I've followed this discussion with great interest, holding back from joining
in only because I felt I would only be making a me too kind of reply.
However, in response to Joe's further clarification, I thought I might get
in quick!
1: The question of whether men are more driven by sexual urges is hardly
one that seems to me to have equipoise! And it seems to me a key difference
(without any judgements intended or implied) is that there are a greater
number of hetero-sexuals in the community than homo-sexuals and
hetero-sexual propositioning is much more common. Thus the earlier study,
of opposite-sex propositions, was less likely to provoke hostility or cause
distress (not to say that there would be no hostility or distress, just
less).
2. Is the risk of harm to the investigator an issue for the IRB? Well, we
take the line that, while our principle concern is to protect subjects, we
also have responsibilities to promote good research and to protect
researchers, within reason. If the only person making the approaches was
the PI one might argue that, as with lab experiments where the researcher
takes the first dose/tries the first procedure on him/her self, that's OK.
However, even in such situations one might want to suggest to the PI that
the risks are too great, the benefits too small, to justify such an
approach. Given that approaches were to be made to people of both sexes
there must have been at least two investigators - can we be sure that both
were sufficiently independent and autonomous that there could be no coercion
by a senior colleague to persuade a junior to take part? Were others to be
involved? Graduate students? Contract researchers?
I still feel this is not an acceptable study.
Paul
Dr Paul Wainwright
School of Health Science
University of Wales Swansea
Singleton Park
Swansea SA2 8PP
Tel: +44 1792 518599
Fax: +44 1792 295769
email: p.wainwright@swansea.ac.uk
> -----Original Message-----
> From: Joe Rosse [SMTP:rosse@altavista.com]
> Sent: Friday, June 23, 2000 9:04 PM
> To: merz@mail.med.upenn.edu
> Cc: mcwirb@mcwirb.org
> Subject: Re: deception research
>
> Thanks to everyone for their thoughtful replies to my question about a
> study in which the investigator proposes to study people's reactions to
> being sexually propositioned. That there were 20 replies--and some
> disagreement--makes me feel better about our committee's hesitancy.
>
> I also thought I might respond to a couple of the most common issues you
> all raised.
>
> 1. No, Jon, it wasn't a test question. I hesitated about explaining
> the rationale, since I wasn't sure I could do it justice. Essentially (as
> I understand it), the investigators are studying an evolutionary
> psychology hypothesis that men are more driven by sexual urges than women.
> Prior studies showed that the vast majority of college males would agree
> to the offer of sex, whereas very few women would. Since an alternative
> explanation is that women might decline because of fear of injury due to
> their smaller size, the investigator wants to replicate the study with
> homosexual encounters (where the size/strength difference is minimized.)
> So, no, the motive is not voyeurism. However, our committee has asked for
> better evidence that the benefits of such a study exceed the risks that we
> (and you) have identified.
>
> 2. There was a pervasive concern about risks to the investigator (which we
> also had). But is that really within the purview of IRBs? We would, of
> course, explicitly state our concern for the investigator's welfare, but
> beyond that point we're concerned about impinging on the investigator's
> autonomy. Similarly, if something happened it could bring poor PR to our
> university, but that doesn't seem relevant either (assuming, of course,
> that the research is scientifically and ethically legitimate). We get
> enough flack from investigators without also being accused of being the PC
> police or the protectors of the (university's) status quo. OTOH, we ARE
> concerned that an irate subject who assaults the investigator could find
> himself in legal trouble, and thus suffer from a risk created by the
> study.
>
> 3. A few of you were concerned that, deception aside, the project
> involved sexual harassment. I'm not an attorney, but my understanding is
> that requests for sex (when there is no authority relationship, as in a
> boss and an employee) constitute harassment only when they are repeated
> and unwanted. I'm not sure this situation--which other than the deception
> could occur naturally in a bar or other social setting--meets that
> standard.
>
> Thanks again--your thoughts have been very helpful. It will be
> interesting to see what our committee decides if the investigator
> re-submits the protocol.
>
> Joe Rosse, Ph.D.
> Chair, Human Reseach Committee
> University of Colorado, Boulder
>
> On Wed, 21 June 2000, Jon Merz wrote:
>
> >
> > i'd like to know what the hypotheses underlying this protocol are, and
> what
> > assertions of possible benefit and utility were put forth that would
> > justify ANY risk.
> >
> > this protocol sounds like a test question.
> >
> >
> > jon merz
> > center for bioethics
> > university of pennsylvania
> > merz@mail.med.upenn.edu
> >
> >
> >
> >
> > _______________________________________________
> > MCWIRB maillist - MCWIRB@mcwirb.org
> > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
> _______________________________________________________________________
>
> $1 million in prizes! 20 daily instant winners.
> AltaVista Rewards: Click here to win!
> http://shopping.altavista.com/e.sdc?e=3
>
> _______________________________________________________________________
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul
6/26/2000 1:40:00 AM
It seems to me that you may be protecting the autonomy of investigator (a
responsiblity I have not heard attributed to IRBs) rather than protecting
subjects which is clearly the role of IRBs. Just because the law draws a very
limited definition of sexual harassment does not mean that from an ethics
perspective this is not sexual harrassment.
Meg McClaskey
Director of Ethics Consultation
Rush North Shore Medical Center
Meg McClaskey
6/26/2000 6:04:00 AM
Certification of IRB Members
We are interested in knowing how many of you have mandated that some type of
a certification, testing, or such be completed by your IRB members before
they may participate as a full member. Or if you require some special
orientation, seminar, or such before one becomes a full member. We are a
non-university institution, so requiring certain outside education is
difficult. We do have an ongoing educational session for members the first
20 minutes of each IRB meeting, and require attendance (non-voting) for at
least two meetings (followed by a Q&A session with staff) before voting
privledges are obtained.
Feel free to reply off-list if you prefer.
Many thanks,
Ginger French, Pharm.D.
Wesley Medical Research Institutes
Ginger French, Pharm.D.
Wesley Medical Research Institutes
Wichita, Kansas
Ginger French
6/26/2000 11:15:00 AM
Thanks to everyone for their thoughtful replies to my question about a study in which the investigator proposes to study people's reactions to being sexually propositioned. That there were 20 replies--and some disagreement--makes me feel better about our committee's hesitancy.
I also thought I might respond to a couple of the most common issues you all raised.
1. No, Jon, it wasn't a test question. I hesitated about explaining the rationale, since I wasn't sure I could do it justice. Essentially (as I understand it), the investigators are studying an evolutionary psychology hypothesis that men are more driven by sexual urges than women. Prior studies showed that the vast majority of college males would agree to the offer of sex, whereas very few women would. Since an alternative explanation is that women might decline because of fear of injury due to their smaller size, the investigator wants to replicate the study with homosexual encounters (where the size/strength difference is minimized.) So, no, the motive is not voyeurism. However, our committee has asked for better evidence that the benefits of such a study exceed the risks that we (and you) have identified.
2. There was a pervasive concern about risks to the investigator (which we also had). But is that really within the purview of IRBs? We would, of course, explicitly state our concern for the investigator's welfare, but beyond that point we're concerned about impinging on the investigator's autonomy. Similarly, if something happened it could bring poor PR to our university, but that doesn't seem relevant either (assuming, of course, that the research is scientifically and ethically legitimate). We get enough flack from investigators without also being accused of being the PC police or the protectors of the (university's) status quo. OTOH, we ARE concerned that an irate subject who assaults the investigator could find himself in legal trouble, and thus suffer from a risk created by the study.
3. A few of you were concerned that, deception aside, the project involved sexual harassment. I'm not an attorney, but my understanding is that requests for sex (when there is no authority relationship, as in a boss and an employee) constitute harassment only when they are repeated and unwanted. I'm not sure this situation--which other than the deception could occur naturally in a bar or other social setting--meets that standard.
