Our IRB requested that I poll McWirb participants regarding CryoLife's
BioGlue®. BioGlue® is not FDA approved. This product has been deemed a
Humanitarian Use Device. Data are not being gathered and this is not
considered research, however, the FDA requires that the PI seek IRB review
and approval. It is expected that use of BioGlue will be less than 4000
subjects nationwide therefore FDA approval is not being sought. It is up to
the IRB to decide whether or not to require informed consent. My questions
if you have had to review this HUD: 1) Did you require an informed consent?
2) If not, did you require that the information and risks regarding this
product be given to the patient? 3) Do you have any other comments regarding
HUD's? Thank you.
Thanks,
Cindy
Cindy Clukey
IRB and QI Committees Coordinator
Eastern Maine Medical Center
(cclukey@emh.org)
(207) 973-7906
Cindy Peterson
7/20/2000 10:55:00 AM
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Although HERI and CIRP may not purposely misled students nor misused data,
the opportunity for these things to happen is extremely high. I don't
understand why identifiers are necessary. If every student was asked to
participate by completing the survey on a yearly basis with the participants
age and standing (i.e., freshman, sophomore, post-grad) the only
identifiers, wouldn't the data be just as valuable? If they are using the
incomplete questionnaires and questionnaires without identifiers now, I
don't see a problem. In any case, each institution should have approval and
oversight from their IRB.
Joan Koenig
IRB Manager
Office Coordinator
Banner Health Research Institute
926 E. McDowell Rd.
Phoenix, AZ 85006
602-271-9018 FAX 602-271-4853
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Although HERI and
CIRP may not purposely misled
students nor misused data, the opportunity for these things to happen is
extremely high. I don't understand why identifiers are necessary. If
every student was asked to participate by completing the survey on a yearly
basis with the participants age and standing (i.e., freshman, sophomore,
post-grad) the only identifiers, wouldn't the data be just as valuable? If
t hey are using the incomplete
questionnaires and questionnaires without identifiers now, I don't see a
problem. In any case, each institution should have approval and oversight from their
IRB. Joan Koenig IRB Manager Office
Coordinator Banner Health Research
Institute 926 E. McDowell Rd. Phoenix, AZ 85006 602-271-9018 FAX 602-271-4853
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Joan
7/20/2000 1:18:00 PM
Clinical equipoise and the local IRB
Hi All,
In a recent message, Charles Weijer reminded us that acceptable risk-benefit ratio and informed consent are separate moral requirements for research (in every document from Nuremberg to the Common Rule). Thus, a person may not consent to a study in which (a) clinical equipoise does not obtain, or (b) non-therapeutic risks have not been minimized or the risks of such procedures are not proportionate to the knowledge to be gained. It
really is that simple.
I heartily concur.
With respect to the assurance of clinical equipoise for a phase III
( multicenter) trial, how do you verify that the former exits? Do you expect the primary reviewer -- if you use one --to summarize his analysis of existent data ( phase I/II trials)? The reviewer may or may not be a member of the community of experts pertinent to the clinical issue at hand. It is not possible to have clinical committee members representative of all medical specialities. Is it reasonable to assume that equipoise exists as the multicenter trial was conceived and designed by a subcommunity of experts ?
The investigator's brochure may provide sufficient supporting information, but not always. I recognize this is part of a broader question : To what extent should a local IRB review the design of a multicenter trial ?
Charles, How do you do it ?
Regards,
Howard
Anonymous
7/20/2000 10:52:00 AM
>>> Marcus, Dr. Steven 07/20/00 01:11PM >>>
wrote:
Interestingly, we have been asked to review the protocol for this
very
same substance. There are some statements which I want clarified
before I
can even consider approval with or without an informed consent is
developed.
I would tink that any surgeon who planned on using this stuff would
be a
fool to not have some formal consent form developed. The risks of
litigation, if the stuff fails to perform as indicated, would be too
great
and would be easily discovered.
...........................................................................................................................................................................
Marcus,
I believe you misconstrue the nature of the risks -- to patient and
physician -- associated with the use of such devices.
The patient is arguably at less risk as these devices are evaluated
by the FDA prior to issuance of the HDE :
The application, however, must contain sufficient information for FDA
to determine that the device does not pose an unreasonable or
significant risk of illness or injury, and that the probable benefit to
health outweighs the risk of injury or illness from its use, taking into
account the probable risks and benefits of currently available devices
or alternative forms of treatment.
(http://www.fda.gov/cdrh/ode/hdeinfo.html)
Patients may be exposed to far greater risks when individual physicians
apply innovative therapies or procedures in the context of medical
care. ( Example: laparoscopic surgical procedures) We do not demand that
a physician employ a written Informed Consent document in such
circumstances. The application of innovative therapy is, as you know, a
daily phenomenon.
The use of a device made available under a HDE is , of course,
analogous to innovative therapy in important respects.
Thus, one may convincingly contend that innovative therapy, using a
device issued under the HDE regulations, is more defensible in the
context of threatened litigation consequent on a bad outcome.
Regards,
Howard
Howard Mann
7/20/2000 10:55:00 AM
We are a not-for-profit hospital system. Is someone who has privileges at
the hospital considered affiliated? Is a non-paid consultant of the
hospital affiliated?
Wendy
7/20/2000 11:43:00 AM
Human Research Subjects Protection Act of 2000
I don't know about any legislative requirements for
training, but I do know that NIH investigators will be
required to be trained according to a Notice from NIH
(June 5, 2000). See
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html
According to that Notice, 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.
Since then (June 17), the Office of Research
Integrity announced that ORI and the Public Health Service
research agencies (such as NIH and FDA) are developing a
new policy on instruction in the responsible conduct of
research for institutions receiving PHS funds for research
or research training. A draft of the policy was posted on
the Internet July 17 (See
http://ori.dhhs.gov/whatsnew.htm )
According to ORI, Following consideration of public
comments and appropriate revisions, it is expected that the
final policy will be announced by October 1, 2000.
Under this policy PHS will expand the requirement
for instruction in the responsible conduct of research from
just trainees to all personnel on PHS grants, including NIH
and FDA grants. The list of individuals who would be
required to undergo such training is extensive and includes
principal investigators, co-principal investigators, senior
investigators, institutional officials who approve PHS
grants, contracts, or cooperative agreements, tenure-track
investigators, students, postdoctoral fellows, technicians,
staff scientists, data management staff, subcontractors,
consultants, clinicians, research nurses, research
associates, research assistants and anyone else involved
in conducting the research or who receives research
training at the institution, or under the direction of the
institution. Also, PHS recommends that departmental and
sponsored research staff, secretarial, and other support
staff receive instruction as appropriate for their jobs and
roles in the research enterprise.
Additionally, the proposed policy would require
institutions receiving PHS funds to certify starting
October 1, 2000 that:
1. The institution will establish a program of
instruction that meets the requirements of this policy and
a written description documenting the program by June 1,
2001. In addition to addressing the requirements of this
policy and its applicability to all PHS-supported staff and
those working on PHS-supported research projects, this
description must address how, or whether, the program is
being applied to those research staff not supported by PHS
funds.
2. The institution will publish the written
description of the program of instruction or otherwise make
it accessible to research staff at the institution or
working under the direction of the institution.
3. The institution will carry out its program
of instruction.
