informed consent disclosures
Kelly:
Our IRB deals with these questions fairly often, usually involving
Department of Psychology surveys of minors or abuse survivors. PIs are
required to inform potential subjects (minors and adults) in writing that if
evidence of suicide risk or suspected recent abuse is uncovered as a result
of the subject's survey responses, the PI is obligated to report these
suspicions to the appropriate authorities. In the case of minors, this
information must be provided both on the consent form for the parents and
the assent form for the minor. Yes, this may mean that the PI loses
potential subjects; however, our primary obligation is to the safety of the
research subject, not to the PI's ability to recruit subjects.
Timothy P. Stratton, Ph.D., R.Ph.
Associate Professor of Pharmacy Administration
School of Pharmacy and Allied Health Sciences
The University of Montana-Missoula
Member, UM IRB
ph: (406) 243-2339
fax: (406) 243-4353
e-mail: timstrat@selway.umt.edu
snail mail: Pharmacy Practice
32 Campus Drive #1522
Missoula, MT 59812-1522
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
Of Kelly Carroll
Sent: Tuesday, July 25, 2000 3:00 PM
To: mcwirb@mcwirb.org
Subject: informed consent disclosures
I've recently received several enquiries from PI's about the degree to
which they need to disclose the following types of information to subjects
in informed consent forms:
if the subject reveals (through interview or questionnaire response) that
they may harm themselves or others,
the investigator will have to take appropriate legal steps
if the investigator believes that child abuse or elder abuse has occurred,
they will have to report it to the proper authorities.
timstrat@selway.umt.edu
7/26/2000 9:43:00 AM
PRIM&R and ARENA to host annual IRB meetings!
PRIM&R and ARENA to host annual IRB meetings!
Paradise Point Resort, San Diego, California – October 29-31, 2000 – Enormous changes are in the air as PRIM&R and ARENA prepare for their 26th annual meetings on institutional review boards (IRBs). While hopes are high that many HHS and other new initiatives will, in fact, result in improved protections for those who participate in research, concerns are also high that IRBs are under-resourced to effectively manage their ever-increasing loads. The October meetings will help IRBs: (1) balance requirements, desires, and realities; (2) develop educational offerings; (3) better understand what can be expected from the newly relocated Office of Human Research Protection (OHRP); and (4) learn about innovative and successful ways to build a better human research protection program.
Public Responsibility in Medicine and Research (PRIM&R) and Applied Research Ethics National Association (ARENA), in cooperation with the University of California at San Diego and Tufts University School of Medicine are pleased to announce PRIM&R and ARENA’s 2000 annual IRB meetings as follows:
PRIM&R – IRBs: Afloat in a Sea of Change
This year’s annual PRIM&R meeting on October 29 and 30, jointly sponsored by Tufts University School of Medicine and the University of California at San Diego, will focus on the evolving relationship between the newly formed HHS Office for Human Research Protection (OHRP) and the community of regulated institutions. Dr. Greg Koski, OHRP’s newly appointed Director, will deliver the keynote address, and will participate actively in the entire meeting. Dr. Bernard Schwetz, Deputy Director of the Food and Drug Administration (FDA), will deliver the second day keynote address. Other plenary speakers will be Alex Capron, of the National Bioethics Advisory Commission (NBAC), and Gregory Carroll of the Bayer Institute of Health Care Communication. There will be panels on “best practices” for IRBs, reports from the NIH, NBAC, ORI, and the Office of the Inspector General, mini-debates on legal and ethical cases that will inform and entertain, and a panel of research subjects discussing their experiences of, and attitudes toward, participating in research.
In over 45 workshops, a broad range of cutting-edge problems will be discussed, including a variety of genetics research issues, IRB educational responsibilities, conflicts of interest, international research, research with special populations (including children, prisoners, and persons with mental illnesses), those in multi-center trials, compliance concerns, privacy and confidentiality, the role of central review boards (CRBs), and the ongoing search for a new paradigm of partnership between the IRB, principal investigator (PI), research participant, sponsor, and federal government.
A full program and registration form are posted on the PRIM&R Web site < http://www.primr.org>. Those who desire additional information or who would prefer to receive a registration form via fax or mail may contact the PRIM&R office by telephone (617) 423-4112, fax (617) 423-1185, or email <info@primr.org>.
ARENA – IRBs: New Directions in 2000
ARENA will hold its 21st Annual IRB meeting in San Diego on October 31. IRBs are experiencing increased responsibilities at a time when research is becoming more complex each day. In our 2000 meeting we plan to focus on two topics: informed consent and education. The agenda will include a number of national experts on these two topics and research participants. We look forward to discussing these exciting issues with the research community. A full program and registration form is posted on the PRIM&R Web site <http://www.primr.org>. Those who desire additional information or who would prefer to receive a registration form via fax or mail may contact the PRIM&R office by telephone can contact the PRIM&R office by telephone (617) 423-4112, fax (617) 423-1185, or email <info
Anonymous
7/26/2000 4:23:00 AM
A Consent Form Question: Has anyone seen a guidance
on the appropriateness of referring a patient
to his/her primary care physician for information
on alternative treatments, if any, that might be
advantageous. This queston arises from
a conversation about discussing alternative treatments
with patients who use websites and other public
information to seek out clinical trials as opposed
to patients who are referred to the trial by physicians
who review the patient's medical history with the PI.
----------------------------------------
Kay Ryan
Email: Kay.Ryan@Med.Nyu.Edu
NYU Medical Center
Kay . Ryan
7/26/2000 12:08:00 PM
>>> Dale E. Hammerschmidt 07/26/00
11:37AM >>> wrote:
>Kay ---
There are a couple points.
First, alternative treatments is really not the point, and some of
the regulatory language is suboptimal. The real point is
alternatives to being in the study. After all, not every study is
therapeutic in intent, and treatments are not the only important
alternatives that a prospective subject may need to know about.
(edit)
...........................................................................................................................................................
Dale's comments are, of course, right on the mark.
The relevant section of our template for the Consent Document
( http://www.ihc.com/ldsh/irb/consent_template.html) uses that
suggested by the NCI :
http://cancertrials.nci.nih.gov/researchers/safeguards/consent/template.html
This is the pertinent section from the latter :
WHAT OTHER OPTIONS ARE THERE?
Instead of being in this study, you have these options:
[List alternatives including commonly-used therapy and No therapy at
this time with care to help you feel more comfortable.]
[If appropriate (for noninvestigational treatments):]
You may get __________________ (STUDY TREATMENTS/DRUGS AT THIS CENTER
AND OTHER CENTERS) even if you do not take part in the study.
Please talk to your regular doctor about these and other options.
[Reference and attach information about alternatives.]
Regards,
Howard
Howard Mann
7/26/2000 12:06:00 PM
It is important to consider the following advice from the OPRR (now OHRP)
document entitled OPRR Compliance Activities: Common Findings and
Guidance (11/29/99) available on the website (ohrp.osophs.dhhs.gov/) when
considering IRB approval contingent upon modifications:
(5) Contingent Approval of Research with Substantive Changes and no
Additional Review by the Convened IRB. OPRR finds that the IRB frequently
approves research contingent upon substantive modifications or
clarifications without requiring additional review by the convened IRB.
OPRR recommends the following guidelines in such cases: (i) When the
convened IRB requests substantive clarifications, protocol modifications, or
informed consent document revisions, IRB approval of the proposed research
must be deferred pending subsequent review by the convened IRB of responsive
material. (ii) Only when the convened IRB stipulates specific revisions
requiring simple concurrence by the investigator may the IRB Chair or
designated reviewer subsequently approve the research on behalf of the IRB.
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: Workman, Don [mailto:Don.Workman@stjude.org]
Sent: Tuesday, July 25, 2000 11:02 AM
To: mcwirb@mcwirb.org
Subject: Labels for IRB Actions
At a recent conference, I became engaged in an interesting dialogue
regarding the labels various IRBs use to describe the actions taken by the
Committee. Most seem to agree that approval and disapproval are
straightforward along with tabled, but what about those protocols and
Informed Consent Forms that would be approved if only minor changes were
made. It seems that some IRBs entertain motions to find the protocol and
ICF approvable pending modification and then designate whether the changes
are substantive (requiring it to come back to full committee) or not
(allowing for Chairman review of the minor changes). Another option is to
entertain a motion that minor modifications are required and indicate
whether administrative approval by the Chair may be done without going back
to the full committee.
It seems the advantage to the label approvable pending modification is
that it states full committee approval, with the contingency specified. The
disadvantage is that it implies approval when approval has not yet been
granted (and may be misread by the Investigator who reads too quickly and
perceives what s/he wishes to read rather than what is there). The
advantage of minor modification required is that it avoids the confusion
of wording, but the wording does not designate approval from the full
committee, implying that the Chair can give approval to studies not
appropriate for expedited review.
Three questions emerge in my thinking. First, is this type of action common
to IRBs? Second, what wording do other IRBs use to designate this kind of
action and what thoughts might be offered from MCWIRBers regarding the best
practice for labeling these kinds of committee actions? And third, which
date becomes the date of IRB approval; the date of the Committee action or
the date of Chair review and approval?
Don E. Workman, Ph.D.
IRB Administrator
St. Jude Children's Research Hospital
332 N. Lauderdale
Memphis, TN 38101
901-495-4359
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Evelyn Studer
7/26/2000 5:19:00 AM
We need to remember that this is just advice and not codified. I think it is
unworkable if interpreted too strictly. We often get restrictions from the IRB
such as reconcile the 3 needle sticks mentioned in the protocol with 4 called
for in the consent form. This is not something we can rephrase for a PI's
simple concurrence and yet it would be absurd to delay the project a whole month
because of this discrepancy (assuming, of course, that the IRB has indicated
that either number is OK and they just want to eliminate the discrepancy).
--Bill Sellers, Wright State University
Studer, Evelyn J. wrote:
> It is important to consider the following advice from the OPRR (now OHRP)
> document entitled OPRR Compliance Activities: Common Findings and
> Guidance (11/29/99) available on the website (ohrp.osophs.dhhs.gov/) when
> considering IRB approval contingent upon modifications:
>
> (5) Contingent Approval of Research with Substantive Changes and no
> Additional Review by the Convened IRB. OPRR finds that the IRB frequently
> approves research contingent upon substantive modifications or
> clarifications without requiring additional review by the convened IRB.
> OPRR recommends the following guidelines in such cases: (i) When the
> convened IRB requests substantive clarifications, protocol modifications, or
> informed consent document revisions, IRB approval of the proposed research
> must be deferred pending subsequent review by the convened IRB of responsive
> material. (ii) Only when the convened IRB stipulates specific revisions
> requiring simple concurrence by the investigator may the IRB Chair or
> designated reviewer subsequently approve the research on behalf of the IRB.
William Sellers
7/26/2000 9:31:00 AM
Hi...On July 19, 2000 there was a message sent to the listserve that
indicated, 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.
Please be advised that this is not true. The Chair is not paid a % of the
IRB application fee at the University of Miami.
Steven G. Ullmann, Ph.D.
Vice Provost for Faculty Affairs
and University Administration
and Dean of the Graduate School
305-284-2002 phone
305-284-6758 fax
Steven G .