Thanks again--your thoughts have been very helpful. It will be interesting to see what our committee decides if the investigator re-submits the protocol.
Joe Rosse, Ph.D.
Chair, Human Reseach Committee
University of Colorado, Boulder
On Wed, 21 June 2000, Jon Merz wrote:
>
> i'd like to know what the hypotheses underlying this protocol are, and what
> assertions of possible benefit and utility were put forth that would
> justify ANY risk.
>
> this protocol sounds like a test question.
>
>
> jon merz
> center for bioethics
> university of pennsylvania
> merz@mail.med.upenn.edu
>
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
_______________________________________________________________________
$1 million in prizes! 20 daily instant winners.
AltaVista Rewards: Click here to win!
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_______________________________________________________________________
Joe Rosse
6/25/2000 7:46:00 AM
Sponsor Contracts with Institution
We always require a signed completed contract PRIOR to initiation of the
trial. The issues that arise are:
1) Liability / indemnification coverage for Investigator / Institution
(contained in contract)
2) Expectations from both parties are clearly delineated. The worse
things you can do is start a
study, have patients enrooling, then indicate how much the budget
ought to be, from either
party.
Rodney Butt
Director, Clinical Research
Boehringer Ingelheim
> -----Original Message-----
> From: David Pittman [SMTP:dpittman@bjc.org]
> Sent: Friday, June 23, 2000 10:38 AM
> To: mcwirb@mcwirb.org
> Subject: Sponsor Contracts with Institution
>
> I need to get an idea of how many other IRB's require the Study Sponsor
> formally contract with the hospital or institution prior to enrolling
> subjects
> into an approved IRB study. We have done this for private as well as
> study
> group protocols, but now have a sponsor declining.
>
> My second question regards the right of the institution to know the amount
> an
> investigator is getting paid, not that the IRB should know.
>
> Finally, thank-you Mr. Koski for monitoring this forum and giving us some
> immediate clarity of what the Feds are expecting! Dr. Pittman
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
rbutt@bur.boehringer-ingelheim.com
6/25/2000 7:44:00 AM
Who can be a principal investigator??
We have allowed non-M.D.s to be principal investigators for IND studies as long as they have appropriate credentials such as a Pharm.D. We require that the PI is assisted by medical doctors (as subinvestigators), and we require that appropriately trained clinicians be directly involved in patient casre and all medical assessments (drug management, adverse experiences, etc). In addition, we modify the consent form to include the name of a medical doctor to contact in the event of research-related injury or for other study-related medical issues.
Ellen G McCarthy, M.P.H.
Lead Administrator,
New England Institutional Review Board
Wellesley, MA
>Message: 1
>From: Gary.Dennison@arcw.org
>Date: Fri, 23 Jun 2000 09:18:45 -0500
>Subject: Who can be a principal investigator??
>To: mcwirb@mcwirb.org
>
>
>
>I have had a question come in from one of my coordinators:
>
>Must the principal investigator in a clinical trial where a drug is being
>utilized always be a Medical Doctor (MD/DO)?
>
>I have not quickly found any regulation that stipulates that it must be. The
>1572 asks for education, training and experience that qualifies the
>investigator as an expert in the clinical investigation of the drug for the use
>under investigation, but could this not also be another qualified individual
>like a D. Pharm.??
>
>Input on this would be greatly appreciated!
>
>
>
>
>
>
>--__--__--
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo/mcwirb
>
>
>End of MCWIRB Digest
>
> 0000,0000,8080 Ellen
G. McCarthy, M.P.H.
0000,0000,8080 Lead
Administrator, New England IRB
0000,8080,0000 Phone: 781 431 7577
Fax : 781 237 0330
Snail Mail Address: 40 Washington St., Suite 130
Wellesley MA 02481
Ellen G . McCarthy
6/25/2000 7:38:00 AM
Sponsor Contracts with Institution
Dr. Pittman,
My Children's Hosptial in San Diego requires a signed contract for clinical
trial conducted at the hospital, prior to any subject enrollment. However,
if the study will take place in a physician's office and the physician will
contracting only certain services (usually labs) to the hosptial, then the
hosptial does not require a sponsor contract.
Rebecca M. Clark
Children's Hostpial-San Diego
Rebecca M. Clark
6/25/2000 7:50:00 AM
Sponsor Contracts with Institution
I need to get an idea of how many other IRB's require the Study Sponsor formally contract with the hospital or institution prior to enrolling subjects into an approved IRB study. We have done this for private as well as study group protocols, but now have a sponsor declining.
My second question regards the right of the institution to know the amount an investigator is getting paid, not that the IRB should know.
Finally, thank-you Mr. Koski for monitoring this forum and giving us some immediate clarity of what the Feds are expecting! Dr. Pittman
Anonymous
6/25/2000 7:50:00 AM
reimbursement to providers for referring subjects
gary pitts wrote:
>> Many CRO's with whom I consult pay for referrals routinely. It never occurred to any of us that this ought to be considered by an IRB. Frankly, I am surprised that anyone brought it to the attention of an IRB and I can't see why anyone should.>>
i don't mean for this to sound heavy handed or self-serving, but that's
a perfect example of why we have IRBs... to look at things solely from
the perspective of protecting subjects' interests. neither you nor your
many CRO's... nor the providers being offered referral fees... are in a
good position to look at this from that perspective (and only that
perspective) and see where it might represent a conflict.
there seems to be near-unanimity in responses already given, but i'll
add one more to the pile. we've had a policy in place since 1990
forbidding referral or finders fees... because it inserts an
undesirable element into the provider-patient relationship, and gives
that provider something else to think about, other than patient's best
interest.
our policy wasn't derived from the AMA Code of Medical Ethics, nor need
it be. but i believe it is directly supported by section 6.02, which
reads: A physician may not accept payment of any kind, in any form,
from any source, such as a pharmaceutical company... for prescribing or
referring a patient to said source.
Daniel K. Nelson, Director, Human Research Studies
Research Associate Professor of Pediatrics and Social Medicine
University of North Carolina-Chapel Hill
Chapel Hill, NC 27599-7097
Phone: 919-966-1344
fax: 919-966-7879
e-mail: dnelson@med.unc.edu
Daniel Nelson
6/25/2000 7:38:00 AM
I thought that an edited transcript of the recent thread on finders' fees might
be a useful thing to have for our IRB staff and members. In putting it together,
I looked up the reference that G. Koski mentioned. Here it is, for those who are
interested...
Lind SE.
Finder's fees for research subjects.
N Engl J Med. 1990 Jul 19;323(3):192-5.
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
6/25/2000 7:46:00 AM
Who can be a principal investigator??
The FDA regulation, 21 CFR 312.53, indicates that a sponsor shall select only
investigators qualified by training and
and experience as appropriate experts to investigate the drug. This raises
several issues which may need to be explored in depth -- beyond these comments.
Individuals prepared at the Pharm.D. level, the basic degree in pharmacy, are
trained in pharmacokinetics and have in the past served as investigators for
phase-I pharmacokinetic studies. Clinical assessment and care required during
these protocols should be provided by qualified individuals.
In addition, the FDA has indicated that a nurse practitioner who is qualified
and licensed to independentally practice in their state, may also be qualified
for the role of investigator. Nurse practitioners have specialized training in
specific areas of practice (gerontology, pediatrics, women's health, family,
etc) which help qualify them to serve as an investigator in studies of
specialized populations.
Many nurse practitioners also practice in rural and under-served areas, where
patients have limited access to medical care as well as limited ability to
participate in clinical trials. With additional training, the nurse
practitioner would be an ideal investigator for many phase-IV studies. This
option may impact on the ethical principles of beneficence and justice while
also addressing the growing, and drastic, need to increase the awareness and
involvement of more patients in the clinical trial process.
