While I have many possible comments about this research, let me limit my
comments here to two arguments against doing the research. First, the
deception here is too great. I can accept deception when the deception is
both essential and limited to being about some component of the research;
i.e., what outcome is being measured or why the research is being done.
Here the deception is that the event is research at all. I agree and would
argue strongly that to do research on someone without any type of prior
consent or notice is inherently unethical. Second, why is someone even
doing this project and calling it research? This does not seem to be
academic research, but appears instead to be some sort of voyeurism. The
premise sounds pathetic. Bad research is unethical research.
Daniel L. Icenogle, MD, JD
Icenogle & Associates
1858 Sand Ridge Ct.
Verona, WI 53593-8814
608.832.0549 (voice and fax)
Electronic mail from Daniel L. Icenogle, MD, c/o Icenogle & Associates at
Dan_Icenogle@icenogle.net. This communication is intended for the use of
the addressee. It may contain information which is privileged or
confidential under applicable law. If you are not the intended recipient or
the agent of the recipient, you are hereby notified that any dissemination,
copy or disclosure of this communication is strictly prohibited. If you
have received this communication in error, please notify Icenogle &
Associates at (608) 832-0549 or via return Internet electronic mail at
Dan_Icenogle@icenogle.net and expunge this communication without making any
copies. Thank you for your cooperation.
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of
Joe Rosse
Sent: Wednesday, June 21, 2000 12:15 PM
To: mcwirb@mcwirb.org
Subject: deception research
I'd greatly appreciate thoughts regarding a social psych protocol that
involves a somewhat unusual form of deception.
The study involves approaching same-sex individuals on the street in which
the experimenter indicates that (s)he has noticed the person before, finds
them attractive, and then asks if they would either go out on a date or
sleep with him/her. After the subject responds, the experimenter would
inform the subject that this was a research study, have them sign an
informed consent form, and ask a few additional questions (including one on
sexual preference). (Although the protocol was not written this way, I'm
sure that the investigator would be OK with a requirement that none of the
subjects' responses--including the initial reaction--would be used if the
subject declined to sign the consent form.)
This protocol has created substantial debate within the committee, for lots
of reasons. The one I'd like input on is the argument that it is never
acceptable to involve people in research (other than simple observation)
without PRIOR consent. Since everyone is pretty much in agreement that the
study cannot be done without that level of deception, this is a crucial
point. This obviously goes beyond more typical deception research in which
participants know they're involved in research, but aren't aware of the true
purpose. OTOH, there is certainly plenty of precedent for this kind of
research within social psychology (including studies using exactly the same
methodology, but studying opposite-sex interactions, which the investigator
wants to replicate with same-sex interactions).
Thanks!
Joe Rosse, Ph.D.
Chair, Human Research Committee
University of Colorado, Boulder
_______________________________________________________________________
Why pay when you don't have to? Get AltaVista Free Internet Access now!
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_______________________________________________________________________
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Icenogle & Associates
6/21/2000 11:57:00 AM
Prorated compensation based on compliance
I believe the sponsor might do well to memorize the following:
Effectiveness = Efficacy + Compliance
Why would a sponsor financially penalize a subject due to non-compliance
when effectiveness of an investigational agent is part of a complete study
analysis? A company might have developped *a magic bullet* but if the
delivery mechanism or regimen is too difficult to comply with those aspects
need to be reconsidered, and difficulty with compliance could pose
unnecessary risk to the subject.
Someone is not evaluating too effectively here.
Elisabeth Clark
Research Ethics Officer
McGill University Health Center
At 04:05 PM 20-06-00 -0500, you wrote:
>I would like some feedback on an amendment to an adult drug protocol that
>makes reimbursement for scheduled appointments contingent upon medication
>compliance. (If a subject shows up and hasn't taken all their medicine, the
>sponsor proposes to pay them less). Arguments for and against this practice
>are welcome!!!
>
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
elisabeth clark
6/21/2000 5:05:00 AM
Prorated compensation based on compliance
I think it's ok as long as the reason they didn't take their medicine isn't due
to an AE. Obviously, it's pretty coercive to have them taking medicine -- even
when they feel bad physically -- to get money!f
However, it seems to be a slippery slope -- for everyone involved. Is
compliance really THAT crucial for this study? Or, is compliance really THAT
bad?? If so, why? We have patients that are occasionally non-compliant, but
not to the extent that we'd think about instituting this type of policy to
change the behavior. I think it's a pretty gray area, and the benefits need to
outweigh the risks this might pose.
Regards,
Cheryl Miller, Pharm.D.
Exec. Dir.
SCIREX Corporation
25 Main St.
Hartford, CT 06106
(Embedded
image moved Malone, Wendy
to file: 06/20/2000 05:05 PM
pic00307.pcx)
To: 'mcwirb@mcwirb.org'
cc: (bcc: Cheryl Miller/SCIREX)
Subject: Prorated compensation based on compliance
I would like some feedback on an amendment to an adult drug protocol that
makes reimbursement for scheduled appointments contingent upon medication
compliance. (If a subject shows up and hasn't taken all their medicine, the
sponsor proposes to pay them less). Arguments for and against this practice
are welcome!!!
Cheryl Miller
6/21/2000 9:05:00 AM
Incentives for patient compliance.
On its face, this procedure seems to be perfectly acceptable:
(a) The effectiveness data would generalizable to other patients given
similar incentives, and would not be generalizable to patients not given
similar incentives.
(b) In addition, the study could help lay the groundwork for empirically
distinguishing 'pure pharmacological' effects from the effects of
self-selection (in this case, patient compliance/non-compliance).
Another potential issue has to do with the nature of the drug and
whether non-compliance could produce substantial risks to the patient or
to society. (For example, patients who don't take all of their
antibiotics risk producing a resistant strain of bacteria).
I see no reason for an IRB to object to the proposed incentive
procedure.
---------------------------------------------------------------------
From: Malone, Wendy
To: 'mcwirb@mcwirb.org'
Subject: Prorated compensation based on compliance
Date: Tue, 20 Jun 2000 16:05:43 -0500
> I would like some feedback on an amendment to an adult drug protocol > that makes reimbursement for scheduled appointments contingent upon > > medication compliance. (If a subject shows up and hasn't taken all > their medicine, the
> sponsor proposes to pay them less).
> Arguments for and against this practice
> are welcome!!!
--
RICHARD B. ANDERSON
Bowling Green State University
randers@bgnet.bgsu.edu
http://personal.bgsu.edu/~randers
Richard Anderson
6/21/2000 9:10:00 AM
IOM IRB/data privacy project: Workshop Summary
The Institute of Medicine's Committee on the Role of Institutional Review Boards
in Health Services Research Data Privacy Protection is releasing a document
today. This document describes the presentations and discussions that took
place at the March 13-14, 2000 IOM workshop on Institutional Review Boards and
Health Services Research Data Privacy Protection. This summary reflects what
transpired at the workshop and does not include committee deliberations,
findings or conclusions. The committee's deliberative report is being published
separately, with release anticipated in early August.
The title of the document is Institutional Review Boards and Health Services
Research Data Privacy: A Workshop Summary.
The document will be available on the National Academies website at www.nap.edu
(search on title) or you can go directly to http://www.nap.edu/catalog/9890.html
).
As always, please do not hesitate to contact me if you have further questions.
Lee
Lee L. Zwanziger, Ph.D.
Senior Program Officer
Division of Health Care Services
Institute of Medicine
Mailing: 2101 Constitution Ave NW, Suite FO3117
Washington, DC 20418
phone: 202/334-3042
fax: 202/334-1463
email: lzwanzig@nas.edu
Lee Zwanziger
6/21/2000 12:06:00 PM
Representing my opinion only from a female perspective, I would say that
various levels of sexual harassment are encountered at times by many women
ranging from the mildly unpleasant to the extremely threatening. It really
affects quality of life if it is frequent or otherwise upsetting to the
recipient. How does this research justify carrying out such behavior?
Evelyn Studer, IRB Administrator
Research Triangle Institute
PO Box 12194
Research Triangle Park, NC 27709-2194
919-541-6442
STUDER@rti.org
-----Original Message-----
From: Dale E. Hammerschmidt [mailto:hamme001@maroon.tc.umn.edu]
Sent: Wednesday, June 21, 2000 3:19 PM
To: rosse@altavista.com; mcwirb@mcwirb.org
Subject: Re: deception research
I'll be interested in responses to this.
It seems to me that this is exposing an individual without consent to a risk
of
pretty substantial embarrassment and might be tricking the individual into
divulging information s/he'd rather keep private.
I think of my two mildly autistic teenagers, and how they might be affected
by
such an approach. My daughter would be frightened and not know how to
respond;
my son would be likely to be enraged. How are the investigators proposing to
exclude such vulnerable individuals from their study?
Given the possibility of encountering someone like my son, or just the
possibility of encountering a malignant homophobe (they aren't that rare,
you
know), I'd also wonder about the investigator's insurance coverage ---
including liability and work-comp.
It's not immediately obvious to me that this one could be designed well
enough
to be both ethical and scientifically valid.
Dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Evelyn Studer
6/21/2000 11:59:00 AM
I think Dale raises a key point. While there are risks to the subjects,
the risk to the investigator could be much worse. Think about Matthew
Shephard in Wyoming. I would hesitate to approve a project like this
because of a worry that the person doing the interviews could be shot or
stabbed by a violent homophobe.
At 02:19 PM 6/21/00 -0500, Dale E. Hammerschmidt wrote:
>
>I'll be interested in responses to this.