7/26/2000 2:58:00 AM
Jeanne ---
This sort of recruiting practice was common when I was a trainee, and
people still do it. It's because they haven't thought through the
implications and because they don't know the rules. It's usually a
well-intentioned mistake.
But it is a mistake. And in this specific case, it's a potentially
bad one, because people with positive blood cultures will
disproportionately be people who are especially vulnerable and will
predictably include many who cannot give consent and some who are
near death with the grieving family at the bedside.
Some hospitals have as part of their routine consent-to-treat process
a provision that patients are asked for permission for the intramural
research use of their medical records ... and very few patients
object. So it MAY have been OK for the investigator to get the
information. But that's qualitatively different from using the
information to invade the patient's privacy.
Ordinarily, it's pretty easy to do this right. The investigator
approaches the physician actually caring for the patients of
interest. The physician, if there's no reason for unusual concern,
asks the patient if it's OK to have a researcher stop by and discuss
a research study. The patient says 'yes' or the patient says 'no.'
Caveat: If the institution does NOT solicit routine consent for
intramural research/teaching use of clinical data, the question of
the investigator's access even to the lab information gets more
difficult. And of course, one may challenge such consent in any
event, as patients get asked to sign a bazillion papers and may not
have noticed this provision --- especially if they were frightened or
in pain. (Two years ago, I was hospitalized with an esophageal
laceration [I have no future as a sword-swallower], and it took great
self-control to find and cross out the two provisions I objected to.)
dale
Dale Hammerschmidt
7/26/2000 9:31:00 AM
informed consent disclosures
Kelly,
The Florida university was the University of South Florida. The law suit
did not go to trial, so USF did not lose. They settled for $3.8 million.
The details should be of interest to every IRB member and administrator. I
think that everyone should read the March 20, 2000 National Law Journal
article. I found it archived at www.law.com. The following URL may work:
http://www.law.com/cgi-bin/gx.cgi/AppLogic+FTContentServer?pagename=law/View
&c=Article&cid=A19220-2000Mar21&live=true&cst=1&pc=0&pa=0 If not, search
the site for informed consent. Unfortunately, it is a violation of their
terms and conditions to post it to the list.
This was a class action suit on behalf of several thousand women who were
enrolled in various protocols during pregnancy. There was no attempt to
allege any physical damage to any mother or child. The researchers had
signed consent forms for every subject.
The allegation was that the consent was not valid because the women did not
understand what they were signing. This was considered by the plaintiffs to
be a civil rights violation.
Andrew Cockburn, PhD
Director of Institutional Research Compliance/Biological Safety
West Virginia University
Morgantown, WV 26506-9006
Telephone: 304-293-7157
FAX: 304-293-4529
Email: acockbur@wvu.edu
> -----Original Message-----
> From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
> Of Kelly Carroll
> Sent: Tuesday, July 25, 2000 5:00 PM
> To: mcwirb@mcwirb.org
> Subject: informed consent disclosures
>
>
>
> I've recently received several enquiries from PI's about the degree to
> which they need to disclose the following types of information to
> subjects
> in informed consent forms:
>
> if the subject reveals (through interview or questionnaire response) that
> they may harm themselves or others,
> the investigator will have to take appropriate legal steps
>
> if the investigator believes that child abuse or elder abuse has
> occurred,
> they will have to report it to the proper authorities.
>
> The IRB clearly must assess risk to the subject and make sure that the
> subject is fully informed of these risks before the subject consents to
> participate in the study. The PI's concerns are that by
> notifying subjects
> of possible, but in their eyes unlikely, risks such as those mentioned
> above, they will lose subjects. These are non-biomedical
> protocols and in
> many cases the PI's are not mandated reporters of such matters
> according to
> state law. Insight on how your IRB, especially non-bio medical IRB's,
> handle this issue is appreciated. Also, if there are clear
> guidelines for
> this type of issue, legal precedent, OHRP citations concerning this,
> etc. that would be helpful.
>
> Finally, does anyone have information on the Florida university that
> recently lost a 60 million class action case for not properly obtained
> informed consent from labor and delivery subjects?
>
> Thanks Kelly
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
Andrew Cockburn
7/26/2000 9:38:00 AM
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_01BFF705.7E758E56
Content-Type: text/plain
Don,
We use 'Approved as submitted', 'Approved with the following revisions',
'Deferred', or, on rare occasion, 'Disapproved'. The following is taken
from our notice form:
APPROVED AS SUBMITTED (The Annual/Interim Report of
the Status of Approved Human Experimentation Protocol has to be submitted
for approval by the {Institutional identification} IRB NO LATER than .
Due to guidelines that the IRB must follow, research CANNOT BE CONTINUED
after the above date until the Annual/Interim Report is received and
approved by the {Institutional identification} IRB.)
APPROVED WITH THE FOLLOWING REVISIONS (If revisions
are required, your study may not be undertaken until the revisions have been
submitted to and have been given final approval by the {Institutional
identification} IRB.)
DEFERRED
The IRB Chair will review revisions unless the IRB specifies subcommittee or
full board review, the latter is when deferred is generally used. The
approval date becomes the date final approval was given, i.e. all revisions
have been made and approved by the IRB.
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: Workman, Don [SMTP:Don.Workman@stjude.org]
> Sent: Tuesday, July 25, 2000 11:02 AM
> To: mcwirb@mcwirb.org
> Subject: Labels for IRB Actions
>
> At a recent conference, I became engaged in an interesting dialogue
> regarding the labels various IRBs use to describe the actions taken by the
> Committee. Most seem to agree that approval and disapproval are
> straightforward along with tabled, but what about those protocols and
> Informed Consent Forms that would be approved if only minor changes were
> made. It seems that some IRBs entertain motions to find the protocol and
> ICF approvable pending modification and then designate whether the
> changes
> are substantive (requiring it to come back to full committee) or not
> (allowing for Chairman review of the minor changes). Another option is to
> entertain a motion that minor modifications are required and indicate
> whether administrative approval by the Chair may be done without going
> back
> to the full committee.
>
> It seems the advantage to the label approvable pending modification is
> that it states full committee approval, with the contingency specified.
> The
> disadvantage is that it implies approval when approval has not yet been
> granted (and may be misread by the Investigator who reads too quickly and
> perceives what s/he wishes to read rather than what is there). The
> advantage of minor modification required is that it avoids the confusion
> of wording, but the wording does not designate approval from the full
> committee, implying that the Chair can give approval to studies not
> appropriate for expedited review.
>
> Three questions emerge in my thinking. First, is this type of action
> common
> to IRBs? Second, what wording do other IRBs use to designate this kind of
> action and what thoughts might be offered from MCWIRBers regarding the
> best
> practice for labeling these kinds of committee actions? And third, which
> date becomes the date of IRB approval; the date of the Committee action or
> the date of Chair review and approval?
>
> Don E. Workman, Ph.D.
> IRB Administrator
>
> St. Jude Children's Research Hospital
> 332 N. Lauderdale
> Memphis, TN 38101
> 901-495-4359
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
------_=_NextPart_001_01BFF705.7E758E56
Content-Type: text/html
Content-Transfer-Encoding: quoted-printable
<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: Labels for IRB Actions Don, We use 'Approved as =
submitted', 'Approved with the following revisions', 'Deferred', or, on =
rare occasion, 'Disapproved'. The following is taken =
from our notice form: =
=
APPROVED AS SUBMITTED (The Annual/Interim Report of the Status of =
Approved Human Experimentation Protocol has to be submitted for =
approval by the {Institutional identification} IRB =
NO LATER =
than . Due to guidelines that the IRB must follow, =
research CANNOT BE CONTINUED after the above date until the =
Annual/Interim Report is received and approved by =
the {Institutional =
identification} IRB.) =
=
APPROVED WITH THE FOLLOWING REVISIONS (If revisions are required, your study =
may not be =
undertaken until the revisions have been submitted to and have been =
given final approval by the {Institutional =
identification} IRB.) =
=
DEFERRED The IRB Chair will =
review revisions unless the IRB specifies subcommittee or full board =
review, the latter is when deferred is generally used. The =
approval date becomes the date final approval was given, i.e. all =
revisions have been made and approved by the IRB. 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: Workman, Don =
[SMTP:Don.Workman@stjude.org] Sent: Tuesday, July 25, 2000 11:02 AM To: mcwirb@mcwirb.org Subject: =
Labels for IRB Actions At a recent conference, I became =
engaged in an interesting dialogue regarding the labels various IRBs use =
to describe the actions taken by the Committee. Most seem to agree =
that "approval" and "disapproval" are straightforward along with =
"tabled," but what about those protocols and Informed Consent Forms that would be =
approved if only minor changes were made. It seems that some IRBs =
entertain motions to find the protocol and ICF "approvable pending =
modification" and then designate whether the changes are substantive (requiring it to come =
back to full committee) or not (allowing for Chairman review of the =
minor changes). Another option is to entertain a motion that "minor =
modifications are required" and indicate whether administrative approval by =
the Chair may be done without going back to the full committee. It seems the advantage to the label =
"approvable pending modification" is that it states full committee =
approval, with the contingency specified. The disadvantage is that it implies =
approval when approval has not yet been granted (and may be misread by the =
Investigator who reads too quickly and perceives what s/he wishes to read =
rather than what is there). The advantage of "minor modification =
required" is that it avoids the confusion of wording, but the wording does not =
designate approval from the full committee, implying that the Chair =
can give approval to studies not appropriate for expedited =
review. Three questions emerge in my =
thinking. First, is this type of action common to IRBs? Second, what wording =
do other IRBs use to designate this kind of action and what thoughts might be =
offered from MCWIRBers regarding the "best practice" for labeling these =
kinds of committee actions? And third, which date becomes the date of IRB =
approval; the date of the Committee action or the date of Chair review and =
approval? Don E. Workman, Ph.D. IRB Administrator St. Jude Children's Research =
Hospital 332 N. Lauderdale Memphis, TN 38101 901-495-4359 _______________________________________________ MCWIRB maillist - =
MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb <=
/FONT>
------_=_NextPart_001_01BFF705.7E758E56--
Betty Dunger
7/26/2000 4:31:00 AM
We had a similar problem -- PI's reading until they saw the one word
approved -- so we use a separate, specific certification letter. Until
the PI gets the certification, he or she cannot begin the project. This
avoids all the confusion; if it isn't certified, it can't be started.
David McGowan
-----Original Message-----
From: Jon Hart [mailto:hart@mail.rockefeller.edu]
Sent: Wednesday, July 26, 2000 10:52
To: mcwirb@mcwirb.org; Workman, Don
Subject: Re: Labels for IRB Actions
In my experience, this is a common practice (in the 3 IRBs I have been a
member of in the present and past). I would caution against the use of any
form of the word approved in conditionally approving a protocol pending
minor revisions (usually things like typos, changing some technical terms
into lay language, etc.) as my experience is once an investigator spots
that word, he/she stops reading. I once asked OPRR what we should use for
the approval date, and was told we should use the date the final and
complete approval takes place (usually by the Chair) (OHRP people: if
you've changed your policy please weigh in). At one institution, we
categorized this kind of committee response as Minor Modifications Needed
which seemed to work well.
