves against
manipulative patients in a worst case scenario if records were not
retained. Again at the risk of opening old wounds how could institutions
protect themselves against manipulative patients who fall into the hands
of lawyers?

I am so bold as to say that IRBs have to have a balanced approach.


Best regards,

HRK

2003-11-03

From: "April Hughes" <AHUGHES@sbgh.mb.ca>

The regulatory authorities retain the right to inspect the sites and verify any data as presented by a Sponsor to that regulatory authority as per section 8 intro's last line. The only way that this can be traced back to a source for verification is by the site retaining the source documents from which the data was obtained for the same period of time. The Trial Sponsor contracts that I see now have a clause in them that require source document retention for 25 years, with that responsibility typically written for both the Investigator and the Institution. Interestingly, Manitoba has privacy legislation in place that restricts the photocopying of any medical record. We do not copy medical records for study files. The CRF data is typically monitored against the actual original source documents. When I was working in Industry in the past I did see instances where photocopies of medical records were used to verify information in the CRF.... in the cases where I was involved, we!
changed this practice immediately as photocopies cannot serve as source documents unless they are legally certified copies ....
April

April Hughes
Senior Administrator, Office of Clinical Research
Associate Director, Clinical Trials and Regulatory Affairs
St. Boniface General Hospital
N1002-409 Tache Avenue
Winnipeg, MB R2H 2A6
Tel: (204) 235-3819
Fax: (204) 237-9860
ahughes@sbgh.mb.ca

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>

Obviously medical records are retained according to provincial law. Where
i take issue is the suggested requirement to retain what amounts to kilos
of duplicated paper called the investigator file, when the originals revert
to the sponsor. Remaining documents are: original CFs, advertisement,
subject enrollment itinary, code sheet and termination report that all
could fit in a single file folder ... elisabeth

At 12:39 11/3/2003 -0600, you wrote:

From: <jjohnson@cato.com>

There is no regulatory requirement for the PI to keep the records for 25
years, but as we have heard from various HC inspectors, it is expected.

The IC documents belong to the research study. It is a regulatory
requirement and therefore belong to whomever has requlatory responsibility
for these documents. The source documents- medical records, various
examination results are the property of the institution/investigator and do
not leave the site. That is why CRFs are so important.

ICFs are not source documents- they are regulatory documents.

Janine

From: "John Lowman" <lowman@sfu.ca>


If the purpose of the signed consent form is to protect the subject, surely
the subject should retain the form.

Against the suggested "balanced approach," REB's are obliged to comply with
the TCPS which calls for protecting subjects -- not researchers and
institutions -- using a subject-centered perspective...

JL

From: "H R Kloppenburg" <hrk@kloppenburg.ca>

Obviously something is going awry here.

At no time did I suggest that the research subject should not get a copy of any consent that the subject gave to participating in the research. Of course, anyone who is asked to sign a document gets a copy. That was not the issue I addressed. The issue I addressed was that there access to the record of biomedical research is governed by much more than contracts between investigator and research sponsor. The civil law of the province will supercede any contracts between investigatory, institution, and research sponsor. And as I observed, the research subject's right to access to the record of research is to be assured above all.

Research subjects are assured a right to access to their care file by provincial laws and laws governing professions. That right controls who retains the consent instrument as it does anything else.

Focussing on the rights of subjects does not mean that one should forget that subjects can misconduct themselves. When the do, the situation has to be anticipated without compromising the principle that research subjects have to be protected against investigator and research sponsor abuse.

Where's the problem?

Best regards,

HRK

From: "John Lowman" <lowman@sfu.ca>


Thanks for the clarification.

Your so-called "balanced approach" is the problem. Use of any kind of
ethics review or REB procedure to protect universities, hospitals or
researchers from subjects is a problem. If that protection is needed, it
should be achieved by a mechanism that is clearly independent from
"research ethics." If the informed consent form is pitched to the research
subject as a matter of "ethics" -- i.e. of protecting them from
researchers, hospitals and universities -- why would the institution keep a
copy? Apparently, it is to achieve the "balance" you allude to. Are
subjects informed that the consent form could be used against them, i.e.
that it could be interpreted as a waiver of liability? Apparently not...