>
>It seems to me that this is exposing an individual without consent to a risk
>of
>pretty substantial embarrassment and might be tricking the individual into
>divulging information s/he'd rather keep private.
>
>I think of my two mildly autistic teenagers, and how they might be
affected by
>such an approach. My daughter would be frightened and not know how to
respond;
>my son would be likely to be enraged. How are the investigators proposing to
>exclude such vulnerable individuals from their study?
>
>Given the possibility of encountering someone like my son, or just the
>possibility of encountering a malignant homophobe (they aren't that rare, you
>know), I'd also wonder about the investigator's insurance coverage ---
>including liability and work-comp.
>
>It's not immediately obvious to me that this one could be designed well
enough
>to be both ethical and scientifically valid.
>
>Dale
>
>Dale Hammerschmidt
>Assoc Prof Med / (Hematology/Oncology/BMT)
>Editor., J. Lab. Clin. Med.
>Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
>612-626-2640; 612-626-2642 (fax)
> InterNet
>72662,76 (CompuServe)
>
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Brian Belanger
6/21/2000 11:27:00 AM
I'll be interested in responses to this.
It seems to me that this is exposing an individual without consent to a risk of
pretty substantial embarrassment and might be tricking the individual into
divulging information s/he'd rather keep private.
I think of my two mildly autistic teenagers, and how they might be affected by
such an approach. My daughter would be frightened and not know how to respond;
my son would be likely to be enraged. How are the investigators proposing to
exclude such vulnerable individuals from their study?
Given the possibility of encountering someone like my son, or just the
possibility of encountering a malignant homophobe (they aren't that rare, you
know), I'd also wonder about the investigator's insurance coverage ---
including liability and work-comp.
It's not immediately obvious to me that this one could be designed well enough
to be both ethical and scientifically valid.
Dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
6/21/2000 11:30:00 AM
Recruitment Procedures for Genetic Family Studies
I am posting this message for Robyn Shapiro at . Robyn is the Director of the MCW Bioethics Center. Please respond either to the MCWIRB list or to Robyn privately.
In genetic familial studies, what process is used for contacting family member prospective research participants: Asking the proband to contact
his or her family members or collecting names and addresses from proband
and having the PI contact the family members directly? What are the
arguments supporting one way or the other?
By the way, please check out the new graphics (yet with the same functionality) at http://www.mcwirb.org
Robert Skip Nelson, MD, PhD
Coordinator, The IRB Discussion Forum
Anonymous
6/21/2000 12:15:00 PM
NIH announcement on REQUIRED EDUCATION
Posted here to MCWIRB for your information:
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS Release Date: June 5, 2000
NOTICE: OD-00-039 National Institutes of Health Policy: Beginning on October 1, 2000, the NIH will require education on the protection of human research participants for all investigators submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects. Background To bolster the Federal commitment to the protection of human research participants, several new initiatives to strengthen government oversight of medical research were announced by HHS Secretary Shalala on May 30, 2000. This announcement also reminds institutions of their responsibility to oversee their clinical investigators and institutional review boards (IRBs). One of the new initiatives addresses education and training. This NIH announcement is developed in response to the Secretary’s directive. Implementation Before funds are awarded for competing applications or contract proposals involving human subjects, investigators must provide a description of education completed in the protection of human subjects for each individual identified as “key personnel” in the proposed research. Key personnel include all individuals responsible for the design and conduct of the study. The description of education will be submitted in a cover letter that accompanies the description of Other Support, IRB approval, and other information in accordance with Just- in-Time procedures. The use of a cover letter is also acceptable for contract proposals. After October 1, 2000, investigators submitting non-competing renewal applications for grants or annual reports for research and development contracts that involves human subjects research must also include a description of such education in their annual progress reports. This NIH policy will eventually be superceded by the DHHS Office of Research Integrity’s institutional assurance on the responsible conduct of research, which is described below. Related Training Requirement The Office of Research Integrity (ORI), Department of Health and Human Services, is developing a policy to implement an extension of the training requirement on the responsible conduct of research (RCR) to all persons supported by PHS research. The protection of human subjects in research will be included in the RCR institutional assurance. A draft of this policy will be posted for comment on the ORI website in June, 2000. Educational Resources While all investigators need education in the basics of human subjects research, some may elect more intensive study if their work involves especially difficult topics or special populations. Many institutions already have developed educational programs on the protection of research participants and have made participation in such programs a requirement for their investigators. The NIH does not plan to issue a list of “endorsed” programs. Rather, the NIH points out that a number of curricula are readily available to investigators and institutions. For example, all NIH intramural investigators and research administrators who oversee clinical projects are required to complete the on-line tutorial “Protection of Human Research Subjects: Computer- Based Training for Researchers”. (See <http://helix.nih.gov:8001/ohsr/newcbt/>) While this training module was developed for NIH staff, it can be downloaded at no cost and modified for use in other institutions, if desired. To facilitate education and the development of curricula, the NIH launched a website on bioethics in 1999. (See <http://www.nih.gov/sigs/bioethics/>)This site is replete with resources (>4500 references) on a broad range of relevant topics, including human subjects in research, medical and healthcare ethics, and the implications of genetics and biotechnology. This website also contains a broad set of annotated web links, including
Anonymous
6/20/2000 8:23:00 AM
Washington Post story re:Koski and gene study investigation
Head of Watchdog Agency Faces Questions
By Rick Weiss and Deborah Nelson
Washington Post Staff Writers
Tuesday , June 20, 2000 ; A02
The new director of the federal government's lead watchdog agency for
human medical experiments is himself embroiled in an ongoing
investigation by that agency into a gene study that he supervised in
his previous job.
Harvard professor Greg Koski was tapped two weeks ago to lead the
Office for Human Research Protections, the agency the Clinton
administration recently renamed, revamped and relocated to a top spot
in the Department of Health and Human Services.
Until the new appointment, Koski was director of human research
affairs at Partners HealthCare System Inc. in Boston, where he oversaw
the protection of research volunteers in experiments carried out by a
consortium of Harvard-affiliated hospitals.
Greg Koski is the right person with the right experience at the right
time to take on this challenge, Secretary of Health and Human
Services Donna E. Shalala said in announcing his position.
Not said, however, was that the employees Koski is poised to supervise
are already investigating a whistleblower's complaint about the
adequacy of patient protection in a gene study by Brigham and Women's
Hospital, one of the consortium of hospitals in his charge.
An HHS spokesman called the apparent conflict of interest routine
and said the new director would recuse himself from overseeing the
agency's Harvard investigation.
But patient protection experts inside and outside the government
criticized that approach as inadequate, because Koski still would
oversee the investigative staff and have authority over staff members'
careers.
It would certainly seem a smart thing for a person like Greg Koski
not to walk into a situation where, if the outcome of the
investigation is to exonerate Harvard, then you have people saying,
'Well, of course. What else could those employees have done? Are they
going to turn in their boss?' said Alex Capron, a professor of law
and medicine at the University of Southern California and a member of
the National Bioethics Advisory Commission.
In ethics what is so very important is not only the absence of a
conflict but the absence of a perception of a conflict, Capron said.
It's an issue that anyone coming into the job has to be sensitive to,
and if I were Greg Koski I wouldn't want to get off on the wrong
foot.
Critics called for the Harvard investigation to be handed over to the
independent HHS Office of Inspector General.
Koski was not available for comment.
Formal complaints of patient abuses in medical research are relatively
rare. The current investigation stems from a former Harvard faculty
member's complaint last September alleging regulatory violations in
several related genetic studies in China run by Harvard researchers
through various institutions, including Brigham and Women's.
Most of the studies involved drawing blood from Chinese participants
to search their DNA for genetic links to various diseases. The
complaint alleged that the researchers and their sponsoring
institutions did not adequately weigh, among other things, the risk
that the Chinese government would discriminate against those
participants found to have a genetic defect.
Koski chaired the Harvard-affiliated science and ethics oversight
committee that was responsible for approving the China experiment
repeatedly in annual reviews. An HHS official said Koski never
personally gave his approval of the China study because a
subcommittee handled those annual reviews a delegation of
authority the HHS official acknowledged may not have been in full
compliance with federal regulations.
A Brigham and Women's spokeswoman disagreed, saying Koski personally
read and ratified the subcommittee's recommendations.
In either case, both officials agreed, Koski was ultimately
responsible for the China study's ongoing approval.
The complaint was filed initially with the federal Office for
Protection from Research Risks (OPRR) the predecessor to
Koski's new Office for Human Research Protections, which came into
formal existence yesterday and has inherited the OPRR's investigative
caseload. Sources said the investigation of the Harvard study could
take months or even years to complete, because the office has a
limited staff.
A Harvard spokeswoman said an internal oversight committee visited
China last April and found adequate protections in place to ensure
that participants were well-informed about the study and that any
genetic information about them would be kept confidential.
The controversy comes at a time of heightened public and congressional
interest in the protection of human subjects in medical experiments
interest that reached critical mass last September following
the death of a mostly healthy teenage patient in a University of
Pennsylvania gene therapy study.
In April the HHS inspector general released a report concluding that
the federal government had made minimal progress in the past two
years toward implementing suitable protections for people in medical
experiments.
Three weeks later, Shalala introduced several initiatives to enhance
protections for human research subjects. But the cornerstone of
Shalala's plan has been the long-awaited upgrading of the OPRR
a relatively low-ranking office in the National Institutes of Health
to the newly renamed Office for Human Research Protections,
which has the prestige of being located within Shalala's office.