4. Initial implementation of the program of
instruction, for existing staff, will be completed by
October 1, 2002.
The policy lays out ten core instructional areas
that such courses should include to the extent applicable.
Thus, instruction should be provided, according to the
notice, on such subjects as data sharing, acquisition,
management, and ownership; mentoring; publication and
authorship practices; peer review; collaborative science;
human subjects; research involving animals; research
misconduct; conflicts of interest and commitment; and
compliance with federal rules. The policy does not mandate
any particular instructional format or program length
requirements, but notes that successful modes include
workshops, lecture series, courses for academic credit, and
self-study using electronic and other media, including the
Internet.
It is important to note that once this policy is
fully implemented, it will supercede NIH's June 5, 2000
notice requiring just investigator education in the
protection of human subjects.
I hope that helps - I know it doesn't address your
question regarding what other other IRBs doing.
---------------------------------------
Christina M. Cahalan, M.H.S., J.D.
Staff Attorney
Vanderbilt University
Office of General Counsel
305 Kirkland Hall
Nashville, Tennessee 37240
(615) 343-3788
(615) 343-3930 fax
Email: tina.cahalan@Vanderbilt.Edu
On Thu, 20 Jul 2000 14:47:21 -0500 John McCallister
wrote:
> The Peoria CIRB is asking what IRBs are doing to be in
> compliance with the need for documentation that IRB members
> and investigators are trained in the protection of research
> subjects and federal regulations. Also, where can I view a
> copy of the legislation?
>
> Thanks in advance
>
> John McCallister,
> Chair, CIRB
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
This e-mail, and any attachments thereto, is intended only for use by
the addressee(s) named herein and may contain legally privileged and/or
confidential information. If you are not the intended recipient of
this e-mail, you are hereby notified that any dissemination,
distribution or copying of this e-mail, and any attachments thereto, is
strictly prohibited. If you have received this e-mail in error, please
immediately notify me by telephone and permanently delete the original
and any copy of any e-mail and any printout thereof.
Christina M
7/20/2000 11:49:00 AM
Recruiting female subjects
>From 1977 until the regulations changed in 1993, the FDA banned women of
childbearing potential from participation in Phase I and II clinical trials
(except when the drug was for a serious or life-threatening illness)
Participation in Phas III was allowed if results of reproductive toxicity
testing were available. Since this testing was often done in parallel with
human trials, the regulation effectively banned women of childbearing
potential from nearly all trials. A good history on this is Ruth Merkatz's
chapter in Women's Health Research: A Medical and Policy Primer (F.P.
Haseltine and B.G. Jacobson, eds.).
The Society for Women's Health Research recently held a workshop on barriers
to recruitment of women into clinical trials, which included a panel on the
ethical/consent issues of recruiting women of childbearing potential. We
plan to publish a report on the meeting within the next couple of months,
and it will be available from our website www.womens-health.com. (That is,
it will if I stop typing this and get back to reviewing the draft. : )
Meanwhile, maybe Dale Hammerschmidt will give the list a sneak perview - he
was one of the speakers at our workshop.)
______________________________________
Sherry A. Marts, Ph.D.
Scientific Director
Society for Women's Health Research
1828 L Street NW, Suite 625
Washington, DC 20036
www.womens-health.org
202-496-5019 vox
202-833-3472 fax
>>From: Wainwright, Paul
To: 'mcwirb@mcwirb.org'
Subject: Recruiting female subjects
Date: Wed, 19 Jul 2000 12:55:19 +0100
Dear List,
A little while ago there was a brief correspondence concerning pregnancy (or
the risks thereof) and participation in trials. A colleague and I have been
thinking about the wider issues of women as trial subjects. We understand
there was a time when FDA regs did not permit the inclusion of women at all
- is this correct? Can anyone point to some helpful literature on this?
A particular concern of mine is that trial protocols routinely insist that
any women of child bearing potential must be using an acceptable form of
contraception - although they rarely specify what action would be taken or
advice given in the event of contraceptive failure during the trial. Does
this lead to under-representation of women in trials?
Any thoughts gratefully received,
Paul Wainwright<<
______________________________________
Sherry A. Marts, Ph.D.
Scientific Director
Society for Women's Health Research
1828 L Street NW, Suite 625
Washington, DC 20036
www.womens-health.org
202-496-5019 vox
202-833-3472 fax
Sherry Marts
7/20/2000 10:49:00 AM
Good Morning,
Our IRB has been asked to review a device that is used as an adjunct in the
surgical repair of acute thoracic aortic dissections. Actually it is a
glue used in the above mentioned procedure. The CDRH has approved the HDE
(Humanitarian Use Exemption), but of course before the device can be used in
the hospital it must receive IRB approval. The FDA does not require an
informed consent.
We are being asked to expedite the review of this device. Can we, or
should we expedite approval of this device? Are devices under HUD reviewed
differently?
Please let me know what you think.
Thanks
Debbie Hunsaker
SLRMC - IRB Coor.
slrmc_mso@sisna.com
Slrmc Medical Staff Office
7/20/2000 4:14:00 AM
Dear Members,
Our central IRB is in the process of setting up internal quality assurance.
Please let me know how your IRB handles this process and what has worked
best for you. Any comments are appreciated.
Thanks,
Joanne Gross
Regulatory Coordinator
Joanneg
7/19/2000 4:24:00 AM
Would anyone be willing to share a copy of their format for approval of protocols? We are in the process of revising our current forms and would appreciate any help or format changes that you are willing to share.
Rosemarie Alston
IRB Administrative Assistant
Capital Health System
RAlston@chsnj.org
fax 609-815-7155
Anonymous
7/19/2000 12:08:00 PM
Compensation for IRB Chair
Eileen:
I actually asked this question about a month ago. In South Florida, most
Chairs do not get paid. One exception, as I have been advised, is U of M,
which pays the Chair a % of the IRB protocol application fee.
Mercy Healthcare Sacramento pays $3500/yr for 50-60 hrs/mth ($58.33/hr)
Another IRB (Couldn't tell which) pays $75 per protocol and $25 per
amendment
UNM pays .25 FTE equal to about $50,000/yr + fringe + $7500 bonus
Boston (Mass Gen, Brigham & Women's Hospitals) pay 5%-100% of their salaries
Fred Hutchinson Cancer Research Center (WA) pays 15% of salary
Research Triangle Institute (NC) pays $50-$65/hr
Other IRBs pay 20%, 33% or more of physician salaries
A few schools pay an undisclosed stipend and course reductions.
That's about all the info I can put my hands on right now. Hope it helps.
Lynn M. Barrett-Mena
-----Original Message-----
From: Eileen Murphy [SMTP:eileen.murphy@sharp.com]
Sent: Wednesday, July 19, 2000 12:45 AM
To: mcwirb@mcwirb.org
Subject: Compensation for IRB Chair
Its budget season, and I am pushing for an increase in the financial
compensation for our IRB Chair. Currently, we provide the Chair a
small stipend
based on the number of meetings attended per year. However, this
system is not
really adequate, for one, because the workload and time committment
continue
between meetings.
Please provide the amount of financial compensation provided to your
IRB Chair.
I am particularly interested in responses from community hospitals,
but welcome
all responses. I'm hoping I can provide support for this increase
from your
responses.
Thank you for your help.
Sincerely,
Eileen Murphy, B.S.
