deception research

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

Deceptive Research

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

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 _______________________________________________________________________
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

Finders' Fees

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

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 _______________________________________________________________________
Joe Rosse 6/25/2000 7:44:00 AM

Deception research

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

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?
Anonymous 6/23/2000 4:51:00 AM

Electronic Signatures

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

deception research

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 _______________________________________________________________________ Why pay when you don't have to? Get AltaVista Free Internet Access now! http://jump.altavista.com/freeaccess4.go _______________________________________________________________________ _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
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

deception research

> 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

deception research

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

deception research

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

new regulations

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

deception research

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

deception research

>-----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

deception research

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

deception research

> 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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