I guess I am surprised that this type of issue does not come up more
frequently as a malpractice theory. The question being asked by the suit is
a reasonable one that needs an answer, although it's always a little
stressful to answer it in the course of litigation. The answer involves the
complexities of innovative therapy, the ability of an IRB to know everything
going on in an institution, and the black letter law of the regulations. I
don't doubt that your arguments, which you have a good handle on, judging by
your post, will ultimately win out; no doubt this will be a stressful time
for you.
As you allude, this particular situation will revolve around the question of
why the treating physician chose this particular protocol to treat the
child. Was it supported in the literature at the time? Had he simply heard
about the research going on elsewhere and thought it was a good idea to use
this combination? If he was out there on this, doing something quite
innovative that was only being done elsewhere as a part of research, then he
is in some difficulty for not handling it as research.
The only way the IRB could be held liable is if it is established that the
situation did amount to research and either the IRB had a duty to
monitor/discover the situation (which I don't think can be proven), or that
the IRB did have actual knowledge and ignored it. That second possibility
is something you should attempt to ascertain.
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
icenogle@execpc.com. 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 icenogle@execpc.com
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
Leilani Price
Sent: Wednesday, April 12, 2000 10:37 AM
To: mcwirb@mcwirb.org
Subject: Investigator Liable?
We have a situation which is beyond my scope as someone new to the field of
IRB. I'm eager to find out the legal ramifications of the following
scenario from those of you who are experienced and/or may have encountered
such a situation:
A few years ago, before I was the IRB Administrator, one of our cancer PI's
treated a child for cancer using commercially available treatments. His/her
therapy was consistent with an arm of a research protocol for a cooperative
group with whom we were not yet affiliated, with the exception of
substituting dexamethazone (commercially avail) for prednisone (as
recommended by the study arm). - CA docs reportedly have switched to
dexamethazone because they felt it was superior to prednisone. -
The study to which the PI's therapy was similar is a study which was not
open at our hospital (it could not have been, of course, because we were not
yet affiliated with the cooperative group).
This case has been brought to court. The plaintiff states that there was
not enough overview by IRB for this PI and that the PI should not have
decided to use dexamethazone if it was not a standard therapy arm.
My feeling is that if all of the drugs were commercially available and the
therapy was generally accepted as standard, then there was no research
involved in this situation and it was not an IRB matter to begin with.
Doesn't the doctor have the right to select the medication best suited for
the patient as long as the drug is marketed for that purpose? Just because
the treatment was similar to a cooperative study arm, doesn't mean that this
PI was treating the patient as if he/she was a research subject, does it?
Thanks for your help!
****************************************************************************
**********
Leilani Price, M.S., Ph.D.
IRB Administrator
Cottage Health System
Post Office Box 689
Santa Barbara, CA 93102-0689
ph: 805-569-8323
fax: 805-569-7875
e-mail: lprice@cottagehealthsystem.org
web: http://www.cottagehealthsystem.org
*************************************************************************
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Daniel L . Icenogle
4/13/2000 8:12:00 AM
It is VERY common for physicians to treat patients according to drug dosing
programs that may be parts of study protocols elsewhere. It would take a very
careful look to decide if it constituted research in an individual case.
The question may well boil down to: Was the therapy given within the scope of
therapy generally accepted as reasonable for the condition the patient had? If
so, the use of a study group's protocol may have been nothing more than a handy
reference for dosing, scheduling, precautions in the use of the drugs the
physician was going to use anyway.
If the study group protocol represented a major shift from the ordinary way of
treating the patient, the issues could be more complex. That being said, the
regs (and common sense) give a practitioner a pretty broad discretion to use
licensed and approved drugs in novel ways to serve the best interests of an
individual patient. It takes more than that to meet the regulatory definition of
research.
Dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
4/13/2000 11:54:00 AM
Conflict of Interest of IRB members
Our IRB is discussing the definition of a Conflict of Interest for an IRB member. The committee has requested that I solicit input from other IRBs on how they address these issues. We have one central IRB which supports both liberal arts and health professions schools/colleges. We have one representative from each college/school on the committee.
An IRB member who is an investigator (PI, Co-I, or any level) or subordinate to an investigator (ie the IRB members dept. head or Dean), on any proposal will excuse themselves from discussion and voting. Our questions is, should an IRB member excuse themselves from discussion and voting on a proposal just because the investigator/proposal is from there own college/school? Most of our colleges/schools are fairly small (30-50 FTE faculty) so chances are the IRB member will know most all faculty from his/her college/school.
Thank you for your assistance.
Scott Swigart, Pharm.D.
Chair, IRB
Nova Southeastern University
Anonymous
4/12/2000 6:32:00 PM
Documentation of IRB minutes
I our minutes we protect the identities of the member making a comment
unless they specifically ask to be identified for the record. We do
distinguish between comments made by the PI and those made by members. If
member Professor Jones makes a comment, our minutes will say, One IRB
Member expressed a concern . . . . If anyone agrees, our minutes will
say Several IRB members expressed a concern . . . .
Mike Kelly
Georgia Tech
At 04:31 PM 4/11/2000 -0500, you wrote:
>Do the minutes for IRB meetings need to reflect the specific source of
comments
>during the discussion?
Mike Kelly
4/12/2000 6:35:00 PM
Update on IOM IRB/Data Privacy Committee Activities
The IOM Committee on the Role of IRBs in Health Services Research Data Privacy
Protection met April 11, 2000.
The meeting was not open to the public, as the committee met only to deliberate
on conclusions for the draft report.
I have just posted notice of the meeting in the National Academies' Current
Project System, but the notice of a closed
meeting cannot have much more information than given just above! If you wish to
review it, however, it should
appear on site tomorrow, 4/13/00.
Copy the following address into your browser bar and then click on meeting 3.
http://www4.nas.edu/cp.nsf/Projects+_by+_PIN/HCSX-H-99-07-A?OpenDocument
Lee
Lee L. Zwanziger, Ph.D.
Senior Program Officer
Division of Health Care Services
Institute of Medicine
National Academies
2101 Constitution Avenue, N.W., Suite FO 3117
Washington, DC 20418
phone: 202/334-3042
fax: 202/334-1463
email: lzwanzig@nas.edu
Lee Zwanziger
4/12/2000 6:32:00 PM
Documentation of IRB minutes
I would have great difficulty in recording the comments made by members of a Research Ethics Board (REB), during meetings. At our REB meetings, the only items recorded are decisions and relevant issues underlying those decisions. In checking with the University's legal counsel, comments are not recorded, decisions are.
Michael Wodlinger
*****************************************
Michael Wodlinger, PhD
Director, Research Services and
Graduate Studies
Nipissing University
100 College Drive, P.O. Box 5002
North Bay, Ontario
Canada P1B 8L7
705.474.3461 (ext. 4565) Fax: 705.474.1947
michaelw@unipissing.ca
Michael Wodlinger
4/12/2000 6:34:00 PM
I would like to know what policies others have adopted
Jo Anne Bennett wrote to discuss whether wallet cards, handouts and
other items should be reviewed by the IRB.
I can think of only two reasons a company would go to the expense of
printing wallet cards, flyers, or anything else:
1) To recruit
2) Patient (and possibly, other health care workers) education
If recruitment/reward is the issue, then the IRB needs to review the
material to be sure it is not coercive, consistent with informed consent
guidelines, accurate....
If patient education and safety is an issue, then the IRB still needs to
review the document. (If your hair turns green as a result of htis
treatment, go imediately to the emergency department and tell them tao
call 800-12345678. If your hair turns purple, just apply Grecian
formula...) Does the card tell the ED personnel what kind of drug
the patient is taking and what kind of ADRs to expect? As an emergency
physician, I'm particularly interested in knowing if these information
cards include a 24/7/365 number for research projects involving
potentially serious ADRs. Many of the cards did not until we (the IRB)
required them.