Koski was chosen to lead that office after a nationwide search and was
hailed by department officials as someone who would reinvigorate
federal patient protection programs.
© 2000 The Washington Post Company
Sheri Alpert
John C. Reilly Center for Science, Technology, and Values
University of Notre Dame
Notre Dame, IN
Sheri Alpert
6/20/2000 3:10:00 AM
Recruitment Procedures for Genetic Family Studies
Having the proband give the names and addresses to the investigator has a lot of
potential for intrusiveness, and we usually don't do that.
Our routine is for the investigator to prepare a study invitation that the
proband gives to the family member of interest, then have that person contact
the investigator.
Once in a while, we've allowed the proband to get oral permission for the
contact, then transmit that permission to the investigator. That's a bit more
liable to situational/social pressure to participate, so we've not liked it if
the information sought is at all sensitive.
Legally, I suppose there's no barrier to the more intrusive approach (this
doesn't involve compromise of medical records and the like). But we've generally
felt that:
a) non-intrusive is better than intrusive;
b) there is a sub-set of the population for which the risk of cold-calling
is not trivial.
Dale
Dale E. Hammerschmidt, M.D.
Associate Professor of Medicine, Univ. Minnesota
Editor, J. Lab. Clin. Med.
Director of Education in Research Ethics and Compliance
Box 480 Mayo Building; Minneapolis 55455
612-624-0123 (voice, Heme/Onc/BMT)
612-626-2640 (voice, Journal office)
612-626-2642 (fax)
hamme001@tc.umn.edu
Dale Hammerschmidt
6/20/2000 8:23:00 AM
NIH announcement on REQUIRED EDUCATION
Does anyone know if local investigators and other key personnel can take the
NIH education, available on-line, and register with NIH in the same fashion
as NIH employees when the education is completed? If they can, does NIH
keep that registration on file such as when subsequent grants are applied
for, that registration is sufficient to indicate that the necessary human
protection education has been done?
Daniel L. Icenogle, MD, JD
Icenogle & Associates
1858 Sand Ridge Ct.
Verona, WI 53593-8814
608.832.0549 (voice and fax)
Electronic mail from Daniel L. Icenogle, MD, c/o Icenogle & Associates at
Dan_Icenogle@icenogle.net. This communication is intended for the use of
the addressee. It may contain information which is privileged or
confidential under applicable law. If you are not the intended recipient or
the agent of the recipient, you are hereby notified that any dissemination,
copy or disclosure of this communication is strictly prohibited. If you
have received this communication in error, please notify Icenogle &
Associates at (608) 832-0549 or via return Internet electronic mail at
Dan_Icenogle@icenogle.net and expunge this communication without making any
copies. Thank you for your cooperation.
Icenogle & Associates
6/20/2000 8:23:00 AM
Recruitment Procedures for Genetic Family Studies
It would be inappropriate and an invasion of privacy for the proband to
release names and addresses of his/her relatives to the PI without their
specific permission. The PI should not be calling or writing the
relatives before they have expressed interest (to the proband) in being
contacted. Thus, the proband should approach the relatives, and obtain
their permission to release their names and addresses to the PI. She/he
would pass on the names and addresses of relatives who have agreed to be
contacted. Then the PI could write these relatives, tell them about
the study, and invite them to call the investigators if they are
interested in participating.
Erica C. Jonlin, Ph.D.
Human Subjects Review Coordinator
Human Subjects Division
Box 355752
(206)543-4798 phone; (206)685-9502 fax
On Mon, 19 Jun 2000, Robert Nelson wrote:
> I am posting this message for Robyn Shapiro at . Robyn is
> the Director of the MCW Bioethics Center. Please respond either to the MCWIRB
> list or to Robyn privately.
>
> In genetic familial studies, what process is used for contacting family member
> prospective research participants: Asking the proband to contact
> his or her family members or collecting names and addresses from proband
> and having the PI contact the family members directly? What are the
> arguments supporting one way or the other?
>
> By the way, please check out the new graphics (yet with the same functionality)
> at http://www.mcwirb.org
>
> Robert Skip Nelson, MD, PhD
> Coordinator, The IRB Discussion Forum
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
Erica Jonlin
6/20/2000 3:14:00 AM
Nominations for Members on National Human Research Protections Advisory Committee
[Federal Register: June 19, 2000 (Volume 65, Number 118)]
[Notices] [Page 37981] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr19jn00-66]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Establishment and Request for Nominations; National Human Research Protections Advisory Committee
AGENCY: Office of Public Health and Science, DHHS.
ACTION: Notice of establishment and request for nominations for members
on National Human Research Protections Advisory Committee.
SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
493, as amended (5 U.S.C. App. 2), the Office of Public Health and
Science (OPHS), announces the establishment of the Advisory Committee
on National Human Research Protections by the Secretary, DHHS, June 6,
2000, of the following Federal advisory committee:
The Department of Health and Human Services (DHHS), National Human
Research Protections Advisory Committee (NHRPAC or Committee) will
provide expert advice and counsel to the Secretary of DHHS, Assistant
Secretary for Health (ASH), the Director, Office for Human Research
Protection (OHRP), and other departmental officials on a broad range of
issues and topics pertaining to or associated with the protection of
human research subjects. NHRPAC will serve as the Department's
principal advisory body on matters pertaining to human subjects
protection.
Members will be selected from among individuals possessing
demonstrated experience and expertise in any of the several areas
pertinent to human subjects protection. The Director, OHRP, shall serve
as Executive Secretary of the Committee.
Duration of this Committee is continuing unless formally determined
by the Secretary, DHHS, that termination would be in the public
interest.
The Secretary, Department of Health and Human Services (DHHS), has
established the Office for Human Research Protections (OHRP) within the
Office of Public Health and Science (OPHS), Office of the Secretary
(OS), which will be under the direction of the Assistant Secretary for
Health (ASH), for the purpose of assuming the responsibilities for
human subjects protection activities currently carried out by the
former Office of Protection from Research Risks (OPRR), National
Institutes for Health (NIH).
The National Human Research Protections Advisory Committee
(NHRPAC), consisting of members appointed from nominees with
demonstrated expertise in the protection of human subjects in research
and federal officials has been chartered in accordance with the Federal
Advisory Committee Act (FACA) to provide expert advice and counsel to
the Secretary, ASH, the Director, OHRP, and other departmental
officials on a broad range of issues and topics pertaining to or
associated with the protection of human research subjects.
Nominations are sought of individuals who possess demonstrated
expertise in human subjects protections, the conduct of research
involving human subjects, the oversight of research involving human
subjects, patient representation or advocacy, biomedical ethics,
researchers, and others possessing pertinent experience and expertise
in the field. Self-nominations or nominations of individuals by
organizations or third parties are invited.
Self-nominations must include a complete curriculum vitae which
provides descriptions of pertinent experience and expertise and a
letter expressing interest in being considered for appointment. The
curriculum vitae, cover letter, or both must contain full contact
information.
Nominations proffered by organizations or third parties must
include a complete curriculum vitae which provides descriptions of the
nominee's pertinent experience and a cover letter of nomination that
indicates that the nominee has been contacted and agreed to the
nomination. Nomination letters from organizations should be on
Anonymous
6/20/2000 8:21:00 AM
Do any of you have dual roles of both managing the IRB and serving as the Chairperson? I manage a County IRB housed at our County Medical Center. It is small operationally having about 50-60 active protocols at any given time. To date, the Chairs have been active researchers who have most of the protocols which I see as a conflict of interest. We have the same issue with members but this is a much easier one to work with since terms allow rotation off the Board. No one really wants the responsibility of the Chair. I am a voting member of the IRB and have considered chairing it as a matter of function and continuity. This sounds so logical, it must have a down side that I'm not seeing and would appreciate feedback on why this might or might not be a good idea.
Anonymous
6/19/2000 1:20:00 PM
Value-laden Institutions and IRBs
Erica has, as usual, raised a nub question on this discussion.
I have another: how does the IRB being part of an institution relate to the
Helsinki Declaration requirement that reviewing committees must be
independent?
I assume that the committee must be independent of researchers or treating
professionals.
But it seems from here that it is almost impossible for institutional boards
to be sufficiently independent of their institutions to qualify. Certainly
a lot of the discussion on this list gives me the impression that the
independence is, at the very least, blurred. The current theme is one such
indication.
Frank Gaze
New Zealand
Frank And Margaret Gaze
6/19/2000 2:50:00 AM
New Human-Research Office Will Lack the Police Power of Its P redecessor
> From this language, it appears that the OHRP will only
> recommend action
> rather than take action.
As a matter of administrative law, it is unclear what this means - ultimately,
all agency subdivisions only recommend actions in that the secretary of the
agency has the final enforcement authority. The important question is whether
the secretary will second guess the recommendation or just rubber stamp it. In
my own view, it will depend strictly on how the polls are balanced against the
lobbyists.
Ed
Edward P. Richards
Executive Director - Center for Public Health Law
Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
Edward Richards
6/19/2000 5:37:00 AM
Good morning...there is a program for certification of IRB professionals
newly in place....I believe the first exam is to be given early this fall.