Jon Hart
At 10:01 AM 7/25/00 -0500, you wrote:
>At a recent conference, I became engaged in an interesting dialogue
>regarding the labels various IRBs use to describe the actions taken by the
>Committee. Most seem to agree that approval and disapproval are
>straightforward along with tabled, but what about those protocols and
>Informed Consent Forms that would be approved if only minor changes were
>made. It seems that some IRBs entertain motions to find the protocol and
>ICF approvable pending modification and then designate whether the
changes
>are substantive (requiring it to come back to full committee) or not
>(allowing for Chairman review of the minor changes). Another option is to
>entertain a motion that minor modifications are required and indicate
>whether administrative approval by the Chair may be done without going back
>to the full committee.
>
>It seems the advantage to the label approvable pending modification is
>that it states full committee approval, with the contingency specified.
The
>disadvantage is that it implies approval when approval has not yet been
>granted (and may be misread by the Investigator who reads too quickly and
>perceives what s/he wishes to read rather than what is there). The
>advantage of minor modification required is that it avoids the confusion
>of wording, but the wording does not designate approval from the full
>committee, implying that the Chair can give approval to studies not
>appropriate for expedited review.
>
>Three questions emerge in my thinking. First, is this type of action
common
>to IRBs? Second, what wording do other IRBs use to designate this kind of
>action and what thoughts might be offered from MCWIRBers regarding the
best
>practice for labeling these kinds of committee actions? And third, which
>date becomes the date of IRB approval; the date of the Committee action or
>the date of Chair review and approval?
>
>Don E. Workman, Ph.D.
>IRB Administrator
>
>St. Jude Children's Research Hospital
>332 N. Lauderdale
>Memphis, TN 38101
>901-495-4359
>
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Jon Hart, Director, Sponsored Programs Administration
The Rockefeller University
1230 York Ave.-Box 82, NY, NY 10021-6399
tel: (212) 327-8054; fax: (212) 327-8400
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
David G
7/26/2000 12:08:00 PM
informed consent disclosures
One case of which I am aware is the University of South Florida case, which
according to the Tampa Tribune of 3/11/00 was settled for $3.8 million.
Perhaps that newspaper has searchable archives that you may be able to
access on-line.
Elyse I. Summers, J.D.
Division of Human Subjects Protection
OHRP
6100 Executive Blvd., Ste. 3B01 (MSC 7507)
Rockville, MD 20892-7507
ph.301-402-5559
fax.301-402-2071
Elyse Od
7/26/2000 9:43:00 AM
>>> Dale E. Hammerschmidt 07/26/00
11:37AM >>> wrote:
>Kay ---
There are a couple points.
First, alternative treatments is really not the point, and some of
the regulatory language is suboptimal. The real point is
alternatives to being in the study. After all, not every study is
therapeutic in intent, and treatments are not the only important
alternatives that a prospective subject may need to know about.
(edit)
...........................................................................................................................................................
Dale's comments are, of course, right on the mark.
The relevant section of our template for the Consent Document
( http://www.ihc.com/ldsh/irb/consent_template.html) uses that
suggested by the NCI :
http://cancertrials.nci.nih.gov/researchers/safeguards/consent/template.html
This is the pertinent section from the latter :
WHAT OTHER OPTIONS ARE THERE?
Instead of being in this study, you have these options:
[List alternatives including commonly-used therapy and No therapy at
this time with care to help you feel more comfortable.]
[If appropriate (for noninvestigational treatments):]
You may get __________________ (STUDY TREATMENTS/DRUGS AT THIS CENTER
AND OTHER CENTERS) even if you do not take part in the study.
Please talk to your regular doctor about these and other options.
[Reference and attach information about alternatives.]
Regards,
Howard
Howard Mann
7/26/2000 12:08:00 PM
I am curious as to what is meant here by intramural research. For
example, if the infection control nurse periodically reviews positive
blood cultures by unit looking for pathogen or resistance trends with
the aim of reducing risk of nosocomial infection, would that be
considered intramural research?
How about if there is an outbreak of aspergillosis on the oncology
ward, and this nurse publishes her findings. Does this require IRB
review and (retrospective) informed consent? Who provides the
informed consent for those aspergillosis patients who died of their
infection?
If a county health department screened a high risk pediatric
population for lead poisoning, analyzed the data by geographic
region, and published the deidentified results, would that require
that their parent or guardian give informed consent?
Are you suggesting that epidemiology projects, quality assurance
projects, healthcare community needs assessments, and healthcare
improvement projects require IRB approval?
If a doctor is using a palm pilot to manage his practice, and decides
to calculate the mean and standard deviation of systolic blood
pressures in his practice, does that require IRB approval and
informed consent?
How about if a munincipality notices that a certain intersection has
a statistically higher risk of traffic fatalities, and they make
changes and monitor them to see if fewer accidents occur. Is that
intramural research? Does it require IRB review? Informed consent
by the drivers?
-Steven
--
Steven Belknap, M.D.
Assistant Professor of Clinical Pharmacology and Medicine
University of Illinois College of Medicine at Peoria
Steven Belknap
7/26/2000 12:18:00 PM
Folks:
I recently had a computer crash that, among other delights, destroyed
my received-e-mail cache. Although I was able to rebuild the hard
disk directory and recover over 99% of my files, that one remains an
interesting 20+-megabyte interleaving of messages, BINHex code,
UUCode and b64MIME code (it seems to have taken all attachments and
interleaved them .... interesting conceptually, but...)
Unfortunately, for some communications with other mcwirbers, the copy
of a message in that cache was my only copy of the person's e-mail
address, and may very well be my only copy of preliminary
communication about speaking engagements, promised reprints,
consulting visits and the like.
If anybody out there is feeling grumpy because I haven't responded to
something, please send me a new e-mail at your earliest convenience.
And don't open any headerless e-mails (that was the event immediately
preceding the crash).
And Norton Filesaver really WILL rebuild your directory if it gets
trashed. I went from a hard drive that was recognized as blank and
unformatted to one that worked fine and had lost little in less than
two hours.
dale
Dale Hammerschmidt
7/26/2000 9:29:00 AM
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We are currently having a discussion (disagreement )concerning the =
reformation of our IRB forms that the PIs complete when reporting SAEs.
How much information is required by regulations? Is the typical =
information required by a sponsor considered too much information for =
the requirements of the IRB?
I would appreciate all advice and/or suggestions.
Thanks.
Robin A. Simuncak
Assistant Director IRB
Medical College of Wisconsin
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<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 4.0 Transitional//EN> We are currently having a discussion =
(disagreement=20
)concerning the reformation of our IRB forms that the PIs complete =
when=20
reporting SAEs. How much information is required by=20
regulations? Is the typical information required by a sponsor =
considered=20
too much information for the requirements of the IRB? I would appreciate all advice and/or=20
suggestions. Thanks. Robin A. Simuncak Assistant Director IRB Medical College of=20
Wisconsin
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Robin Simuncak
7/26/2000 12:02:00 PM
>Kay ---
There are a couple points.
First, alternative treatments is really not the point, and some of
the regulatory language is suboptimal. The real point is
alternatives to being in the study. After all, not every study is
therapeutic in intent, and treatments are not the only important
alternatives that a prospective subject may need to know about.
Second, the person conducting a study may have expertise in only the
aspect of the disease in question that relates most directly to the
study hypothesis. He may be a pharmacologist with expertise in the
kinetics of HMGCoA reductase inhibitors, and the alternative
treatments appropriate for a patient might be things requiring a
seasoned clinician with credentials in internal medicine.
Third, the appropriate alternative treatments for a group of patients
may be so varied that a discussion in the CF will be either
hopelessly complex or uselessly superficial.
In thinking about this issue, I find it useful to get away from the
unfortunate phrase alternative treatments, and try to think instead
of the patient's appropriate questions:
1) What will happen or be recommended if I decide not to be in the study?
--- and ---
2) If I enter the study, how will my treatment be different from what
would happen if I chose to be treated without being in the study?
--- and in the case of a novel therapy ---
3) Can I get the new therapy without being in the study?
So what it's appropriate to say may vary a lot according to the
details of the study and the patient population providing the
subjects. And who ought to say it may vary according to expertise and
to the nature of the relationship between the patients/subjects and
the investigator. And how much belongs in the CF depends on how
coherently the issues can be addressed there. Pretty often, it may
turn out that it's appropriate for the CF to provide only rather
broad generalities, and for the patient indeed to re-consult his or
her own physician if the decision is against study participation, or
if a decision cannot be reached without further input from a
clinician outside of the study.
Make sure those questions get answered, you'll be doing well.
Dale H.
Dale Hammerschmidt
7/26/2000 9:31:00 AM
In my experience, this is a common practice (in the 3 IRBs I have been a
member of in the present and past). I would caution against the use of any
form of the word approved in conditionally approving a protocol pending
minor revisions (usually things like typos, changing some technical terms
into lay language, etc.) as my experience is once an investigator spots
that word, he/she stops reading. I once asked OPRR what we should use for
the approval date, and was told we should use the date the final and
complete approval takes place (usually by the Chair) (OHRP people: if
you've changed your policy please weigh in). At one institution, we
categorized this kind of committee response as Minor Modifications Needed
which seemed to work well.
Jon Hart
At 10:01 AM 7/25/00 -0500, you wrote:
>At a recent conference, I became engaged in an interesting dialogue
>regarding the labels various IRBs use to describe the actions taken by the
>Committee. Most seem to agree that approval and disapproval are
>straightforward along with tabled, but what about those protocols and
>Informed Consent Forms that would be approved if only minor changes were
>made. It seems that some IRBs entertain motions to find the protocol and
>ICF approvable pending modification and then designate whether the changes
>are substantive (requiring it to come back to full committee) or not
>(allowing for Chairman review of the minor changes). Another option is to
>entertain a motion that minor modifications are required and indicate
>whether administrative approval by the Chair may be done without going back
>to the full committee.
>
>It seems the advantage to the label approvable pending modification is
>that it states full committee approval, with the contingency specified. The
>disadvantage is that it implies approval when approval has not yet been
>granted (and may be misread by the Investigator who reads too quickly and
>perceives what s/he wishes to read rather than what is there). The
>advantage of minor modification required is that it avoids the confusion
>of wording, but the wording does not designate approval from the full
>committee, implying that the Chair can give approval to studies not
>appropriate for expedited review.
>
>Three questions emerge in my thinking. First, is this type of action common
>to IRBs? Second, what wording do other IRBs use to designate this kind of
>action and what thoughts might be offered from MCWIRBers regarding the best
>practice for labeling these kinds of committee actions? And third, which
>date becomes the date of IRB approval; the date of the Committee action or
>the date of Chair review and approval?
>
>Don E. Workman, Ph.D.
>IRB Administrator
>
>St. Jude Children's Research Hospital
>332 N. Lauderdale
>Memphis, TN 38101
>901-495-4359
>
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Jon Hart, Director, Sponsored Programs Administration
The Rockefeller University
1230 York Ave.-Box 82, NY, NY 10021-6399
tel: (212) 327-8054; fax: (212) 327-8400
Jon Hart
7/26/2000 9:38:00 AM
It is important to consider the following advice from the OPRR (now OHRP)
document entitled OPRR Compliance Activities: Common Findings and
Guidance (11/29/99) available on the website (ohrp.osophs.dhhs.gov/) when
considering IRB approval contingent upon modifications:
(5) Contingent Approval of Research with Substantive Changes and no
Additional Review by the Convened IRB. OPRR finds that the IRB frequently
approves research contingent upon substantive modifications or
clarifications without requiring additional review by the convened IRB.