If companies have another reason for handing out cards, please enlighten
me and we can continue the discussion
Ron Low
SUNY Downstate (Brooklyn)
Ronald Low
4/12/2000 6:40:00 PM
No IRB review necessary before grant submission to NIH
In case there are any readers who have not heard the news...
The NIH has determined that overworked IRBs no longer have to review new grants within 60 days of submission. After a grant has been favorably reviewed by the study section and given a fundable priority sscore, it can then be sent to the IRB for review.
The url for further information is:
http://grants.nih.gov/grants/irb_review_pol.htm
Barbara Bigby
Scripps Clinic
Anonymous
4/12/2000 11:37:00 AM
Conflict of Interest of IRB members
With regard to Scott Swigart's inquiry about conflict of interest policies
for IRB members, our IRB does not currently have a formal conflict of
interest policy statement right now other than to say that members should
recuse themselves if there is a conflict of interest. Developing a more
explicit policy regarding what constitutes a conflict is on our list of
things to do. However, I have had considerable experience in running
selection boards to review proposals for extramural funding, and we have
developed formal conflict of interest policies there. I think the same
principles apply. I suggest that the following questions need to be asked:
1. Does the IRB member have a financial interest in the project being
reviewed?
2. Does the IRB member feel that he or she might not be completely
objective in doing the review for any reason whatsoever (e.g., being a
friend of the PI, or having some stongly-held religious objection to the
kind of experiment being proposed, for example)?
3. If the facts of the situation were all to be made known and published
on the front page of the newspaper, might the general public perceive that
a conflict of interest was present?
If the answer to any of these questions is yes, then the IRB member
should recuse her/himself. Hopefully most IRBs have sufficient members
that if one person recuses, the Board will still have a quorum. (That's
why it is good to have members with different backgrounds from different
parts of the organization.) We have an IRB Vice Chair available to take
over should the Chair ever have a conflict of interest. It is best to err
on the side of caution. Like virginity, once an IRB's credibility with
regard to ethics is lost, it is very difficult to get it back.
Brian Belanger
Chair, IRB, Natl. Institute of Standards and Technology.
At 05:21 PM 4/7/00 -0500, you wrote:
>Our IRB is discussing the definition of a Conflict of Interest for an IRB
>member. The committee has requested that I solicit input from other IRBs on
>how they address these issues. We have one central IRB which supports both
>liberal arts and health professions schools/colleges. We have one
>representative from each college/school on the committee.
>
>An IRB member who is an investigator (PI, Co-I, or any level) or
subordinate to
>an investigator (ie the IRB members dept. head or Dean), on any proposal will
>excuse themselves from discussion and voting. Our questions is, should an IRB
>member excuse themselves from discussion and voting on a proposal just because
>the investigator/proposal is from there own college/school? Most of our
>colleges/schools are fairly small (30-50 FTE faculty) so chances are the IRB
>member will know most all faculty from his/her college/school.
>
>Thank you for your assistance.
>
>Scott Swigart, Pharm.D.
>Chair, IRB
>Nova Southeastern University
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Brian Belanger
4/12/2000 6:32:00 PM
Documentation of IRB minutes
I used to document who said what at our meetings, but found out at the Dec '99 PRIM&R meeting that you should not. The comments are supposed to remain confidential.
**************************************************************************************
Leilani Price, M.S., Ph.D.
IRB Administrator
Cottage Health System
Post Office Box 689
Santa Barbara, CA 93102-0689
ph: 805-569-8323
fax: 805-569-7875
e-mail: lprice@cottagehealthsystem.org
web: http://www.cottagehealthsystem.org
*************************************************************************
>>> Sara Plaspohl 04/11 2:31 PM >>>
Do the minutes for IRB meetings need to reflect the specific source of comments
during the discussion? I am fairly new in my role, and have been told by
contacts at other institutions that this is not necessary, and the minutes
should protect the identity of those who make the comments about the protocol
under review. However, this has been challenged by the manager of our
Biomedical Research Department, who says it is important for the minutes to
reflect whether a comment is made by the PI, study coordinator, IRB member,
etc., and should identify the specific person making the comment or asking a
question.
Should anonymity be upheld in the documentation of IRB discussion? I would
appreciate advice from my MCWIRB colleagues.
Thanks,
Sara Plaspohl
Director, Office of Clinical Trials Compliance
Memorial Health University Medical Center
4700 Waters Avenue
Savannah, GA 31404
(912) 350-6866
plaspsa1@memorialmed.com
Leilani Price
4/12/2000 6:38:00 PM
Documentation of IRB minutes
I used to document who said what at our meetings, but found out at the Dec '99 PRIM&R meeting that you should not. The comments are supposed to remain confidential.
**************************************************************************************
Leilani Price, M.S., Ph.D.
IRB Administrator
Cottage Health System
Post Office Box 689
Santa Barbara, CA 93102-0689
ph: 805-569-8323
fax: 805-569-7875
e-mail: lprice@cottagehealthsystem.org
web: http://www.cottagehealthsystem.org
*************************************************************************
>>> Sara Plaspohl 04/11 2:31 PM >>>
Do the minutes for IRB meetings need to reflect the specific source of comments
during the discussion? I am fairly new in my role, and have been told by
contacts at other institutions that this is not necessary, and the minutes
should protect the identity of those who make the comments about the protocol
under review. However, this has been challenged by the manager of our
Biomedical Research Department, who says it is important for the minutes to
reflect whether a comment is made by the PI, study coordinator, IRB member,
etc., and should identify the specific person making the comment or asking a
question.
Should anonymity be upheld in the documentation of IRB discussion? I would
appreciate advice from my MCWIRB colleagues.
Thanks,
Sara Plaspohl
Director, Office of Clinical Trials Compliance
Memorial Health University Medical Center
4700 Waters Avenue
Savannah, GA 31404
(912) 350-6866
plaspsa1@memorialmed.com
Leilani Price
4/12/2000 6:40:00 PM
FROM: US NEWS & WORLD REPORT Dated 4/17/2000
http://www.usnews.com/usnews/issue/000417/nycu/kids.htm
Drug trials are clamoring for kids, but scrutinize the study before
signing up
By Stacey Schultz
Five-year-old Emily Morock is being very brave. As the nurse at Children's
Mercy Hospital in Kansas City, Mo., draws blood from her left arm, the small
girl watches, fascinated, and doesn't flinch. It wasn't so easy for little
Teyonna Latimer, also 5, who, moments earlier, kicked and screamed as her mom
and a nurse held her still for a needle stick.
The girls are not sick: They are enduring the needles in the name of science.
Like thousands of children across the country, Emily and Teyonna are taking
part in a clinical trial of a drug approved for adults but never studied in
children in this case an antihistamine. Doctors at Children's Mercy Hospital
are trying to figure out how much is needed to relieve allergies in a small
child. Up until a few years ago, if you had a 200-pound man and the dose was
200 mg, you would guess that a child who weighs 10 pounds should get 10 mg,
says Kathy Johnson, clinical research coordinator at the hospital. But there
is so much more we need to understand about drug metabolism before we give
medicines to young children.
A concerted drug-testing effort is filling that gap. In 187 pediatric trials
now planned or underway, researchers are studying the safety of
antidepressants, the proper doses of heart medication, and the best ways to
use potent antibiotics, among other things. The boom was sparked in 1997 when
Congress granted drug companies an extra six months of patent exclusivity,
potentially worth millions of dollars, for medicines tested in children; after
December, the Food and Drug Administration will require that virtually all new
drugs be tested in kids. I have been doing pediatric research for 25 years,
says Philip Walson, professor of pediatric pharmacology and pharmacy at Ohio
State University. And I can honestly say that there has been more research
done in the past three years than in all the others combined.