IRB Coordinator
Sharp HealthCare
San Diego, California
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
lynn barrett-mena
7/19/2000 6:00:00 AM
As the chair of the recently referred to Mercy Healthcare Sacramento
RIRB, the numbers, while not entirely correct, bring to light other
questions:
a. What are the responsibilities of the Chair. Does he just preside
over the meeting, or does he do more (review protocols, amendments,
expedited reviews, SAE's, write Policies and Procedures, etc. etc.?)
b. What support staff does he have.
c. Is Chair just another phrase for Chair, Director, Coordinator, and
other ancillary tasks?
Md
7/19/2000 10:37:00 AM
Compensation for IRB Chair
We are a community hospital IRB, less than 50 new protocols per year. No compensation is provided to anyone, except annual $100 gift certificate to the community members.
>>> eileen.murphy@sharp.com 07/18/00 10:44PM >>>
Its budget season, and I am pushing for an increase in the financial
compensation for our IRB Chair. Currently, we provide the Chair a small stipend
based on the number of meetings attended per year. However, this system is not
really adequate, for one, because the workload and time committment continue
between meetings.
Please provide the amount of financial compensation provided to your IRB Chair.
I am particularly interested in responses from community hospitals, but welcome
all responses. I'm hoping I can provide support for this increase from your
responses.
Thank you for your help.
Sincerely,
Eileen Murphy, B.S.
IRB Coordinator
Sharp HealthCare
San Diego, California
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
David Pittman
7/19/2000 10:43:00 AM
Paid IRB members and conflict of Interest
If we pay the community or unaffiliated IRB members, should they not then be considered employees? Is there a potential conflict of interest when the paid unaffiliated IRB board member participates in discussing and voting for or against an institutional protocol? At what point does the payment, gift, stipend, or special privilege become an ethical issue for the unaffiliated board member who must consider the protocol submittted by or through the paying institution.
Anonymous
7/19/2000 5:14:00 PM
>>> Clukey, Cindy 07/19/00 10:15AM >>> wrote :
Our IRB requested that I poll McWirb participants regarding CryoLife's
BioGlue®. BioGlue® is not FDA approved. This product has been deemed a
Humanitarian Use Device. Data are not being gathered and this is not
considered research, however, the FDA requires that the PI seek IRB review
and approval. It is expected that use of BioGlue will be less than 4000
subjects nationwide therefore FDA approval is not being sought. It is up to
the IRB to decide whether or not to require informed consent. My questions
if you have had to review this HUD: 1) Did you require an informed consent?
2) If not, did you require that the information and risks regarding this
product be given to the patient?
We did not stipulate the use of an IRB-approved Consent Document.. We expect the surgeon to discuss the nature of the device, its use and risks with the patient in the context of acquiring consent to perform the surgical procedure. We do not require documentary evidence that he accomplished the latter.
3) Do you have any other comments regarding
HUD's? Thank you.
Sure. Peruse this thread from the MCWIRB archives :
http://www.mcwirb.org/cgi-bin/WebX.cgi?mcwirb- Howard Mann Humanitarian Use Device 3/9/00 1:43pm
Regards,
Howard
Howard Mann
7/19/2000 11:22:00 AM
Compensation for IRB Chair
Some chairs are paid as consultants for each hour of work performed for the
IRB, usually starting around $50/hr.
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: Eileen Murphy [mailto:eileen.murphy@sharp.com]
Sent: Wednesday, July 19, 2000 12:45 AM
To: mcwirb@mcwirb.org
Subject: Compensation for IRB Chair
Its budget season, and I am pushing for an increase in the financial
compensation for our IRB Chair. Currently, we provide the Chair a small
stipend
based on the number of meetings attended per year. However, this system is
not
really adequate, for one, because the workload and time committment continue
between meetings.
Please provide the amount of financial compensation provided to your IRB
Chair.
I am particularly interested in responses from community hospitals, but
welcome
all responses. I'm hoping I can provide support for this increase from your
responses.
Thank you for your help.
Sincerely,
Eileen Murphy, B.S.
IRB Coordinator
Sharp HealthCare
San Diego, California
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Evelyn Studer
7/19/2000 4:09:00 AM
Jack --
I trust Bob would include me among those few knowledgeable
commentators who disagree. Little argumentation is provided for Bob's
claims, other than (1) this is the way a lot of people do it (fallacy of
tradition), and (2) we get
people's consent. As I said earlier an acceptable risk-benefit ratio and
informed consent are separate moral requirements for research (in every
document from Nuremberg to the Common Rule). Thus, a person may not
consent to a study in which (a) clinical equipoise does not obtain, or
(b) non-therapeutic risks have not been minimized or the risks of such
procedures are not proportionate to the knowledge to be gained. It
really is that simple.
If anyone from the discussion group would like a pdf copy (Adobe
Acrobat) of my article on this in Schizophrenia Research (1999) just
write to me directly at
charles.weijer@dal.ca (please don't send requests to the whole list).
The file is
about 100kb.
Cheers, Charles.
Charles Weijer
7/19/2000 8:37:00 AM
Is it ethical to use a placebo instead of an active control?
The statistical difficulty of using an active control instead of a placebo in a study is fully recoginzed. However, are we carrying out our ethical resposibility to protect the patient when we allow the use of a placebo instead of a proven drug that works (active control). In particular, is it ethical if the potential consequences of not using that active controll item is possibly life threatening. Can we in good conscience give that hypertensive patient a placebo and a stoke instead of an active control drug?
Admitedly, the patient should be told about treatment options. However, are we doing our job to protect the patient if we even allow the patient an option that could cause injury or death?
Anonymous
7/18/2000 11:01:00 AM
Is it ethical to use a placebo instead of an active control?
Jack's post quoting Bob on Helsinki, and Dale's post on economic
disadvantage, move me to cite Marcia Angell's recent NEJM editorial, The
Pharmaceutical Industry -- To Whom Is It Accountable? June 22, 2000, Vol.
342, No. 25, in which she suggests a more critical look at me-too drug
development research, particularly with regard to placebo controls, and
also suggests that the pharmaceutical industry may have social obligations
with respect to drug pricing. Of course, these aren't issues that can be
adequately addressed in the course of a single protocol review, but they
are things that those involved in clinical research need to think hard
about.
Nancy M. P. King, JD
Professor of Social Medicine
CB# 7240
Wing D School of Medicine
UNC-Chapel Hill, NC 27599-7240
DIRECT/VOICEMAIL ph 919.843.8270
DEPARTMENT ph 919.962.1136
DEPARTMENT fax 919.966.7499
nmpking@med.unc.edu
How can one remember his ignorance,
which growth requires,
who has so often to use his knowledge?
--Henry David Thoreau
Nancy M . P . King
7/18/2000 11:01:00 AM
Is it ethical to use a placebo instead of an active control?
This is a really interesting issue - the last time my committee discussed a
similar trial we were informed that the Medicines Control Agency (UK version
of the FDA) required placebo data in order to issue a licence, even though
the trial was a comparison with an existing established product.
Any other UK or European comments?
Paul Wainwright
> -----Original Message-----
> From: Bob Short [SMTP:zcyborg@aol.com]
> Sent: Tuesday, July 18, 2000 3:03 AM
> To: mcwirb@mcwirb.org
> Subject: Is it ethical to use a placebo instead of an active control?