OPRR recommends the following guidelines in such cases: (i) When the
convened IRB requests substantive clarifications, protocol modifications, or
informed consent document revisions, IRB approval of the proposed research
must be deferred pending subsequent review by the convened IRB of responsive
material. (ii) Only when the convened IRB stipulates specific revisions
requiring simple concurrence by the investigator may the IRB Chair or
designated reviewer subsequently approve the research on behalf of the IRB.
Evelyn Studer, IRB Administrator
Research Triangle Institute
PO Box 12194
Research Triangle Park, NC 27709-2194
Phone: 919-541-6442 Fax: 919-541-7250
STUDER@rti.org
Evelyn Studer
7/26/2000 9:58:00 AM
It is common to recruit patients for studies in somewhat similar ways.
However, IMHO, what must happen is that someone who has the authority to
review the chart/lab/whatever does so in order to identify the patients who
would qualify for the study and then that person also broaches the subject
of the study to the patient. The investigator, who has no privilege to the
identity of the patient, cannot make contact until the patient has agreed to
learn more about the study and agrees to meet with the investigator. Only
then can the identity of the patient be revealed to the investigator.
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
Gaffney, Jeanne
Sent: Tuesday, July 25, 2000 3:22 PM
To: 'mcwirb@mcwirb.org'
Subject: Recruiting Patients
I am Coordinator for the IRB of a hospital system (11 hospitals). The
following situation just came to my attention today. If this scenario has
been recently discussed on list, please forgive.
It seems that a physician/researcher (pulmonologist) at one of our hospitals
is recruiting patients for a sepsis study. This study currently has IRB
approval by our local IRB. The question of recruiting practice did not come
up at the meeting when the study was approved. It was assumed that he would
be using his own practice patients. Today I received a call from the Micro
Lab Director. It seems that the PI has requested from our microbiology lab,
the names of hospital patients that have a positive blood culture, then
approaches them about the study. I have been assured by our Quality
Improvement Director that this is a breach of confidentially and that any
information on/about the patient should be shared only with the attending
physician. Since this has come up, I have found that at least one other
physician within our system that is using this recruiting tool. Is this
type of recruiting common practice within the hospital setting? Some
departments within the hospital have access to patient's medical
information/labwork, etc., via MIDAS and other software programs. Does it
make a difference if the physician/researcher is a hospital employee?
Jeanne Gaffney
Human Research Review Board
Baptist Health System
Birmingham, AL
205/592-5700
205/592-5094 fax
jeanne.gaffney@bhsala.com
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Icenogle & Associates
7/26/2000 9:32:00 AM
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this format, some or all of this message may not be legible.
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Don,
We use 'Approved as submitted', 'Approved with the following revisions',
'Deferred', or, on rare occasion, 'Disapproved'. The following is taken
from our notice form:
APPROVED AS SUBMITTED (The Annual/Interim Report of
the Status of Approved Human Experimentation Protocol has to be submitted
for approval by the {Institutional identification} IRB NO LATER than .
Due to guidelines that the IRB must follow, research CANNOT BE CONTINUED
after the above date until the Annual/Interim Report is received and
approved by the {Institutional identification} IRB.)
APPROVED WITH THE FOLLOWING REVISIONS (If revisions
are required, your study may not be undertaken until the revisions have been
submitted to and have been given final approval by the {Institutional
identification} IRB.)
DEFERRED
The IRB Chair will review revisions unless the IRB specifies subcommittee or
full board review, the latter is when deferred is generally used. The
approval date becomes the date final approval was given, i.e. all revisions
have been made and approved by the IRB.
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: Workman, Don [SMTP:Don.Workman@stjude.org]
> Sent: Tuesday, July 25, 2000 11:02 AM
> To: mcwirb@mcwirb.org
> Subject: Labels for IRB Actions
>
> At a recent conference, I became engaged in an interesting dialogue
> regarding the labels various IRBs use to describe the actions taken by the
> Committee. Most seem to agree that approval and disapproval are
> straightforward along with tabled, but what about those protocols and
> Informed Consent Forms that would be approved if only minor changes were
> made. It seems that some IRBs entertain motions to find the protocol and
> ICF approvable pending modification and then designate whether the
> changes
> are substantive (requiring it to come back to full committee) or not
> (allowing for Chairman review of the minor changes). Another option is to
> entertain a motion that minor modifications are required and indicate
> whether administrative approval by the Chair may be done without going
> back
> to the full committee.
>
> It seems the advantage to the label approvable pending modification is
> that it states full committee approval, with the contingency specified.
> The
> disadvantage is that it implies approval when approval has not yet been
> granted (and may be misread by the Investigator who reads too quickly and
> perceives what s/he wishes to read rather than what is there). The
> advantage of minor modification required is that it avoids the confusion
> of wording, but the wording does not designate approval from the full
> committee, implying that the Chair can give approval to studies not
> appropriate for expedited review.
>
> Three questions emerge in my thinking. First, is this type of action
> common
> to IRBs? Second, what wording do other IRBs use to designate this kind of
> action and what thoughts might be offered from MCWIRBers regarding the
> best
> practice for labeling these kinds of committee actions? And third, which
> date becomes the date of IRB approval; the date of the Committee action or
> the date of Chair review and approval?
>
> Don E. Workman, Ph.D.
> IRB Administrator
>
> St. Jude Children's Research Hospital
> 332 N. Lauderdale
> Memphis, TN 38101
> 901-495-4359
>
>
>
> _______________________________________________
> 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: Labels for IRB Actions Don, We use 'Approved as =
submitted', 'Approved with the following revisions', 'Deferred', or, on =
rare occasion, 'Disapproved'. The following is taken =
from our notice form: =
=
APPROVED AS SUBMITTED (The Annual/Interim Report of the Status of =
Approved Human Experimentation Protocol has to be submitted for =
approval by the {Institutional identification} IRB =
NO LATER =
than . Due to guidelines that the IRB must follow, =
research CANNOT BE CONTINUED after the above date until the =
Annual/Interim Report is received and approved by =
the {Institutional =
identification} IRB.) =
=
APPROVED WITH THE FOLLOWING REVISIONS (If revisions are required, your study =
may not be =
undertaken until the revisions have been submitted to and have been =
given final approval by the {Institutional =
identification} IRB.) =
=
DEFERRED The IRB Chair will =
review revisions unless the IRB specifies subcommittee or full board =
review, the latter is when deferred is generally used. The =
approval date becomes the date final approval was given, i.e. all =
revisions have been made and approved by the IRB. 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: Workman, Don =
[SMTP:Don.Workman@stjude.org] Sent: Tuesday, July 25, 2000 11:02 AM To: mcwirb@mcwirb.org Subject: =
Labels for IRB Actions At a recent conference, I became =
engaged in an interesting dialogue regarding the labels various IRBs use =
to describe the actions taken by the Committee. Most seem to agree =
that "approval" and "disapproval" are straightforward along with =
"tabled," but what about those protocols and Informed Consent Forms that would be =
approved if only minor changes were made. It seems that some IRBs =
entertain motions to find the protocol and ICF "approvable pending =
modification" and then designate whether the changes are substantive (requiring it to come =
back to full committee) or not (allowing for Chairman review of the =
minor changes). Another option is to entertain a motion that "minor =
modifications are required" and indicate whether administrative approval by =
the Chair may be done without going back to the full committee. It seems the advantage to the label =
"approvable pending modification" is that it states full committee =
approval, with the contingency specified. The disadvantage is that it implies =
approval when approval has not yet been granted (and may be misread by the =
Investigator who reads too quickly and perceives what s/he wishes to read =
rather than what is there). The advantage of "minor modification =
required" is that it avoids the confusion of wording, but the wording does not =
designate approval from the full committee, implying that the Chair =
can give approval to studies not appropriate for expedited =
review. Three questions emerge in my =
thinking. First, is this type of action common to IRBs? Second, what wording =
do other IRBs use to designate this kind of action and what thoughts might be =
offered from MCWIRBers regarding the "best practice" for labeling these =
kinds of committee actions? And third, which date becomes the date of IRB =
approval; the date of the Committee action or the date of Chair review and =
approval? Don E. Workman, Ph.D. IRB Administrator St. Jude Children's Research =
Hospital 332 N. Lauderdale Memphis, TN 38101 901-495-4359 _______________________________________________ MCWIRB maillist - =
MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb <=
/FONT>
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Betty Dunger
7/26/2000 4:33:00 AM
The OPRR guidelines seem to imply that there must be a
"convened" IRB to review modifications to protocols and
informed consent forms. Since we are in the e-commerce age and
since we find it difficult to schedule meetings of our IRB because of
people's full calendars, we try to use email to do business where we
can. (We do not have regularly scheduled IRB meetings because of
the small number of cases we process.)
A typical situation here: The IRB meets in person to consider a
case. We develop a list of concerns and convey in writing to the PI
as explicitly as possible what those concerns are and what would need to
be done to satisfy the IRB. As Chair, I usually make a follow-up
call to the PI to ensure that he/she understands all the points in the
letter. Our PIs tend to be highly responsive [fortunately], and so
when the PI sends back a revised protocol and informed consent form, more
often than not it is fully satisfactory to the IRB. When I receive
the revised documents, I email them to the IRB members and ask them
whether they feel that the PI has successfully addressed all of the
concerns of the Board. If the members all email a "yes"
back to me, then it seems that there is no need for another face to face
meeting. At that point I can prepare and process the approval,
(keeping on file copies of the emails to verify that the Board approved
the modifications). If one or more members of the Board feel that
the PI has not adequately addressed the Board's concerns, then we
can call a meeting and discuss it, but if we can handle most of the
modified protocols/ICFs by email, we can act much more quickly than if we
must "convene" follow-up meetings to review these documents.
Brian Belanger
IRB Chair, Natl. Institute of Standards and Technology
brian.belanger@nist.gov
At 01:29 PM 7/25/00 -0400, you wrote:
>It is important to consider the following advice from the OPRR (now
OHRP)
>document entitled "OPRR Compliance Activities: Common
Findings and
>Guidance" (11/29/99) available on the website
(ohrp.osophs.dhhs.gov/) when
>considering IRB approval contingent upon modifications:
>
>"(5) Contingent Approval of Research with Substantive Changes
and no
>Additional Review by the Convened IRB. OPRR finds that the IRB
frequently
>approves research contingent upon substantive modifications or
>clarifications without requiring additional review by the convened
IRB.
>OPRR recommends the following guidelines in such cases: (i) When
the
>convened IRB requests substantive clarifications, protocol
modifications, or
>informed consent document revisions, IRB approval of the proposed
research
>must be deferred pending subsequent review by the convened IRB of
responsive
>material. (ii) Only when the convened IRB stipulates specific
revisions
>requiring simple concurrence by the investigator may the IRB Chair
or
>designated reviewer subsequently approve the research on behalf of
the IRB."