Risk and reward. The effort will require more than 17,000 children and
increasing numbers of doctors are asking parents to sign up their kids. The
decision of an adult to enter a clinical trial is rarely easy; deciding to
sign up a child can be even trickier. Some experts worry that the rush to test
drugs in kids has led to ethically questionable behavior, such as taking
children off a standard medication to study the effects of a newer one or
offering families large sums of money for taking part. On the plus side,
children in trials get close medical attention and a chance to make a
difference to other kids. For sick children, a study of a new drug also offers
a chance of getting more-effective therapy. And the risks are small, providing
parents choose trials conducted by experts in pediatric medicine and closely
supervised by local review boards.
Prescribing drugs for children is a kind of experiment in any case, medical
researchers are quick to point out, because 80 percent of the drugs given to
kids have been tested only in adults. Under FDA regulations, doctors are free
to use these drugs in children, but dosages and toxic effects can be
guesswork. In rare cases, those guesses have been fatally wrong. Decades ago,
chloramphenicol, an FDA-approved antibiotic, killed several infants when it
accumulated to toxic levels in their systems. Doctors later discovered that
children do not metabolize the drug the same way adults do. We didn't study
it in kids before we gave it to them, says Dianne Murphy, associate director
for pediatrics at the FDA. And we really didn't understand the harm we were
causing.
The new wave of trials addresses the problem by testing approved drugs in
healthy kids like Emily and Teyonna, to see how their bodies process the
drugs, and by comparing the effectiveness of different drugs in sick kids. No
clinical research is without risks, says Ralph Kauffman, director of medical
research at Children's Mercy Hospital, but the hazards of pediatric clinical
trials usually amount to inconvenience, not danger. Studies may include
additional visits to the doctor, extra blood tests, X-rays, and urine
samples, Kauffman says. These are not things that inflict lasting harm on a
child. Most drugs tested in children have been studied previously in adults,
Kauffman adds. There is always a small risk of an adverse reaction to a
drug, he says. But because kids are so closely monitored in clinical trials,
children are at much lower risk of an adverse event in a study than they are
taking a drug that has never before been tested.
Still, parents have been spooked by rare but well-publicized clinical trial
disasters such as the death last fall of 18-year-old Jesse Gelsinger in a
study of gene therapy at the University of Pennsylvania. You ask some parents
to join a clinical trial, and they immediately turn off, says Jeffrey Blumer,
professor of pediatrics and pharmacology at Case Western Reserve University
School of Medicine in Cleveland. Other participants sour later, when they
discover that their child got the old therapy during a trial of a new drug or
got a dose of the new medication too small to do any good.
When a family doctor or pediatrician suggests joining a clinical trial, Blumer
says, parents should check out who is running it. Look for researchers who
have university affiliations, he advises, because university-based research
often gets more careful ethical scrutiny. Committees of experts called
institutional review boards (IRBs) act as the ethical watchdogs, and
university-based hospitals are likely to have an IRB on site, rather than
relying on a centralized IRB that may not monitor individual trials as
carefully.
On trial. Mark Brown, associate professor of clinical pediatrics at the
University of Arizona, learned how big the difference can be when he tried to
recruit patients for a trial of a new asthma drug. The study sought kids with
asthma who were not already taking inhaled antinflammatory drugs. Our IRB
felt that it would be unethical to take a child off medication if it was
already controlling the condition, Brown says. Every asthmatic child his
office could identify was already on medication, preventing him from
recruiting a single patient. But just blocks away another doctor who was also
taking part in the study exceeded his quota. The reason: The physician
encouraged patients to stop their medication and join the trial. Brown
suspects a less stringent IRB had OK'd this potentially risky step.
Parents should also get a full explanation of the purpose and plan of the
study, along with potential risks and benefits. Emily's mother says that a
nurse called her and explained the trial. Later, she signed a six-page consent
form detailing the same information. Ben Wilfond, a bioethicist at the
National Institutes of Health, says parents should discuss these materials
with their child's primary-care physician as well as with the study staff.
Take your time making the decision, Wilfond says. If someone is trying to
pressure you to sign up, that's a red flag.
Don't be surprised if the trial organizers offer money or gifts. Roughly a
quarter of pediatric studies pay for participation, typically from $200 to
$400, according to Jonathan Rackoff, a researcher at NIH. Emily and Teyonna
both received $200 for their cooperation. NIH's Wilfond says incentives are
not necessarily unethical. But some studies are offering $1,000 or more, which
bothers Wilfond: When the money becomes too large and distorts people's
judgment, that's a problem.
Ultimately, experts say, taking part in a well-run trial can be rewarding for
children. They stand to gain a sense of pride in helping other kids and, along
the way, learn a little bit about medical science. Loren Persley, a
16-year-old from Kansas City who entered a study of an antihypertensive drug
last year, says she was paid about $400. But her favorite part of the study
wasn't the cash. It was staying overnight in the hospital and watching
technicians test her blood in the lab. I got to see a readout on paper of how
high the levels of the drug were in my blood, Persley says. I had so much
fun, the money didn't really matter to me. But, she adds, it was a nice way
to say thank you.
Adana Y . Adams
4/12/2000 6:35:00 PM
I would like to know what policies others have adopted regard ing the following:
Jo Anne,
The ICH Guidelines (Good Clinical Practice, 8.2.7) says that before the
clinical phase of the trial commences, there needs to be IRB approval for
certain documents such as protocol, amendments, informed consents, and any
other written information to be provided to the subject. It seems open to
interpretation. But, I feel this information (diary cards, for example) may
support the informed consent and may affect subject's willingness to
participate in the trial.
Also, you mentioned the IRB's MPA does not require review of materials or
documents that do not have an impact on the safety of study participants.
An MPA is used for studies supported by HHS. I suspect if this study is
sponsored by a pharmaceutical company, then probably the MPA is not
applicable in this case.
I hope this answers your question.
Gayatri Choudhary, M.P.H.
Regulatory Quality Control Specialist
PRA International
4105 Lewis & Clark Drive
Charlottesville, Virginia 22911
ChoudharyGayatri@praintl.com
(804) 951-3101
-----Original Message-----
From: Jo Anne Bennett [mailto:jbennett@DOHLAN.CN.CI.NYC.NY.US]
Sent: Tuesday, April 11, 2000 8:38 PM
To: mcwirb@mcwirb.org
Subject: I would like to know what policies others have adopted
regarding the following:
I would like to know what policies others have adopted regarding the
following:
A pharmaceutical company sponsor has requested one of our extramural
investigators to seek IRB approval for all documents, forms or items related
to the study that a participant might see (including, for example,
identification cards that they are given to show physicians or emergency
room personnel, and diary cards they use to record temperature and symptoms
in the days immediately following study injection). The sponsors indicate
that they feel this is in accord with ICH guidelines.
The investigators, however, do not concur and have submitted to us
their home institution's IRB policy which, pursuant to its MPA, does not
require review of materials or documents that do not have an impact on the
safety of study participants. The other IRB has issued a memo that it
does not agree with the sponsor that it should review ALL study materials
in Protocol #xxxx.
Any comments would be appreciated. Thank you
Jo Anne Bennett, RN, PhD
Vice Chairperson
Institutional Review Board
New York City Department of Health
Box 65
346 Broadway, Room 707A
New York, NY 10013
(212) 442-3381
FAX: 212-442-3535
jbennett@dohlan.cn.ci.nyc.ny.us
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Gayatri
4/12/2000 6:32:00 PM
Documentation of IRB minutes
>
>Should anonymity be upheld in the documentation of IRB discussion?
YES
There is no reason to name names. The summary of the controverted
discussion is sufficient. My test is whether, one year later, I could read
those minutes (and other documentation) and re-create the nature of the
discussion so that I could tell someone what the major issues were.