JL

From: "H R Kloppenburg" <hrk@kloppenburg.ca>


You and I obviously can't communicate.

Institutions and researchers keep copies of signed consents to participate as a research subject because clinicians are required to do so by the regulations of their professions i.e. to keep records of dealings with patients and clients, and failing that, by the requirement of their institutional environment, and likelier than not, their insurers. Hospitals are required to keep copies of signed consent forms because of legislation and if that doesn't exist, because their risk managers and insurers would insist on that happening.

I know that manipulative and exploitive research subjects do exist. Whether it is within the scope of ethics to take practical measures to balance the certainty of than happening from time to him (happily as rarely) against the importance of keeping a contemporaneous record of dealings and information flowing between research subject and researcher / investigator, is what I suspect is an issue about which we substantially differ. In the marketplace of ideas that is the listserv perhaps a modus vivendi will be attained.

Another distinction exists that should be recognized here. It is the distinction between offence and defence quite like those terms are used in football. A signed consent is never an offence or offensive document so that it can be said to be used against a research subject by a researcher / investigator. A signed consent to participate in research is a defence document to be used to prove the communication of facts, e.g. the risks and benefits of research participation. It may be used defensively against a manipulative or dishonest research subject. A consent only has a defence purpose if the research subject takes the offence typically by alleging wrongdoing in procuring a signed consent, or by the researcher / investigator doing investigations not sanctioned by the terms of the consent.

And if a researcher is compelled to obtain a signed consent by a research sponsor, insurer, professional regulations or guidelines, or institutional regulation, the content of that consent as a transaction between researcher and research subject is properly and necessarily a matter for ethical review.

If the police or a regulatory agency use power in law to obtain a copy of a signed consent from the researcher's records, and use it against a research subject as in a criminal proceeding that is not the problem of the investigator, it is a problem of legal institutions and legislation and one of equality before the law. The researcher / investigator is not using the signed consent against the subject. Everyone who generates a piece of paper no matter how private it is intended to be is subject to sub poena (subject to very limited exceptions in law).

Research subjects are subject to the law quite like investigators / researchers. If a researcher does not want to get a signed consent for fear of compromising a research subject in point of law at some later date, and therefore does not obtain a signed consent, that is a problem between the researcher and the institution wherein s/he functions, secondly is an issue between the researcher and his / her ethics committee, thirdly, an issue between the researcher and his professional governing body, and finally an issue between between the researcher / investigator and his insurer. The listing here does not indicate a ranking of importance.

If the researcher does not retain a copy of a signed consent, no matter for whose protection or for what purpose it was obtained, the researcher will be accountable for failing to do so. Whether s/he is held to account obviously depends on the attitude of the institution where s/he operates and the researcher's professional environment generally, and any court or tribunal where the researcher may appear and regret not having retained a copy of the written document.


HRK

From: "Maria McDonald" <mcdonaldm@smh.toronto.on.ca>

We strongly discourage the storage of the consent form in the clinical
record/medical chart. We firmly believe the consent form should be
stored in the study file, in a secure fashion. If, for medical
treatment purposes, there should be a note on the clinical
record/medical chart that the participant is in the study, then
something more concise than a 10 page consent form should be filed
detailing pertinent medical information (since a lot in the consent form
deals with the rights of the participants). A consent form on a
hospital record, which record is easily obtained by lawyers, treating
doctors, patients, etc., could end up being a red flag for insurance or
litigation purposes. Also, consider, for example, if the consent form
has references to genetic testing.

Similarly, we do not encourage sending a copy of the consent form to a
treating or family doctor. A shorter letter from the principal
investigator outlining pertinent medical information is a better method
of informing the treating or family doctor.

I worked for 7 years in personal injury and medical malpractice
litigation for plaintiffs. I found I could get my hands on just about
anything I wished since the general principle is that once a plaintiff
starts a claim for injuries, he or she puts into issue all aspects of
his or her health. Thus, I have a strong bias regarding this issue.

I am interested to hear other views on this topic.

Maria Z. McDonald, LLB
Vice-Chair, Research Ethics Board
St. Michael's Hospital

From: "Cam McDermaid" <cmcdermaid@cmcc.ca>

I've followed this discussion with some interest. I think Maria has
an excellent point.