Individuals who are doctorally prepared, including those with a biological,
physiological, nursing, or pharmacy background, are awarded grants to conduct
clinical studies. These awards are to the principal investigator.
It is also interesting to note that the FDA regulations use the terms
investigator and subinvestigator while NIH uses the terms principal
investigator and consultant.
Education to prepare clinicians to become investigators has been a key topic of
discussion at many institutions and regulatory agencies.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
George (Trey) Turner, III, M.A., R.Ph.
Clinical Research Management Program
Duke University, Graduate School of Nursing
Box 3322, DUMC, Durham, NC, 27710
Phone: 919-668-5108 Fax: 919-668-6120
eMail: george.turner@duke.edu
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
turne051@mc.duke.edu
6/25/2000 7:39:00 AM
reimbursement to providers for referring subjects
Any remuneration (in cash or in kind) for patient referrals paid to
physicians who are not employees of the hospital at which the IRB is based
constitutes a direct violation of the Stark law. Please beware and take
care!
Kate
-----Original Message-----
From: Felix Barker [mailto:Felix@pco.edu]
Sent: Friday, June 23, 2000 11:01 AM
To: mcwirb@mcwirb.org
Cc: TSanogo@mail2.allegro.net
Subject: Re: reimbursement to providers for referring subjects
The concept of payment or substantial gratuity is not, in my view,
appropriate. WE have given coffee mugs with the logo of the study to
potential referring individuals as more of a promotiom of the study rather
than a direct gratuity for a referal. We also have had group dinners as
another form of thak you. But this was not a result of a specific referral
and was more an overall informational and promotional effort in the
recruitment phase of the study. None of this was necessarily reviewed by the
IRB as part of the recruitment protocol. Should it have been?
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Katharine Sacks
6/25/2000 7:46:00 AM
Sponsor Contracts with Institution
We always require a signed completed contract PRIOR to initiation of the
trial. The issues that arise are:
1) Liability / indemnification coverage for Investigator / Institution
(contained in contract)
2) Expectations from both parties are clearly delineated. The worse
things you can do is start a
study, have patients enrooling, then indicate how much the budget
ought to be, from either
party.
Rodney Butt
Director, Clinical Research
Boehringer Ingelheim
> -----Original Message-----
> From: David Pittman [SMTP:dpittman@bjc.org]
> Sent: Friday, June 23, 2000 10:38 AM
> To: mcwirb@mcwirb.org
> Subject: Sponsor Contracts with Institution
>
> I need to get an idea of how many other IRB's require the Study Sponsor
> formally contract with the hospital or institution prior to enrolling
> subjects
> into an approved IRB study. We have done this for private as well as
> study
> group protocols, but now have a sponsor declining.
>
> My second question regards the right of the institution to know the amount
> an
> investigator is getting paid, not that the IRB should know.
>
> Finally, thank-you Mr. Koski for monitoring this forum and giving us some
> immediate clarity of what the Feds are expecting! Dr. Pittman
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
rbutt@bur.boehringer-ingelheim.com
6/25/2000 7:46:00 AM
Thanks to everyone for their thoughtful replies to my question about a study in which the investigator proposes to study people's reactions to being sexually propositioned. That there were 20 replies--and some disagreement--makes me feel better about our committee's hesitancy.
I also thought I might respond to a couple of the most common issues you all raised.
1. No, Jon, it wasn't a test question. I hesitated about explaining the rationale, since I wasn't sure I could do it justice. Essentially (as I understand it), the investigators are studying an evolutionary psychology hypothesis that men are more driven by sexual urges than women. Prior studies showed that the vast majority of college males would agree to the offer of sex, whereas very few women would. Since an alternative explanation is that women might decline because of fear of injury due to their smaller size, the investigator wants to replicate the study with homosexual encounters (where the size/strength difference is minimized.) So, no, the motive is not voyeurism. However, our committee has asked for better evidence that the benefits of such a study exceed the risks that we (and you) have identified.
2. There was a pervasive concern about risks to the investigator (which we also had). But is that really within the purview of IRBs? We would, of course, explicitly state our concern for the investigator's welfare, but beyond that point we're concerned about impinging on the investigator's autonomy. Similarly, if something happened it could bring poor PR to our university, but that doesn't seem relevant either (assuming, of course, that the research is scientifically and ethically legitimate). We get enough flack from investigators without also being accused of being the PC police or the protectors of the (university's) status quo. OTOH, we ARE concerned that an irate subject who assaults the investigator could find himself in legal trouble, and thus suffer from a risk created by the study.
3. A few of you were concerned that, deception aside, the project involved sexual harassment. I'm not an attorney, but my understanding is that requests for sex (when there is no authority relationship, as in a boss and an employee) constitute harassment only when they are repeated and unwanted. I'm not sure this situation--which other than the deception could occur naturally in a bar or other social setting--meets that standard.
Thanks again--your thoughts have been very helpful. It will be interesting to see what our committee decides if the investigator re-submits the protocol.
Joe Rosse, Ph.D.
Chair, Human Reseach Committee
University of Colorado, Boulder
On Wed, 21 June 2000, Jon Merz wrote:
>
> i'd like to know what the hypotheses underlying this protocol are, and what
> assertions of possible benefit and utility were put forth that would
> justify ANY risk.
>
> this protocol sounds like a test question.
>
>
> jon merz
> center for bioethics
> university of pennsylvania
> merz@mail.med.upenn.edu
>
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
_______________________________________________________________________
$1 million in prizes! 20 daily instant winners.
AltaVista Rewards: Click here to win!
http://shopping.altavista.com/e.sdc?e=3
_______________________________________________________________________
Joe Rosse
6/25/2000 7:44:00 AM
Reading the many responses on deception research generated by the study
proposing that a researcher would approach a same sex person and try to
establish a tryst and then inform the person that this was just a research
study, has been fascinating. Aside from the many potential psychological
and social harms to the person, the physical risks to the researcher, given
today's social currents, have been well described.
But harking to history, does any remember THE TEAROOM TRADE - IMPERSONAL SEX
IN PUBLIC PLACES, by Laud Humphreys (Aldine Publishing, 1970)? The book
describes a study by a graduate student at Washington University (Humphreys)
who first posed as a watch queen (voyeur/lookout) for gay men having sex in
a men's public restroom in Forest Park. Unbeknownst to the men, he wrote
down their license plate numbers and subsequently obtained their addresses
after posing as a market researcher. After a year, and changing his
appearance so he would not be recognized, he paid the men a visit, this time
posing as a researcher and informing the men that they had been randomly
selected for an interview as part of a social health survey of men in the
community. Many of the men did speak to him and he acquired much data
(including illegal practices) for his study. His dissertation was approved
and published and then the research community went nuts. His PhD was
rescinded and his controversial study went down in the annals as unethical.
Robert Levine has a good discussion of this case in his Ethics and
Regulation of Research, 2nd edition (1988). As Levine writes: the study
presented serious threats to the privacy of a highly vulnerable group of men
who had taken great pains to preserve their privacy (p.219).
This is such a hot topic, one must weigh the costs and benefits with
exquisite sensitivity to all of the persons who stand to be harmed
(unknowing subjects and knowing researchers). Deception may have a place in
research but it is a practice not to be abused.
Ruth Fischbach
Ruth L. Fischbach, Ph.D., M.P.E.
Senior Advisor for Biomedical Ethics
National Institutes of Health
Office of Extramural Research
Building 1, Room 158
1 Center Drive, MSC 0152
Bethesda, MD 20892-0152
(301)496-1414 - Phone
(301)402-7062 - FAX
rlfisch@nih.gov
URL for Bioethics Resources on the Web
http://www.nih.gov/sigs/bioethics
Ruth L. Fischbach, Ph.D., M.P.E.