Actually, our minutes are very short and sweet. Often there are two
paragraphs for a study. Para 1 - the decision and Para 2 the discussion
items. The real documentation of issues is in the individualized letters
to the PIs where the concerns are laid out in full excrutiating detail. The
FDA investigator needs to see that there were (or were not) discussion
items and to see what happened. Other readers do not need that level of
detail.
Erica
Erica Heath
President, IRC
415-485-0717
heath
4/12/2000 6:32:00 PM
Documentation of IRB minutes
Sara,
The minutes for our IRB indicate the source of comments during the discussion. It is important to indicate if the comments come from a voting member of the IRB, a non-voting member (e.g. the administrator of the IRB), or a visitor, such as a PI. Including this information in the minutes precludes anonymity. I am not aware of any problems arising from taking minutes as described above in the seven years I have been the IRB administrator at KU, and indicating the source of comments helps to follow the discussion better than if comments were not attributed to anyone.
David Hann
David Hann
4/12/2000 6:35:00 PM
Principal Investigator Training
Can anyone explain what exactly GCP training is. Is this training different
than the routine training and education we provide to all investigators?
Sree murthy
s.murthy@drexel.edu
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
Of Doherty_Catherine_T/mskcc_Medicine@mskmail.mskcc.org
Sent: Monday, April 10, 2000 12:40 PM
To: mcwirb@mcwirb.org
Subject: Re: Principal Investigator Training
At our Center we do not require that an investigator have formal
training in GCP. However, it IS a requirement that, before becoming a
PI on their own, they must be mentored by a senior Attending. One of
the senior Attendings is the PI, the junior Attending is a co-PI who
receives on-the-job training from the senior Attending.
Cathy Doherty
Memorial Sloan-Kettering Cancer Center
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Sreekant Murthy
4/11/2000 3:45:00 AM
Can use some help on when a study can be inactivated (no longer come under
IRB purview).
1. If contact with subjects is complete and data analysis continues (no
personal identifiers on the data, however, the investigator has the means
to identify the data, either he or someone else holds the linkage) can the
study be inactivated? If the investigator wants to retain the linkage,
then maybe he is not finished with data analysis?
2. What is the operational definition of identifiable data? The most
obvious is that is it contains personal identifying information. How 'bout
if data is coded, the investigator does not hold the link, but someone else
does? How 'bout if the investigator holds the link?
Pat German
Pat German
4/11/2000 9:03:00 AM
IRB Approval of Emergency Use IND
Karl:
We've dealt with this in two semantic ways (gg).
One is to have an expectation that the physician seek the approval, NOT of the
IRB, but of an IRB officer as a consultant. The IRB's documentation then
carefully avoids calling it an IRB approval.
The other is to use wording like the following in the letter to the sponsor:
An IRB officer has reviewed the request and agrees that the
regulatory criteria have been satisfied for the use of the
experimental agent/device XXXX without the prior approval of a
convened IRB quorum.
Then, the IRB officer providing guidance has a checksheet to complete,
documentaing the process, and can provide a copy to the requesting physician.
What sponsors want is assurance that the proper IRB process is being followed.
The problem generally comes in that the person you get on the phone from the
sponsor invariably turns out to be someone who doesn't know the rules well
enough to understand that emergency approval is imprecise slang for involving
the IRB in the process to make sure that all the regulatory ducks are in a row.
Also almost invariably, that person is not going to notice the cautious wording
above and will be quite happy with it.
Dale
Dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
4/11/2000 9:03:00 AM
I would like to know what policies others have adopted regarding the following:
I would like to know what policies others have adopted regarding the following:
A pharmaceutical company sponsor has requested one of our extramural investigators to seek IRB approval for all documents, forms or items related to the study that a participant might see (including, for example, identification cards that they are given to show physicians or emergency room personnel, and diary cards they use to record temperature and symptoms in the days immediately following study injection). The sponsors indicate that they feel this is in accord with ICH guidelines.
The investigators, however, do not concur and have submitted to us their home institution's IRB policy which, pursuant to its MPA, does not require review of materials or documents that do not have an impact on the safety of study participants. The other IRB has issued a memo that it does not agree with the sponsor that it should review ALL study materials in Protocol #xxxx.
Any comments would be appreciated. Thank you
Jo Anne Bennett, RN, PhD
Vice Chairperson
Institutional Review Board
New York City Department of Health
Box 65
346 Broadway, Room 707A
New York, NY 10013
(212) 442-3381
FAX: 212-442-3535
jbennett@dohlan.cn.ci.nyc.ny.us
Jo Anne Bennett
4/11/2000 4:28:00 PM
IRB Approval of Emergency Use IND
My question focuses on what an IRB requires for the review and approval of the use of an investigational drug that was (or is about to be) administered under an emergency IND. Assume that the conditions allowing for waiver of prior IRB approval are met (21CFR56.102d). Clearly the FDA prefers that the use of the investigational drug be restricted to the one patient until the IRB has convened and approved this use. My question is what each of you is requiring of the investigator to review and approve this use. It appears reasonable to require the consent form (which was presumably used), the investigator brochure (with any dosing and toxicity information, along with indications) and the specific patient information (including why and how the drug was used). Yet how many IRBs would require a complete investigational protocol written to authorize the subsequent use of the drug in your institution? The FDA regulations appear ambiguous on this point. To require the IRB to approve the use of an investigational drug does not necessarily imply that the IRB must approve a protocol that would allow for any future use of the investigational drug under the same circumstances. It could be interpreted to mean that the single use was justified, and that any future use would also need to be justified to the IRB on a case-by-case basis. My hesitation in requiring more is for those investigational drugs which are rarely used in an institution. We currently require a complete protocol and new consent form, a policy which some investigators complain about when they do not anticipate using the investigational drug ever again. Granted their judgment may be wrong, but that is not my question. How many of you require a complete protocol and consent form (in the IRB format) when you review an intervention that was performed under an emergency IND?
Robert Skip Nelson, MD, PhD
Coordinator, The IRB Discussion Forum
Anonymous
4/11/2000 9:03:00 AM
Principal Investigator Training
At our Center we do not require that an investigator have formal
training in GCP. However, it IS a requirement that, before becoming a
PI on their own, they must be mentored by a senior Attending. One of
the senior Attendings is the PI, the junior Attending is a co-PI who
receives on-the-job training from the senior Attending.
Cathy Doherty
Memorial Sloan-Kettering Cancer Center
Doherty Catherine T/Mskcc Medicine
4/11/2000 3:45:00 AM
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Dear MCWIRB Forum:
I just had an investigator request copies of the IRB minutes. He did not
provide a specific reason for wanting the minutes, but was quick to state
that the minutes we part of the public domain and that under the Freedom of
Information Act I had to provide him with the information.
As per a recent MCWIRB discussion, I no longer reference comments or
concerns to a specific member. However, some older minutes do reference
members by name in my discussion notes.
Have any of you had similar request. If so, what was your response? Did you
only provide him/her with the minutes that pertain to their study
information? Any and all advice is welcome.
Thanks,
Matthew Van Patton
IRB
Spartanburg Regional Medical Center
101 East Wood Street
Spartanburg, South Carolina 29303
Phone: 864.560.6705
Fax: 864.560.7327
mvanpatt@srhs.com
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<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> IRB Minutes Dear MCWIRB Forum: I just had an investigator request =
copies of the IRB minutes. He did not provide a specific reason for =
wanting the minutes, but was quick to state that the minutes we part of =
the public domain and that under the Freedom of Information Act I had =
to provide him with the information. As per a recent MCWIRB discussion, I =
no longer reference comments or concerns to a specific member. However, =
some older minutes do reference members by name in my discussion notes. =
Have any of you had similar request. =
If so, what was your response? Did you only provide him/her with the =
minutes that pertain to their study information? Any and all =
advice is welcome. Thanks, Matthew Van Patton IRB Spartanburg Regional Medical =
Center 101 East Wood Street Spartanburg, South Carolina =
29303 Phone: 864.560.6705 Fax: 864.560.7327 mvanpatt@srhs.com
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Matthew
4/11/2000 7:22:00 AM
Alternate IRB Members and Quorum
If your IRB roster lists alternate members, must these individuals be considered
in determining quorum? For example, if you have 12 regular members and 3
alternates would you base quorum for a meeting on 12 (7 members for quorum) or
15 (9 members for quorum)?? I have just recently began using this option for my
IRB, and this is a question that I don't remember ever seeing a clear cut answer
to.