A consent form is an attempt to document the consent encounter. What
would be the purpose of a consent form in a health record? If we are
considering protection of the participant, it seems far more
important that a notation describing the participants allocation,
dosage, adverse reactions etc. would be of far more use clinically
and in the participant's best interests.

Cheers

Cam

From: "H R Kloppenburg" <hrk@kloppenburg.ca>


Store the research subject's consent where you will but these question still needs to be answered:

if a research subject presents at the Central Records department of a hospital and demands (as is his / her right) production of his / her complete and entire hospital / health care record will that record including the record of any participation in biomedical research be produced to him / her?
if a research subject presents at the reception area of his / her physician's clinic / office and demands (as is his / her right) production of his / her hospital / chart including the record of any participation in biomedical research be produced to him / her?

Once we know the answer to these questions we can then talk about where the research file and consent therein should be stored. The patient's / research subject's right to get a copy of his / her medical record is paramount, and I daresay, established beyond argument. Once one recognizes that case authority and legislation creates a right of access, it seems me me that the storage site is really irrelevant (unless clinicians having knowledge of a history of research participation will be distracted or such knowledge will take away from the quality of care). If the research subject presents and wants his / her medical record, it should be produced from wherever it may be without delay.

To store the research file off hospital or health care record or off chart the fact that the patient's health care record whether in a hospital setting or physicians office belongs to the patient in the absence of exceptional reasons which it is incumbent on the person having the record to demonstrate. Moreover making it difficult by having the consent stored off record for a research subject or even his lawyer to access the entire health care record smacks of suppressing information which the patient is entitled to get. Moverover, in a civil action the entire record will be discoverable.

If the patient does not have a right to demand and receive access i.e. get a copy of the record of his participation in biomedical research, that fact ought to be stated in the consent instrument in terms like this:

The record of your participation will be the property of the study doctor, and the research sponsor. You will not have a right to get a copy of it. The study doctor and the research sponsor will decide whether you should have a copy of the record of your participation in this research protocol.

I am so bold as to say that no IRC would tolerate this sort of thing. Hence where the consent is stored does not, I suggest change anything ethically. The issue is ensuring disclosure and production when a research subject demands it.

H R Kloppenburg Q.C.

2. University Fails Researcher: Academic Integrity and Freedom

From: "John Lowman" <lowman@sfu.ca>

Listservers:

Here is an article from the Vancouver Sun describing another instance of a
university administration -- this time Exeter University in England --
failing to defend academic freedom and the integrity of research. Once
again, the research involves assisted suicide and euthanasia, and once
again the researcher is Russel Ogden (the article briefly describes his
earlier conflict with Simon Fraser University):

__________________________________________

Academic wins ruling on assisted-suicide research
U.K. university must pay $143,000 after breaking promise to protect sources

Douglas Todd
Vancouver Sun

Saturday, November 01, 2003 Page B3

One of Canada's most controversial researchers has won $143,000 in damages
from a prestigious British university after it reneged on a promise to
protect him while he explored a secret global network conducting assisted
suicides.

In an unprecedented ruling, Exeter University was ordered to pay damages to
Russel Ogden, a PhD student from Vancouver, after it backed out of a
commitment to hide the identities of scores of people who told him they
helped terminally ill people kill themselves.

"Years of my life were squandered solely because of Exeter's refusal to keep
its written commitments and follow its own policies," Ogden said.

He now teaches criminology at Kwantlen University College in Richmond, where
he is continuing his research into assisted suicides, which are illegal.

The ruling against Exeter University, which was made by an independent
university ombudsman said the ethics committee that oversaw Ogden's research
"mishandled" his case and "demonstrated serious incompetence."

Ogden spent years interviewing an underground network of more than 100
people in Canada, Britain, the Netherlands and the U.S. who claimed
first-hand involvement in helping people with AIDS commit suicide.

To obtain the trust of his sources, Ogden had to offer them absolute
confidentiality, particularly if courts ordered him to release their names.

Exeter's ethics committee initially approved this guarantee of anonymity,
Ogden said. But he found out two years into his research, in 1997, that the
committee had changed its mind and backed away from supporting him against
legal efforts to force him to reveal his sources.