An accreditation program for IRBs and investigators is in the
works....information on both may be obtained from the ARENA/PRIM&R offices
in Boston.
gk
> -----Original Message-----
> From: Dr. Michael Owen [SMTP:mowen@acs.ryerson.ca]
> Sent: Monday, June 19, 2000 7:47 AM
> To: mcwirb@mcwirb.org
> Subject: IRB/REB Certification
>
> As a non-American listener, I wish to inquire about IRB certification --
> is there a process/requirement for IRBs or for IRB administrators to be
> certified? If so,where would I be able to locate the regulations (federal
> or state) on IRB certification.
>
> As a member of SRA I understand that there have been some discussions of
> certification programs/processes for IRB administrators. Is there a Body
> of Knowledge or www site where one might review the requirements for
> certification of IRB administrators?
>
> Thank you,
>
> Michael Owen
> Ryerson Polytechnic University
> Toronto
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Greg
6/19/2000 5:37:00 AM
New Human-Research Office Will Lack the Police Power of Its P redecessor
> From this language, it appears that the OHRP will only
> recommend action
> rather than take action.
As a matter of administrative law, it is unclear what this means - ultimately,
all agency subdivisions only recommend actions in that the secretary of the
agency has the final enforcement authority. The important question is whether
the secretary will second guess the recommendation or just rubber stamp it. In
my own view, it will depend strictly on how the polls are balanced against the
lobbyists.
Ed
Edward P. Richards
Executive Director - Center for Public Health Law
Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
Edward Richards
6/19/2000 2:50:00 AM
The independent authority of the new OHRP.
The Chronicle of Higher Education has recently posted a correction to its
June 14th article which noted certain constraints on the prerogatives of the
new Office for Human Research Protections (OHRP) to independently suspend
research projects at universities, at the request of DHHS officials.
Additional clarification may yet be needed as the Federal Register
specifically states that OHRP's Division of Compliance Oversight has four
roles including (3) recommends remedial or corrective action as necessary
to agency or Department officials as appropriate;. Also, nowhere else is
it identified or stated that the Office of the Director, OHPR, has this
authority, and the full functional statement for OHRP does not address this
issue. [See Federal Register June 13, 2000, Page 37137.]
Maybe this level of ambiguity is needed although it seems to unnecessarily
raise uncertainty as to intent, compared to the actual straight forward
reading of the Federal Register notice.
Will there be a more definitive statement forthcoming as to intent of the
full scope of independent authority to be exercised by OHRP to suspend
research projects without review (and possible veto) by more senior
officials in DHHS?
John H. Mather MD
Chief Officer, (10R),
Office of Research Compliance and Assurance,
Veterans Administration
M . D . Orca
6/19/2000 2:50:00 AM
Dr. Weiner:
If the IRB at the across town medical center is becoming the IRB of
record, then it must perform an initial review of the transferred studies.
The consents would have to be amended to reflect the new IRB, new location
and any other changes. The process for informing the subjects currently
enrolled is outlined below.
If another PI is appointed to replace a departing PI at the current
institution, the consents for subjects currently on study would have to be
amended, following IRB approval of the change. Those subjects who have
completed their involvement in the study would not have to be
contacted/reconsented. Notification/reconsenting is usually by one of two
means: (1) an entirely new consent form that contains the new information,
or (2) an amendment to the existing form. The trouble with phone
conversations or mailings as the only means of conveying the new information
is that there is no positive record of notification. They can be used as
initial notification when circumstances warrant, followed by signing an
amended form at the next visit. The IRB and the new PI should be able to
agree on an acceptable method of notification.
Not an official OHRP or FDA message.
[Please note, today is the day, OPRR is gone, OHRP is here.]
Paul W. Goebel, Jr.
Division of Human Subject Protections
Office for Human Research Protections
Department of Health and Human Services
6100 Executive Boulevard, suite 3B01, MSC-7507
Rockville, MD 20892-7507
Phone: 301-402-4372
email: pg122v@nih.gov
Fax: 301-402-4256
OHRP url: http://grants.nih.gov/grants/oprr/oprr.htm
When I was with FDA, my guidance was
Paul Od
6/19/2000 5:35:00 AM
To all
It seems that many IRBs are struggling with trying to establish
investigator compliance. Having the PI fill out a form that asks any
number of questions plus receiving copies of all informed consents
within the monitoring period may not be sufficient. It would seem that
an IRB should have access to the information extracted by CROs. The
informed consent does seem to give us that option. Has anyone
approached a CRO for their information and if so what was their
response?
Norman Leopold,DO
IRB chair
Crozer Chester Medical Center
610-447-6188
Norman Leopold
6/19/2000 1:20:00 PM
It is logical and makes sense but
-- as the chair of the IRB would you be supervising your own work as manager?
-- as manager do you assist investigators in putting their best foot
forward, in counselling potential whistle-blowers, in helping to write the
consent form? If yes, consider the conflict of interest in reviewing your
own work.
-- as the chair you need the respect of the investigators and the trust of
the administration in order to enforce unpopular decisions. Would you be
given the respect and trust or is that given only to MDs? or only to
researchers? Would there need to be a paradigm shift before you could
function effectively?
ERICA
>Do any of you have dual roles of both managing the IRB and serving as the
>Chairperson? I manage a County IRB housed at our County Medical Center. It is
>small operationally having about 50-60 active protocols at any given time. To
>date, the Chairs have been active researchers who have most of the protocols
>which I see as a conflict of interest. We have the same issue with members but
>this is a much easier one to work with since terms allow rotation off the
>Board. No one really wants the responsibility of the Chair. I am a voting
>member of the IRB and have considered chairing it as a matter of function and
>continuity. This sounds so logical, it must have a down side that I'm not
>seeing and would appreciate feedback on why this might or might not be a good
>idea.
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
#################################
Erica Heath
IRC
PO Box 170 - San Anselmo CA 94979
Phone 415-485-0717
WEB www.irb-irc.com
#################################
heath
6/19/2000 1:20:00 PM
BOB
I am responding as president of a Central IRB.
Every institution has the right and responsibility to designate the IRB to
serve for that institution. Most institutions designate an in-house IRB.
It also has the right to allow another IRB to review in selected cases or
to contract with another institution's board. You don't need to state any
reasons.
Your hospital IRB (given it is authorized by the institution to make the
decision) has the right to decide whether or not to allow review of a
central IRB to be accepted within your hospital.
Others have covered the usual reasons: control and liability. Another is
consistency within the institution.
There are some institutions that contract with an external IRB. These are
typically low-volume places where maintaining an educated IRB is difficult.
Others find that the only people who agree to serve as members are
researchers with a conflict of interest.
Bottom line, I love having institutions agree to allow us to review
studies but you have to have a policy you can live with and the central
IRB's desires and the sponsor's desires should not really play a role in
your decision.
Erica
>Our hospital based IRB has chosen not to authorize central and other outside
>IRBs to approve studies conducted in our institution. Although federal
>regulations would allow the the IRB to delegate this responsiblity to another
>IRB, our IRB has chosen not to accept this action. The hospital's lack of
>control and increased liability were two major issues considered in adopting
>this policy.
>
>I am sure there are many other logical arguments for and against the use of a
>local rather than a Central IRB. I would welcome your comments, both for and
>against the issue.
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
#################################
Erica Heath
IRC
PO Box 170 - San Anselmo CA 94979
Phone 415-485-0717
WEB www.irb-irc.com
#################################
heath
6/19/2000 1:20:00 PM
Dear Michael,
Increasingly, some local IRBs (or comite de docencia) charge a
considerable amount for reviewing Protocols and amendments in Argentina.
I guess this is quite simmilar to the case yo state in the US. This funding
is done by sponsors, in most cases pharmaceutical companies running or
sponsoring their own trials.
I guess this is simmilar to what you state as conflict of interests.
The question pehaps would be, how to make sure IRBs are finnancialy covered
for their work but at the same time rule out any conflict of interests ?
I can´t think of an answer.
Anyone?
Anne Blanchard
Argentina
-----Mensaje original-----
De: Michael Jann [mailto:Jann_mw@Mercer.EDU]
Enviado el: Lunes, 19 de Junio de 2000 07:34 a.m.
Para: Anne
Asunto: Re: RV: Central VS Local IRB
In the USA, it's an issue of conflict of interest for central IRB's who
receive
support from industry to review and approve their protocols.
Anne wrote:
> Dear Jann,
> In Argentina we have the umbrella system (approval by a local IRB and
> approval by an independant IRB is always requested)
> What is the difference between Central and Independant IRBs?
> Thanks,
> Anne Blanchard
> ARGENTINA
> Tel/Fax: (+5411) 4832-6745
> e-mail: anne@ssdnet.com.ar
>
> -----Mensaje original-----
> De: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]En nombre de
> michael jann
> Enviado el: Viernes, 16 de Junio de 2000 02:41 p.m.
> Para: mcwirb@mcwirb.org
> Asunto: Re: Central VS Local IRB
>
> Central IRB's are acceptable in cases where the facility doesn't have its
> own
> IRB. We see this usage incraesing. However, our University has never
> accepted
> central IRB's. One, being a University, it's a different scenario.
> However, I
> have one specific problem with Central IRB's is that these places maybe
> under a
> conflict of interest as the industry actually pays them a fee for their
> review.
> If there was another mechanism for facilites for IRB reviews, contracting
> out to
> another independent IRB maybe a solution.
>
> Bob Short wrote:
>
> > Our hospital based IRB has chosen not to authorize central and other
> outside
> > IRBs to approve studies conducted in our institution. Although federal
> > regulations would allow the the IRB to delegate this responsiblity to
> another
> > IRB, our IRB has chosen not to accept this action. The hospital's lack
of
> > control and increased liability were two major issues considered in
> adopting
> > this policy.
