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Top Candidate for OPRR

Wednesday, May 17, 2000 Physician Is Called Top Candidate to Head Unit That Oversees Human-Subjects Research By JEFFREY BRAINARD E. Greg Koski, who directs the human-research program at Massachusetts General Hospital, is the top choice of the Department of Health and Human Services to lead a new federal office devoted to protecting humans involved in medical experiments, said a source close to the selection process. The source, who spoke on the condition of anonymity, disclosed Dr. Koski's strong candidacy on Tuesday. If Dr. Koski took the position, he would oversee a reorganization of the protection program now at the National Institutes of Health. In the past 19 months, the N.I.H.'s Office for Protection From Research Risks has riveted the attention of universities by suspending research involving human subjects at seven institutions, citing violations of federal regulations. Then last month,the Health and Human Services inspector general and members of Congress faulted the department for not doing more to protect research volunteers. Following earlier criticisms, Donna Shalala, the secretary of Health and Human Services, decided last year to elevate the N.I.H. office by placing it among those that are part of her office. An advisory committee had recommended the move to enhance the office's stature. The committee also said the shift would remove the potential conflict of interest that existed because the research-risks office has been part of the N.I.H., which finances some of the research the office has overseen. Ms. Shalala advertised for a new director of the relocated office, to be called the Office of Human Research Protection. University officials have anticipated that the choice of the new director may signal a change in the office's approach and, possibly, a reduction of its stepped-up enforcement efforts. Some observers suggested that the new job description had been purposely written in such a way to make it difficult for the current director of the research-risks office, Gary B. Ellis, to become the top candidate. (See an article from The Chronicle, February 4.) Dr. Koski could not be reached for comment, and a spokesman for the Department of Health and Human Services said on Tuesday that he had no news to release about the appointment. Dr. Koski is an assistant professor of anesthesiology at Harvard Medical School, and has a medical degree and a doctorate in physiology. He has experience as a clinical researcher, and has been director of human-research affairs at Massachusetts General since 1996. In that position, he has overseen training of staff members about compliance with federal regulations concerning experiments involving human volunteers. He has also served on the hospital's institutional-review board, which reviews experiments involving humans, and was chairman of the board's human-studies subcommittee. His résumé includes a statement about how his career path changed after he attended the institutional-review board for the first time. A reviewer described a study proposed by one of my own colleagues as `something that one might get away with in a Nazi concentration camp, but not at the MGH,' he wrote. The need for better training of clinical investigators, more and better mentors, greater awareness of and sensitivity to ethical and regulatory matters, all became painfully obvious. However unintended, this new pursuit became my `calling.' http://chronicle.com/daily/2000/05/2000051703n.htm Dr. Koski's resume: http://www.seminole-tec.com/CVs_2/Koski.htm

Anonymous 5/17/2000 6:23:00 AM

Mandatory Reporting of Child Abuse and Neglect

This website provides a summary of the law, with links to information for all 50 states. http://www.smith-lawfirm.com/mandatory_reporting.htm Christina M. Gullion, Ph.D. Biostatistician/Senior Scientist Department of Clinical Research Medical City Dallas Hospital 7777 Forest Lane, Suite C-740 Dallas TX 75230 phone: 972-566-4718, fax: 972-566-4715

Gullion Christina 5/16/2000 12:53:00 PM

Compliance Officers

We need information about Compliance Officer duties, and how many sites use a Compliance Officer as part of the research subjects protection model.

Anonymous 5/16/2000 7:03:00 AM

Looking for Expertise in Research Integrity

I have been asked by my director to get some information on people who consult in the area of setting an Office of Research Integrity or setting up the process. My administration is now ready to make this an official office at the hospital. If you consult in this area, or know of someone who does, please contact me off line at rebcaclark@aol.com or 858-576-4008. Thanks for your help. Rebecca M. Clark Children's Hospital San Diego

Anonymous 5/16/2000 11:52:00 AM

Mandatory Reporting of Child Abuse and Neglect

> This website provides a summary of the law, with links to > information for > all 50 states. > > http://www.smith-lawfirm.com/mandatory_reporting.htm While national compilations are very useful tools for comparative purposes, they are not a substitute for an attorney's analysis of your specific state laws. I have yet to see a compilation that was perfect. I would say that every large IRB needs to know its state law on this point. You may find that hospital counsel at the local children's hospital has already done the work for you and will be willing to share it. Edward P. Richards, J.D., M.P.H. 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 5/16/2000 12:53:00 PM

IRB Chair Time Commitment

Is anybody aware of any general information existing anywhere about the appropriate amount of time (in terms of hours per week or portions of an FTE) that an IRB chair should be putting in for that aspect of their job? E.g., guidance on this issue in terms of employment contract issues? In particular, I am dealing with the single IRB at an academic medical center/medical school at a major state university, with several hundred new protocols being reviewed each year; the IRB does a great deal of rewriting, at least in part, of almost all consent forms that go through it, and the Chair is charged with actually doing all the rewriting (e.g., taking the comments given at IRB meetings and turning them into minutes and actual wording instructions for the investigators, and then later reviewing how the investigators have responded to the instructions); dealing with almost all of the substantive issues raised by investigators; resolving almost all issues relating to interpretation of regulations, including determinations of exemptions, etc. The IRB administrative personnel largely confine their work to keeping track of the paperwork, etc. I would also appreciate any specific information anyone is willing to provide about estimates of such time commitment at their own medical centers. I assume off-list (private) replies are probably most appropriate. Thanks very much. Jerry Menikoff University of Kansas jmenikof@kumc.edu