This week an official from Exeter, in southwestern England, acknowledged
Ogden's case had revealed a gap in the university's ethical approval policy.
The official apologized to Ogden for the "inconvenience" it caused him and
wished him the best in his career.

Ogden was not impressed, however. Because of Exeter's mishandling, Ogden
said he lost the chance to obtain his PhD. He also cannot publish his
research, he said, since his sources aren't protected from exposure.

This is not the first time Ogden has run into conflict with universities,
their ethics committees and the courts.

In 1998, after a multi-year legal battle, Ogden received an official apology
from Simon Fraser University, where he had earlier earned a master's degree
in criminology while uncovering 34 Canadians with AIDS who had died through
assisted suicides.

Ogden's master's thesis, first revealed to a wide audience in The Vancouver
Sun in 1994, received international media attention and helped changed the
way the public saw assisted suicide among people with AIDS.

SFU admitted it failed to financially support Ogden when he had to defend
his unusual research techniques in Vancouver coroner's court.

In 1995, after a lengthy hearings, then-Vancouver coroner Larry Campbell,
now mayor of Vancouver, ruled Ogden was not in contempt of court for
refusing to identify the people who said they had participated in the
smothering death of an AIDS patient.

Ogden -- who generally believes new laws must be created to cover
euthanasia -- has received strong support from many professors for pushing
the boundaries of academic freedom.

In 1996, an independent SFU committee awarded him the Sterling Prize in
Support of Controversy, which annually goes to researchers conducting
important and contentious work.

"I don't see myself as a rabble-rouser at all," Ogden said. "I see myself as
someone who simply wants to engage in free inquiry. The trouble is a lot of
universities don't see this as their raison d'etre.

"The need for this kind of research has been identified by government and
society. When a university resists free enquiry, I feel I have a duty to ask
questions and hold them accountable. How else is the research going to get
done?"

Ogden says he's grateful to Kwantlen University College for recently
agreeing to support his current research, into what he says is the now
widespread use of "new technologies for assisted death."

One technique involves the use of helium gas, he said. Another requires a
"de-breather," a technology based on scuba diving equipment in which the
person dies by repeatedly inhaling their own breath.

These new technologies, Ogden said, are making euthanasia "quick, painless
and undetectable."

Sun religion and ethics reporter

dtodd@png.canwest.com


_______________________________________

From: "John Lowman" <lowman@sfu.ca>

Here is the CAUT Bulletin article on Russel Ogden's experience at Exeter

http://www.caut.ca/english/bulletin/2003_nov/news/exeter.asp

November 2003 CAUT Bulletin (Canadian Association of University Teachers)
Exeter Pays Canadian Prof $140K Damages