> >
> > I am sure there are many other logical arguments for and against the use
> of a
> > local rather than a Central IRB. I would welcome your comments, both
for
> and
> > against the issue.
> >
> > _______________________________________________
> > MCWIRB maillist - MCWIRB@mcwirb.org
> > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Anne
6/19/2000 5:40:00 AM
Electronic Signatures -Reply
We have dealt with this issue on several levels. I would suggest that:
You state clearly in you policies and procedures how this is to operate including log-on procedures, security etc.
Next I would review the the Guidance documents for Computerized Systems used in Clinical Trials - See FDA Web
and 21 CFR 11.100(c)
>>> Erin Morgan 06/19 11:10 am >>>
I am the new IRB Coordinator for Spartanburg Regional Medical Center. Does
anyone have any suggestions on using electronic signatures for approval
letters? We use an electronic signature for the chairman with my typed
initials on the bottom. Is this ok by FDA/OPRR/Joint Commission.....etc.
standards?
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul Papagni
6/19/2000 8:58:00 AM
New Human-Research Office Will Lack the Police Power
At the OPRR/FDA TOWN MEETING held in Chapel Hill, NC, on Friday, 16 June, the
following individuals served as panelist.
Jeffrey Cohen OPRR
J. Thomas Puglishi OPRR
Paul Goebel OPRR
Bonnie Lee FDA
Joan Porter OCRA/VA
Marjorie Speers, NBAC, CDC
The panel was specifically asked about the authority that OHRP could exercise.
Dr. Puglishi indicated that, based clarification received earlier in the week
from the Secretary, OHRP would have the same authority that was held by OPRR.
He did not elaborate on the regulatory references that provide that authority.
As indicated earlier, there was no indication that there would be an increase in
the number of audit visits from OHRP. However, they indicated that IRB
meetings that lasted for excessively periods were probably not effective
meetings -- six-hours was the example mentioned.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
George (Trey) Turner, III, M.A., R.Ph.
Clinical Research Management Program
Duke University, Graduate School of Nursing
Box 3322, DUMC, Durham, NC, 27710
Phone: 919-668-5108 Fax: 919-668-6120
eMail: george.turner@duke.edu
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
turne051@mc.duke.edu
6/19/2000 1:20:00 PM
IRB Certification with ARENA/PRIM&R at Oct. Conference
A number of you have expressed interest in learning more about the ARENA
certification exam which will be held on Oct. 28 in San Diego. Either Gary
Chadwick (gary_chadwick@urmc.rochester.edu) or Susan Kornetsky
(kornetsky@a1.tch.harvard.edu) can fill you in on the particulars. Handbooks
and further information can also be obtained from the Professional Testing
Corporation, 1350 Broadway, NY, NY, 10018 (telephone: 212/356-0660).
Please let me know if you have difficulty reaching one of these three
resources, and I will be happy to help you find out more about both the test
and process in general.
A renewing summer to all!
Joan Rachlin
rachlinj@aol.com
6/19/2000 4:12:00 PM
foreign language consent forms
This message is in MIME format. Since your mail reader does not understand
this format, some or all of this message may not be legible.
------_=_NextPart_001_01BFDA2E.DBEA9D40
Content-Type: text/plain
Joan,
Although perhaps not optimal, our IRB requires that the investigator
document/certify that the IRB-approved informed consent document was
translated into the non-English language by someone fluent and that the
translated IC was translated back to English by another individual. The
investigator must further provide a contact person (someone fluent in the
language), including telephone number, in the non-English consent for the
subject to contact for questions.
Hope this helps.
Betty
Betty L. Dunger
Coordinator, Institutional Review Board Activities
MetroHealth Medical Center
Cleveland, OH 44109-1998
email: bdunger@research.metrohealth.org
(216) 778-5459 (IRB office)
(216) 778-3884 (direct)
(216) 778-8720 (fax)
------_=_NextPart_001_01BFDA2E.DBEA9D40
Content-Type: text/html
Content-Transfer-Encoding: quoted-printable
<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: foreign language consent forms Joan, Although perhaps not =
optimal, our IRB requires that the investigator document/certify that =
the IRB-approved informed consent document was translated into the =
non-English language by someone fluent and that the translated IC was =
translated back to English by another individual. The =
investigator must further provide a contact person (someone fluent in =
the language), including telephone number, in the non-English consent =
for the subject to contact for questions. Hope this =
helps. Betty Betty L. Dunger Coordinator, Institutional Review =
Board Activities MetroHealth Medical Center Cleveland, OH =
44109-1998 email: =
bdunger@research.metrohealth.org (216) 778-5459 (IRB office) (216) 778-3884 (direct) (216) 778-8720 (fax)
------_=_NextPart_001_01BFDA2E.DBEA9D40--
Betty Dunger
6/19/2000 1:17:00 PM
Our hospital based IRB has chosen not to authorize central and other outside IRBs to approve studies conducted in our institution. Although federal regulations would allow the the IRB to delegate this responsiblity to another IRB, our IRB has chosen not to accept this action. The hospital's lack of control and increased liability were two major issues considered in adopting this policy.
I am sure there are many other logical arguments for and against the use of a local rather than a Central IRB. I would welcome your comments, both for and against the issue.
Anonymous
6/19/2000 1:20:00 PM
Dr. Weiner:
If the IRB at the across town medical center is becoming the IRB of
record, then it must perform an initial review of the transferred studies.
The consents would have to be amended to reflect the new IRB, new location
and any other changes. The process for informing the subjects currently
enrolled is outlined below.
If another PI is appointed to replace a departing PI at the current
institution, the consents for subjects currently on study would have to be
amended, following IRB approval of the change. Those subjects who have
completed their involvement in the study would not have to be
contacted/reconsented. Notification/reconsenting is usually by one of two
means: (1) an entirely new consent form that contains the new information,
or (2) an amendment to the existing form. The trouble with phone
conversations or mailings as the only means of conveying the new information
is that there is no positive record of notification. They can be used as
initial notification when circumstances warrant, followed by signing an
amended form at the next visit. The IRB and the new PI should be able to
agree on an acceptable method of notification.
Not an official OHRP or FDA message.
[Please note, today is the day, OPRR is gone, OHRP is here.]
Paul W. Goebel, Jr.
Division of Human Subject Protections
Office for Human Research Protections
Department of Health and Human Services
6100 Executive Boulevard, suite 3B01, MSC-7507
Rockville, MD 20892-7507
Phone: 301-402-4372
email: pg122v@nih.gov
Fax: 301-402-4256
OHRP url: http://grants.nih.gov/grants/oprr/oprr.htm
When I was with FDA, my guidance was
Paul Od
6/19/2000 5:37:00 AM
Dr. Leopold:
The latest information available to me is that neither FDA nor OHRP requires
IRBs to routinely receive either copies of signed consents or interim study
data from the investigator, CRO or sponsor. I don't see where the current
regulations (21 CFR 56 and 45 CFR 46) require the IRB to establish
investigator compliance. Yes, the DHHS inspector general reports recommend
more IRB oversight but no such regulatory changes have yet been made.
When the comprehensive IRB regulations became effective in 1981, they
required IRBs to perform initial review and then continuing review at least
once per year. With minor modifications in 1991, these regulations are the
same today. In 1981 there was no expectation that the IRBs would look over
the shoulder of the PI, or to police the actions of the PI, receive all the
signed consents, or sift through the data of ongoing studies. To my
knowledge, the IRB is not required by FDA or OHRP to do these things today.
The IRB was to perform a thorough initial review and at least once per year
determine whether active studies could continue for another year. In order
to perform continuing review, the IRB needs to know about the activity that
has taken place. FDA guidance is in the information sheets, (see process
for conducting continuing review in the information sheet Continuing
Review after Study Approval) and OHRP guidance is in the OPRR Reports
number 95-01 Continuing Review - Institutional and Institutional Review
Board Responsibilities.
However, reviewing the progress of the study once per year cannot guarantee
compliance on the part of the PI. In order for the IRBs to closely oversee
the ongoing studies, there would need to be a massive increase in resources
for the IRB. For FDA regulated studies, this seems to be duplication of a
task that is assigned by FDA regulations to sponsors of studies. Both the
IND and IDE regulations require sponsors to monitor ongoing studies, see 21
CFR 312.53 and 21 CFR 812.43 and 46, respectively. That is why sponsors
either hire monitors or contract with CROs to do the monitoring. The
monitors are to perform on-site visits of study sites to determine whether
the study is being conducted according to the protocol. These site visits
occur several times per year.
I would welcome any news that I may have missed, but I believe requiring
IRBs to actively assure compliance of all the PIs is premature, if it is to
happen at all.
What is presently required is that IRBs are to have authority to observe or
have a third party observe the consent process and the research see 21 CFR
56.109(f) and 45 CFR 46.109(e). This requirement has been interpreted to
mean the IRB should investigate or have an investigation done by a third
party when it receives information that the rights and welfare of the human
subjects of a particular study are not being adequately protected. It was
anticipated that the IRB would receive such information for only a small
percentage of ongoing studies. This regulation also gives the IRB the
authority to investigate ongoing studies in the absence of such complaints,
as the IRB deems appropriate.
Not an official OHRP or FDA statement.
Paul W. Goebel, Jr.