Thanks for your help.
Gary Dennison
4/10/2000 4:10:00 PM
Conflict of Interest of IRB members
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I agree with Andrew Cockburn that frequently the IRB member from the same
department as the Investigator has insights into the research that no one else
on the board has. We would never recuse a member simply because they share an
academic home with the PI.
Our members are automatically recused if their name appears anywhere in the
application or if they have any reason to believe they will have a role in the
research after it is funded. Other than that, we pretty much leave it up to
the judgment of the member. Members occasionally recuse themselves from
considering applications in which a subordinate or a superior are involved but
not always. We have a relatively large board and never have an approval
decided
by a close vote so it would be difficult for one slightly conflicted member to
have an impact.
Mike Kelly
Georgia Tech
At 05:21 PM 4/7/2000 -0500, you wrote:
>Our IRB is discussing the definition of a Conflict of Interest for an IRB
>member. The committee has requested that I solicit input from other IRBs on
>how they address these issues. We have one central IRB which supports both
>liberal arts and health professions schools/colleges. We have one
>representative from each college/school on the committee.
>
>An IRB member who is an investigator (PI, Co-I, or any level) or subordinate
to
>an investigator (ie the IRB members dept. head or Dean), on any proposal will
>excuse themselves from discussion and voting. Our questions is, should an IRB
>member excuse themselves from discussion and voting on a proposal just because
>the investigator/proposal is from there own college/school? Most of our
>colleges/schools are fairly small (30-50 FTE faculty) so chances are the IRB
>member will know most all faculty from his/her college/school.
>
>Thank you for your assistance.
>
>Scott Swigart, Pharm.D.
>Chair, IRB
>Nova Southeastern University
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
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I agree with Andrew Cockburn that frequently the IRB member from the same
department as the Investigator has insights into the research that no one
else on the board has. We would never recuse a member simply
because they share an academic home with the PI.
Our members are automatically recused if their name appears anywhere in
the application or if they have any reason to believe they will have a
role in the research after it is funded. Other than that, we pretty
much leave it up to the judgment of the member. Members
occasionally recuse themselves from considering applications in which a
subordinate or a superior are involved but not always. We have a
relatively large board and never have an approval decided by a
close vote so it would be difficult for one slightly conflicted member to
have an impact.
Mike Kelly
Georgia Tech
At 05:21 PM 4/7/2000 -0500, you wrote:
>Our IRB is discussing the definition of a Conflict of Interest for an
IRB
>member. The committee has requested that I solicit input from
other IRBs on
>how they address these issues. We have one central IRB which
supports both
>liberal arts and health professions schools/colleges. We have
one
>representative from each college/school on the committee.
>
>An IRB member who is an investigator (PI, Co-I, or any level) or
subordinate to
>an investigator (ie the IRB members dept. head or Dean), on any
proposal will
>excuse themselves from discussion and voting. Our questions is,
should an IRB
>member excuse themselves from discussion and voting on a proposal
just because
>the investigator/proposal is from there own college/school?
Most of our
>colleges/schools are fairly small (30-50 FTE faculty) so chances are
the IRB
>member will know most all faculty from his/her college/school.
>
>Thank you for your assistance.
>
>Scott Swigart, Pharm.D.
>Chair, IRB
>Nova Southeastern University
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
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Mike Kelly
4/10/2000 8:13:00 AM
Alternate IRB Members and Quorum
Alternate members attend in the absence of the member and can vote. Their attendance and vote(s) are recorded in the minutes.
>>> pcasebol@medicorpihn.com 04/07/00 12:43PM >>>
We are just beginning to appoint alternate members to our IRB. These questions
were raised and I am not sure of the answers. Can alternate members attend IRB
meetings even though they are not needed for the quorum? If they attend, can
they vote? If they vote, how is it documented in the minutes? Thanks
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Dee Long
4/10/2000 4:58:00 AM
Alternate IRB Members and Quorum
Penny,
The way my policies are structured for alternates is that yes, the can attend
an IRB meeting when their primary member is there. This is a good idea when
the alternate is new and needs experience with the Board. But they cannot
vote or be considered part of the quorum unless they are present in their
official capacity, as an acting alternate for their primary member. This is
all written out in my procedures/SOPs, so we all know where we stand.
Rebecca M. Clark
Scripps Hosptials/Children's Hospital
San Diego
Rebecca M. Clark
4/10/2000 4:10:00 PM
Conflict of Interest of IRB members
It has been the policy at various institutions at which I have worked, that
it is not necessary for an IRB member to excuse themselves just because
they are of a similar discipline or happen to work occasionally with the
investigator. We have required members to excuse themselves only if they
are involved in the project under review. Confidentiality of the vote is
protected by not naming members in the Minutes when reporting their comments.
Jon Hart
At 05:21 PM 4/7/00 -0500, you wrote:
>Our IRB is discussing the definition of a Conflict of Interest for an IRB
>member. The committee has requested that I solicit input from other IRBs on
>how they address these issues. We have one central IRB which supports both
>liberal arts and health professions schools/colleges. We have one
>representative from each college/school on the committee.
>
>An IRB member who is an investigator (PI, Co-I, or any level) or
subordinate to
>an investigator (ie the IRB members dept. head or Dean), on any proposal will
>excuse themselves from discussion and voting. Our questions is, should an IRB
>member excuse themselves from discussion and voting on a proposal just because
>the investigator/proposal is from there own college/school? Most of our
>colleges/schools are fairly small (30-50 FTE faculty) so chances are the IRB
>member will know most all faculty from his/her college/school.
>
>Thank you for your assistance.
>
>Scott Swigart, Pharm.D.
>Chair, IRB
>Nova Southeastern University
>
>
>_______________________________________________
>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
4/10/2000 4:55:00 AM
Determination of exempt status
Hi,
We are starting to receive many research proposals for review that involve analysis of patient-related data contained within electronic databases.The promotion of the concept of the electronic medical record necessitates the creation and maintenance of such databases. These databases may involve, for example, clinical, biochemical, microbiologic, pathologic and radiographic data. Much of this research is done in, or in association with, departments of Medical Informatics.
In the typical proposal, the investigator requests specified, existent data from an institutional Information Broker. The latter first determines, pursuant to institutional policy, whether the researcher is entitled to the information. Then, the information is provided --in electronic form -- to the investigator without identifying information such as the patient's name, medical record number, etc. A meaningless identifier *is* attached for tracking and audit purposes only.
As described, this would not appear to constitute human subjects research. The relevant regulation in the Common Rule ( CFR 46.102 (f)(2)) stipulates --with respect to the definition of a human subject -- that :
Private information must be individually identifiable (i.e., the identity of the subject is or may *readily* ( emphasis mine ) be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
In this scenario, the investigator would not readily be able to link the data with individual patients --it is merely theoretically possible.
Is my analysis correct?
Regards,
Howard
Anonymous
4/10/2000 2:28:00 PM
Conflict of Interest of IRB members
In our situation, we would quickly run out of IRB members if all excused
themselves based on knowing/being in same department as the PI, etc! We
basically follow the guidelines you describe as your current guidelines.