>
> The statistical difficulty of using an active control instead of a placebo
> in a
> study is fully recoginzed. However, are we carrying out our ethical
> resposibility to protect the patient when we allow the use of a placebo
> instead
> of a proven drug that works (active control). In particular, is it
> ethical if
> the potential consequences of not using that active controll item is
> possibly
> life threatening. Can we in good conscience give that hypertensive
> patient a
> placebo and a stoke instead of an active control drug?
>
> Admitedly, the patient should be told about treatment options. However,
> are we
> doing our job to protect the patient if we even allow the patient an
> option
> that could cause injury or death?
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul
7/18/2000 4:58:00 AM
Jill Replogle wrote:
> The Agenda
> The Minutes
> Copies of any Informed Consents for the meeting
> Full protocols go to just four of the members
> Any newsletters or relevant news articles
> The updated annual calendar of reviews (we may skip one or two months per year)
> The Member List>>
perhaps there's more to the above than meets the eye, but this implies
that the only materials relating to initial submissions seen by EVERY
member are consent forms (i.e. i'm admittedly reading between the two
lines that refer to informed consents and full protocols to just
four...). if this is the case, see more complete checklists provided
by e.g. erica heath and stewart laidlaw. i believe both FDA and OHRP
would frown on procedures that did not place, AT A MINIMUM, consent form
and protocol summary in hand of each and every member?
dan
Daniel K. Nelson, Director, Human Research Studies
Research Associate Professor of Pediatrics and Social Medicine
University of North Carolina-Chapel Hill
Chapel Hill, NC 27599-7097
Phone: 919-966-1344
fax: 919-966-7879
e-mail: dnelson@med.unc.edu
Daniel Nelson
7/18/2000 2:12:00 AM
Please forgive my ignorance regarding exempt reviews, but I would appreciate clarification on a statement I read. On page 182 of the IRB 101 manual it states, If an institution does not have a Multiple Project Assurance on file with OPRR, proposed research activities cannot be reviewed using exempt procedures.
We do not have an MPA at my hospital. Therefore it sounds as though we are not eligible to perform exempt reviews. Is this correct? Does this only apply to government funded studies? What about our cooperative group studies which are categorized under our CPA?
Clarification would be much appreciated. Thanks.
Leilani S. Price, Ph.D.
IRB Administrator
Cottage Health System
P.O. Box 689
Santa Barbara, CA 93102-0689
ph: 805-569-8323
fx: 805-569-7875
email: lprice@cottagehealthsystem.org
Leilani Price
7/18/2000 8:16:00 AM
Where do I find information on different types of assurances?
Of special interest is multiple assurance.
Thanks
Sandy
7/18/2000 11:46:00 AM
Just curious as to your notation that the protocol is for clinicians only.
What do the non-clinician members of the committee read which gives them the
information they need to determine the adequacy of the consent form?
-----Original Message-----
From: Rebecca Eveland [mailto:reveland@hillcrest.com]
Sent: Monday, July 17, 2000 4:23 PM
To: mcwirb@mcwirb.org
Subject: re: Packet to IRB members
Our IRB requires the following:
1. Agenda
2. Minutes of the last meeting
3. New Studies:
A. Protocol(clinicians only)
B. IRB Application
C. Consent Form (including: Patient's Bill of Rights and separate
consent
for anonymous genetic testing)
4. Continuing Review:
A. Completed Continuing Review Form
B. Research progress report
C. Copies of each currently approved consent form
D. Protocol
5. Amendments to Protocol
A. Sponsor's cover letter regarding same
B. Investigator's cover regarding same
C. Copy of protocol change(s)
D. Copy of protocol (when changes are numerous)
6. Amendments to Consent Form
A. Sponsor's cover letter regarding same
B. Investigator's cover regarding same
C. Consent Form currently in use
D. Newly amended Consent Form
7. Severe Adverse Events (Internal and External)
A. Sponsor's cover letter regarding same
B. Investigator's cover regarding same
C. MedWatch Form
D. Completed Severe Adverse Event reporting form
8. Education: Literature is provided regarding changes in regulations,
review
of regulations, and timely matters. (Due to recent developments, this
month's
agenda contains 13 items for review and discussion.)
9. Additional items as warranted
Hope this helps.
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Susan T .
7/18/2000 2:12:00 AM
IRB relationship to Administrative review
Our IRB is small enough to have only one paid employee. He recently retired, and the Administrative reviewer for the hospital is currently performing both functions: IRB Coordinator & Administrative reviewer.
Should we not allow this person to be a voting member, or does it matter?
Anonymous
7/18/2000 11:35:00 AM
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this format, some or all of this message may not be legible.
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Eileen,
Absolutely, you should look at the consent and other issues. I believe this
should be done with any amendment regardless of type of review, i.e. full
board/expedited. After all, the requested protocol changes may impact on
the consent - perhaps by providing new information on risks/benefits or on a
individual's willingness to continue as a participant or even providing a
new contact person and telephone number. Basically the entire study is
again reviewed.
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)
> -----Original Message-----
> From: Eileen_M_Yates@rush.edu [SMTP:Eileen_M_Yates@rush.edu]
> Sent: Tuesday, July 18, 2000 12:41 PM
> To: mcwirb@mcwirb.org
> Subject: (no subject)
>
> Hello,
>
> In a recent IRB meeting the following issue was raised and has caused
> quite
> a debate, please advise:
> When an amendment incorporates changes that require a full board review,
> is it
> appropriate to raise additional issues (other than the outlined changes,
> such as
> Is the consent form still appropriate?) with the study at this review? Or
> should the committee only review the amendment and then at the next
> scheduled
> continuing review raise the issues with the investigator? It is my stance
> that
> any opportunity to perform a check on the progress of the study is in
> the best
> interest of the rights and welfare of the subjects. Please let me know
> what you
> think.
>
> Thanks,
>
> Eileen M. Yates
> IRB Administrator
> Office of Research Affairs
> Rush-Presbyterian-St. Luke's Medical Center
> Chicago, IL. 60612
> 312-942-5498
> Eileen_M_Yates@rush.edu
>
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
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<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: (no subject) Eileen, Absolutely, you =
should look at the consent and other issues. I believe this =
should be done with any amendment regardless of type of review, i.e. =
full board/expedited. After all, the requested protocol changes =
may impact on the consent - perhaps by providing new information on =
risks/benefits or on a individual's willingness to continue as a =
participant or even providing a new contact person and telephone =
number. Basically the entire study is again reviewed. 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) -----Original Message----- From: Eileen_M_Yates@rush.edu =
[SMTP:Eileen_M_Yates@rush.edu] Sent: Tuesday, July 18, 2000 12:41 PM To: mcwirb@mcwirb.org Subject: =
(no subject) Hello, In a recent =
IRB meeting the following issue was raised and has caused quite a debate, please advise: When an amendment incorporates =
changes that require a full board review, is it appropriate to raise additional =
issues (other than the outlined changes, such as "Is the consent form still =
appropriate?) with the study at this review? Or should the committee only review the =
amendment and then at the next scheduled continuing review raise the issues =
with the investigator? It is my stance that any opportunity to perform a =
"check" on the progress of the study is in the best interest of the rights and welfare of =
the subjects. Please let me know what you think. Thanks, Eileen M. Yates IRB Administrator Office of Research Affairs Rush-Presbyterian-St. Luke's Medical =
Center Chicago, IL. 60612 312-942-5498 Eileen_M_Yates@rush.edu _______________________________________________ MCWIRB maillist - =
MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb <=
/FONT>
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Betty Dunger
7/18/2000 11:07:00 AM
Is it ethical to use a placebo instead of an active control?