Division of Human Subject Protections
Office for Human Research Protections
Department of Health and Human Services
6100 Executive Boulevard, suite 3B01, MSC-7507
Rockville, MD 20892-7507
Phone: 301-402-4372
email: pg122v@nih.gov
Fax: 301-402-4256
OHRP url: http://grants.nih.gov/grants/oprr/oprr.htm
Paul Od
6/19/2000 1:20:00 PM
New Human-Research Office Will Lack the Police Power of Its P redecessor
At the OPRR/FDA Town Meeting held in Chapel Hill last Friday the message
conveyed to me was that OHRP would retain full regulatory authority. The
emphasis would likely move to education with accreditation/registration of
IRBs rather than an increase in the number of audits.
Evelyn Studer, IRB Administrator
Research Triangle Institute
PO Box 12194
Research Triangle Park, NC 27709-2194
919-541-6442
STUDER@rti.org
-----Original Message-----
From: Robert Nelson [mailto:rmnelson@mcw.edu]
Sent: Sunday, June 18, 2000 4:01 PM
To: mcwirb@mcwirb.org
Subject: re: New Human-Research Office Will Lack the Police Power of Its
Predecessor
Here is a section of the Federal Register notice:
3. Division of Compliance Oversight (ACN 3)--(1) Conducts inquiries and
investigations into alleged noncompliance with HHS Regulations for
Protection
of Human Subjects; (2) prepares inquiry and investigative reports; (3)
recommends remedial or corrective action as necessary to agency or
Department
officials as appropriate; and (4) conducts a program of oversight of awardee
institution implementation of HHS Regulations for the Protection of Human
Subjects.
>From this language, it appears that the OHRP will only recommend action
rather than take action. Others have reported to me that the office will
retain
and even strengthen the regulatory authority that was present with the OPRR.
Given the importance and sensitivity of this issue, perhaps someone in the
know can comment.
Robert Skip Nelson, MD, PhD
Coordinator, The IRB Discussion Forum
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Evelyn Studer
6/19/2000 5:37:00 AM
Religious (or value intensive) Institutions and IRB's
Howard Mann's points about committee membership and fostering (potential)
participant informed consent are well taken. I believe that it is possible
to develop informed consent language that is compatible with a Catholic
hospital's religious convictions and provides full disclosure to
participants. Appropriate language can remain respectful of Catholic
views, the potential subject's right to autonomy, and avoid advocacy of
Catholic religious views on reproduction (or theology for that matter.)
As someone who works with Catholic thought on a daily basis, I would like
to make an additional point. While it's true that the Ethical and
Religious Directives list several proscribed procedures--such as physician
assisted suicide, abortion, and elective surgical sterilization; within
the total of 70 Directives most are concerned with broader issues of
mission obligation--social responsibility, provision of pastoral and
spiritual care, respect and consent within the professional-patient
relationship, issues in care for the dying, and forming partnerships with
other health care providers. Catholic health care services, particularly
teaching hospitals, are strongly encouraged to participate in research as a
part of the overall mission to benefit persons, respect human dignity, and
improve community health. So there is a whole complex of values (not
always explicitly stated) that underlies consideration of a research
protocol.
Ellen Bernal
Howard Mann on 06/17/2000 02:33:13 AM
Please respond to mcwirb@mcwirb.org
To: mcwirb@mcwirb.org
cc: (bcc: Ellen W Bernal/SVMC/MHP/CHP)
Subject: re: Religious (or value intensive) Institutions and
IRB's
Hi,
This is an important and interesting issue, and demands a recognition of
the
value pluralism that is an inescapable and ineradicable feature of American
society.
Key notions in human subjects protection are respect for research subjects
as
persons and the promotion of subject autonomy. In the context of a decision
to
enroll as a research subject, an individual is entitled to full disclosure
of
all information pertinent to that decision. An IRB should guard against
prejudicing that decision by circumscribing the information that is
presented
in the Consent Document -- in content or form -- as an overt expression of
religious or other moral-laden convictions.
While an institution may not sanction certain kinds of research, and an
investigator may choose (at least in theory) an IRB to review her protocol,
the
potential research subject is not typically free to choose either.
The deliberations of an IRB are inherently value intensive; this is the
nature of human discourse. IRBs should deal with value pluralism by
ensuring
appropriate diversity in its membership, guarding against moral advocacy,
and
maintaining an expansive attitude towards disclosure of information to the
research subject.
Regards,
Howard
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Ellen Bernal
6/19/2000 5:37:00 AM
In the UK the system for Research Ethics Committees (nearest equivalent to
IRBs) regulations require that multi-centre studies involving 5 or more
sights are reviewed by a Multi-Centre REC, which are based Regionally.
Local RECs then have the option of accepting or rejecting, but not
modifying, the proposal, except to take account of certain specific local
issues. LRECs have always had the option of sub-contracting work to other
RECs, if for example their workload was excessive, but I have never heard of
one doing so. The MRECs do pass work between themselves, again usually on
workload grounds.
Paul Wainwright
> -----Original Message-----
> From: Bob Short [SMTP:zcyborg@aol.com]
> Sent: Friday, June 16, 2000 4:52 PM
> To: mcwirb@mcwirb.org
> Subject: Central VS Local IRB
>
> Our hospital based IRB has chosen not to authorize central and other
> outside
> IRBs to approve studies conducted in our institution. Although federal
> regulations would allow the the IRB to delegate this responsiblity to
> another
> IRB, our IRB has chosen not to accept this action. The hospital's lack of
> control and increased liability were two major issues considered in
> adopting
> this policy.
>
> I am sure there are many other logical arguments for and against the use
> of a
> local rather than a Central IRB. I would welcome your comments, both for
> and
> against the issue.
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul
6/19/2000 2:50:00 AM
A very active Principal Investigator at one of our institutions is
thinking of leaving and moving to a hospital system across town.
He may want to move all or some of his patients to the new institution.
Do the patients need to be reconsented, or put through the other
institution's IRB (I suspect that is their call to make).
Also, I assume that another PI can take his place if the patients stay
with the current institution's physicians. In such case, all the
consents presently give the exiting PI's contact information. Do the
patient's need to be notified (I say yes)...and by what method?
Mailing, phone conversation, signed agreement, reconsent?
Thanks for you help.
Craig Weiner, MD
Chair
Mercy Healthcare Sacramento Regional IRB
Md
6/19/2000 5:37:00 AM
Good morning...there is a program for certification of IRB professionals
newly in place....I believe the first exam is to be given early this fall.
An accreditation program for IRBs and investigators is in the
works....information on both may be obtained from the ARENA/PRIM&R offices
in Boston.
gk
> -----Original Message-----
> From: Dr. Michael Owen [SMTP:mowen@acs.ryerson.ca]
> Sent: Monday, June 19, 2000 7:47 AM
> To: mcwirb@mcwirb.org
> Subject: IRB/REB Certification
>
> As a non-American listener, I wish to inquire about IRB certification --
> is there a process/requirement for IRBs or for IRB administrators to be
> certified? If so,where would I be able to locate the regulations (federal
> or state) on IRB certification.
>
> As a member of SRA I understand that there have been some discussions of
> certification programs/processes for IRB administrators. Is there a Body
> of Knowledge or www site where one might review the requirements for
> certification of IRB administrators?
>
> Thank you,
>
> Michael Owen
> Ryerson Polytechnic University
> Toronto
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Greg
6/19/2000 5:37:00 AM
The independent authority of the new OHRP.
The Chronicle of Higher Education has recently posted a correction to its
June 14th article which noted certain constraints on the prerogatives of the
new Office for Human Research Protections (OHRP) to independently suspend
research projects at universities, at the request of DHHS officials.
Additional clarification may yet be needed as the Federal Register
specifically states that OHRP's Division of Compliance Oversight has four
roles including (3) recommends remedial or corrective action as necessary
to agency or Department officials as appropriate;. Also, nowhere else is
it identified or stated that the Office of the Director, OHPR, has this
authority, and the full functional statement for OHRP does not address this
issue. [See Federal Register June 13, 2000, Page 37137.]
Maybe this level of ambiguity is needed although it seems to unnecessarily
raise uncertainty as to intent, compared to the actual straight forward
reading of the Federal Register notice.
Will there be a more definitive statement forthcoming as to intent of the
full scope of independent authority to be exercised by OHRP to suspend
research projects without review (and possible veto) by more senior
officials in DHHS?
John H. Mather MD
Chief Officer, (10R),
Office of Research Compliance and Assurance,
Veterans Administration
M . D . Orca
6/19/2000 2:50:00 AM
I would like advice from mcwirb members regarding investigator audits by the
IRB office. Our IRB has reason to suspect that improper consent is being
obtained by an investigator. The investigator has the approval of two
separate IRB's and we believe that they have been using the wrong consent
form to consent patients at our institution. We are planning to audit the
investigator files and will probably suspend the study (with proper
notification to the sponsor and FDA) until the audit is completed. Has
anyone else had this experience and how did you handle the situation. Are
we on the right track?
DonnaSchoenfelder
IRB Coordinator
INTEGRIS Baptist Medical Center
schods@integris-health.com
(405) 951-2958
Donna S .
6/19/2000 1:20:00 PM
I don't think it is a good idea to provide names of study participants to
the IRB. Any audit of a the research records could verify what is there vs.
what needs to be there and only the member(s)/individual doing the audit
would see the neames of the participants. That offers additional protections
of confidentiality. Of course, one usually staates in the form that the IRB
( and others) may view the records. But unless there were a major dispute,
it would be better to avoid providing all the names to all the IRB members.
Alternatively, and with less confidentiality, the names might be only
available during the meeting and in the room.