-----Original Message-----
From: Scott Swigart [mailto:swigart@hpd.acast.nova.edu]
Sent: Friday, April 07, 2000 6:21 PM
To: mcwirb@mcwirb.org
Subject: Conflict of Interest of IRB members
Our IRB is discussing the definition of a Conflict of Interest for an IRB
member. The committee has requested that I solicit input from other IRBs on
how they address these issues. We have one central IRB which supports both
liberal arts and health professions schools/colleges. We have one
representative from each college/school on the committee.
An IRB member who is an investigator (PI, Co-I, or any level) or subordinate
to
an investigator (ie the IRB members dept. head or Dean), on any proposal
will
excuse themselves from discussion and voting. Our questions is, should an
IRB
member excuse themselves from discussion and voting on a proposal just
because
the investigator/proposal is from there own college/school? Most of our
colleges/schools are fairly small (30-50 FTE faculty) so chances are the IRB
member will know most all faculty from his/her college/school.
Thank you for your assistance.
Scott Swigart, Pharm.D.
Chair, IRB
Nova Southeastern University
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Alice K .
4/10/2000 7:33:00 AM
principle investigator training
Our IRB has been challenged recently on 2 separate occasions by persons wanting
to be the principle investigator on a clinical study who has no GCP training.
Each claims that they are (rightfully so) qualified for the technical aspects of
the study, and they have people on staff who are trained in GCPs whose job it is
to assure GCP compliance.
Both investigators claim that since the GCPs do not explicitly state that the
investigator must have GCP training, only to be aware of the GCPs, that they
are only responsible for assuring that someone associated with the study has
such training.
Does this seem reasonable, to have an investigator with no GCP training?
Until now, all investigators presenting to our IRB have been required to have
documented GCP training (we even offer to teach it to those that need it), and
nobody has challenged us on this requirement.
Do other IRBs require principle investigators to have formal, documented GCP
training?
Thank you.
Steve Springer
Steve Springer-St
4/10/2000 4:55:00 AM
Conflict of Interest of IRB members
We would not recuse an IRB member just because the investigator is from
their own department. Such members are usually the most knowledgeable about
the risks and procedures, so excluding them would be a very bad idea (in my
opinion).
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 Scott Swigart
> Sent: Friday, April 07, 2000 6:21 PM
> To: mcwirb@mcwirb.org
> Subject: Conflict of Interest of IRB members
>
>
> Our IRB is discussing the definition of a Conflict of Interest for an IRB
> member. The committee has requested that I solicit input from
> other IRBs on
> how they address these issues. We have one central IRB which
> supports both
> liberal arts and health professions schools/colleges. We have one
> representative from each college/school on the committee.
>
> An IRB member who is an investigator (PI, Co-I, or any level) or
> subordinate to
> an investigator (ie the IRB members dept. head or Dean), on any
> proposal will
> excuse themselves from discussion and voting. Our questions is,
> should an IRB
> member excuse themselves from discussion and voting on a proposal
> just because
> the investigator/proposal is from there own college/school? Most of our
> colleges/schools are fairly small (30-50 FTE faculty) so chances
> are the IRB
> member will know most all faculty from his/her college/school.
>
> Thank you for your assistance.
>
> Scott Swigart, Pharm.D.
> Chair, IRB
> Nova Southeastern University
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
Andrew Cockburn
4/10/2000 5:01:00 AM
Alternate IRB Members and Quorum
I just read two somewhat contradictory answers. In our case we
consider that alternate members are alternate, ie they vote and count
for quorum only if the other alternate is not present; otherwise they
can be present at the meetings but they do not vote nor can they be
counted for quorum (in reality rarely anybody wants to be in a meeting
if they are not needed).
If you act by letting the alternate and the regular member vote
and count for quorum you could not consider the alternate an
alternate. Supose you have a roster of 13 regular members and two
alternates (total of 13 members), your quorum is 7, but if you let the
alternates vote even if the regular members are present, then your
quorum would be 8 (total of 15). And in the later case, why call them
alternates?
Of course, we are not the holders of any sacred truth.
Enzo
E. Bard
IRB Administrator
SUNY Downstate
______________________________ Reply Separator _________________________________
Subject: re: Alternate IRB Members and Quorum
Author: at Internet
Date: 4/7/00 11:43 AM
We are just beginning to appoint alternate members to our IRB. These questions
were raised and I am not sure of the answers. Can alternate members attend IRB
meetings even though they are not needed for the quorum? If they attend, can
they vote? If they vote, how is it documented in the minutes? Thanks
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
ebard@netmail.hscbklyn.edu
4/10/2000 12:06:00 PM
Subject: emancipated youth
David- See the definition of children in the federal regulations (45 CFR
46.402). This definition does not mention age 18.
The definition of children is:
persons who have not attained the legal age for consent to treatments or
procedures involved in the research, under the applicable law of the
jurisdiction in which the research will be conducted.
Under this definition, persons who are able to consent for health care under
state law, would be considered adults under the regulations. In general,
emancipated minors are adults under the federal regulations.
John Santelli, MD, MPH
Chairperson, IRB G
Centers for Disease Control and Prevention
Message: 2
Date: Fri, 07 Apr 2000 10:48:47 -0500
From: David Swenson >
To: >
Subject: emancipated youth
Our IRB has an interesting question posed. What are the guidelines for
reviewing emancipated youth. More specifically, we have a proposed study
that will examine the parenting needs of young mothers (age 15-18) who have
been emancipated from their parents. While they are below adult age, they
have been emancipated by the courts to live independently, and in many cases
their parent(s) are either absent, unavailable, or would not be willing to
participate in making amjudgement about their daughter's participation in
such a study.
Does anyone know of any similar cases or guidelines for such situations?
Thanks,
Dave Swenson
dswenson@css.edu
David X. Swenson PhD LP
Associate Professor of Management
College of St. Scholastica
1200 Kenwood Ave.
Duluth, MN 55811
(218)723-6476
FAX: (218)723-6290
John
4/9/2000 11:30:00 AM
Subject: emancipated youth
David- See the definition of children in the federal regulations (45 CFR
46.402). This definition does not mention age 18.
The definition of children is:
persons who have not attained the legal age for consent to treatments or
procedures involved in the research, under the applicable law of the
jurisdiction in which the research will be conducted.
Under this definition, persons who are able to consent for health care under
state law, would be considered adults under the regulations. In general,
emancipated minors are adults under the federal regulations.
John Santelli, MD, MPH
Chairperson, IRB G
Centers for Disease Control and Prevention
Message: 2
Date: Fri, 07 Apr 2000 10:48:47 -0500
From: David Swenson >
To: >
Subject: emancipated youth
Our IRB has an interesting question posed. What are the guidelines for
reviewing emancipated youth. More specifically, we have a proposed study
that will examine the parenting needs of young mothers (age 15-18) who have
been emancipated from their parents. While they are below adult age, they
have been emancipated by the courts to live independently, and in many cases
their parent(s) are either absent, unavailable, or would not be willing to
participate in making amjudgement about their daughter's participation in
such a study.
Does anyone know of any similar cases or guidelines for such situations?
Thanks,
Dave Swenson
dswenson@css.edu
David X. Swenson PhD LP
Associate Professor of Management
College of St. Scholastica
1200 Kenwood Ave.
Duluth, MN 55811
(218)723-6476
FAX: (218)723-6290
John
4/9/2000 11:30:00 AM
Our IRB is trying to establish an appropriate
definition for a Legal Representative. Due to
the nature of some of our studies someone
other than the subject may be asked to sign the
consent on their behalf. How has your IRB
defined the criteria for this individual and the
circumstances that they may be used?