Senior Advisor for Biomedical Ethics
National Institutes of Health
Office of Extramural Research
Building 1, Room 158
1 Center Drive, MSC 0152
Bethesda, MD 20892-0152
(301)496-1414 - Phone
(301)402-7062 - FAX
rlfisch@nih.gov
URL for Bioethics Resources on the Web
http://www.nih.gov/sigs/bioethics
Ruth Od
6/25/2000 2:06:00 PM
reimbursement to providers for referring subjects
Thanks very much.
Gary
gary365@aol.com
6/25/2000 7:39:00 AM
reimbursement to providers for referring subjects
We also have been grappling with this issue. Previously several investigators
offered finders fees with the intent similar to Dale's to keep the study in
the mind of the residents and prompt a call to the study coordinators regarding
a potential subject. We have grown uncomfortable with this practice in light of
the ethical and professional issues as well as the increasing aggressiveness
to payments by the pharmaceutical sponsors. Currently we do not allow finders
fees or other inducements for patient referral. We however do allow
consultation fees to the residents in return for a significant contribution
to the study such as completion of a screening checklist or log. The rule is
that the payment must be in return for significant work toward the study, must
involve more than referring the potential subject, and must be proportional to
the time and complexity required.
I'd appreciate any perspectives on this practice - Are we simply establishing
price..... or is this different than payment for subject referral
Steve Tharratt, M.D.
Chair - HSRC B
Univ. of CA, Davis
Steve Tharratt
6/25/2000 7:46:00 AM
reimbursement to providers for referring subjects
The concept of payment or substantial gratuity is not, in my view, appropriate. WE have given coffee mugs with the logo of the study to potential referring individuals as more of a promotiom of the study rather than a direct gratuity for a referal. We also have had group dinners as another form of thak you. But this was not a result of a specific referral and was more an overall informational and promotional effort in the recruitment phase of the study. None of this was necessarily reviewed by the IRB as part of the recruitment protocol. Should it have been?
Felix Barker
6/23/2000 7:28:00 AM
reimbursement to providers for referring subjects
Barbara ---
You've already gotten a lot of good answers.
We examined this a few years ago from more a common morality perspective. We
concluded that, in theory, it could be OK to have a finder's reward if it were
of a size and nature that it would only serve as a memory aid --- keep people
from forgetting about the study when suitable patients came to hand. It would
not be OK if it were of a size or nature that it could actually threaten the
integrity of medical decision-making.
>From that theoretical perspective, we then moved to thinking about how one would
ever develop the decision-making algorithm that would allow one reliably to
decide which incentives were OK and which ones were not OK. That's where we had
our brick-wall experience. We could easily identify some incentives that were
obviously too great to allow. We could identify a few that most of us felt were
trivial, and probably harmless. But the great majority of ones we actually saw
(textbooks, course fees, tickets for nights out, etc.) were in the middle range,
where some folks would be vulnerable and others would not, or where the
authority relationship between the investigator and the referring person (often
a trainee) would be key.
We ended up deciding that, in practice, it made more sense simply not to allow
such recruitment incentives. That also is consistent with the general
impropriety of clinical referral kickbacks, as well as more recent statements on
specific research referrals that have been made by some professional groups.
Dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
6/23/2000 7:27:00 AM
Prorated compensation based on compliance
Re: Intent-to-treat
Several answers:
(a) Intent-to-treat analysis is often the primary analysis for CLINICAL
EFFICACY TRIALS, which are but a subset of human subjects research;
(b) The primary analysis is virtually never the only analysis, and many
study goals may depend upon having a sufficient proportion of
participants sufficiently compliant for the question of interest
even to be posed. Pretty often, these secondary questions are of key
importance in the strategic development of a product, even if they are
not the ones for which answers will be presented in a licensing
application. No effect demonstrated, but compliance too low
for adequate power is an outcome legitimately to be avoided, and is
hardly a useful guide for design of the next study.
(c) In studies other than clinical efficacy trials, intent-to-treat
analysis may not even be a relevant concept, and the scientific
question being posed may be absolutely compliance-dependent.
(d) The whole concept of intent-to-treat analysis should be understood
for what it is: a convention that encourages one to analyze clinical
interventions from a real-world, start-of-the-road perspective. It's
not the only valid way to look at data, and it may be entirely the
wrong way if the question being asked is one of basic biology rather
than therapeutic outcome.
(e) The acceptability of a compliance or completion incentive, in my view,
does not depend on the analysis being employed, anyway. I think the
ethical issue hinges on whether the incentive is great enough to
influence risk acceptance rather than just serving as a reminder.
Dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
6/23/2000 7:28:00 AM
I am the new IRB Coordinator for Spartanburg Regional Medical Center. Does anyone have any suggestions on using electronic signatures for approval letters? We use an electronic signature for the chairman with my typed initials on the bottom. Is this ok by FDA/OPRR/Joint Commission.....etc. standards?
Anonymous
6/23/2000 4:51:00 AM
One should be a bit cautious about electronic signatures...validation and
non-repudiation are critical elements, features that may only be provided with
technologies such as digital certificates, etc. Probably best to get official
guidance from the agency! Greg Koski
> -----Original Message-----
> From: Erin Morgan [SMTP:emorgan@srhs.com]
> Sent: Monday, June 19, 2000 10:49 AM
> To: mcwirb@mcwirb.org
> Subject: Electronic Signatures
>
> I am the new IRB Coordinator for Spartanburg Regional Medical Center. Does
> anyone have any suggestions on using electronic signatures for approval
> letters? We use an electronic signature for the chairman with my typed
> initials on the bottom. Is this ok by FDA/OPRR/Joint Commission.....etc.
> standards?
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Greg
6/23/2000 4:51:00 AM
reimbursement to providers for referring subjects
A major pharmaceutical company that funds a number of our studies, has a clause in their contract prohibiting this practice. They state that we cannot pay a fee in exchange for the referral of patients for the study. That the payment or receipt of fees for the referral of patients may violate federal, state or local laws or professional standards and could result in disciplinary action or criminal prosecution.
Colleen Corcoran
6/23/2000 7:37:00 AM
Prorated compensation based on compliance
I would like some feedback on an amendment to an adult drug protocol that
makes reimbursement for scheduled appointments contingent upon medication
compliance. (If a subject shows up and hasn't taken all their medicine, the
sponsor proposes to pay them less). Arguments for and against this practice
are welcome!!!
Wendy
6/23/2000 7:28:00 AM
Dr. Rosse:
Our IRB has examined the deception in terms of the use of placebos in a run in period for a study, for example. This type of deception is quite nicely handled by the consent process which at least mentions the option.
It is quite another thing however to potentialy insult or embarrass a subject, then in effect, ask for ethical justification by consent.
I believe that our local IRB would have considerable issue with this specific approach. It is hard to obtain ethical forgiveness in retrospect.
Also, in our area, it would be likely that the research interviewer would be at risk of sustaining bodily harm if they resorted to this approach!
I am not sure of the objective of this research, but I believe that we would advise a different approach - one in which the subject and rearcher had an opportunity to evaluate each other and at least obtain voluntary, verbal consent, before any sort of potentially stressful interaction took place - perhaps with another subsequent unknow encounter.
Thanks.
Paul R. G. Cunningham, MD,
Chair, University and Medical Center IRB.
East Carolina University, Greenville, NC 27858
>>> Joe Rosse 06/21/00 01:15PM >>>
I'd greatly appreciate thoughts regarding a social psych protocol that involves a somewhat unusual form of deception.