Russel Ogden, a criminologist at Kwantlen University College in Surrey,
B.C., has won $140,466 in damages from Exeter University after it broke a
commitment to protect him while he conducted his PhD dissertation research
on a secret global network conducting assisted suicides. Ogden studied at
Exeter between 1995 and 1998.
The U.K.-based university was ordered to pay damages to Ogden because of its
failure to abide by an assurance it would help keep secret the identities of
the many respondents who told Ogden they had provided euthanasia and
assisted suicide for terminally ill people.
"Years of my life were squandered solely because of Exeter's refusal to keep
its written commitments and follow its own policies," Ogden says.
In 1999, Exeter's Senate Committee of Academic Enquiry ruled the ethics
committee that oversaw Ogden's research had "mishandled" his case and
"demonstrated serious incompetence." The committee also found the level of
supervision fell short of the university's published standards.
Nevertheless, the university refused to offer a remedy.
The only recourse Ogden had was to petition the university's "visitor," in
Exeter's case the Queen. His appeal to the Queen as visitor was handled by
the Lord Chancellor, who was ordered to take jurisdiction on her behalf.
The Lord Chancellor's department confirmed the findings of the academic
enquiry, scolded Exeter for its refusal to award a remedy and ordered
damages for "negligent action."
Ogden spent two years interviewing more than 100 people in Canada, Britain,
the Netherlands and the United States who claimed first-hand involvement in
helping people with AIDS commit suicide.
To conduct his interviews, Ogden had to offer respondents absolute
confidentiality, particularly if courts ordered him to release their names.
Exeter's ethics committee initially approved this guarantee of
confidentiality and gave a written statement recognizing "that entry into
commitments of this kind is integral to the pursuit of truth through
sociological research, and (we) accept the obligation to support and sustain
those who do so."
But in 1997, two years into his research, Ogden learned that just five days
after he received ethical approval, the chair of the committee had quietly
altered the statement, rescinding the committee's support. The change meant
Ogden's research participants were misled about the true conditions for
their informed consent.
In his ruling, the Lord Chancellor said "the main consequence of that
negligence was he could not use the research he had undertaken in reliance
of the university's assurances. In practice therefore he was denied the
opportunity to obtain a PhD at Exeter University."
Ogden had previously fought a high-profile battle with Simon Fraser
University over its refusal to financially support his legal efforts to
protect the confidentiality of the subjects in his MA thesis research, which
had uncovered 34 Canadians with AIDS who had died through assisted suicides.
Ogden's research received widespread attention in the mid-1990s and changed
understanding of suicide among people with AIDS.
After lengthy hearings, Vancouver's coroner ruled in 1995 that Ogden was not
in contempt of court for refusing to identify his respondents. And in 1998,
after a multi-year legal battle, Ogden received an official apology from
Simon Fraser University and compensation for his legal costs in defending
SFU's research policy in coroner's court.
In January this year Ogden faced another subpoena, this time from the B.C.
Crown who will be prosecuting a 72-year-old woman next year on two counts of
aiding suicide.
Ogden said he asked Exeter's ethics committee for guidance on what he should
say to the court, but his answer came from the university solicitors.
"They told me not to communicate with the ethics committee."
"Ogden's experiences show the serious problems social scientists face in
conducting important research into socially-sanctioned behaviour," said
James Turk, executive director of CAUT.
"Without being able to offer respondents confidentiality, this kind of
research cannot be done except with grave risk to the researcher. Yet, these
studies are often of vital social importance."
Turk said CAUT is "having discussions with the Canadian funding agencies to
explore mechanisms to deal with this problem."
Certainly Ogden is delighted that Kwantlen University College has undertaken
to support his current research. "The vice-presidents called me to a meeting
and said they would set aside money, just in case." He says after everything
he's been through, "their commitment to free enquiry is refreshing."
Background: CAUT Bulletin reports June 1998 "When Research Ethics & the Law
Conflict," October 1998 "Consultation Underway at Simon Fraser Following
Coroner's Inquest," and November 1998 "Charting the Way for Research
Ethics."

From: "H R Kloppenburg" <hrk@kloppenburg.ca>

So that those interested can evaluate the story, could you get for us a verbatim copy of the reasons for judgment that you refer to. IN that way we can establish the utility of this as a precedent in Canada.

HRK

From: "John Lowman" <lowman@sfu.ca>


The judgment (with Russel Ogden' annotations) is posted at:
http://www.sfu.ca/~palys/AnnotatedOgdenDecision.pdf

(Thanks to Prof. Kloppenburg for preparing the .pdf version and Ted Palys
for posting it)

At 05:32 PM 09/11/03 -0600, you wrote:
>So that those interested can evaluate the story, could you get for us a
>verbatim copy of the reasons for judgment that you refer to. IN that way
>we can establish the utility of this as a precedent in Canada.
>
>HRK
>

3. Democratic Participation in Research Ethics

From: <Florence.Piron@msss.gouv.qc.ca>


Bonjour,

Réfléchissant à une manière d'améliorer la participation démocratique aux
débats d'éthique de la recherche, je me suis demandée pourquoi les séances
de délibération des comités d'éthique de la recherche n'étaient pas, à ma
connaissance, ouvertes au public, tout citoyen pouvant poser les questions
qui lui semblent importantes. Il semble que c'est plutôt la culture du
secret qui domine ces procédures, comme si des recherches financées
publiquement devaient être protégées du regard de la société civile ou des
autres chercheurs. Pourquoi? Qu'est-ce qui justifie cette situation? Que
pensez-vous de la possibilité de rendre ces séances de délibération
ouvertes et accessibles, en particulier quand de grands projets sont
débattus?