Thanks,
Christy Klepetko
IRB Coordinator
Christy Klepetko
4/8/2000 2:36:00 AM
>>> Christy Klepetko wrote:
>Our IRB is trying to establish an appropriate
>definition for a Legal Representative. Due to
>the nature of some of our studies someone
>other than the subject may be asked to sign the
>consent on their behalf. How has your IRB
>defined the criteria for this individual and the
>circumstances that they may be used?
Hi,
I believe you are asking about the notion of a legally -authorized
representative ( LAR) that we have previously discussed in this forum.
As this is a legal construct ,having its basis in State or Federal
statutory codes, an IRB may not simply devise a definition to suit its
practical interests.
You may start by determining whether your State Code addresses this
issue in the context of biomedical research. For example, in Utah, there
are two provisions that concern consent in the context of healthcare:
1. Special Power of Attorney for Health Care
( http://www.le.state.ut.us/~code/TITLE75/htm/75_02087.htm)
2. Consent to healthcare
(http://www.le.state.ut.us/~code/TITLE78/htm/78_10007.htm) Section
(4)
Neither section addresses consent for participation in therapeutic
research.
The Statute enumerating the General powers and duties of guardian
stipulates :
(c) A guardian may give any consents or approvals that may be
necessary to enable the ward to receive medical or other professional
care, counsel, treatment, or service.
There is no mention of therapeutic research here either. Note also
that Federal policy is not intended to preempt State law. Thus, I find
the stipulation of a legally-authorized representative in the FDA
regulations and Common Rule vexing.
One solution would involve an expanded and clarified defintion of a LAR
( should we exclude the L ?) in the federal regulations governing
biomedical research. Here is an informative discussion, but not a
present solution:
http://bioethics.gov/capacity/Advance.htm#Legally
Any other ideas anyone ?
Regards,
Howard
Howard Mann
4/8/2000 2:36:00 AM
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OPRR is interested in talking with IRBs that routinely address or have
policies related to investigator financial conflict of interest. Please
contact Gary Ellis directly at Gary_Ellis@nih.gov. Thanks for your help.
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<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> Conflict of Interest OPRR is interested in talking with =
IRBs that routinely address or have policies related to investigator =
financial conflict of interest. Please contact Gary Ellis =
directly at Gary_Ellis@nih.gov. Thanks for your help.
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Tom Od
4/7/2000 10:58:00 AM
IRB review of faculty research involvement
A faculty member who functions as the data manager and statistician for
certain projects at a nearby academic medical is seeking advice. She is
considered an investigator on these projects with her contribution being
that she statistically analyzes the data after it has been collected and
contributes to the write-up and presentation of data. Some data come to her
in a completely anonymous form (no identifiers). Other data may have an
identifier so that she can contact the researcher if further information is
needed. The PI from the neighboring University already has their IRB
approval. She is asking this:
If the research is approved at the institution where the data are
collected, and the institution is a university with its own IRB, does she
need to obtain IRB approval at her own University as well? I am especially
interested in your opinion as to whether she needs her own IRB approval
when, for some projects, the data come with absolutely no identifiers
Teresa Savage
4/7/2000 10:58:00 AM
IRB review of faculty research involvement
My interpretation of this situation has been that it is a voluntary question
for the local IRB. It boils down to whether the local institution wants to
know what all its personnel is getting involved with and whether you want to
ensure that the other IRB has done its job. While it may be difficult to
get the other IRB to change its position on particular issues you may
identify in the research, there may be enough of a potential risk or
controversy that your local institution may not want its personnel involved.
Moreover, it makes no difference to me that the local involvement is only
with statistical evaluation, or some other relatively minor component of the
research.
There is no reason that the local IRB could not make an independent decision
that the research is exempt-but this decision would apply only locally.
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
icenogle@execpc.com. 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 icenogle@execpc.com
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
Teresa Savage
Sent: Thursday, April 06, 2000 4:54 PM
To: mcwirb@mcwirb.org
Subject: IRB review of faculty research involvement
A faculty member who functions as the data manager and statistician for
certain projects at a nearby academic medical is seeking advice. She is
considered an investigator on these projects with her contribution being
that she statistically analyzes the data after it has been collected and
contributes to the write-up and presentation of data. Some data come to her
in a completely anonymous form (no identifiers). Other data may have an
identifier so that she can contact the researcher if further information is
needed. The PI from the neighboring University already has their IRB
approval. She is asking this:
If the research is approved at the institution where the data are
collected, and the institution is a university with its own IRB, does she
need to obtain IRB approval at her own University as well? I am especially
interested in your opinion as to whether she needs her own IRB approval
when, for some projects, the data come with absolutely no identifiers
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Daniel L . Icenogle
4/7/2000 10:58:00 AM
Our IRB has an interesting question posed. What are the guidelines for
reviewing emancipated youth. More specifically, we have a proposed study
that will examine the parenting needs of young mothers (age 15-18) who
have been emancipated from their parents. While they are below adult
age, they have been emancipated by the courts to live independently, and
in many cases their parent(s) are either absent, unavailable, or would
not be willing to participate in making amjudgement about their
daughter's participation in such a study.
Does anyone know of any similar cases or guidelines for such
situations?
Thanks,
Dave Swenson
dswenson@css.edu
David X. Swenson PhD LP
Associate Professor of Management
College of St. Scholastica
1200 Kenwood Ave.
Duluth, MN 55811
(218)723-6476
FAX: (218)723-6290
david swenson
4/7/2000 11:00:00 AM
Alternate IRB Members and Quorum
My answers, yours may differ:
If an alternate is attending as the replacement for a regular member, they
function exactly as a regular member does (reviewing, discussing, voting,
counting towards a quorum).
If an alternate is not attending as the replacement for a regular member,
they are a member of the general public. Our IRB meetings are open, so they
are welcome to attend; but they can not review, vote, or count toward a
quorum. If the chair recognizes them, they can make comments. (We
frequently have alternates attend meetings to observe how the IRB works.)
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 Penny Casebolt
> Sent: Friday, April 07, 2000 12:44 PM
> To: mcwirb@mcwirb.org
> Subject: re: Alternate IRB Members and Quorum
>
>
> We are just beginning to appoint alternate members to our IRB.
> These questions
> were raised and I am not sure of the answers. Can alternate
> members attend IRB
> meetings even though they are not needed for the quorum? If they
> attend, can
> they vote? If they vote, how is it documented in the minutes? Thanks
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
Andrew Cockburn
4/7/2000 12:52:00 PM
Our institution currently has a standard outline for preparing informed consent forms which contains standard language regarding confidentiality, compensation, participation is voluntary etc. In your experience, do most IRB's have standard formats or are sponsor written informed consent forms accepted? Also, do most IRB's strictly adhere to their formats?
Anonymous
4/6/2000 10:54:00 AM
Our IRB is in the process of evaluating it's manner of participation in
cooperative research activities with other institutions [we currently review for
studies that are conducted by our investigators in two other facilities which
have their own IRBs]. I am wondering if there are members of MCWIRB who would
be willing to share their experiences [good and bad] with this type of IRB
review and to also share with me copies of letters of agreement or memos of
understanding [MOU] that are used in establishing cooperative research ventures
between IRBs.
Copies of letters of agreement or MOUs can be e-mailed to me at
Gary.Dennison@arcw.org or FAXed to (414) 225-1656. Thanks for your help!
Gary Dennison
4/6/2000 4:10:00 PM
Unanticipated problems - - 46.103(b)(5)
We have been reviewing our SOPs, and are re-visiting an old friend, 45
CFR 46.103(b)(5).
I am sure you all remember 103: Assurances ... shall include ...
(b)(5) written procedures for ensuring prompt reporting to the IRB,
appropriate institutional officials, and the Department or Agency head
of (i) any unanticipated problems involving risks to subjects or others
....
Of course, we require our PIs to notify the IRB of unanticipated
problems, and if there is any change in risk to the participants, our
IRB would require a modification to the consent form and most likely a
re-consenting of previously enrolled participants.