Howard provides some good references.
You'll find several interesting and sometimes conflicting views. The
Helsinki Declaration has long stated that all participants are entitled to
the best proven therapy. That's problematic on at least two fronts:
-- There's pretty broad consensus that there are risks of withholding
therapy that are well within the range of risks to which a person
may consent; bearing the risk of an untreated stuffy nose is quite
different from bearing the risk of an untreated pneumonia.
-- Proven is a term with fuzzy margins, as is best. This problem
is magnified when one considers therapy availability --- should
the threshhold be different where the best proven therapy is
unavailable to the general public from that where said therapy
is in fact the standard therapy? If so, is it exploitative to do
studies in a context where economic disadvantage limits therapy
availability (so that placebos may seem more tolerable than they
might otherwise be)? If so, how do you decide when the
exploitation is either unacceptable or adequately offset by some
individual or societal benefit?
This is not always an easy question. But it tends for an IRB to focus on an
evaluation of the risk that is posed by the period of placebo use.
Dale
Dale Hammerschmidt
7/18/2000 8:19:00 AM
Is it ethical to use a placebo instead of an active control?
Dear Bob,
One solution is to provide frequent (e.g., weekly) examination of the
patient and switch to the proven drug if the situation warrants.
However, an approach that might be of greater practical value would be
to change the research question to: WHat is the effect of the
experimental treatment relative to the standard treatment?
Joan Sieber
Bob Short wrote:
>
> The statistical difficulty of using an active control instead of a placebo in a
> study is fully recoginzed. However, are we carrying out our ethical
> resposibility to protect the patient when we allow the use of a placebo instead
> of a proven drug that works (active control). In particular, is it ethical if
> the potential consequences of not using that active controll item is possibly
> life threatening. Can we in good conscience give that hypertensive patient a
> placebo and a stoke instead of an active control drug?
>
> Admitedly, the patient should be told about treatment options. However, are we
> doing our job to protect the patient if we even allow the patient an option
> that could cause injury or death?
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Joan E . Sieber
7/18/2000 8:16:00 AM
Is it ethical to use a placebo instead of an active control?
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Bob --
Well said. The fundamental duty of the IRB is the protection of human subjects. An
essential component of this task is ensuring that the medical treatment of subjects
is not knowingly compromised as a result of study participation (clinical
equipoise). Working on these premises, an IRB would have to reject a
placebo-controlled trial if an effective standard therapy was available, unless the
study population was restricted to those who had failed to respond to such
treatment (and any standard second line treatment). Consent is not an answer in
such cases, as requirements for an acceptable risk-benefit ratio and informed
consent are separate moral prerequisites for research.
For the record, the scientific difficulties of active controls have, in my view,
been overstated. On this see:
Weijer C. Placebo-controlled trials in schizophrenia: Are they ethical? Are they
necessary? Schizophrenia Research 1999; 35: 211-218.
Canadian guidelines (Tri-Council Policy Statement, 1998) now state that The use of
placebo controls in clinical trials is generally unacceptable when standard
therapies or interventions are available for a particular patient population.
Be well, Charles.
Bob Short wrote:
> The statistical difficulty of using an active control instead of a placebo in a
> study is fully recoginzed. However, are we carrying out our ethical
> resposibility to protect the patient when we allow the use of a placebo instead
> of a proven drug that works (active control). In particular, is it ethical if
> the potential consequences of not using that active controll item is possibly
> life threatening. Can we in good conscience give that hypertensive patient a
> placebo and a stoke instead of an active control drug?
>
> Admitedly, the patient should be told about treatment options. However, are we
> doing our job to protect the patient if we even allow the patient an option
> that could cause injury or death?
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
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Bob --
Well said. The fundamental duty of the IRB is the protection of human
subjects. An essential component of this task is ensuring that the medical
treatment of subjects is not knowingly compromised as a result of study
participation (clinical equipoise). Working on these premises, an IRB would
have to reject a placebo-controlled trial if an effective standard therapy
was available, unless the study population was restricted to those who
had failed to respond to such treatment (and any standard second line treatment).
Consent is not an answer in such cases, as requirements for an acceptable
risk-benefit ratio and informed consent are separate moral prerequisites
for research.
For the record, the scientific difficulties of active controls have,
in my view, been overstated. On this see:
Weijer C. Placebo-controlled trials in schizophrenia: Are they ethical?
Are they necessary? Schizophrenia Research 1999; 35: 211-218.
Canadian guidelines ( Tri-Council Policy Statement , 1998) now
state that The use of placebo controls in clinical trials is generally
unacceptable when standard
therapies or interventions are available for a particular patient population.
Be well, Charles.
Bob Short wrote:
The statistical difficulty of using an active control
instead of a placebo in a
study is fully recoginzed. However, are we carrying out our ethical
resposibility to protect the patient when we allow the use of a placebo
instead
of a proven drug that works (active control). In particular,
is it ethical if
the potential consequences of not using that active controll item is
possibly
life threatening. Can we in good conscience give that hypertensive
patient a
placebo and a stoke instead of an active control drug?
Admitedly, the patient should be told about treatment options.
However, are we
doing our job to protect the patient if we even allow the patient an
option
that could cause injury or death?
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
--------------65C5F4B45989CB666D0A8D23--
Charles Weijer
7/18/2000 4:58:00 AM
Please provide information on what you include in the IRB packet to Committee members the week prior to the meeting.
Thank you
Anonymous
7/18/2000 2:12:00 AM
community representatives
At 01:02 PM 7/14/2000 -0400, MacKay, Charles (OD) wrote:
> Commendable civic virtue. A fine list. But to force the position on someone
> by not offering adequate remuneration blunts their civic zeal. It is really
> a greater contribution if you are shown how much value the organization
> places on your effort and you decline it or donate the payment to charity.
At 11:57 AM 7/14/2000 -0400, MacKay, Charles (OD) wrote:
> I repeat that it is inequitable to expect individuals to give of their time
> and valuable view points without fair remuneration. Abe Lincoln used to have
> the motto up that A lawyer is only paid for his time and advice. Sounds
> fair to me. Not to compensate such members is exploitation, pure and
> simple.
I can find much sympathy for the desire to give people their just due. In
the past, I too have argued against exploitation, like the exploitation of
medical residents. So, I can also find sympathy for the political view that
we should find better ways of acquiring personnel resources, such as
increasing the pay of those who are in high demand and short supply,
whether hospital residents or IRB members. I can also find heaps of
sympathy for wanting to pay those who really need the income. But I do not
believe this issue is, in fact, all quite so pure and simple. In fact
from the size of my response below, one will ascertain that I believe it is
quite a complex issue, and one worth spending some time to address. So,
please forgive the lack of tightness of my arguments and whatever else
warrants forgiveness--I don't want to spend more time rewriting it.