As I was pondering over ways to improve the democratic participation to
research ethics debates, I wondered why the sessions of the REB were not,
to my knowledge, opened to the public and to their questions. It seems that
the REBs are following a policy of secrecy, as if publicly-funded research
projects should be protected against civil society's interrogations (or
other scientists's interrogations). Why? What can justify such a situation?
Why not make those REB's sessions open and accessible to all, espacially
when big projects are debated?

Florence Piron
Anthropologue
Québec

From: "Michael Owen" <mowen@spartan.ac.brocku.ca>

Dear Dr. Piron
This is an interesting question. The issue, I think, is not
democratic participation but one of respecting privileged information
submitted by researchers to the REB, whether from the social
sciences, sciences, humanities or biomedical sciences. As you may
know, research grant applications to federal agencies are protected
information and cannot be released without the permission of the
researcher. A similar argument may be made here.

The practice of REBs vary from institution to institution. Some REBs
have closed meetings, others have meetings that are open but reserve
the right to go in camera for the discussion of protocols and other
issues.

Michael

From: "Short, Donald" <dshort@tor.fasken.com>

Yet again we need to "folow the money".
There are all sorts of competitive issues amongst drug manufacturers and perhaps competing research teams.

I worry that observing an REB process could become a way of looking for stock tips by seeing promising Phase 2 trials.
The public are represented on REB's and I see no overriding "public interest" in opening the process. Rather casual observers may hinder the process and thus contribute to the already existing delays

Don Short
Toronto REB-LS

From: "Jack Corman" <irbs@interlog.com>

Interesting question. I would agree with Richard Neuman and Don Short that,
in general, full public access to REB debates for individual research
projects on the grounds of public funding by itself is not sufficient reason
to allow it. Public consultations on general issues, of course.

Given that ethics review is generally conducted by a group of individuals
that are drawn from society's elite classes, perhaps the question, at least
in part, is how to ensure that during the review process the right of the
person to self-determination (i.e., the autonomy principle) is protected
from arbitrary and patronizing decisions by the CER/REB.

Another part of the question might be how can society ensure that ethics
review is conducted according to appropriate standards and in compliance
with the law, in the public interest of a free and democratic society, then
an independent accreditation and oversight mechanism separate from the
CER/REB/research sponsor/investigator needs to be developed to achieve that
end.


Jack Corman

4. Liability for Lay Members

From: "Richard Neuman" <rneuman@mun.ca>

We recently raised the issue of liability coverage for lay members of
the REB with the University insurance carrier. Under the current policy
lay members on the REB are covered for liability providing they are
dealing with research conducted by University faculty, staff or
students. They are not covered in the case where the REB reviews an
application from an outside agency, e.g., a health board, Workmen's
Compensation Board, or a high school school student. On the other hand
University faculty and staff members on the REB are fully covered in
both situations.
We are considering our options and would be interested in practices
elsewhere. We have been informed it may be possible to add liability
coverage for lay members to the University's existing insurance policy,
at a cost to be determined. An alternative may be to appoint lay
members on the REB to an adjunct position in the University. The REB
could also simply refuse to review outside applications, but we are
moving to a Provincial Health Research Ethics Board and we don't
consider this option as appropriate. We would very much appreciate your
comments.
Richard Neuman, Co-Chair, Human Investigation Committee

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>

Richard -- Our institution's liability assurance includes in the
designation for categories of individuals who are covered, an entry "all
employees of the hospital including volunteers ... ". We are assured by
our legal counsel that volunteers includes community representatives to the
REBs ... elisabeth

From: "Luc Simon" <Luc.Simon@vrr.ulaval.ca>

Here also our institution's liability assurance includes persons serving on
various institutional committees.

I my opinion, it would be wise to let the institution make the decision
concerning the review of "outside protocols" by the REB. This way, if there
is ever a need to bring into play the liability insurance, you could
document that every member of the REB was indeed involved in the conduct of
"Institutional affairs" and should be covered.

This can be viewed as another advantage of remembering that the REB is part
of an Institutional Human Subject Protection Program, and that Institutional
officers should not be kept out of the loop.

Regards,

Luc Simon

5. The Placebo Initiative Report

From: "Sampson, Heather" <Heather.Sampson@rmp.uhn.on.ca>

To members of the NCHER List serve:
I have heard from a number of you, and I thank you for sharing the
information, that you have had difficulty accessing the National Placebo
Initiative's (NPI) Draft Report sent out last week by CIHR/HC. One of the
NPI committee members has very kindly mounted the report and the
stakeholders' questionnaire on his website (in both languages).