>
>Evelyn Studer, IRB Administrator
>Research Triangle Institute
>PO Box 12194
>Research Triangle Park, NC 27709-2194
>919-541-6442
>STUDER@rti.org
Brian Belanger
7/26/2000 12:09:00 PM
In order to help institutions and IRBs develop institutional guidelines, IRB
operating procedures, and investigator education programs, OHRP would like
to put together a resource list of such documents that institutions could
utilize as acceptable samples. If your institution would like to
contribute to this undertaking, and if your institution has documents in
electronic form that it is willing to share freely with the IRB community,
please e-mail me directly (NOT THRU MCWIRB) at tp10y@nih.gov, including the
to-be-shared documents via attachment or website link. Thanks very much!
Tom Puglisi, PhD
Director, Human Subject Protections
Office for Human Research Protections
tp10y@nih.gov / 301-402-5189
Tom Od
7/26/2000 3:46:00 AM
informed consent disclosures
I've recently received several enquiries from PI's about the degree to
which they need to disclose the following types of information to subjects
in informed consent forms:
if the subject reveals (through interview or questionnaire response) that
they may harm themselves or others,
the investigator will have to take appropriate legal steps
if the investigator believes that child abuse or elder abuse has occurred,
they will have to report it to the proper authorities.
The IRB clearly must assess risk to the subject and make sure that the
subject is fully informed of these risks before the subject consents to
participate in the study. The PI's concerns are that by notifying subjects
of possible, but in their eyes unlikely, risks such as those mentioned
above, they will lose subjects. These are non-biomedical protocols and in
many cases the PI's are not mandated reporters of such matters according to
state law. Insight on how your IRB, especially non-bio medical IRB's,
handle this issue is appreciated. Also, if there are clear guidelines for
this type of issue, legal precedent, OHRP citations concerning this,
etc. that would be helpful.
Finally, does anyone have information on the Florida university that
recently lost a 60 million class action case for not properly obtained
informed consent from labor and delivery subjects?
Thanks Kelly
Kelly Carroll
7/26/2000 4:42:00 AM
We had a similar problem -- PI's reading until they saw the one word
approved -- so we use a separate, specific certification letter. Until
the PI gets the certification, he or she cannot begin the project. This
avoids all the confusion; if it isn't certified, it can't be started.
David McGowan
-----Original Message-----
From: Jon Hart [mailto:hart@mail.rockefeller.edu]
Sent: Wednesday, July 26, 2000 10:52
To: mcwirb@mcwirb.org; Workman, Don
Subject: Re: Labels for IRB Actions
In my experience, this is a common practice (in the 3 IRBs I have been a
member of in the present and past). I would caution against the use of any
form of the word approved in conditionally approving a protocol pending
minor revisions (usually things like typos, changing some technical terms
into lay language, etc.) as my experience is once an investigator spots
that word, he/she stops reading. I once asked OPRR what we should use for
the approval date, and was told we should use the date the final and
complete approval takes place (usually by the Chair) (OHRP people: if
you've changed your policy please weigh in). At one institution, we
categorized this kind of committee response as Minor Modifications Needed
which seemed to work well.
Jon Hart
At 10:01 AM 7/25/00 -0500, you wrote:
>At a recent conference, I became engaged in an interesting dialogue
>regarding the labels various IRBs use to describe the actions taken by the
>Committee. Most seem to agree that approval and disapproval are
>straightforward along with tabled, but what about those protocols and
>Informed Consent Forms that would be approved if only minor changes were
>made. It seems that some IRBs entertain motions to find the protocol and
>ICF approvable pending modification and then designate whether the
changes
>are substantive (requiring it to come back to full committee) or not
>(allowing for Chairman review of the minor changes). Another option is to
>entertain a motion that minor modifications are required and indicate
>whether administrative approval by the Chair may be done without going back
>to the full committee.
>
>It seems the advantage to the label approvable pending modification is
>that it states full committee approval, with the contingency specified.
The
>disadvantage is that it implies approval when approval has not yet been
>granted (and may be misread by the Investigator who reads too quickly and
>perceives what s/he wishes to read rather than what is there). The
>advantage of minor modification required is that it avoids the confusion
>of wording, but the wording does not designate approval from the full
>committee, implying that the Chair can give approval to studies not
>appropriate for expedited review.
>
>Three questions emerge in my thinking. First, is this type of action
common
>to IRBs? Second, what wording do other IRBs use to designate this kind of
>action and what thoughts might be offered from MCWIRBers regarding the
best
>practice for labeling these kinds of committee actions? And third, which
>date becomes the date of IRB approval; the date of the Committee action or
>the date of Chair review and approval?
>
>Don E. Workman, Ph.D.
>IRB Administrator
>
>St. Jude Children's Research Hospital
>332 N. Lauderdale
>Memphis, TN 38101
>901-495-4359
>
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Jon Hart, Director, Sponsored Programs Administration
The Rockefeller University
1230 York Ave.-Box 82, NY, NY 10021-6399
tel: (212) 327-8054; fax: (212) 327-8400
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
David G
7/26/2000 12:06:00 PM
Human Research Subjects Protection Act of 2000
I have developed a two part training program for our IRB members. The first
part explains the IRB from an historical perspective and provides an
overview of applicable federal regulations. The second part focuses on the
actual operation of the IRB and includes several practical exercises. A
part of the training also explains the role of the IRB in the correctional
setting. I utilize the OHRP videotapes in the training. Since we are just
getting started and have not begun to review protocols, I have not addressed
PI training.
(Mr.) Lanue B. Ryan, MA
Senior Management Analyst &
Executive Director
Institutional Review Board
Office of Health Services
Florida Department of Corrections
2601 Blair Stone Road
Tallahassee, FL 32399-2500
Phone: 850.922.6645
Fax: 850.487.8082
-----Original Message-----
From: LaRusso, Sandra ARMC-Prof Svcs
[mailto:LaRussoS@armc.co.san-bernardino.ca.us]
Sent: Friday, July 21, 2000 4:09 PM
To: 'mcwirb@mcwirb.org'
Subject: RE: Human Research Subjects Protection Act of 2000
Wendy:
We spend the first few minutes of each IRB meeting on an educational topic.
I have also developed a newsletter that goes out to all IRB members,
principal investigators, and department chairs. On a more formal note, I am
in the process of putting together an educational binder for the IRB
members. It will contain resource information and several self study
modules. I do one-on-one orientations with all new IRB members. I have not
started to work on anything specific for P.I.s as yet. Our standard
operating procedures apply regardless of the funding source.
> -----Original Message-----
> From: Wendy Westling [SMTP:MSJ.CIAMXW@memo.msj.org]
> Sent: Friday, July 21, 2000 11:33 AM
> To: mcwirb@mcwirb.org
> Subject: re: Human Research Subjects Protection Act of 2000
>
> I would be interested in finding out what organizations without federally
> funded studies are doing regarding providing education for PIs and IRB
> members.
> It does not appear that as yet, there are any federal educational
> requirements
> for PIs or others conducting human subject research that is industry
> sponsored.
> I would like to know what kind of educational programs are being offered
> by
> such organizations. Thank you for your response.
>
> Wendy Westling
> IRB Chairperson
> Mission St. Joseph's Health System
> Asheville, NC
>
>
> _______________________________________________
> 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
Anonymous User
7/25/2000 7:29:00 AM
Human Research Subjects Protection Act of 2000
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
Anonymous
7/25/2000 7:29:00 AM
I was absolutely sure that I had read somewhere that conducting
interviews could be
considered, in some instances, to be like questionaires; i.e., that if
no
identifying characteristics were collected and no harm could come to the
subjects,
then informed consent was not necessary. The idea was that the simple
act of
answering the questions was equivalent to giving informed consent. Now I
can't find
where I had read this information.
Am I just imagining having read this in some guidelines (could be US or
Canadian),
or does someone have a reference. This would help greatly with a paper
I am
currently writing.
Thanks,
Janice
Janice Singer
7/25/2000 6:15:00 AM
Survey of College Freshmen
This question is directed at university IRBs. It involves the Cooperative
Institutional Research Program survey that is given to all incoming
university freshmen at (we are told) over 200 universities. Results are
tabulated at UCLA and published for the academic community. The survey was
exempted by UCLA's IRB several years ago although the questions change from
year-to-year. We at Georgia Tech began examining this survey a year ago
after a parent complained that her 17 year-old daughter was required to
take the survey in order to register for college, that parental permission
was not sought, and that it contained sensitive questions. Our IRB had
never been sent an application because the survey was declared exempt at
its source and our local PI thought that eliminated need for local review.
Our IRB just received a protocol for this year's survey and again have
serious problems with it. (At our IRB's direction, students under 18 are
now excluded from the survey here.) The survey is still claimed to be
exempt. CIRP still claims that there are no sensitive questions -- yet it
asks students about their alcohol consumption (a crime), whether they
suffer from depression (a health problem that could affect future
employability and insurability), their political and moral views, and
family history. They must provide their full name and social security
number to allow followup.
At our insistence, the survey forms given to Georgia Tech freshmen must
emphasize that completion of any or all questions is voluntary. Yet,
proctors are told to convince the reluctant students to complete the
forms. It's hard to imagine a group more vulnerable to coercion than
college freshmen on their first day away from home.
I'd like to hear from other university IRBs about their knowledge and
handling of this national survey. I'm told that we're the only IRB that
has voiced any concerns about the survey. Thanks for your comments.
Mike Kelly
IRB Chair
Georgia Tech
Mike Kelly
7/25/2000 6:25:00 AM
>From our local newspaper last week:
Fifty-five percent of employers are monitoring their workers' Internet
use, and 38 percent examine workers' e-mail messages, according to a survey
by the American Management Association. Another survey by Angus Reid Group
found 73 percent of employees agreed with their employers' right to minotor
their e-mail and Internet use at work. However, 46 percent admitted they
surf the Web for personal reasons at work, and 55 percent sent and [received
personal e-mails].
If you access the American Management Association web page, there are
additional research results posted that indicate on average employees are
informed of such monitoring about 83.5% of the time in the sectors AMA
queried (mfg, finan. Svcs, wholesale/retail, bus/prof services, public adm,
other non-profit).
Among other significant issues associated with research conducted on the web
remains the question of confidentiality. When aspects of the research
relate to matters which could influence insurability, employability, or
reputation within the organization if the personal information became known,
one may need to ask whether the web is the medium of choice.
_________________________________________________________
Celia S. Walker
Director, Regulatory Compliance
410 University Services Center
Colorado State University
Fort Collins, CO 80523-2046
970-491-1563 (v) 970-491-2293 (fax) cwalker@research.colostate.edu
Regulatory Compliance web site:
http://www.research.colostate.edu/regulatory
Celia
7/24/2000 8:41:00 AM
genetic samples/long-term use
Our Independent Ethics Committee is seeing increasing numbers of
pharmacogenetic sub-studies tacked on to clinical drug trials. These are
generally to search for genes or genetic markers involved in the disease
of interest, or response to treatments for the specific disease. In most
cases, the samples remain linked to identifying information for some
specified duration related to exploration of the specific
disease/treatment that is the focus of the clinical trial. Request is
commonly made for separate consent to then destroy the linkage
(annonymize the sample) and keep the annonymous sample indefinitely for
research into other diseases and treatments.