Sorry, but much of the logic of the opposing argument here escapes me. This
argument would seem to me to be appropriately characterized as a no pay,
no work, or tit only for tat argument--one of do no more good for
others than they do for you. I am not aware of a foundation in either
medical ethics or general ethics for such a position. But perhaps I am in
error. Perhaps the reality is that my having devoted extensive time to
non-profit and government boards and activities for many years has warped
my thinking. Regardless, I think that those of us who are able, have a duty
to give to the community, to society, beyond our immediate family and
friends. It appears to me the opposing argument here, as formulated, if
carried to its logical conclusion in implementation, would destroy
volunteerism. If generalized to human relationships, it would destroy much
more. Applied consistently in IRBs, the result would be the end of research
as we know it, because research is dependent upon volunteers. If it valid
to declare, Not to compensate such members is exploitation, pure and
simple, then I fail to understand how it would not be equally (actually
more so) appropriate to aver that not to compensate research subjects is
exploitation, pure and simple. And if that is so, then as IRBs, we could
rarely approve the research that we currently approve.
Aside from the methodological problems that paying research subjects would
cause with research process and validity, the compensation for research
subjects would be incredibly more expensive than that of compensating IRB
members. For me, it is inconsistent to expect to be paid for my relatively
small and generally riskless role in the approval of research, and to
expect the research subjects to offer not only their time for free, but
their bodies, their personalities, their personal histories, medical and
otherwise--accepting all the risks associated with being a research
subject, of which most IRB members will probably be much more knowledgeable
than most research subjects. Granted, utility alone is not sufficient basis
upon which to base the argument--so, perhaps research subjects should be
compensated. But, if there is remuneration that should be provided in
this system, then as IRB members with our primary charge being the
protection of human subjects, it seems to me that before we start trying to
put more into our own pockets, it is research subjects for whom we should
first be seeking remuneration. If we win that battle, then, maybe we ought
to reconsider remuneration for community IRB members who are willing, even
happy, to volunteer their time, effort, and resources.
Regarding the comment of to force the position on someone, I am not
familiar with any experiences in which force has been used to put people
into positions on IRBs--I only know of them as positions in which people
get to exercise their free will to choose to be or not to be on the IRB.
Nor am I supporting any such potential experiences on IRBs or anything
else. Those who do not want to volunteer their time and effort shouldn't.
If they want to do this kind of work, but only if they get paid for it, I
do not begrudge them the opportunity to find a commercial IRB or one that
wants to pay--or they can create one. But if one can acquire services, or
products, for less than fair market value, is it exploitation to do so?
Not necessarily. There are numerous examples of instances when commercial
enterprises and individuals acquire things for less than fair market value.
Regarding the comment that not offering adequate remuneration blunts their
civic zeal, I do not believe that most of our reasonably well-paid
politicians in Washington and the state houses have any more civic zeal
than those who do it for free, or who at least certainly do it for much
less, as mayors, commissioners, volunteers, etc. in their little towns and
counties. Nor do I believe that they tend to have more civic zeal than
those who work for free as Red Cross volunteers or as volunteers in the
thousands of other non-profit organizations that depend on volunteers for
their existence to provide free and low cost benefits to the community. Or
those who do it for free on Federal and State Boards, Blue Ribbon Panels,
and Commissions. I have observed situations in which those who were getting
paid were far less productive, far less qualified, far less prepared, and
sporting far worse attitudes than even most of those who did the work
without pay. It is not civic zeal in my experience that is enhanced by
money--that is financial zeal.
I believe there is also a significant problem with the general idea of
adequate remuneration in the context of civic virtue or civic duty. What
is adequate remuneration in this context? What are the criteria for
determining adequate remuneration? Is the criterion one of time spent on
task? Or of showing up for a meeting? Of being on time? Of how
well-prepared for the meeting? Or of what the market pays that individual
for time, or for task, or for credentials? Do we deduct for those who
nodded off during the meeting, or those who said not a word, or those who
wasted everyone else's time asking questions already covered before their
late arrival? Or do we employ some combination of these and other criteria?
So, does a physician who volunteers get remunerated the same as the
volunteer nurse, or the minister, priest, rabbi, or nun? Does the new
attending get remunerated the same as the physician who is earning
$500,000/year. Does a lawyer who normally gets $300 an hour get remunerated
the same as a retired science teacher. Does a $20,000-a-day management
consultant and a millionaire biotech entrepreneur get remunerated the same
as the relatively poorer $300-an-hour lawyer or the poorer $500,000-a-year
physician? Is any one member just as valuable to the IRB as any other? That
seems highly unlikely to me. Other discussions in this forum have indicated
that some believe that not all are equally valuable, equally productive,
equally educated or qualified, etc. If all are not equal, then to avoid
exploiting some, we should develop scales indicating how much to pay
volunteers based on. . . , based on what--their education, experience,
credentials, earning power? But, developing such scales are very resource
intensive--expensive--if done properly, that is, working diligently to
ensure that no one is exploited from an inadequately considered or poorly
developed scale. Are some not being exploited if they are all getting the
same amount? But, using another criterion as primary, someone might argue
that they, as members of an IRB, are all doing the same work, so they
should all be paid the same. Is that the acceptable conclusion?
So, it is no longer exploitation as long as they are being paid? Being paid
something? Being paid anything? $250? $100? $5. Where is the line? Their
individual value, experience, education, ability to contribute do not
matter? If that is so regarding community representatives, then should the
same not apply to employees? If community volunteer nurses are to be paid
the same as physician volunteers and millionaire biotech entrepreneur
volunteers, why do employed nurses not get paid by their employers at the
same wage rate as physicians for their time on IRBs? How do we ameliorate
that inequity, that exploitation? Do we insist that employers pay the
nurses more? Or since a nurse or someone with a master's degree or even a
bachelor degree can perform the function, perhaps we should reduce the
wages of physicians for the time that they spend doing IRB work? We know
how far that brick will fly.
Frankly, there are some people for whom there could never be adequate
remuneration provided by IRBs, ethics committees, and many other
organizations--these organizations cannot afford to pay what some
volunteers are worth. Following the line of reasoning as presented in the
original argument that stimulated these current words, that people should
not do this work without adequate remuneration, and given that it is not
possible for some to be adequately remunerated, then those who cannot be
adequately remunerated would be freed from the responsibility of civic
duty. I think not. I do not expect the Bill Gates of the world to volunteer
for IRBs, but I do expect them to do other things for the benefit of
society. Thank goodness Gates did not demand adequate remuneration for
the $20 billion or so that he put into foundations. For whatever motive, he
decided to give back some of his good fortune to the community.
Also, how can it possibly be a greater contribution if you are given
something in return for the contribution? The IRS has never to my knowledge
accepted that argument. In fact, if I give $500 to my symphony or public
broadcasting corporation, the IRS does not let me ADD the value of any
tickets or gift that I might receive. Quite the opposite, they insist that
I DEDUCT that value from my declared contribution. Finally, and probably
less significant, even if I am given adequate remuneration and choose to
donate it, that can detract from the altruistic spirit of the good
intention because I can take a tax deduction for it and get 39.6% of it
back on my IRS return and another chuck from my state.