The study involves approaching same-sex individuals on the street in which the experimenter indicates that (s)he has noticed the person before, finds them attractive, and then asks if they would either go out on a date or sleep with him/her. After the subject responds, the experimenter would inform the subject that this was a research study, have them sign an informed consent form, and ask a few additional questions (including one on sexual preference). (Although the protocol was not written this way, I'm sure that the investigator would be OK with a requirement that none of the subjects' responses--including the initial reaction--would be used if the subject declined to sign the consent form.)
This protocol has created substantial debate within the committee, for lots of reasons. The one I'd like input on is the argument that it is never acceptable to involve people in research (other than simple observation) without PRIOR consent. Since everyone is pretty much in agreement that the study cannot be done without that level of deception, this is a crucial point. This obviously goes beyond more typical deception research in which participants know they're involved in research, but aren't aware of the true purpose. OTOH, there is certainly plenty of precedent for this kind of research within social psychology (including studies using exactly the same methodology, but studying opposite-sex interactions, which the investigator wants to replicate with same-sex interactions).
Thanks!
Joe Rosse, Ph.D.
Chair, Human Research Committee
University of Colorado, Boulder
_______________________________________________________________________
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_______________________________________________________________________
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Paul Cunningham
6/22/2000 2:44:00 AM
foreign language consent forms
I prefer translations be done by a separate, uninterested (in the research)
entity. For more information on the translation of informed consents and
other medical documents by multi-lingual specialists in research and
medicine check the website: latninc.com
Marta-Inés Castillejo, M.A.
IRB Administrator
404-851-5703
-----Original Message-----
From: Joan Volin [SMTP:volinjo@cuadmin.cis.columbia.edu]
Sent: Monday, June 19, 2000 12:50 PM
To: mcwirb@mcwirb.org; mcwirb@mcwirb.org
Subject: foreign language consent forms
I have a questioh regarding the translation of consent forms into
languages other than English. We have a Hispanic Research
Recruitment Center here, that reviews all Spanish consent forms, and
compares them to the English. They will also do the
translations, for a fee. They must approve all Spanish consent
forms
before we will approve them. However, we have no such system for
other languages. Essentially, we have to trust the investigators.
Even if we can find someone to check the consent forms, they may not
be fluent enough in either English or the foreign language, or they
man y not have sufficient knowledge of medical procedures and
terminology to do an appropriate translation.
I was wondering how other institutions handle this problem. Does
anyone know of any general translating centers - local, regional,
national or international?
Because of the demographics of our catchment area, most of our
foreign-language consent forms are Spanish. But there are others,
and I would like to have the same level of confidence in those
consent forms that I have in our Spanish consent forms.
Thanks,
JoanVolin
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Marta-Ines
6/22/2000 10:16:00 AM
foreign language consent forms
I have a questioh regarding the translation of consent forms into
languages other than English. We have a Hispanic Research
Recruitment Center here, that reviews all Spanish consent forms, and
compares them to the English. They will also do the
translations, for a fee. They must approve all Spanish consent forms
before we will approve them. However, we have no such system for
other languages. Essentially, we have to trust the investigators.
Even if we can find someone to check the consent forms, they may not
be fluent enough in either English or the foreign language, or they
man y not have sufficient knowledge of medical procedures and
terminology to do an appropriate translation.
I was wondering how other institutions handle this problem. Does
anyone know of any general translating centers - local, regional,
national or international?
Because of the demographics of our catchment area, most of our
foreign-language consent forms are Spanish. But there are others,
and I would like to have the same level of confidence in those
consent forms that I have in our Spanish consent forms.
Thanks,
JoanVolin
Joan Volin
6/22/2000 10:16:00 AM
> I might suggest a hypothetical study in
> which unknowing
> subjects are approached in the street and served by the
> researcher with
> (bogus) legal papers, say a summons and complaint alleging
> something the
> subject is claimed to have done. Then, after the subject
> responds, the
> researcher informs the subject this was a research study,
> debriefs and gains
> consent, and then proceeds to ask the subjects how they felt
> initially about
> being sued.
You have done a brilliant job in identifying an issue which might upset even
more people than the original study!
While I do not know what the original investigator had in mind, this might be a
very important study to determine exactly what we are posing as the risks, i.e.,
to measure the sense of homophobic rage in a community. This is something that
is very difficult to measure for a couple reason. First, the political
correctness problem that people do not want to admit to it in surveys. Second,
the flip side - some people do not want to admit that they would be flattered by
the proposition. I do not know that this makes the methodology less
problematic, but at least we should approach this as a serious question that may
demand some varient of this methodology.
Ed
Edward P. Richards
Executive Director - Center for Public Health Law
Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
Edward Richards
6/22/2000 7:44:00 AM
reimbursement to providers for referring subjects
we have decided this constitutes fee splitting (even if only pizza is being offered
to residents) and prohibited it
stewart laidlaw, phd
harbor-ucla rei
Barbara Riter wrote:
> A principal investigator has requested several times that he be allowed to pay
> residents, fellows, attending physicians and other health care providers for
> referring patients to him who meet specific enrollment criteria into an
> approved study. He has proposed direct payments in the form of cash, movie
> tickets,gift certificates. Our IRB has refused this. What is the experience
> of other IRBs? Does any allow direct payment for such a referral? Does anyone
> consider this to be acceptable or ethical?
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Stewart Laidlaw Phd
6/22/2000 10:58:00 AM
Joe Rosse wrote:
> I'd greatly appreciate thoughts regarding a social psych protocol that involves a somewhat unusual form of deception.>
wow!! our social-psych colleagues think we on biomedical boards have a
tough job, because the risks of our studies may include death... but
i'm not sure i'd trade?
i can't add much to the discussion that has already ensued, regarding
potential risks and/or justification for the study. but assuming you
resolve those, let me toss out one more issue i haven't seen raised...
> After the subject responds, the experimenter would inform the subject that this was a research study, have them sign an informed consent form, and ask a few additional questions (including one on sexual preference).>>
why are you having them sign a consent form? presumably the survey can
and SHOULD be anonymous, with this kind of information. at that point,
the only link to the study would be that signature. seems like this
might be a case for considering a waiver of WRITTEN documentation of
consent under 45 CFR 46.117(c)(1), to minimize risk from breach of
confidentiality? by all means obtain consent, and hand them an
information sheet if desirable, but seems like signed consent form may
itself constitute a risk, in this scenario.
p.s. another naive question: are answers valid if subjects are thinking
to themselves that this might be an entrapment operation?
dan
Daniel K. Nelson, Director, Human Research Studies
Research Associate Professor of Pediatrics and Social Medicine
University of North Carolina-Chapel Hill
Chapel Hill, NC 27599-7097
Phone: 919-966-1344
fax: 919-966-7879
e-mail: dnelson@med.unc.edu
Daniel Nelson
6/22/2000 2:44:00 AM
Prorated compensation based on compliance
Re Dale's comment that a sponsor may be unable to use the data. . .The
primary analysis for many if not most clinical trials is the
intent-to-treat analysis, which does not exclude patients for any reason
(except possibly enrolled in error because inclusion/exclusion criteria were
not met). In that analysis, even if the patient were taking the wrong dose
or another drug altogether, they would be included in the analysis. It is
hard for me to see a reason why the exposure experience of a properly
enrolled patient would not be useable.
> -----Original Message-----
> From: Dale E. Hammerschmidt [SMTP:hamme001@maroon.tc.umn.edu]
> Sent: Wednesday, June 21, 2000 8:03 AM
> To: wendy_malone@srhc.iwhs.org; mcwirb@mcwirb.org
> Subject: Re: Prorated compensation based on compliance
>
> This would probably hinge on the magnitude of the penalty, degree of risk,
> etc.