As Chair of the NPI, I continue to be indebted to the committee members, not
only for their dedication and hard work, but for their unfailing creativity,
as shown here in solving this problem of accessibility.

Cheers & we look forward to your comments, suggestions & recommendations via
the website.

Heather

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

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>

Congratulations Heather on getting the report out, and on the collaborative
spirit present on the committee you chaired to get the 'sharing' done.

How can i get a copy of the 97 p. report without printing it myself (wink).
Do i contact the CIHR?
thanks ... elisabeth

From: "Michael Goodyear" <michael.Goodyear@cdha.nshealth.ca>

One problem is that you always hit the group straight away with NCEHR, and to reply off line you have to compose a separate message. Whereas with IRB you have to select Reply All, and even then you may not get past the moderator - he rejects half my posts!

Now what have you been doing to yourself?

>>> clarke@muhchem.mcgill.ca 11/24/03 04:06PM >>>
Congratulations Heather on getting the report out, and on the collaborative
spirit present on the committee you chaired to get the 'sharing' done.

How can i get a copy of the 97 p. report without printing it myself (wink).
Do i contact the CIHR?
thanks ... elisabeth

From: "Clark, Elisabeth" <clarke@muhchem.mcgill.ca>

well over last 2 weeks i set up a downtown Retreat for 25 people, developed
the background papers, produced 60 PP slides on 6 topics, sorted out the
SAE reporting requirements for Canada, wrote SAE policy, definitions and
FAQ list, SAE reporting forms for local and non-local, lost my cousin from
infarc and went to a funeral over the w/e and am present this AM with a
shining face ... elisabeth

6. "Mini Olivieri Symposium" on the Journal of Medical Ethics website

From: "Nancy Ondrusek" <nondrusek@sympatico.ca>

I found out about this from the US IRB Forum listserve, but I think it will
be of particular interest here.

Nancy

"Mini Olivieri Symposium" on the Journal of Medical Ethics website available free of
charge on a pre-publication basis: http://www.jmedethics.com
/
Go to left-hand menu "NEW FEATURE: Advanced Publications" and scroll down
to find "The Mini Olivieri Symposium
."

7. PRE: Consultation: TCPS Implementation Feedback Framework

From: "Blake, Andrea" <ablake@ncehr-cnerh.org>

From: TDG@pre.ethics.gc.ca [mailto:TDG@pre.ethics.gc.ca]
Sent: November 5, 2003 1:56 PM
Subject: FW: Consultation: TCPS Implementation Feedback Framework/Cadre de
rétroaction sur l'application de l'EPTC


This is an invitation to participate in a public consultation on a proposal
developed by the Interagency Advisory Panel on Research Ethics (PRE)
regarding the implementation of the Tri-Council Policy Statement: Ethical
Conduct for Research Involving Humans (TCPS) in institutions funded by the
three granting Agencies in which research with human subjects is being
conducted.

The deadline for receiving written submissions on the proposed TCPS
Implementation Feedback Framework (TIFF) is November 30, 2003.

Documents are attached in WORD and PDF format.


From: "Blake, Andrea" <ablake@ncehr-cnerh.org>
To: "List Serv (E-mail)" <ethics@lists.ncehr-cnerh.org>
Subject: [Ethics] FW: REMINDER/RAPPEL: Consultation on TIFF/sur CRA-ETPC: 30Nov. 2 003
Date: Thursday, November 20, 2003 11:50 AM

RAPPEL

English to follow French Text

La présente a pour objet de vous inviter à participer à une consultation
publique concernant une proposition conçue par le Groupe consultatif
interagences en éthique de la recherche (GER) pour la mise en œuvre et
l’application de l'Énoncé de politique de trois Conseils : Éthique de la
recherche avec des êtres humains (EPTC)
http://pre.ethics.gc.ca/francais/policystatement/policystatement.cfm
<http://pre.ethics.gc.ca/francais/policystatement/policystatement..cfm> ,
dans les établissements subventionnés par les trois Organismes
subventionnaires et dans lesquels on entreprend de la recherche avec des
êtres humains. La date de réception de commentaires écrits sur le « Cadre de
rétroaction sur l’application de l’Énoncé de politique des trois Conseils ;
Éthique de la recherche avec des êtres humains (CRA-EPTC) » est fixée au 30
novembre 2003.