Sorry, but I think the exploitation argument does not have much solid
grounding. It also suffers from one of the same problems of which
utilitarianism is often accused. Its calculus becomes, if not impossible,
too complex to be worth the extensive effort for the lesser benefit. I
certainly do not claim to have all the answers, but for me at least, we do
far better to encourage altruism. Thus, my general argument is for the
encouragement of greater altruism, specifically in IRBs and ethics
committees, that may help to move us just slightly toward a less Hobbesian
brutish society. Perhaps I am bucking a normal trend and getting more
idealistic in my advancing age, but for me, Peace Corps, Job Corps, the
American Association of Retired People, Red Cross, and similar kinds of
organizations and activities that encourage our citizens, young and old, to
develop a sense of responsibility to give unselfishly to others are doing
wholesome work. Bravo to those organizations that demonstrate their
appreciation in one form or another to those who volunteer, but if they can
continue to find qualified and motivated people who will do the work
without requiring a tit for tat pecuniary reward, well. . . , I think Abe
Lincoln would not object, for he also said each of the following:
I have just tried to do my very best each and every day.
You cannot bring about prosperity by discouraging thrift.
Wanting to work is so rare a merit that it should be encouraged.
You cannot build character and courage by taking away men's initiative and
independence.
Best regards to all,
Phillip Michaels
Phillip Michaels
7/17/2000 11:28:00 AM
Dear mcwirbers,
I would would be very grateful if anyone could tell me whether there are
Independant IRB SOPs to be read on line. Do Independant IRBs make SOPs
public for customers who may wish to read them before submitting their
protocol to them?
You can respond privately, if you wish.
Many thanks,
Anne Blanchard
Argentina
Anne
7/17/2000 2:34:00 AM
As a third and forth year medical student, I was a student IRB member at the
University of Cincinnati Medical Center, 1973-1975. It was the early days
of IRB's. It was very educaitonal for me, and I felt I contributed my share
to the review process.
Toby Acheson MD
TriHealth IRB
Cincinnati
Toby Acheson
7/17/2000 2:37:00 AM
We send:
Agenda
Minutes of last meeting
Educational Information
An update on regulatory information, if any
Primary, secondary reviewer and Chair will receive:
Human Protocol Proceessing form
Internal Review from with Signature of PI, Chair and Hospital CEO
The protocol summary
If it is a clinical trial, complete invetigator's brochure
Consent/permission/Assent
Any pertinent publication or regulation that may concern that research
project
Conflict of Interest form for all investigators and coinvestigators
Adverstisements, if any
All other reviewers will receive everything except Investigator's brochure.
Sree Murthy
Associate VP for Ressearch
Drexel and MCP Hahnemann Universities
s.murthy@drexel.edu
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
Of Sandy Richmond
Sent: Friday, July 14, 2000 5:08 PM
To: mcwirb@mcwirb.org
Subject: Packet to IRB members
Please provide information on what you include in the IRB packet to
Committee
members the week prior to the meeting.
Thank you
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Sreekant Murthy
7/17/2000 9:25:00 AM
A Subject's Right to Withdraw Collected Research Data?
Howard ---
I agree fundamentally with your points about there being circumstances where
there might be an argument for a subject's right to demand removal of samples or
data already collected.
However, I am concerned about the practical implementation, and I think the far
better way is to handle the issues up front:
-- minimizing the risks
-- disclosing the risks
-- getting consent for the accurately-portrayed risks
-- including in that process a frank discussion of the liability to or
protection from use of the samples/data for purposes other than that for
which consent is sought.
The biggest argument for a right of removal comes in the circumstance when
disclosure has not been frank, and there's a change either in confidentiality
risk or in the type of research being done.
But you are absolutely right that people may wish to support some sorts of
research and not others, and there ARE genuine concerns about respect for
autonomy when one gets consent for study A and then uses the samples for study
B.
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
7/17/2000 8:26:00 AM
Recruiting community members
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It was suggested by a fellow mcwirb member (thanks Sandra) that I put this
issue out as a separate discussion item. (I had included it in a response
to a related discussion.) Therefore...
As an additional discussion item...how do you/fellow mcwirb participants
recruit community members? To date we have done it, for the most part, by
word of mouth, contacting local churches/groups or press release. We are
especially interested in targeting minority groups for representation. Any
thoughts/comments would be appreciated.
Thank you.
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)
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<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> Recruiting community members It was suggested by a fellow mcwirb =
member (thanks Sandra) that I put this issue out as a separate =
discussion item. (I had included it in a response to a related =
discussion.) Therefore... As an additional =
discussion item...how do you/fellow mcwirb participants recruit =
community members? To date we have done it, for the most part, by =
word of mouth, contacting local churches/groups or press release. =
We are especially interested in targeting minority groups for =
representation. Any thoughts/comments would be =
appreciated. Thank =
you. 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)
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Betty Dunger
7/17/2000 2:34:00 AM
lets see
for new proposals
- a summary of the proposal (we call it the submission form - six pages) prepared
by the PI and addressing all the hot button issues (inclusion of women, risks,
mitigation thereof, etc)
- the abstract from the proposal
- the consent form (omitting the boilerplate sections
for higher risk new proposals
- also the protocol in full
for continuing review
- the continuing review form (two pages)
- the consent form (truncated as above)
for amendments
- the PI cover letter
- the text of the amendment
- the new consent form (if there is one, truncated as before)
for adverse events
- the PI cover letter
- the text of the adverse event report (truncated as much as possible)
other stuff, like information items, etc
that enough detail? if not, I would be happy to expand
Sandy Richmond wrote:
> Please provide information on what you include in the IRB packet to Committee
> members the week prior to the meeting.
>
> Thank you
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Stewart Laidlaw Phd
7/17/2000 2:34:00 AM
I served as a full voting member of a University Medical IRB for 3
years in the early 80's while completing a doctorate in a health
sciences field. It was a wondeful experience for me while at the
same time I feel I contributed to the IRB. I was a conscientious
reviewer and presenter and spent many many hours reviewing
proposals. A mature student can offer considerable expertise. My
experience has stayed with me all these years and I am now
Chairperson of our newly forming health department IRB.
Richard Danila, Ph.D., M.P.H.
Acting State Epidemiologist
and Acting Section Manager
Acute Disease Epidemiology Section
Minnesota Department of Health
717 SE Delaware St. SE
Minneapolis, MN 55414
Voice: (612) 676-5414
FAX: (612) 676-5743
richard.danila@health.state.mn.us
Richard Danila
7/17/2000 2:37:00 AM
A Subject's Right to Withdraw Collected Research Data?
Dear McWirbers,
Your insight and assistance regarding the following would be helpful.
SCENARIO
i. A subject enrolls in a research project that includes medical record data extraction and questionnaires regarding medical care for X disease. Full written informed consent is provided. The informed consent form indicates that the subject may withdraw from the research without penalty.
ii. The research procedures are performed. The data is obtained using standard instruments. There are 95 total subjects. The study is now closed to accrual and statistical analysis is performed.
iii. The subject returns 2 months later and requests to be withdrawn from the study. Part of the request is the removal of her data from the project.
iv. It would require a significant expenditure of time and resources for the investigator to identify the data, redact it, and re-do data analysis.
QUESTIONS:
1. When a subject withdraws from the research should her/his research information also be withdrawn?
a. What should be the reasonable expectation placed on the investigator?
b. What if the data can be deidentified?
2. At what point is it impracticable to remove data/specimens from a project.
3. What if the removal of such information negatively impacts the statistical analysis of the entire project? For example, the 1 out of 95 could be a significant percentage, depending on the information.