>
> A sponsor may be unable to use data under certain circumstances, such as
> lack of
> completion of the test interval or insufficient compliance. It therefore
> seems
> reasonable that a modest compliance/completion incentive could be built in
> to a
> protocol. The tricky part is deciding when such an incentive is excessive,
>
> creating a reason to stay in the study against one's best interests (in
> other
> words, acquiring a coercive flavor).
>
> We have at times had some informal rules of thumb, but none has really
> stood the
> test of time (other than as a tool for flagging things for further
> discussion).
> For example, if more than half of the total payment to a participant is
> given as
> a completion bonus, we'd worry. If non-compliance in the ordinary range of
>
> patient performance is significantly penalized, we'd worry. If the likely
> reasons for non-compliance or non-completion were related to serious risk
> rather
> than inconvenience, we'd worry about incentive structure. But if only a
> small
> proportion of payment came in as a completion bonus, and if only a modest
> penalty were assessed for serious non-compliance, and if the goal were
> clearly
> memory-jogging rather than increasing tolerance of risk, we'd be open.
>
> So I'm afraid what I have to offer is more a suggested way of thinking
> about the
> issue than a good set of rules for aslgorithmic decision making.
>
> Dale
>
> > reimbursement for scheduled appointments contingent upon medication
> > compliance.
>
> Dale E. Hammerschmidt, M.D.
> Associate Professor of Medicine, Univ. Minnesota
> Editor, J. Lab. Clin. Med.
> Director of Education in Research Ethics and Compliance
> Box 480 Mayo Building; Minneapolis 55455
> 612-624-0123 (voice, Heme/Onc/BMT)
> 612-626-2640 (voice, Journal office)
> 612-626-2642 (fax)
> hamme001@tc.umn.edu
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Gullion Christina M
6/22/2000 7:43:00 AM
Prorated compensation based on compliance
As a CRA, I have been involved with several studies where the investigator
payment for the visit - or the study would be pro-rated for missing or late
data points because that patient could not be included in the primary
(safety and efficacy) analysis. There was also an analysis which included
partial data. Patient compliance can be an issue in a pivitol study.
Other MCWIRBers have raised the question of why patient compliance is so bad
- which would be my first question to a site. If there is a consistent
problem across all sites, there are additional issues in the mix that the
sponsor is not addressing. Compliance is then, in my opinion, a symptom.
> -----Original Message-----
> From: Gullion Christina M [SMTP:Christina.Gullion@lonestarhealth.com]
> Sent: Thursday, June 22, 2000 10:47 AM
> To: mcwirb@mcwirb.org
> Subject: RE: Prorated compensation based on compliance
>
> Re Dale's comment that a sponsor may be unable to use the data. . .The
> primary analysis for many if not most clinical trials is the
> intent-to-treat analysis, which does not exclude patients for any reason
> (except possibly enrolled in error because inclusion/exclusion criteria
> were
> not met). In that analysis, even if the patient were taking the wrong
> dose
> or another drug altogether, they would be included in the analysis. It is
> hard for me to see a reason why the exposure experience of a properly
> enrolled patient would not be useable.
>
> > -----Original Message-----
> > From: Dale E. Hammerschmidt [SMTP:hamme001@maroon.tc.umn.edu]
> > Sent: Wednesday, June 21, 2000 8:03 AM
> > To: wendy_malone@srhc.iwhs.org; mcwirb@mcwirb.org
> > Subject: Re: Prorated compensation based on compliance
> >
> > This would probably hinge on the magnitude of the penalty, degree of
> risk,
> > etc.
> >
> > A sponsor may be unable to use data under certain circumstances, such as
> > lack of
> > completion of the test interval or insufficient compliance. It therefore
> > seems
> > reasonable that a modest compliance/completion incentive could be built
> in
> > to a
> > protocol. The tricky part is deciding when such an incentive is
> excessive,
> >
> > creating a reason to stay in the study against one's best interests (in
> > other
> > words, acquiring a coercive flavor).
> >
> > We have at times had some informal rules of thumb, but none has really
> > stood the
> > test of time (other than as a tool for flagging things for further
> > discussion).
> > For example, if more than half of the total payment to a participant is
> > given as
> > a completion bonus, we'd worry. If non-compliance in the ordinary range
> of
> >
> > patient performance is significantly penalized, we'd worry. If the
> likely
> > reasons for non-compliance or non-completion were related to serious
> risk
> > rather
> > than inconvenience, we'd worry about incentive structure. But if only a
> > small
> > proportion of payment came in as a completion bonus, and if only a
> modest
> > penalty were assessed for serious non-compliance, and if the goal were
> > clearly
> > memory-jogging rather than increasing tolerance of risk, we'd be open.
> >
> > So I'm afraid what I have to offer is more a suggested way of thinking
> > about the
> > issue than a good set of rules for aslgorithmic decision making.
> >
> > Dale
> >
> > > reimbursement for scheduled appointments contingent upon medication
> > > compliance.
> >
> > Dale E. Hammerschmidt, M.D.
> > Associate Professor of Medicine, Univ. Minnesota
> > Editor, J. Lab. Clin. Med.
> > Director of Education in Research Ethics and Compliance
> > Box 480 Mayo Building; Minneapolis 55455
> > 612-624-0123 (voice, Heme/Onc/BMT)
> > 612-626-2640 (voice, Journal office)
> > 612-626-2642 (fax)
> > hamme001@tc.umn.edu
> >
> >
> >
> > _______________________________________________
> > 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
Elizabeth
6/22/2000 8:13:00 AM
Joe:
A talk radio show here in Seattle not long ago featured a number of call-ins
which dealt with the topic of unsolicited same-sex propositions. The reason
it was a subject of discussion, if I recall correctly, was because there had
been a local incident -- an assault, a fight, a shooting, I'm not sure
which -- in which the person propositioned took offense and took action of
some sort against the person making the proposition. What I do recall
clearly, however, was one caller who said that if HE had been propositioned
by some guy, he'd have beaten the crap out of him. No questions asked.
Teach the guy a lesson.
So here's my two cents on this. How do you know ahead of time that the
question itself won't be found offensive, embarrassing, humiliating, or
threatening by the person being asked? How do you guarantee ahead of time
that the subject will be forgiving once he/she learns it was done in the
interests of research? How do you make sure that the researcher won't get
the crap beaten out of him or her by someone like the caller I referred to?
How do you make sure that the researcher wouldn't respond to being hit by
hitting back? How can you know, ahead of time, that disclosing the
deception on this matter won't be felt to be even more objectionable by the
person asked than the initial proposition itself, a possibility that might
be real if the person asked found the initial proposition offensive?
What is the purpose of the research, and how do you justify any benefit
against the creation of risk that cannot be assessed (in terms of
likelihood, severity, duration) ahead of time? Recall the Ginny Jones show
incident. Are there alternative ways of studying what the researcher wants
to know?
What if the researcher went on talk radio in your community and just posed
this whole issue, as you have presented it to us, to listeners? What might
he/she learn in such a discussion? If the researcher is interested in
switching topics, I might suggest a hypothetical study in which unknowing
subjects are approached in the street and served by the researcher with
(bogus) legal papers, say a summons and complaint alleging something the
subject is claimed to have done. Then, after the subject responds, the
researcher informs the subject this was a research study, debriefs and gains
consent, and then proceeds to ask the subjects how they felt initially about
being sued.
My bottom line is you can't do this research as proposed. The risks are too
real, on one dimension or another. And you don't jack people around on
topics like this without prior consent.
Good luck,
Tom Dalglish, J.D., Ph.D.
Community Representative, Committee C
University of Washington
(206) 543-0098 (University)
(206) 706-1000 (Office)
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
Of Joe Rosse
Sent: Wednesday, June 21, 2000 10:15 AM
To: mcwirb@mcwirb.org
Subject: deception research
I'd greatly appreciate thoughts regarding a social psych protocol that
involves a somewhat unusual form of deception.