Recently, however, we reviewed a protocol wishing to keep the sample
linked for 50 years, to study the disease/treatment related to the
trial, and then other diseases/treatments. Subjects would retain the
right to have their sample destroyed at any time. We had a big problem
with this (among other things, without further input about what research
was taking place over time, how would subjects know when to exercise
their right to withdraw their sample?) and requested a study design more
in line with the format described above. Of course the sponsor is not
happy with our stand.
Has anyone else encountered such a design? What was your response?
Thanks,
Nancy Ondrusek
Nancy Ondrusek
7/24/2000 11:47:00 AM
If anyone is still following this debate, the following reference is worth
looking at. It is a review paper by Aspinall and Goodman, from the BMJ in
1995, looking at placebo controlled trials of Ondansetron for control of
post-operative nausea and vomiting, a condition for which there was clearly
an alternative treatment available. By the authors' estimate, some 2180
patients had been given placebo as prophylaxis and 440 had been given
placebo when already experiencing postoperative nausea or vomiting.
http://www.bmj.com/cgi/content/full/311/7009/844
Paul Wainwright
Paul
7/24/2000 8:39:00 AM
Looking for out of print book
Hi,
I hope someone can help me.
I am currently searching for Faden, King, & Beauchamp's, A history and theory of
informed consent., and Sieber's, Planning ethically responsible research.
If you have a copy you would like to sell, please contact me.
(I can only lend them from my library for 2 weeks at a time, and that is never
long enough!).
Janice Singer
janice.singer@nrc.ca
Janice Singer
7/24/2000 8:41:00 AM
Human Research Subjects Protection Act of 2000
The University of Pennsylvania has been working on and will
institute mid-August a 4 hour web based educational program for
researchers performing clinical trials. It contains four modules
(ethics, IRB, GCP, Conflict of Interest).
At 01:32 PM 7/21/00 -0500, you wrote:
>I would be interested in finding out what organizations without
federally
>funded studies are doing regarding providing education for PIs and
IRB members.
> It does not appear that as yet, there are any federal educational
requirements
>for PIs or others conducting human subject research that is industry
sponsored.
>I would like to know what kind of educational programs are being
offered by
>such organizations. Thank you for your response.
>
>Wendy Westling
>IRB Chairperson
>Mission St. Joseph's Health System
>Asheville, NC
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
> +++++++++++++++++++++++++++++++++++++++++++++++++++++ Marcia D. Markowitz,
Director Phone:
(215)662-4253 Office of Clinical
Trials
Fax: (215)662-4939
University of
Pennsylvania
E-mail: mmarkowi@mail. 3620 Hamilton Walk 151 Anatomy/Chemistry Philadelphia, PA 19104-6061
+++++++++++++++++++++++++++++++++++++++++++++++++++++
Marcia D . Markowitz
7/24/2000 2:41:00 AM
>From our local newspaper last week:
Fifty-five percent of employers are monitoring their workers' Internet
use, and 38 percent examine workers' e-mail messages, according to a survey
by the American Management Association. Another survey by Angus Reid Group
found 73 percent of employees agreed with their employers' right to minotor
their e-mail and Internet use at work. However, 46 percent admitted they
surf the Web for personal reasons at work, and 55 percent sent and [received
personal e-mails].
If you access the American Management Association web page, there are
additional research results posted that indicate on average employees are
informed of such monitoring about 83.5% of the time in the sectors AMA
queried (mfg, finan. Svcs, wholesale/retail, bus/prof services, public adm,
other non-profit).
Among other significant issues associated with research conducted on the web
remains the question of confidentiality. When aspects of the research
relate to matters which could influence insurability, employability, or
reputation within the organization if the personal information became known,
one may need to ask whether the web is the medium of choice.
_________________________________________________________
Celia S. Walker
Director, Regulatory Compliance
410 University Services Center
Colorado State University
Fort Collins, CO 80523-2046
970-491-1563 (v) 970-491-2293 (fax) cwalker@research.colostate.edu
Regulatory Compliance web site:
http://www.research.colostate.edu/regulatory
Celia
7/24/2000 8:41:00 AM
From a university IRB perspective, what is the affiliation classification of an IRB Board Member that is also a student (part and full time if there is a difference)? What about a volunteer?
Anonymous
7/24/2000 2:40:00 PM
Subject: Web-based surveys
I am wondering if anyone can direct me to sources about confidentiality
issues and Web-based surveys - if there are any guidelines or accepted
conventions about confidentiality. While the researcher will gather consent
in person, a longitudinal survey study is proposed, whereby participants
will complete Web-based surveys 4 times over 2 years. These surveys include
information about depression (Beck) and eating disorders (using other
standardized instruments. The participant will be assigned a code number at
the beginning of their participation and will use this throughout the 4 waves.
Data will be sent to the PI's university-based, email account. The PI will
be the only one with the links between names and code numbers.
Any advice or thoughts about issues the IRB should be thinking about?
Thanks in advance.
Sincerely,
Leslie B. Alexander, Ph.D., PRofessor and Chair
Bryn Mawr College IRB
Leslie Alexander
7/24/2000 2:41:00 AM
If anyone is still following this debate, the following reference is worth
looking at. It is a review paper by Aspinall and Goodman, from the BMJ in
1995, looking at placebo controlled trials of Ondansetron for control of
post-operative nausea and vomiting, a condition for which there was clearly
an alternative treatment available. By the authors' estimate, some 2180
patients had been given placebo as prophylaxis and 440 had been given
placebo when already experiencing postoperative nausea or vomiting.
http://www.bmj.com/cgi/content/full/311/7009/844
Paul Wainwright
Paul
7/24/2000 8:41:00 AM
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Jack --
First off let me say that I think it is great to have an impassioned argument on
MCW-IRB. I'd like to see more issues of substance debated in this way on the list
serve.
Jack thinks I am being paternalistic and he is right. When IRBs are doing their job
they are acting paternalistically. This is the case because IRBs are a social
oversight mechanism designed to protect research subjects. By requiring that every
research study has an acceptable risk-benefit ratio, they in fact ensure that no
research subject is presented with an unreasonable choice. To suggest that consent
might somehow make up for a study whose risks exceed its benefits is simply an
abnegation of the IRB's responsibilities.
If all we were talking about were placebo controlled trials of nasal steroids or
skin creams I doubt I would bother writing about the issue. The real problem cases
here are circumstances in which patients are being deprived of needed medical
treatment. The most common violator here is the placebo controlled trial in
psychiatric research. New drugs in psychiatry are often tested against placebo,
despite they fact that effective treatment exists for schizophrenia, depression,
obsessive compulsive disorder, panic attacks, generalized anxiety and so on. Such
trials not only violate the ethics of research, the lead to needless suffering of
vulnerable persons. IRBs all too often approve such studies due to a variety of
reasons: (1) pressure from the institution and the investigator as such trials may
be reimbursed at $7000 per patient or more; (2) lack of a clear understand of their
responsibilities, including risk-benefit analysis; or (3) capitulation to
questionable claims that good science or the FDA requires a placebo control.
None of these is a sufficient reason to approve a placebo control when standard
therapy exists.
I think you rather overstate the murkiness of standard therapy. If it were really
so nebulous, doctors would spend their days in a state of perpetual confusion --
and of course they don't. It is true that it is rare for their to be a single
standard therapy for a medical condition -- many may exist. This presents choice
for an active control arm, but not a justification for a placebo control arm. The
IRB may establish whether a standard treatment exists for a particular condition in
a number of ways: (1) consultation with an impartial expert practitioner (she must
in no way be involved with the study of the trial investigators); (2) review of
Medline for randomized controlled trials demonstrating the efficacy of particular
treatment; and (3) definitive review articles (such as ones in the New England
Journal of Medicine). In general, if a standard treatment exists, a placebo
controlled trial is prohibited. Ironically enough, a greater proportion of
psychiatric treatments are backed up by RCT results -- fully 65% -- than any other
area of medicine (Quality in Health Care 1996; 5: 215-217.). Go figure.
It makes one wonder what is driving the frenzy of placebo controlled trials in
psychiatry. Could it be the tremendous corporate profits that may be reaped with
another me-too SSRI or antipsychotic drug?
Be well, Charles.
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Jack --
First off let me say that I think it is great to have an impassioned
argument on MCW-IRB. I'd like to see more issues of substance debated in
this way on the list serve.
Jack thinks I am being paternalistic and he is right. When IRBs are
doing their job they are acting paternalistically. This is the case because
IRBs are a social oversight mechanism designed to protect research subjects.
By requiring that every research study has an acceptable risk-benefit ratio,
they in fact ensure that no research subject is presented with an unreasonable
choice . To suggest that consent might somehow make up for a study whose
risks exceed its benefits is simply an abnegation of the IRB's responsibilities.
If all we were talking about were placebo controlled trials of nasal
steroids or skin creams I doubt I would bother writing about the issue.
The real problem cases here are circumstances in which patients are being
deprived of needed medical treatment. The most common violator here is
the placebo controlled trial in psychiatric research. New drugs in psychiatry
are often tested against placebo, despite they fact that effective treatment
exists for schizophrenia, depression, obsessive compulsive disorder, panic
attacks, generalized anxiety and so on. Such trials not only violate the
ethics of research, the lead to needless suffering of vulnerable persons.
IRBs all too often approve such studies due to a variety of reasons: (1)
pressure from the institution and the investigator as such trials may be
reimbursed at $7000 per patient or more; (2) lack of a clear understand
of their responsibilities, including risk-benefit analysis; or (3) capitulation
to questionable claims that good science or the FDA requires a placebo
control. None of these is a sufficient reason to approve a placebo control
when standard therapy exists.
I think you rather overstate the murkiness of standard therapy. If
it were really so nebulous, doctors would spend their days in a state of
perpetual confusion -- and of course they don't. It is true that it is
rare for their to be a single standard therapy for a medical condition
-- many may exist. This presents choice for an active control arm, but
not a justification for a placebo control arm. The IRB may establish whether
a standard treatment exists for a particular condition in a number of ways:
(1) consultation with an impartial expert practitioner (she must in no
way be involved with the study of the trial investigators); (2) review
of Medline for randomized controlled trials demonstrating the efficacy
of particular treatment; and (3) definitive review articles (such as ones
in the New England Journal of Medicine ). In general, if a standard
treatment exists, a placebo controlled trial is prohibited. Ironically
enough, a greater proportion of psychiatric treatments are backed up by
RCT results -- fully 65% -- than any other area of medicine (Quality in
Health Care 1996; 5: 215-217.). Go figure.
It makes one wonder what is driving the frenzy of placebo controlled
trials in psychiatry. Could it be the tremendous corporate profits that
may be reaped with another me-too SSRI or antipsychotic drug?
Be well, Charles.
--------------DAB9CA5812A4644B9D790447--
Charles Weijer
7/24/2000 8:41:00 AM
Looking for out of print book
Hi,
I hope someone can help me.
I am currently searching for Faden, King, & Beauchamp's, A history and theory of
informed consent., and Sieber's, Planning ethically responsible research.
If you have a copy you would like to sell, please contact me.
(I can only lend them from my library for 2 weeks at a time, and that is never
long enough!).
Janice Singer
janice.singer@nrc.ca
Janice Singer
7/24/2000 8:41:00 AM
Possibility of misuse of longitudinal files
A recent posting on this list said:
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.