Imagine that an IRB member looks at a record of an HIV study and discovers
that the spouse, companion, son or whatever is HIV+ and didn't disclose
this to them beforehand and now everyone in the IRB knows. Awkward ( and it
has happened a few times)
> -----Original Message-----
> From: Bob Short [SMTP:zcyborg@aol.com]
> Sent: Wednesday, June 14, 2000 8:43 PM
> To: mcwirb@mcwirb.org
> Subject: re: Audit process
>
> I see basically four questions to be answered. (1) Has the PI conducted a
> study on a patient in your Institution, (2)is there a properly signed
> consent
> on the chart, (3) was the appropriate version of the consent form used,
> and
> (4) was the consent form from the appropriate IRB)
>
> To comply with JCAHO, a copy of the signed informed consent must be a
> permanent
> part of the hospital chart. In keeping with the IRB's responsiblity to
> protect
> the patient, it would not be unreasonable to require that the names of all
> study participants be submitted as part of the continuing review process.
> This
> of course assumes that the PI has used your IRB and will be required to
> submit
> a request for IRB continuing approval. If the PI's annual report
> required
> the names of all study participants, then confirming that a copy was on
> the
> chart and current would not be difficult. In fact the procedure could
> also
> serve as part of the hospital's JCAHO QA activities.
>
> Even with sponsored studies that are monitored by a CRO, there appears to
> be a
> growing expectation that the IRB will also monitor the invesigators. The
> expanding responsibility to train both the IRB and the PI members as well
> as
> monitoring the researcher's activities is an exceptional challenge.
>
> I too am very interested in how other sites are handling
> monitoring/auditing
> responsibilities when the study is conducted through a CRO.
>
> Perhaps another approach to solve this challenge would be to require an
> approval document from the IRB office before anyone can be placed on a
> study in
> the institution.
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Charles Od
6/19/2000 1:20:00 PM
Religious (or value intensive) Institutions and IRB's
Patrick & Jon & others
The language of the pregnancy/contraception statement is important but I
think that the issue is broader.
This is a very important question for all of us. However, I think Jon's
evaluation is too, what... ethical?, etherial? academic?.
Every IRB is set up by and reports to an institution. Every IRB reflects
the culture and mandate of that institution. In fact, that is a
substantial part of what local review means. Local conveys the local
institutional or local community standards. So the values, culture and
mandate in a Catholic setting will be reflected by the IRB in that setting.
Patrick's question is very well taken. Reflecting the local culture and
values of the institution seems to me to be what an IRB in the university
does. I have heard it said that people seeking care at universities know
that it is a research place and know they might be research subjects.
Regardless of what I think of this attitude, it does reflect the local
situation.
The question is more difficult when the IRB in a value-laden institution
offers services to community members living with different values.
In answer to Patrick, it would seem to me (opinion time) that an
investigator who is in a private practice who is not committed to seeking
IRB approval from the closest hospital, is free to seek IRB from another
source. Your service is offered to them but it is not mandatory that they
seek your service. If they do seek your service, however, I should think
that the directive of the institution would not allow substitution of
another value system.
We are most often on the other end. As an independent IRB we seek to
discover the local values. One of the questions we ask (which many
investigators resist answering since they don't see the relevance) is about
the predominant religion in the area. It does not mean that the decision
has to conform to the local standard (e.g., we can't approve an abortion
study in a pro-choice town), but it does mean that we must take the local
values into acount.
ERICA
PS, I love your title, VP Mission Integration. This argument seems to be
at the heart of the job.
>>The discussion ultimately turned to a larger discussion of what is the duty of
>>the IRB to its home institution vs. its duty to the community.
>
>the duty of the IRB is simple: protection of human subjects. if you think
>it is broader than that, please point me to any regulations, provisions of
>your MPA, legal decisions, or any ethical writings that would expand on
>that singular duty.
>
>allowing any type of institutional constraint to infect and undermine the
>fundamental rights of human subjects to be fully informed about the scope
>of their research participation, and in particular about means to minimize
>the risks they face in that participation, is simply a violation of all the
>principles, declarations, regulations, and ethics espoused in the last 50
>years on human subjects research.
>
>
Erica Heath
President, IRC
415-485-0717
heath
6/19/2000 5:37:00 AM
Value-laden Institutions and IRBs
Hi,
In Argentina and Venezuela both local (institutional ) and Independant
approvals are mandatory.
Increasingly, some local IRBs (or comite de docencia) charge a
considerable amount for reviewing Protocols and amendments. Independant IRBs
in Argentina are few and renowned. And they approve for protocols taking
place throughout thte country.
Anne Blanchard
ARGENTINA
Tel/Fax: (+5411) 4832-6745
e-mail: anne@ssdnet.com.ar
-----Mensaje original-----
De: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]En nombre de
Frank and Margaret Gaze
Enviado el: Sábado, 17 de Junio de 2000 05:18 p.m.
Para: mcwirb@mcwirb.org
Asunto: Re: Value-laden Institutions and IRBs
Erica has, as usual, raised a nub question on this discussion.
I have another: how does the IRB being part of an institution relate to the
Helsinki Declaration requirement that reviewing committees must be
independent?
I assume that the committee must be independent of researchers or treating
professionals.
But it seems from here that it is almost impossible for institutional boards
to be sufficiently independent of their institutions to qualify. Certainly
a lot of the discussion on this list gives me the impression that the
independence is, at the very least, blurred. The current theme is one such
indication.
Frank Gaze
New Zealand
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Anne
6/19/2000 2:50:00 AM
IRB Certification with ARENA/PRIM&R at Oct. Conference
I guess things are moving quickly.
I was not aware that an exam was inminent, and that it would have 250 questions.
Please send us more information about this.
Thanks
Italo Biaggioni
|--------+----------------------->
| | Patty Rensing|
| | |
| | |
| | 06/19/2000 |
| | 02:11 PM |
| | Please |
| | respond to |
| | mcwirb |
| | |
|--------+----------------------->
>----------------------------------------------------------------------------|
| |
| To: mcwirb@mcwirb.org |
| cc: (bcc: Italo Biaggioni/VUMC/Vanderbilt) |
| Subject: IRB Certification with ARENA/PRIM&R at Oct. Conference |
>----------------------------------------------------------------------------|
I am interested in taking the IRB Certification exam through the ARENA/PRIM&R
at the October Conference but,I have a few questions:
1) This will be the first examination date for the new IRB Certification
Proagram. Depending on the results of the exam, could it be changed for the
next group?
2) I know the exam is 250 multiple choice questions in 4 major areas. How do
you study for the exam?
3) Will there be a pre-test, or maybe a work seminar that you can attend?
Either now or in the future?
I haven't decided when I want to take the exam so I thought I would see if
anyone else in the MCWIRB group had any comments, concers or questions?
Thanks in advance,
Patty Rensing
IRB Coordinator
Sarasota Memorial Hospital
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Italo Biaggioni
6/19/2000 2:38:00 PM
New Human-Research Office Will Lack the Police Power of Its Predecessor
Chronicle of Higher Education: June 14, 2000
By JEFFREY BRAINARD
Washington
The restructured federal office created to oversee research involving human volunteers will lack the power to independently penalize institutions that violate federal rules, the Clinton administration announced on Tuesday. The revamped unit -- the Office of Human Research Protection -- will instead make recommendations for remedial or corrective action to officials of the Department of Health and Human Services.
The unit will succeed the Office for Protection from Research Risks, which had the power to take enforcement actions on its own. That authority irked university officials when the office issued a series of suspensions against institutions in recent months for violating regulations for the protection of research volunteers.
Health and Human Services Secretary Donna E. Shalala announced the office's new mission on Tuesday in a notice in the Federal Register.
According to the notice, the office will retain the job of overseeing compliance with federal regulations by institutions. It will also develop educational programs for researchers about their responsibilities for protecting research subjects, and evaluate the effectiveness of the federal rules, among other duties.
Many university officials see the office's new direction as a retreat from the spate of suspensions issued by the Office for Protection from Research Risks. Members of Congress, meanwhile, have been pressuring the department for enhanced protections for research volunteers. Ms. Shalala has said the establishment of the research-protection office is part of the department's plan to do just that.
Anonymous
6/18/2000 10:01:00 AM
Bob,
None of my 4 IRBs will accept a central IRB review for research in the
institution. First, because we have good IRBs to do that job. Second,
liability and control (would you believe my hospitals like control?!) and
third, we don't want to use non-local review when local review and local
opinion is readily available.
However, I do tell local researchers who are doing studies in their offices
that they are free to choose which IRB they want to use and central can be
very beneficial if they have time constraints or if they already have a few
ongoing studies with a specific central IRB. Our central IRBs are good and
the only thing that they just can't offer is local membership.
Rebecca M. Clark
Scripps Health/Children's Hospital IRBs
San Diego, CA
(858) 576-4008
rebcaclark@aol.com
Rebecca M. Clark
6/18/2000 5:09:00 AM
Policy on Promotional Messages
I was pleased to read Dr. Nelson's communication regarding promotional messages on MCWIRB.
Robert Nelson Policy on Promotional Messages 6/16/00 2:57pm
MCWIRB is increasingly recognized as a unique discussion forum for the global clinical research community. Consequently, it will be under constant threat from those who intentionally, or unintentionally, exploit MCWIRB for promotional purposes. Some of these activities are flagrant, others are insidious. MCWIRB and all of its members must be vigilant to ensure that our discussions promote better understanding of human subject protection and not the marketing of products, services, companies, institutions, or organizations.