[editing done here -- see Joe's original message]
Joe Rosse, Ph.D.
Chair, Human Research Committee
University of Colorado, Boulder
_______________________________________________________________________
thomas k. dalglish
6/22/2000 2:38:00 AM
reimbursement to providers for referring subjects
Many CRO's with whom I consult pay for referrals routinely. It never
occurred to any of us that this ought to be considered by an IRB. Frankly, I
am surprised that anyone brought it to the attention of an IRB and I can't
see why anyone should.
G.
gary365@aol.com
6/22/2000 11:02:00 AM
To MCWIRB readers,
I am the editor of the newslette Clinical Trials Advisor. We have been
following the regulatory, legislative, and organizational changes at HHS and
Capitol Hill with the goal of helping site staff deal with these changes and
stay in compliance. We are interested in obtaining your views/thoughts so
that we might better develop our editorial content to meet your needs.
Can you take a few minutes and answer several questions off the list serve.
Send your answers to our managing editor, Michael Levin-Epstein at
LEComm1@aol.com
Here are our questions:
1. What are you (your site, your IRB) doing to prepare for the Oct 1 mandate
regarding education and training of IRB staff, study staff, and investigators?
2.Have you done any formal training on human subjects protection with your
staff previous to this mandate?
3. Where did you obtain the training material? NIH website? URochester? IRB
101, others? consultants?
4. How many of your investigators are trained? IRB members?
5. What training needs do you have that are most pressing? that you need help
with?
6. What are other sites that you know doing to comply with this mandate? Do
you know of any model training programs?
Thanks for any insight you can provide on these issues. We also welcome your
thoughts and insight on any other topic for a story in the newsletter. If you
are not familiar with CTA, visit our website at www.clinicaltrialsadvisor.com
to see a sample copy.
Thanks for your help.
Terry Hartnett
Editor, Clinical Trials Advisor
(703) 503-9680
tmhartnett@aol.com
6/22/2000 2:38:00 AM
reimbursement to providers for referring subjects
Hi Barbara. These finder's fees were specifically considered by the AMA
Council on medical ethics several years ago and were deemed unethical.
Stuart Lind wrote a very thoughtful article about this as a Sounding Board
piece in the New England Journal a few years ago. You may also want to look
at the OIG report issued last week that deals with this subject. Our IRBs
just say no. This issue will likely be among those discussed at a public
forum on investigator conflicts of interest that is planned for August 15
and 16 in Washington.....Greg Koski
> -----Original Message-----
> From: Sent: Thursday, June 22, 2000 2:03 PM
> To: mcwirb@mcwirb.org
> Subject: reimbursement to providers for referring subjects
>
> A principal investigator has requested several times that he be allowed to
> pay
> residents, fellows, attending physicians and other health care providers
> for
> referring patients to him who meet specific enrollment criteria into an
> approved study. He has proposed direct payments in the form of cash,
> movie
> tickets,gift certificates. Our IRB has refused this. What is the
> experience
> of other IRBs? Does any allow direct payment for such a referral? Does
> anyone
> consider this to be acceptable or ethical?
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Greg
6/22/2000 4:12:00 PM
reimbursement to providers for referring subjects
I belive the term for that is kickback and your IRB is probably wise to
continue to disapprove of such practices. We do allow principal
investigators to notify our clinics and clinical departments regarding an
approved study in which they may have patients that would be potential
research candidates but such referrals by the physician or other healthcare
provider would be based on the potential benefit to the patient and/or the
patient's interest and willingness to participate in research. The IRB
reviews all such notices before they are sent out as a part of the
requirement to review and approve all recruitment/advertisement documents.
> -----Original Message-----
> From: Barbara Riter [SMTP:briter@wihri.org]
> Sent: Thursday, June 22, 2000 11:03 AM
> To: mcwirb@mcwirb.org
> Subject: reimbursement to providers for referring subjects
>
> A principal investigator has requested several times that he be allowed to
> pay
> residents, fellows, attending physicians and other health care providers
> for
> referring patients to him who meet specific enrollment criteria into an
> approved study. He has proposed direct payments in the form of cash,
> movie
> tickets,gift certificates. Our IRB has refused this. What is the
> experience
> of other IRBs? Does any allow direct payment for such a referral? Does
> anyone
> consider this to be acceptable or ethical?
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Sandra Armc-Prof Svcs
6/22/2000 4:21:00 PM
reimbursement to providers for referring subjects
MUSC does not allow finder's fees for research.
Barbara Riter wrote:
>
> A principal investigator has requested several times that he be allowed to pay
> residents, fellows, attending physicians and other health care providers for
> referring patients to him who meet specific enrollment criteria into an
> approved study. He has proposed direct payments in the form of cash, movie
> tickets,gift certificates. Our IRB has refused this. What is the experience
> of other IRBs? Does any allow direct payment for such a referral? Does anyone
> consider this to be acceptable or ethical?
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Becky Roberts
6/22/2000 11:02:00 AM
reimbursement to providers for referring subjects
MUSC does not allow finder's fees for research.
Barbara Riter wrote:
>
> A principal investigator has requested several times that he be allowed to pay
> residents, fellows, attending physicians and other health care providers for
> referring patients to him who meet specific enrollment criteria into an
> approved study. He has proposed direct payments in the form of cash, movie
> tickets,gift certificates. Our IRB has refused this. What is the experience
> of other IRBs? Does any allow direct payment for such a referral? Does anyone
> consider this to be acceptable or ethical?
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Becky Roberts
6/22/2000 11:04:00 AM
reimbursement to providers for referring subjects
In many cases this would be considered a violation of the federal fraud and
abuse laws.
Susan C. Atkinson
Corporate Counsel
Saint Joseph's Health System
Atlanta, GA
> -----Original Message-----
> From: Gary365@aol.com [SMTP:Gary365@aol.com]
> Sent: Thursday, June 22, 2000 3:53 PM
> To: mcwirb@mcwirb.org
> Subject: Re: reimbursement to providers for referring subjects
>
> Many CRO's with whom I consult pay for referrals routinely. It never
> occurred to any of us that this ought to be considered by an IRB.
> Frankly, I
> am surprised that anyone brought it to the attention of an IRB and I can't
>
> see why anyone should.
>
> G.
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Susan
6/22/2000 4:12:00 PM
reimbursement to providers for referring subjects
Many CRO's with whom I consult pay for referrals routinely. It never
occurred to any of us that this ought to be considered by an IRB. Frankly, I
am surprised that anyone brought it to the attention of an IRB and I can't
see why anyone should.
G.
gary365@aol.com
6/22/2000 11:04:00 AM
At 10:15 AM -0700 6/21/00, Joe Rosse wrote:
>I'd greatly appreciate thoughts regarding a social psych protocol that
>involves a somewhat unusual form of deception.
>
>The study involves approaching same-sex individuals on the street in which
>the experimenter indicates that (s)he has noticed the person before, finds
>them attractive, and then asks if they would either go out on a date or
>sleep with him/her. . . .
others have raised the numerous risks inherent in this research.
i'd like to know what the hypotheses underlying this protocol are, and what
assertions of possible benefit and utility were put forth that would
justify ANY risk.
this protocol sounds like a test question.
jon merz
center for bioethics
university of pennsylvania
merz@mail.med.upenn.edu
Jon Merz
6/21/2000 11:59:00 AM
>-----Original Message-----
>The study involves approaching same-sex individuals on the
>street in which the experimenter indicates that (s)he has
>noticed the person before, finds them attractive, and then
>asks if they would either go out on a date or sleep with
>him/her.