Longitudinal studies of aging and human development, in which respondents
are followed over
time, are essential to research in many academic fields. There are numerous
such
studies, some of which, like HERI's have yielded hundreds of publications.
Obtaining enough identifying information to follow subjects is essential to
the success
of the research and, in my experience, poses extremely low risks to subjects.
As the recent HERI/CIRP posting indicated, analysis files never contain direct
identifiers of subjects. In order for subjects to be compromised, it would
require either a deliberate
act on the part of a member of the investigator's staff or a deliberate and
illegal intrusion
into carefully guarded data files by an outsider. Neither of these events
is likely.
I have worked with many such data sets for the past 30 years. I don't know
of a single documented
instance in which data have been misused or in which respondents to a major
national
longitudinal study have been identified or compromised in any way.
I would be interested in any documented examples that readers of this list
can provide.
Richard T. Campbell Dcamp@uic.edu
Professor of Sociology Phone: 312.413.0480
Director, Research Methods Core Fax: 312.996-2703
Health Research and Policy Centers web: wwww.uic.edu/~dcamp
University of Illinois at Chicago Address on web page
Dick Campbell
7/21/2000 9:23:00 AM
Human Research Subjects Protection Act of 2000
Wendy:
We spend the first few minutes of each IRB meeting on an educational topic.
I have also developed a newsletter that goes out to all IRB members,
principal investigators, and department chairs. On a more formal note, I am
in the process of putting together an educational binder for the IRB
members. It will contain resource information and several self study
modules. I do one-on-one orientations with all new IRB members. I have not
started to work on anything specific for P.I.s as yet. Our standard
operating procedures apply regardless of the funding source.
> -----Original Message-----
> From: Wendy Westling [SMTP:MSJ.CIAMXW@memo.msj.org]
> Sent: Friday, July 21, 2000 11:33 AM
> To: mcwirb@mcwirb.org
> Subject: re: Human Research Subjects Protection Act of 2000
>
> I would be interested in finding out what organizations without federally
> funded studies are doing regarding providing education for PIs and IRB
> members.
> It does not appear that as yet, there are any federal educational
> requirements
> for PIs or others conducting human subject research that is industry
> sponsored.
> I would like to know what kind of educational programs are being offered
> by
> such organizations. Thank you for your response.
>
> Wendy Westling
> IRB Chairperson
> Mission St. Joseph's Health System
> Asheville, NC
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Sandra Armc-Prof Svcs
7/21/2000 11:41:00 AM
Remuneration for IRB members
Hi all,
We are a community IRB, financially supported by two hospitals,
with a volunteer membership. Our board has in the past discussed and
dismissed the idea of monetary remuneration for any volunteer. One
volunteer drives 60 miles each way and once came to town the night
before a snowstorm and stayed in a hotel, in order not to miss the
meeting. Attendance and commitment of these volunteers is commendable.
Still, I am testing ways of enhancing member participation at IRB
meetings. What are the best ways to motivate IRB members? For
institutional IRB members, I believe Dr. Gary Ellis had a big part of
the answer, which is that IRB membership should be highly valued by
senior instititional leadership. (1)
I wonder about several aspects of volunteer behavior:
1. There's a perception that you can't push a volunteer, that
expectations should be lower than those for an employee. Does
volunteer status convey a defense against demands for extending extra
time and effort? My perception is that volunteers, even more than
employees, must be lead, that is, motivated by appeals to their
interest and innate sense of commitment. Offer the carrot, hold the
stick. Our IRB attempts to motivate members through regular
distribution of interesting/inspiring articles about research (carrot),
in addition to the scarey ones about noncompliance, instititions being
shut down, etc.(stick). To continue with the equine metaphor, we lead
them to water....but we can't MAKE them read...(And to be fair, the
volume of printed material from the IRB makes reading prioritization
necessary.)
On the other hand, does paying IRB members make them more productive or
reliable or committed? Is there a positive association between level of
remuneration and members' time and effort put into
preparation/participation? What effect, if any, does the addition of
money have in the equation?
2. My recollection of cognitive dissonance from undergraduate
days is that providing an external reward decreases internal
justification for behavior. That is, students NOT given a small
monetary award for a task found more intrinsic value in performing the
task than did the awarded students. Based on this, I wonder if even a
small amount of money devalues the IRB member's intrinsic sense of
contribution.
3) It would be interesting to test these ideas on IRB members who
were and were not remunerated, by evaluating objective measures such as
productivity and attendance and having them estimate their preparation
time and self-rate the value of their service. A hypothetical
model would have a continuum between the volunteer at one end whose
motivation is purely intrinsic and internal, and the highly paid IRB
member (employee) at the other. Would there be a difference?
Stephanie Fofonoff, Coordinator
Inter-Institutional Review Board of Billings
Billings, Montana
406/245-8528
sfofonoff@billingsclinic.org
(1) Ellis, G. (1999). Keeping research subjects out of harm's way.
JAMA. 282(20), 1963-1964.
Stephanie Fofonoff
7/20/2000 1:53:00 AM
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>
> It has come to our attention that Institutional Review Boards around the
> nation have begun a discussion of various aspects of the Cooperative
> Institutional Research Program (CIRP) at UCLA. We at the Higher Education
> Research Institute (which houses the CIRP) would like to take this
> opportunity to address some of those issues. Before doing so, however, we
> would like to raise one general point.
>
> HERI supports the efforts of Institutional Review Boards to protect the
> safety and rights of human subjects, and we would like to address their
> concerns about our survey programs. But quite apart from that, apart from
> the laws and guidelines governing research on human subjects, and even apart
> from the personal moral commitment the entire staff of HERI has to protect
> our respondents, there are practical research reasons why we believe the
> protection of CIRP respondents is a vital issue. Quite simply, the validity
> of our results depends on the voluntary cooperation of respondents to give
> accurate and honest answers to our questions. If respondents believe that
> their responses are not kept in confidence, or if they feel that they have
> been coerced into making those responses, it is less likely that they will
> cooperate, and our results will suffer accordingly.
>
> To address the specific issues:
> (1) Does the CIRP have IRB approval?
> In past years, the IRB at UCLA had exempted CIRP from regular review. This
> exemption was last renewed in 1997. However, due to changing guidelines and
> inquiries from other IRBs, UCLA’s IRB conducted a formal review of the 2000
> survey and its protocols. We are pleased to announce that the 2000 CIRP has
> been officially approved. For your reference, the approval # is
> G00-06-053-01.
> (2) How does HERI preserve confidentiality?
> HERI does request identifying information from the respondents (name,
> address, date of birth, etc.). Collecting this information is the only way
> in which students can be followed-up at later points in their college careers
> or after they have graduated. HERI stores this identifying information
> separately from the students’ responses to the survey, and keeps it in a
> secure location accessible only to the Associate Director for Operations.
> The only link between the file containing responses and the file containing
> the identifying information is an arbitrary 6-digit sequence number which is
> useless for the purposes of identification without access to the secure file.
>
> We should point out that in 35 years of administering the CIRP to over 10
> million students at over 1,700 institutions, we do not know of a single
> instance in which a respondent’s confidentiality had been violated.
> (3) Item content
> There has been some discussion that certain questions in the CIRP survey are
> “sensitive,” insofar as students’ responses to those questions somehow could
> be used against them. To the extent that such questions exist in the CIRP
> (and opinions on which questions those might be vary widely), students would
> only be at risk if responses to those questions could be tied to the
> individual making them. Since this cannot happen with the data files kept at
> HERI, we believe that the risk to students in this regard is extremely
> minimal.
> (4) Voluntary survey completion
> As we mentioned before, freedom from coercion is an important factor in
> obtaining the cooperation of respondents. To ensure this, institutions
> participating in the survey are directed to read to their students a
> statement that explains the purpose of the survey, emphasizes its voluntary
> nature, and guarantees the confidentiality of their responses. Among other
> things, the students are told “Your participation is voluntary and will not
> affect your standing at (name of campus).”
>
> Some have commented that our instructions do not specifically emphasize the
> student’s right to refuse to respond to any question. Yet, an analysis of
> the most recent CIRP survey suggests that the students understand their
> rights quite well. Examining the responses of almost 370,000 students to 241
> items on the survey, we find that over 86% did not respond to at least one
> question, over 52% did not respond to at least five questions, and over 42%
> did not respond to at least ten questions. Moreover, 11% of the respondents
> did not provide a Social Security Number, and a similar percentage did not
> provide their name or address.
>
> Nonetheless, we would be more than willing to add language to our statement
> specifically indicating that survey participation is not only voluntary, but
> that response to any particular question is also voluntary.
> (5) Respondents under 18 years of age
> There is some concern about whether the CIRP should be administered to
> freshmen under the age of 18. At many institutions, college students under
> the age of 18 are considered “emancipated minors” and need not be excluded
> from this type of research. At UCLA, for example, the IRB informs
> investigators that “students under 18 years of age may be considered adults
> for the purpose of participating in a research project with no more than
> minimal risk” (UCLA Investigator’s Manual for the Protection of Human
> Subjects, p. 4-22). Indeed, given the voluntary and confidential nature of
> the CIRP data collection and data storage process (described above),
> completing the CIRP survey involves no more than minimal risk to the student.
>
> Finally, we would like to add a few words about the use of CIRP data. One of
> the principal motives underlying the founding of CIRP was to encourage
> college officials to take a greater interest in their students and in how
> they were developing over time. Much of what we now know about the impact of
> college on students has come from CIRP data, and the findings from this
> research continue to be used as a basis for strengthening undergraduate
> programs. Hundreds of institutions have used the CIRP survey to improve
> their educational programs and services to their students. CIRP data enable
> institutions not only to get a comprehensive portrait of their new freshmen,
> but also to compare their students to students at similar institutions, to
> compare student cohorts over time, and to obtain baseline data for measuring
> student change and development during college. Dozens of organizations,
> including Ford, Kellogg, and Mellon Foundations, the National Science
> Foundation, the U.S. Department of Education, the National Institutes of
> Health, and others, have used results from the CIRP to inform their
> discussion and implementation of national policy concerning higher education.
>
> We welcome your inquiries on our CIRP survey procedures. For further
> information, please contact the Higher Education Research Institute directly
> at (310) 825-1925 or email heri@ucla.edu.
>
> Prof. Alexander W. Astin, Director
> Higher Education Research Institute
>
> Prof. Linda J. Sax, Director,
> Cooperative Institutional Research Program
**************************************************************
William S. Korn, Associate Director for Operations
Higher Education Research Institute
Graduate School of Education & Information Studies
University of California, Los Angeles
3005 Moore Hall/Mailbox 951521
Los Angeles, CA 90095-1521
(310) 825-1925 (voice) (310) 206-2228 (FAX)
wkorn@ucla.edu
**************************************************************
--=====================_700371390==_.ALT
Content-Type: text/html; charset=iso-8859-1
Content-Transfer-Encoding: quoted-printable
It has come to our attention that
Institutional Review Boards around the nation have begun a discussion of
various aspects of the Cooperative Institutional Research Program (CIRP)
at UCLA. We at the Higher Education Research Institute (which
houses the CIRP) would like to take this opportunity to address some of
those issues. Before doing so, however, we would like to raise one
general point.