Vous trouverez les documents, l’appel de commentaires et la proposition
CRA-ETPC, sur le site suivant sous Participation publique, Appel des
commentaires:

http://pre.ethics.gc.ca/francais/publicparticipation/callforcomments/consult
ationmemo.cfm

<http://pre.ethics.gc.ca/francais/publicparticipation/callforcomments/consul
tationmemo.cfm>

REMINDER

This is an invitation to participate in a public consultation on a proposal
developed by the Interagency Advisory Panel on Research Ethics (PRE)
regarding the implementation of the Tri-Council Policy Statement: Ethical
Conduct for Research Involving Humans
http://pre.ethics.gc.ca/english/policystatement/policystatement.cfm
<http://pre.ethics.gc.ca/english/policystatement/policystatement.cfm>
(TCPS) in institutions funded by the three granting Agencies in which
research with human subjects is being conducted. The deadline for receiving
written submissions on the proposed TCPS Implementation Feedback Framework
(TIFF) is November 30, 2003.

The call for comments and the TIFF proposal are available on the PRE-website
under Public Participation, Call for Comments, at :

http://pre.ethics.gc.ca/english/publicparticipation/commentondocuments.cfm

8. CALL FOR PROPOSALS FOR CASE VIGNETTES for NCEHR Communiqué

From: "Blake, Andrea" <ablake@ncehr-cnerh.org>

REMINDER - Please forward this e-mail or print and post/circulate it so that
those who do not receive NCEHR list serv messages have an opportunity to
contribute.

Thanks, NCEHR Communiqué Editorial Board

Deadline for submissions: December 15, 2003
> -----Original Message-----
> From: Blake, Andrea
> Sent: November 5, 2003 3:21 PM
> To: List Serv (E-mail)
> Subject: CALL FOR PROPOSALS FOR CASE VIGNETTES for NCEHR Communiqué
>
> CALL FOR PROPOSALS FOR CASE VIGNETTES
>
> Please post and circulate to all researchers, including graduate students,
> in your institution.
>
> In the Spring 2004 Issue of Communiqué, NCEHR wishes to include brief case
> examples of specific social science-based research methodologies, tools
> and techniques that raise challenges for the researcher during a
> TCPS-based ethics review or for the REBs. NCEHR invites members of the
> research community and REBs to submit a proposal for a Case Vignette to be
> included in the Spring 2004 issue of Communiqué.
>
> Steps:
> 1. State in a few sentences the methodology, tool or technique
> to be discussed.
> 2. State in a few sentences where the challenge comes into play
> with the TCPS-based ethics review process
>
> DUE DATE for CASE VIGNETTE PROPOSALS: DECEMBER 15, 2003
>
> NCEHR will then select CASE VIGNETTE proposals that represent a broad
> spectrum of the challenges for the research community and REBS related to
> social science research. The authors of the selected CASE VIGNETTES will
> be asked to submit 1-2 page descriptions by February 15, 2004.
>
> NCEHR wishes to thank in advance everyone who participates in helping to
> widen the understanding of the diversity of social science methodology
> issues related to TCPS-based ethics reviews.
>
> Please submit your proposal to Andrea Blake (ablake@ncehr-cnerh.org) by
> the due date of December 15, 2003.
>
Andrea Blake
ablake@ncehr-cnerh.org

774 promenade Echo Drive
Ottawa ON K1S 5N8
TEL: 613-730-6225
FAX: 613-730-8251
http://ncehr-cnerh.org

9. Frontline: Dangerous Prescription

From: "Mark Wilson" <healthresearch@sympatico.ca>


The recent front line documentary might be of interest to some list members.

Frontline: Dangerous Prescription
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/

The program explores the FDA and addresses issues that are increasingly
entering the public spotlight

For those who missed this program on public television, there are
interviews with a variety of people including Marcia Angell, Sidney Wolfe
, FDA officials, etc., which can be viewed with real media technology -
one of the public benefits of information technology.

MHW