I look forward to comments and thoughts from others.
Anonymous
6/18/2000 6:17:00 AM
I do the same combination and I do not think there is an ethical or
procedural problem with doing so. However, there is one significant
political difficulty that must be factored in. The chair of the IRB must
have the ability to effect the changes to the protocols and to the research
systems in the institution that the IRB desires. That ability can only come
from a political power held by the chair. This power can come from having
the support of the institution's administration, but in some cases, mostly
academic settings, it must come from the acceptance of the chair by the
investigators as a respected and reliable source of authority. Therefore,
the right choice as chair can vary from institution to institution, but for
example and as a general rule, in an academic medical institution, the chair
probably needs to be an MD, particularly one with research experience.
Dan
Daniel L. Icenogle, MD, JD
Icenogle & Associates
1858 Sand Ridge Ct.
Verona, WI 53593-8814
608.832.0549 (voice and fax)
Electronic mail from Daniel L. Icenogle, MD, c/o Icenogle & Associates at
Dan_Icenogle@icenogle.net. This communication is intended for the use of
the addressee. It may contain information which is privileged or
confidential under applicable law. If you are not the intended recipient or
the agent of the recipient, you are hereby notified that any dissemination,
copy or disclosure of this communication is strictly prohibited. If you
have received this communication in error, please notify Icenogle &
Associates at (608) 832-0549 or via return Internet electronic mail at
Dan_Icenogle@icenogle.net and expunge this communication without making any
copies. Thank you for your cooperation.
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of
Sandra LaRusso
Sent: Thursday, June 15, 2000 5:04 PM
To: mcwirb@mcwirb.org
Subject: IRB Managers as Chairs
Do any of you have dual roles of both managing the IRB and serving as the
Chairperson? I manage a County IRB housed at our County Medical Center. It
is
small operationally having about 50-60 active protocols at any given time.
To
date, the Chairs have been active researchers who have most of the protocols
which I see as a conflict of interest. We have the same issue with members
but
this is a much easier one to work with since terms allow rotation off the
Board. No one really wants the responsibility of the Chair. I am a voting
member of the IRB and have considered chairing it as a matter of function
and
continuity. This sounds so logical, it must have a down side that I'm not
seeing and would appreciate feedback on why this might or might not be a
good
idea.
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Icenogle & Associates
6/18/2000 5:09:00 AM
Heart study will sell patient data for profit
Betty Dunger at thought this article may be of interest to the group.
----------------
By Ronald Rosenberg and Liz Kowalczyk, Globe Staff, 6/16/2000
Patient data from the world-famous Framingham Heart Study - the pioneering research into heart attacks and strokes that has been available free of charge for 50 years - for the first time will be sold for a profit under a new venture started by the study's sponsor, Boston University.
The university has struck a deal with a group of venture capitalists, who have committed $21 million to form Framingham Genomic Medicine Inc.
The company will use the heart study's vast collection of genetic, clinical, and behavioral data from the 10,000 participants, all families from Framingham, to create a huge electronic database. Pharmaceutical and biotechnology companies are expected to pay annual fees to access the treasure trove of medical information.
The university, which owns 20 percent of the new company, said that researchers worldwide will still have access to heart study data cost-free and that patient privacy will be protected.
But the National Heart, Lung and Blood Institute, the government agency that has paid for much of the study, said that the protections so far are inadequate and that it will send its director to Boston this month to try to negotiate an agreement with the nonprofit university and its for-profit spinoff.
The Framingham deal is not unprecedented - drug companies racing to create the next generation of genetically developed drugs and diagnostic exams routinely purchase patient databases from hospitals, health insurance companies, and pharmacy chains. And the idea of assembling a comprehensive genetic database was launched by DeCode Genetics, which has the rights to the genetic, medical, and genealogical information of Iceland's 270,000 residents.
But Framingham Genomic would be the first US company to gain broad access to such a large multigenerational patient group.
The proposal is sure to reignite the debate over private profit through use of government-funded data, an issue that flared on the international stage in March when President Bill Clinton and British Prime Minister Tony Blair issued a statement saying that all raw data from the government-funded Human Genome Project should be made public quickly. The statement devastated biotechnology stocks when it was misinterpreted by the markets as meaning the two governments would oppose patenting human genomic data.
''There is only one Framingham study in the whole wide world,'' said Dr. Claude Lenfant, director of the institute that has contributed more than $40 million to the heart study. ''The language could be interpreted as such that they would have exclusive access to the data. We would never accept that. This data was obtained with public money. Why should we give access to one person or one company?''
Boston University spokesman David Lampe said that the university and the company are still trying to agree on the details, but that they want to realize the full potential of the heart study data to benefit the public - something that can be done only with private money from investors.
The Framingham Heart Study, which has been collecting data from families who live in its namesake city west of Boston for 52 years, has accumulated vast amounts of information, including 500,0000 chest X-rays and electrocardiograms, 5,000 blood samples, and truckloads of paper medical records that include diet diaries and early studies of male balding patterns. The heart study also owns 160 computer databases.
Data on the participants' habits such as smoking and red-meat consumption is public, but researchers must submit a specific proposal to gain access to genetic and family-history information - including DNA samples from 5,000 Framingham residents.
Analysis of the Framingham residents' lives has led to the publication of more then 1,000 studies and given the nation the very concept of cardiovascular risk factors - traits such as high cholesterol and behaviors such as cigarette smoking.
Scientists sign a transfer agreement that prevents them from redistributing the data for profit and requires them to return ''enhanced'' or new data they generate to the heart study, Lenfant said.
This is the crux of the negotiations between Boston University and the National Heart, Lung and Blood Institute.
Lampe said all raw data will be available to researchers, as it has always been, but that the company may want to own some new data that it generates, such as genotyping - looking for variations among the participants' DNA that could explain disease or differing reactions to drugs.
''It will cost the company $20 million to do that on all this data, so naturally they want to own it,'' he said. ''But that's still under negotiation. Should that go back to the government? Exactly who owns what is the critical question.''
Framingham Genomic also wants the heart study's research committee to approve proposed projects from companies more quickly than has done for researchers, and to free companies from having to provide detailed descriptions of competitive projects.
Along with concerns about these areas, Lenfant said he wants strict guarantees to protect participants' confidentiality and assurances that Boston University researchers who have a financial interest in Framingham Genomic won't be involved in oversight of the company. Lampe said none do.
Boston University has sent letters to the study's 6,000 surviving participants and said only two people have requested that their medical records be excluded from the company's database.
Lenfant said that agency lawyers are reviewing the institute's agreement with Boston University and sorting out who owns which portion of the heart study data. Ownership depends on how a particular research contract was funded, through a broad contract or a very specific grant.
He said the institute could try to kill the deal if negotiations with Boston University fail, but he doesn't believe such a dramatic step will be necessary.
''Any process that is going to speed up bringing medical benefits to patients, I'm all for that. So much of research ends up in libraries,'' he said.
With the forthcoming release of the first draft of the human genome, the mapping of more than 100,000 genes, Framingham Genomics chief scientific officer Dr. Fred Ledley expects the heart study database to be a resource for studies by pharmaceutical researchers looking to identify the connection between specific genes and health and disease outcomes.
''Frankly, we're excited about the additional resources because we can now use the heart study data to pursue new research areas such as dementia, how high blood pressure affects loss of cognitive function plus access to all the company's data,'' said Dr. Philip A. Wolf principal investigator of the Framingham Heart Study and a professor of neurology at the Boston University School of Medicine.
Ledley said stock in Framingham Genomic will be put in a charitable trust for the benefit of the city of Framingham. The company will also contribute cash to fund an ethics advisory board and science education in the city's schools, Lampe said.
Jim Fair, 54, a middle school teacher in Millis and a second generation study member, whose late father and elderly mother were among the original Framingham Heart Study participants, said he does not object to the for-profit deal.
''As long as the Framingham Heart Study gets a new source of revenue and continues to protect our privacy, it's OK with me, because the information from the study has helped my family,'' said Fair, 54, whose late father benefited from the study's results on high blood pressure.
Ledley also consulted with George J. Annas, a medical ethicist and chairman of the Health Law Department of Boston University's School of public health.
''There are still some issues to work out between Boston University, the study and the company, but Fred Ledley understands the need to deal with ethical issues before he begins,'' he said.
This story ran on page A01 of the Boston Globe on 6/16/2000.
© Copyright 2000 Globe Newspaper Company.
Anonymous
6/16/2000 11:49:00 AM
Central IRB's are acceptable in cases where the facility doesn't have its own
IRB. We see this usage incraesing. However, our University has never accepted
central IRB's. One, being a University, it's a different scenario. However, I
have one specific problem with Central IRB's is that these places maybe under a
conflict of interest as the industry actually pays them a fee for their review.
If there was another mechanism for facilites for IRB reviews, contracting out to
another independent IRB maybe a solution.
Bob Short wrote:
> Our hospital based IRB has chosen not to authorize central and other outside
> IRBs to approve studies conducted in our institution. Although federal
> regulations would allow the the IRB to delegate this responsiblity to another
> IRB, our IRB has chosen not to accept this action. The hospital's lack of
> control and increased liability were two major issues considered in adopting
> this policy.
>
> I am sure there are many other logical arguments for and against the use of a
> local rather than a Central IRB. I would welcome your comments, both for and
> against the issue.
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Michael Jann
6/16/2000 10:21:00 AM
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