HERI supports the efforts of Institutional Review Boards to protect the
safety and rights of human subjects, and we would like to address their
concerns about our survey programs. But quite apart from that,
apart from the laws and guidelines governing research on human subjects,
and even apart from the personal moral commitment the entire staff of
HERI has to protect our respondents, there are practical research reasons
why we believe the protection of CIRP respondents is a vital issue.
Quite simply, the validity of our results depends on the voluntary
cooperation of respondents to give accurate and honest answers to our
questions. If respondents believe that their responses are not kept
in confidence, or if they feel that they have been coerced into making
those responses, it is less likely that they will cooperate, and our
results will suffer accordingly.
To address the specific issues:
(1) Does the CIRP have
IRB approval?
In past years, the IRB at UCLA had exempted CIRP from regular
review. This exemption was last renewed in 1997. However, due to
changing guidelines and inquiries from other IRBs, UCLA=92s IRB conducted a
formal review of the 2000 survey and its protocols. We are pleased
to announce that the 2000 CIRP has been officially approved. For
your reference, the approval # is G00-06-053-01.
(2) How does HERI
preserve confidentiality?
HERI does request identifying information from the respondents
(name, address, date of birth, etc.). Collecting this information
is the only way in which students can be followed-up at later points in
their college careers or after they have graduated. HERI stores
this identifying information separately from the students=92 responses to
the survey, and keeps it in a secure location accessible only to the
Associate Director for Operations. The only link between the file
containing responses and the file containing the identifying information
is an arbitrary 6-digit sequence number which is useless for the purposes
of identification without access to the secure file.
We should point out that in 35 years of administering the CIRP to over 10
million students at over 1,700 institutions, we do not know of a
single instance in which a respondent=92s confidentiality had been
violated.
(3) Item content
There has been some discussion that certain questions in the CIRP
survey are =93sensitive,=94 insofar as students=92 responses to those questi=
ons
somehow could be used against them. To the extent that such
questions exist in the CIRP (and opinions on which questions those might
be vary widely), students would only be at risk if responses to those
questions could be tied to the individual making them. Since this
cannot happen with the data files kept at HERI, we believe that the risk
to students in this regard is extremely minimal.
(4) Voluntary survey
completion
As we mentioned before, freedom from coercion is an important factor
in obtaining the cooperation of respondents. To ensure this,
institutions participating in the survey are directed to read to their
students a statement that explains the purpose of the survey, emphasizes
its voluntary nature, and guarantees the confidentiality of their
responses. Among other things, the students are told =93Your
participation is voluntary and will not affect your standing at (name
of campus) .=94
Some have commented that our instructions do not specifically emphasize
the student=92s right to refuse to respond to any question. Yet, an
analysis of the most recent CIRP survey suggests that the students
understand their rights quite well. Examining the responses of
almost 370,000 students to 241 items on the survey, we find that over 86%
did not respond to at least one question, over 52% did not respond to at
least five questions, and over 42% did not respond to at least ten
questions. Moreover, 11% of the respondents did not provide a
Social Security Number, and a similar percentage did not provide their
name or address.
Nonetheless, we would be more than willing to add language to our
statement specifically indicating that survey participation is not only
voluntary, but that response to any particular question is also
voluntary.
(5) Respondents under 18
years of age
There is some concern about whether the CIRP should be administered
to freshmen under the age of 18. At many institutions, college
students under the age of 18 are considered =93emancipated minors=94 and nee=
d
not be excluded from this type of research. At UCLA, for example,
the IRB informs investigators that =93students under 18 years of age may be
considered adults for the purpose of participating in a research project
with no more than minimal risk=94 (UCLA Investigator=92s Manual for the
Protection of Human Subjects, p. 4-22). Indeed, given the
voluntary and confidential nature of the CIRP data collection and data
storage process (described above), completing the CIRP survey involves no
more than minimal risk to the student.
Finally, we would like to add a few words about the use of CIRP
data. One of the principal motives underlying the founding of CIRP
was to encourage college officials to take a greater interest in their
students and in how they were developing over time. Much of what we
now know about the impact of college on students has come from CIRP data,
and the findings from this research continue to be used as a basis for
strengthening undergraduate programs. Hundreds of institutions have
used the CIRP survey to improve their educational programs and services
to their students. CIRP data enable institutions not only to get a
comprehensive portrait of their new freshmen, but also to compare their
students to students at similar institutions, to compare student cohorts
over time, and to obtain baseline data for measuring student change and
development during college. Dozens of organizations, including
Ford, Kellogg, and Mellon Foundations, the National Science Foundation,
the U.S. Department of Education, the National Institutes of Health, and
others, have used results from the CIRP to inform their discussion and
implementation of national policy concerning higher education.
We welcome your inquiries on our CIRP survey procedures. For
further information, please contact the Higher Education Research
Institute directly at (310) 825-1925 or email
heri@ucla.edu .
Prof. Alexander W. Astin, Director
Higher Education Research Institute
Prof. Linda J. Sax, Director,
Cooperative Institutional Research Program ************************************************************** William S. Korn, Associate Director for Operations Higher Education Research Institute Graduate School of Education & Information Studies University of California, Los Angeles 3005 Moore Hall/Mailbox 951521 Los Angeles, CA 90095-1521 (310) 825-1925 (voice) (310)
206-2228 (FAX) wkorn@ucla.edu
**************************************************************
--=====================_700371390==_.ALT--
William S . Korn
7/20/2000 1:18:00 PM
Clinical equipoise and the local IRB
Howard asked, in a MCWIRB response to Charles:
>
>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 ?
>
Q. To what extent should the local IRB review the design of a
multicenter trial?
A. As much as is necessary to know if you want grant approval so your
institution can take part.
May I suggest that there is clinical equipoise and local clinical equipoise.
For instance, a study may have equipoise in a large academic center that
has available alternatives and knowledge but have less equipoise in a rural
center in which the options are quite limited.
We reviewed a randomized trial that was put out for the university centers
and seemed to be universally accepted by their IRBs. But in the search for
more recruitment, the study center broadened the number of sites to some
with fewer resources. At the center(s) we reviewed it was clear that the
equipoise was much more tenuous. They could offer much less and could do
only one of the arms well.
Erica
Aside: this could sound like an argument for local review. To
short-circuit that (repeat) discussion I would counter that it would make a
good argument except that, even though we were remote, we were also aware
of it and were questioning it. And we also had to fight the 77 other IRB
argument with an academic study coordinator who did not understand the
concept of equipoise.
Erica Heath
President, IRC
415-485-0717
heath
7/20/2000 10:52:00 AM
No blanket prohibition against placebo control
There should be no blanket prohibition against placebo controlled
trials. They should be evaluated on a case-by-case basis. Take the
following hypothetical research proposal:
A sub-population of depressed patients has mild symptoms that persist
despite good diet and exercise, but the patients forego standard
pharmacological treatment because they want to avoid the risk of
potential side-effects--such as delayed sexual climax. It is
hypothesized that a zinc dietary supplement, with no known sexual
side-effects, will be effective for this population. This population is
willing to take zinc supplements (but unwilling to take standard drugs
that carry risk of sexual side-effects). The experimenter design a
placebo-controlled study to test the effects of zinc on depression, in
this specific sub-population of depressed patients.
Clearly, it would be wrong for an IRB to reject such a proposal simply
because it includes a placebo control group.
>If all we were talking about were placebo controlled trials of nasal steroids or
>skin creams I doubt I would bother writing about the issue. The real problem cases
>here are circumstances in which patients are being deprived of needed medical
>treatment. The most common violator here is the placebo controlled trial in
>psychiatric research. New drugs in psychiatry are often tested against placebo,
>despite they fact that effective treatment exists for schizophrenia, depression,
>obsessive compulsive disorder, panic attacks, generalized anxiety and so on.
--
RICHARD B. ANDERSON
Bowling Green State University
randers@bgnet.bgsu.edu
http://personal.bgsu.edu/~randers
Richard Anderson
7/20/2000 1:42:00 PM
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.
-----Original Message-----
From: Howard Mann [mailto:LDHMANN@ihc.com]
Sent: Wednesday, July 19, 2000 4:38 PM
To: cclukey@emh.org; mcwirb@mcwirb.org
Subject: Re: Humanitarian Device Use
>>> 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- Debbie Hunsaker Humanitarian Use Device 7/20/00 9:14am
2
Regards,
Howard
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Dr . Steven
7/20/2000 10:55:00 AM
Charles, Jack, and all,
Some comments on the recent discussion.
1.) I don't read the codes as Charles does. The US CFR says reasonable
in relation to anticipated benefits, if any, and the importance of the
knowledge Nuremberg says risk should never exceed humanitarian
importance of the problem In both cases it seems to me they are allowing
high risk to the subject if the total benefit justifies it AND there is
informed consent.
2.) This seems reasonable enough to me. Yes IRBs were set up to protect
vulnerable populations but I suspect they also reflect the long standing
paternalism of the profession. The horrible thing about Tuskegee was not
that the subjects were black and poor all on its own but that they were in
no position to make an informed choice. When subjects can make a fully
informed choice without coercion, I see no reason to condemn placebo
controlled trials. Such acts are commendable on my view and the system
depends importantly on their virtue.
3.) The problem that bothers me is not placebos per se. The real issues
seems to me to be inferior treatment without informed consent. That can
happen when we have good reason to believe the experimental treatment is
better--for example when we repeat Phase III trials such as in ECMO. No
placebo here but same problem. And as Charles points out, we can also know
the experimental treatment is probably inferior--so even those getting
treatment in placebo controlled trials may be getting inferior
treatment. Similar situations arise when data comes in during a trial but
we do not inform patients of what can be gleaned from them. Here the
ethical issues run into statistical issues of Bayesians vs
frequentists. The former think we can reasonably look at all times at the
data as it comes in. This may seem an esoteric topic, but it has huge
ethical implications that IRBs are pretty much completely unaware of.
Cheers, Harold
Harold Kincaid
Professor and Director, Center for Ethics and Values in the Sciences
Department of Philosophy
University of Alabama at Birmingham
900 13th St. So.
Birmingham, AL 35294-1260
205 934 8797
205 975 6639 (fax)
kincaid@uab.edu
http://www.uab.edu/philosophy/faculty/kincaid
http://www.uab.edu/ethicscenter
Harold Kincaid
7/20/2000 7:08:00 AM
Recruiting female subjects
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
Paul
7/20/2000 11:49:00 AM
Recruiting female subjects
As an attorney, and the co-author with Ruth Merkatz on that article, I feel
the need to clarify that what the FDA issued in 1993 was a new Guideline on
the inclusion of women of childbearing potential in clinical trials, which
replaced an outdated Guideline published sometime in the 1970s. For what
it's worth, neither is or was a regulation. From a legal standpoint, the
difference between a guideline and a regulation may or may not be be viewed
as an important distinction in terms of what may actually be required of a
clinical trial sponsor. Just thought I'd point that out.
Elyse I. Summers, J.D.
Division of Human Subjects Protection
OHRP
6100 Executive Blvd., Ste. 3B01 (MSC 7507)
Rockville, MD 20892-7507
ph.301-402-5559
fax.301-402-2071
Elyse Od
7/20/2000 11:49:00 AM
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