The OPRR Guidebook discussing the development of cell lines states: ...the underlying principle would be that withdrawal releases the subject from providing further information or tissue samples, and perhaps requires the removal of the subject's identity from all research records, but does not require the investigator to eliminate the resulting data from the study or to destroy the cell line. [p5-48 - 5-49]
thank you for your help.
-steve
Steven Peckman
Associate Director-Human Subjects Research
Office for Protection of Research Subjects
University of California, Los Angeles
310.825.5344
speckman@oprs.ucla.edu
Anonymous
7/17/2000 8:26:00 AM
We are currently filling vacancies on our IRB. Since many of the subjects tend to be students, we are looking at the possibility of having a student serve on the board.
Do any institutions have a student representative on the IRB? If so, in what capacity (voting or non-voting). What are some of the pros and cons of having a student serve?
Thanks in advance.
Susie Hayes
Compliance Coordinator
University of Memphis
slhayes@cc.memphis.edu
Anonymous
7/17/2000 8:24:00 AM
Interesting question. Our IRB receives a consent agenda (amoung other
documents) 10 days prior to the meeting. This consent agenda includes
alot of housekeeping material, including the progress reports, some
SAE's, and annual reports. ANY item can be extracted for discussion and
a separate vote. Otherwise, the consent agenda is voted on as one item
(with appropriate abstentions noted). HOWEVER, the FDA auditor, which
concluded her interview last Wednesday, didn't like this one vote on
numerous matters function, suggesting that each item be voted on
separately (which could be time consuming for ? gain).
Does anyone else use a consent agenda? If so, how?
Thanks,
Craig Weiner, MD
Chair
Mercy Healthcare Sacramento Regional IRB
Craig Weiner
7/17/2000 11:04:00 AM
The Agenda
The Minutes
Copies of any Informed Consents for the meeting
Full protocols go to just four of the members
Any newsletters or relevant news articles
The updated annual calendar of reviews (we may skip one or two months per
year)
The Member List
-----Original Message-----
From: Sandy Richmond [mailto:srichmond@shc.org]
Sent: Friday, July 14, 2000 4:08 PM
To: mcwirb@mcwirb.org
Subject: Packet to IRB members
Please provide information on what you include in the IRB packet to
Committee
members the week prior to the meeting.
Thank you
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Jill
7/17/2000 2:34:00 AM
community representatives
We are a small board and review 45 new protocols a year, meeting 1.25 hr. once a month. We have two community representatives and give them $100 gift certificates once a year. Dr. Pittman
>>> fitp@aol.com 07/12/00 07:41PM >>>
,Our IRB is seeking advice on how much to pay our community representatives.
They provide an invaluable service and are a necessary and insightful component
of the Board. I have spoken with administrators of several Boards and the
honorarium ranges from $100/meeting to $50/hour including several hours of
preparation time. Any advice would be appreciated.
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
David Pittman
7/17/2000 8:24:00 AM
Sandy,
For my IRBs, we send each member:
- the meeting agenda
- a report called the Coordinators Report that lists all activity being
presented at the current meeting (continuing/final study reports, amendments,
serious AEs,INDs), expedited matters, info items, and pertinent
correspondence to investigators (your study is closed because you didn't
submit a request to renew your approval)
- new study information that includes a full protocol, full application form
(ours is a few pages long) and an informed consent in our institutions format
- materials to the subcommittees. We have a Continuing/Final report
committee, AEs/INDs committee and Amendment Committee. They review copies of
all the materials the IRB Office gets in for these areas.
Rebecca
Rebecca M. Clark
Scripps Health/Children's Hospital IRBs
San Diego, CA
(858) 576-4008
rebcaclark@aol.com
Rebecca M. Clark
7/17/2000 2:37:00 AM
An attendance notice, agenda, minutes from previous meeting, one full protocol for review, partial (missing the sponsor's protocol) protocols to be reviewed, annual, continuation, and final reports, any articles of interest.
>>> srichmond@shc.org 07/14/00 05:07PM >>>
Please provide information on what you include in the IRB packet to Committee
members the week prior to the meeting.
Thank you
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Dee Long
7/17/2000 2:40:00 AM
We have a graduate student from psychology serve as a voting member on a one
year appointment.
Nanci Stewart Woods, Ph.D.
Associate Professor of Psychology
Coordinator, Undergraduate Psychology
Austin Peay State University
Clarkville, TN 37044
931-221-7236
woodsn@apsu.edu
-----Original Message-----
From: Susie Hayes [mailto:slhayes@msuvx2.memphis.edu]
Sent: Friday, July 14, 2000 11:48 AM
To: mcwirb@mcwirb.org
Subject: student representative
We are currently filling vacancies on our IRB. Since many of the subjects
tend
to be students, we are looking at the possibility of having a student serve
on
the board.
Do any institutions have a student representative on the IRB? If so, in
what
capacity (voting or non-voting). What are some of the pros and cons of
having a
student serve?
Thanks in advance.
Susie Hayes
Compliance Coordinator
University of Memphis
slhayes@cc.memphis.edu
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Nanci Woods
7/17/2000 8:24:00 AM
community representatives
,Our IRB is seeking advice on how much to pay our community representatives. They provide an invaluable service and are a necessary and insightful component of the Board. I have spoken with administrators of several Boards and the honorarium ranges from $100/meeting to $50/hour including several hours of preparation time. Any advice would be appreciated.
Anonymous
7/17/2000 11:28:00 AM
This is the short and simple. To every short & simple rule there is an
exception.
Erica
1. Agenda
2. Minutes of prior meeting
3. Discussion Items
3a Journal articles etc for continuing ed.
3b Reports
3bi Expedited reviews conducted
3bii Adverse events
3biii ad nauseum
4. Initial reviews
5. Continuing reviews
6. Major modifications
7. Returns from prior meetings
Initial Reviews
Protocol, consent document, CRFs, IB, ads and recruitment materials etc.
Everyone gets full protocol and consent.
Selected people get the rest unless it is of a manageable size.
Continuing review
CR report form, summary letter/report consent document used for the most
recent enrollment.
Selected people get the prior protocol.
Erica
>Please provide information on what you include in the IRB packet to Committee
>members the week prior to the meeting.
>
>Thank you
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Erica Heath
President, IRC
415-485-0717
heath
7/17/2000 2:41:00 AM
Recruiting community members
Dear Betty,
Could study participants be consulted while entering a study if they are
interested in participating for future IRB meetings? Perhaps as guests, in
the same way some investigators may be invited to make comments but abstain
from voting?
I think experience from subjects is a delicate issue, anyway. But although
they may be biased by their experience, they may provide a valid insight to
the trial.
Regards,
Anne Blanchard
Argentina
Anne
7/17/2000 2:34:00 AM
Dear Members,
Our IRB has been struggling with some aspects of archival data collection and we would like to pose the topic to the list-serv for input.
What do institutional review boards consider archival data collection that
requires the Board's review for exemption?
Do they require investigators to go through a review if:
a) they are new professors and brought data that was already collected and reviewed by another IRB with them to the new institution or
b) they come on board as a collaborator/author after the data was reviewed and collected at another university. In both cases there is no active data collection from the archival data files.
Thanks in advance for your help.
Elisa Gaucher
Florida Atlantic University
Anonymous
7/14/2000 5:01:00 AM
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