We would have thought this meant unanticipated problems at our site,
not those reported to us at other sites; though of course we might
still require a modification of the consent form.
However, I am not sure that we have taken this to mean that any time we
have an experiment in which an unanticipated event might alter the risks
to participants, that we also have a reporting requirement to the OPRR
(the Department or Agency head).
How do the rest of you handle this? Do you routinely notify OPRR
whenever an unanticipated event changes the risk to a participant? only
when the sponsor is NIH?
Thanks!
David Hudson
David Hudson
4/6/2000 10:57:00 AM
Please post the response to Gary's question online as I am interested also.
Elaine Hogan Miller
Abbott Northwestern Hospital
Minneapolis
____________________Reply Separator____________________
Subject: Cooperative Research
Author:
Date: 4/5/00 11:01 AM
I have received several requests from other MCWIRBers asking me to share any
information I received in response to my query concerning cooperative research
agreements among IRBs. The problem is, with the exception of one person who
responded to say that they didn't do cooperative research, I have not received
any responses. I thought that I would re-post my original request to see if it
generates any responses or any discussion among MCWIRB members:
Our IRB is in the process of evaluating it's manner of participation in
cooperative research activities with other institutions [we currently review for
studies that are conducted by our investigators in two other facilities which
have their own IRBs]. I am wondering if there are members of MCWIRB who
would be willing to share their experiences [good and bad] with this type of IRB
review and to also share with me copies of letters of agreement or memos of
understanding [MOU] that are used in establishing cooperative research ventures
between IRBs.
Copies of letters of agreement or MOUs can be e-mailed to me at
Gary.Dennison@arcw.org or FAXed to (414) 225-1656.
Thanks for your help!
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Elaine Hogan-Miller
4/6/2000 4:10:00 PM
FDA regs/OPRR regs interaction
Still reviewing the NAT/IND study. A more general question.
The study is clearly subject to the FDA regs re: consent. (21 CFR
50.20) The exceptions to the requirement for consent in the FDA regs
are based on individual emergencies or emergency research -- Sections
50.23 and 50.24. The FDA regs do not address waiver of consent by the
IRB under the OPRR scheme -- 45 CFR 116(d) -- minimal risk, no adverse
affect, not practicable to do and provide information later. Neither do
the FDA regs (at least the Part 50 -- Protection of Human Subjects)
reference the OPRR regs.
Yet, I've seen some discussion on this list that I understand to say
that an IRB can use the OPRR waiver regs to waive the consent required
by the FDA.
I'd like to understand the connection.
Has the FDA taken action elsewhere to make the OPRR regs applicable?
Is it because FDA is an agency under DHHS that the DHHS regs are
applicable?
Thank you.
Mary
Mary L. Crumbaker
Administrative Director
Saccomanno Research Institute
St. Mary's Hospital; Grand Junction, CO
Ph: 970-244-2497; Fx: 970-241-4366
mcrumbaker@stmarygj.com
4/6/2000 5:47:00 AM
I believe that we all need to be conscious of wordings that are
inappropriate:
understand -- The subjects themselves cannot know whether they
understand; they may misunderstand and yet believe they have understood.
(The use of understand generally indicates that a lawyer has been
concerned about liability -- resist that inclination.)
if you refuse -- Few, if any, subjects relying on a physician for
their care, and perhaps for their lives, can refuse suggestions from
that physician. Instead, to avoid coercion, use if you choose not to
participate. It makes it a little easier, but not easy, to decide not
to participate.
Dick Kelley, community member, Newark Beth Israel Medical Center
Richard A Kelley
4/6/2000 10:54:00 AM
Faxed Informed Consent by LAR
I am IRB Coordinator for Sarasota Memorial Hospital and we are in the process of making up policy and guidelines for accepting Faxed Informed Consent by a Legally Authorized Represssentative. We have had two study sponsor make this request in the last month. We approved one study and disapproved the other study. If anyone would has a current policy or has worked with setting up guidelines regarding faxed consent, I would appreciated a copy of your policy or any input regarding this subject. You can reply off line if you like. Thanks in advance.
Patty Rensing
SMH IRB Coordinator
patty-rensing@smh.com
941-917-6268
Anonymous
4/5/2000 12:45:00 PM
This is a very late response, but one that has been on the tip of my tongue
for a while!
I write the consent forms for my company, and have created a template that
meets the 6th to 8th grade reading level. It is so simple and concise, I
figured it would be an IRB's dream. We submitted this to one of our new
sites, and what do they do? Replace half of the language with the IRB
approved language that, among other things states I understand... many
times, says I have been fully informed of the study, and I have received
a signed copy of this consent form (as they haven't even signed it yet!).
The language contains many larger words than our template did, yet the study
coordinator says this is what is in ALL of our consents. It is so
disappointing to me, a sponsor, who spent extra time creating a template
that contains all of the elements yet remains reader friendly. I spent 2
years as an IRB manager, so I have seen the worst of the worst when it comes
to consent forms - thus my extra effort to break this sponsor stereotype.
I have requested they take out the word fully and change have received
to will receive. It will remain to be seen if they are willing to change
this - the study coordinator seemed to think the IRB was very comfortable
with their language and would not be willing to change it. This is also the
second time I have asked for the word fully to be removed from this
context from an IRB template. What do you MCWIRB-ers think about this?? I
mean, this is straight from the FDA information sheets - I don't understand
the resistance.
Linda Apholz
Clinical Research Associate
813-887-2572
-----Original Message-----
From: Howard Mann [mailto:ldhmann@ihc.com]
Sent: Wednesday, March 22, 2000 12:52 PM
To: mcwirb@mcwirb.org
Subject: re: Standard Consent Format
Re: Standard Consent Format
Hi,
As with most IRB's, we prescribe the format of the Consent Document. In my
experience, the documents provided by sponsors are far too complex and
typically contain language suited to contractual arrangements - for example,
we've all seen the I understand... and I will... statements, which I
find
offensive.
We too have been guided by the consent template published by the NCI. You
may
peruse our template at :
http://www.ihc.com/ldsh/irb/consent_template.html
Regards,
Howard
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Linda
4/5/2000 5:44:00 AM
IRB Approval of Emergency Use IND
I have a somewhat different take on this than most. According to
the FDA information sheets, The emergency use provision in the FDA
regulations is an exemption [emphasis in original] from prior
review and approval by the IRB. These treatment uses are just that, treatment. Our IRB reviews and approves (or doesn't) research, not treatment. Under the exemption as noted, we do not review and approve emergency use. We tell this to investigators and companies, tell them they may not use the drug again this way unless they submit an emergency use protocol. We also remind them that persons given the drug under this provision do not become research subjects and they may not use data about the patient in their study. Note that in the information sheets FDA also says that FDA acknowledges, however, that it would be inappropriate to deny emergency treatment to a
second individual if the only obstacle is that the IRB has not had
sufficient time to convene a meeting to review the issue. If IRBs approve emergency use in a pro forma manner, there is no point to such review and approval. We do not think the IRB should assume any kind of responsibility for medical treatment and we do not believe the FDA requires this. Recently when a pharmaceutical manufacturer got upset with us for refusing IRB approval for emergency use, we faxed them a copy of the FDA information sheet (Emergency
Use of an Investigational Drug or Biologic). Executives and
lawyers reviewed the FDA statement and our position and decided we were right.
When physicians do try to use investigational agents repeatedly,
companies usually balk and refuse to release the drug. When we have
learned of this, we insist upon the submission of an emergency use
protocol, which we review.
Joel E. Frader, M.D.
Program in Medical Ethics and Humanities
Northwestern University Medical School
General Academic Pediatrics
Children's Memorial Hospital
Joel Frader, M.D.
4/5/2000 10:18:00 AM
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