As described, this study involves significant risk, but for the
investigator, not the subject. It wouldn't surprise me if the cheeky
experimenter had his (or her) nose bloodied on occasion, or worse. Physical
violence against gays is abhorrent, but it does occur. I'd want to know
whether the investigator(s) understood the risk they were taking.
The study is not entirely risk-free for potential subjects, either. I
predict that many will react badly when the deception is revealed, mostly
due to embarassment. It is hard for me to imagine a rationale that would
convince me this is ethical research.
Roger Bertholf
Chair, IRB-03
University of Florida
Health Science Center/Jacksonville
Roger
6/21/2000 11:10:00 AM
Joe, seems to me like an upside-down perception of what's at stake, driven
(it seems) by a fixation on deception. For the moral issue here to be
about *deception*, the problem would have to be the concealing from the
subjects that they were being involved in an experiment. But that's
besides the point. The problem is that (arguably) they are being verbally
abused, without even prior permission as an excuse. Deception has nothing
at all to do with this, except as a red herring or a flimsy precedent: If
the evil of deceiving people is supposedly justified for the sake of
social science, then why not other evils too?
BTW, note that I think of this as verbal abuse not because of the same-sex
context; would say the same about any propositioning by a walk-up stranger
of whatever sex (but, given gender power-relations, worse for male at
female approaches).
Noam
Noam J. Zohar, PhD [Director, Graduate Program in Bioethics]
Department of Philosophy
Bar Ilan University
Ramat Gan 52900, Israel
nzohar@mail.biu.ac.il
Noam Zohar
6/21/2000 11:46:00 AM
Prorated compensation based on compliance
> A sponsor may be unable to use data under certain
> circumstances, such as lack of
> completion of the test interval or insufficient compliance.
> It therefore seems
> reasonable that a modest compliance/completion incentive
> could be built in to a
> protocol.
I wonder - isn't the theory that you are not paying the subjects for the
research but for their inconvenience and time? If that is the case, failure to
comply could only be penalized to the extent that it affects the subject's
inconvenience or time. Thus coming to the appointment is the big cost and the
cost of taking the pill is very low. You might be able to knock $0.50 off for
not taking the pill, but I doubt that is going to do much good.
Ed
Edward P. Richards
Executive Director - Center for Public Health Law
Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
Edward Richards
6/21/2000 5:47:00 AM
Prorated compensation based on compliance
> I wonder - isn't the theory that you are not paying the subjects for the
> research but for their inconvenience and time?
I think that's open to debate. I believe that most ethicists (and most IRBs)
think that one should not pay specifically for the bearing of risk --- even
though we have the non-research precedent of hazardous duty pay. But a
compliance incentive is not automatically a bad thing in my view ... it just has
the potential to be a bad thing if it is excessive and if it could become an
inappropriate incentive to bear risk. For an IRB, the biggest problem with
compliance or completion incentives may be that they do not lend themselves to
easy rules --- you pretty much have to look at each one on its own merits.
Dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
6/21/2000 9:07:00 AM
Recruitment Procedures for Genetic Family Studies
It depends.
If the relative will (or might be) identified as having the problem, than
allowing the PI to contact them is risky. On the other hand, if the study is
looking for normal relatives of (e.g.) alcoholics, then as long as the
proband doesn't care that their relatives know, (Hi Mr. Jones, Iam am
contacting you because Rusty is an alcoholic) then we have allowed the PI to
call.
SHK
> -----Original Message-----
> From: Robert Nelson [SMTP:nelsonro@email.chop.edu]
> Sent: Monday, June 19, 2000 8:22 PM
> To: mcwirb@mcwirb.org
> Subject: Recruitment Procedures for Genetic Family Studies
>
> I am posting this message for Robyn Shapiro at . Robyn
> is
> the Director of the MCW Bioethics Center. Please respond either to the
> MCWIRB
> list or to Robyn privately.
>
> In genetic familial studies, what process is used for contacting family
> member
> prospective research participants: Asking the proband to contact
> his or her family members or collecting names and addresses from proband
> and having the PI contact the family members directly? What are the
> arguments supporting one way or the other?
>
> By the way, please check out the new graphics (yet with the same
> functionality)
> at http://www.mcwirb.org
>
> Robert Skip Nelson, MD, PhD
> Coordinator, The IRB Discussion Forum
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Scott
6/21/2000 12:15:00 PM
Mental Health Parity Study
I am a consultant in the Washington office of the Hay Group, an international HR
and benefits consulting firm. We are responding to a US Dept of Health and
Human Services request for proposal to examine the effects of mental health
parity in the health benefit plan for all Federal employees. New parity
provisions will be effective for the plan year beginning January 1, 2001.
The HHS-sponsored study is a 3 year effort that will examine pre and post parity
claims and encounter data and conduct surveys and focus groups of plan
participants to address parity impacts on benefit design, cost, access,
utilization, quality and satisfaction. All aspects of data collection from plan
participants will need to be approved by an IRB. HayGroup does not maintain an
IRB as part of its normal business practices.
The Hay Group has conducted several studies for NIMH and other government
organizations examining the cost, management and other aspects of various
menthal health parity proposals. We have also studied how private sector
organizations have modified employee health benefit plans in response to the
Mental Health Parity Act.
We are interested in forming an alliance with an IRB that could assist us in
performing work on this project, should we be awarded the contract. Inquiries
may be directed to me at this email address or by phone at (703) 841-3135.
Thank you for your assistance.
Mike Gaffney
Hay Group
Mike Gaffney
6/21/2000 11:57:00 AM
Prorated compensation based on compliance
This would probably hinge on the magnitude of the penalty, degree of risk, etc.
A sponsor may be unable to use data under certain circumstances, such as lack of
completion of the test interval or insufficient compliance. It therefore seems
reasonable that a modest compliance/completion incentive could be built in to a
protocol. The tricky part is deciding when such an incentive is excessive,
creating a reason to stay in the study against one's best interests (in other
words, acquiring a coercive flavor).
We have at times had some informal rules of thumb, but none has really stood the
test of time (other than as a tool for flagging things for further discussion).
For example, if more than half of the total payment to a participant is given as
a completion bonus, we'd worry. If non-compliance in the ordinary range of
patient performance is significantly penalized, we'd worry. If the likely
reasons for non-compliance or non-completion were related to serious risk rather
than inconvenience, we'd worry about incentive structure. But if only a small
proportion of payment came in as a completion bonus, and if only a modest
penalty were assessed for serious non-compliance, and if the goal were clearly
memory-jogging rather than increasing tolerance of risk, we'd be open.
So I'm afraid what I have to offer is more a suggested way of thinking about the
issue than a good set of rules for aslgorithmic decision making.
Dale
> reimbursement for scheduled appointments contingent upon medication
> compliance.
Dale E. Hammerschmidt, M.D.
Associate Professor of Medicine, Univ. Minnesota
Editor, J. Lab. Clin. Med.
Director of Education in Research Ethics and Compliance
Box 480 Mayo Building; Minneapolis 55455
612-624-0123 (voice, Heme/Onc/BMT)
612-626-2640 (voice, Journal office)
612-626-2642 (fax)
hamme001@tc.umn.edu
Dale Hammerschmidt
6/21/2000 5:02:00 AM
> I'd greatly appreciate thoughts regarding a social psych
> protocol that involves a somewhat unusual form of deception.
Until you start collecting indentified information, I do not see the risk to the
subjects. Without risk, I do not see why the first part triggers the IRB review
at all, thus there is no reason it triggers the need for a pre-consent risk
assessment, even if there is a little deception, it is not deception that poses
a risk, except perhaps of disappointment. You do get consent before you collect
the personal data that might pose a risk if disclosed.
Ed
Edward Richards
6/21/2000 10:55:00 AM
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