Jerry Menikoff 5/15/2000 9:54:00 AM

IRB Chair Time Commitment

Jerry: One good source of general information is Final Report: Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects, (June 15, 1998), prepared for The Office of Extramural Research, NIH, the Project Officer for which was Charles MacKay, Ph.D. (the so-called Bell Report, since it was prepared by James Bell et. al.). See page 29 under heading of Chair Effort in Chapter IV dealing with the administrative burden and time involved. As for more recent, personal, or anecdotal data, you may get better off-line. Tom Dalglish J.D., Ph.D Community Member, 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 Jerry Menikoff Sent: Sunday, May 14, 2000 10:08 AM To: MCWIRB@mcwirb.org Subject: IRB Chair Time Commitment Is anybody aware of any general information existing anywhere about the appropriate amount of time (in terms of hours per week or portions of an FTE) that an IRB chair should be putting in for that aspect of their job? E.g., guidance on this issue in terms of employment contract issues? In particular, I am dealing with the single IRB at an academic medical center/medical school at a major state university, with several hundred new protocols being reviewed each year; the IRB does a great deal of rewriting, at least in part, of almost all consent forms that go through it, and the Chair is charged with actually doing all the rewriting (e.g., taking the comments given at IRB meetings and turning them into minutes and actual wording instructions for the investigators, and then later reviewing how the investigators have responded to the instructions); dealing with almost all of the substantive issues raised by investigators; resolving almost all issues relating to interpretation of regulations, including determinations of exemptions, etc. The IRB administrative personnel largely confine their work to keeping track of the paperwork, etc. I would also appreciate any specific information anyone is willing to provide about estimates of such time commitment at their own medical centers. I assume off-list (private) replies are probably most appropriate. Thanks very much. Jerry Menikoff University of Kansas jmenikof@kumc.edu _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

thomas k. dalglish 5/15/2000 9:54:00 AM

Responsibility to Report Abuse?

Even though researchers are obligated to maintain confidentiality of information provided in a research setting, there are situations where the investigator may be bound, both legally and ethically, to violate that confidence. For instance, if the person represents an immediate and serious threat to themselves or others, or the investigators learns about child and/or elder abuse. In projects where the interview and/or questionnaire may reveal this type of information, we require the investigator to include language in the informed consent/minor assent regarding the potential violation of confidentiality. Debra L. Comeaux, Compliance Specialist Committee for the Protection of Human Subjects University of Houston Division of Research (713) 743-9215 dcomeaux@uh.edu -----Original Message----- From: Matt Westbrook [mailto:matt@fuller.edu] Sent: Monday, May 15, 2000 11:11 AM To: mcwirb@mcwirb.org Subject: Responsibility to Report Abuse? Need a little help here everyone. This question has to do with liability in research with children and adolescents in the social sciences. A solicitation of information on the methodological and ethical issues confronting researchers working with this population is in order. While researchers are obligated to maintain confidentiality of information provided by human participants (particularly those responding to open-ended interview questions addressing adolescent moral identity), there is additional concern with the safety and protection of these participants. Reporting abuse, neglect and mental illness in a research setting may be an issue if such material is presented in the interviewing process. Here are the questions: 1. Under these circumstances, would researchers be mandated to report? 2. Should this potential breech of confidentiality be included in the Informed Consent document? 3. Are there other issues concerning mandatory reporting of abuse in this type of research setting? In addition, it would be of assistance to receive feedback on whether or not researchers must expand their protocols to include more in-depth investigation of potential abuse. Whew! Have any of you had experience with this issue in a similar context? _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Debra Comeaux 5/15/2000 11:53:00 AM

Washington Post CASE STUDY 1

OK - this has strayed from the initial thread - but what the heck.... I recognize and have lived the problem from the IRB side. Just call me a trouble-maker.. Let's walk in the other guy's shoes a moment. Case Study 1: You are the clinical director at a medium size (e.g., struggling) pharmaceutical company. You have a multisite study. It was approved and started at 5 prestigious (or semi-) centers. Now IRB #6 has called it unethical and wants us to change the design by (insert change here). If we agree to change the study, it means re-writing it, getting ump-ti-ump sign-offs, and re-submitting to FDA and the previous 5 IRBs. It could also mean invalidating the data obtained to this point. Of course, if we accept their assessment, it also means we personally were too blinded to see the ethical flaw which we might not want to accept. (As background, remember this is the fifth study on which this has happened in as many years and in 3 of these the study was completed and FDA accepted the data. The fourth was discontinued for lack of enrollment. As clinical director you are tired of IRBs second-guessing the design and your job is to get the job done.) So, as the clinical director of this sponsoring company, what are you going to do? Your answer here: Erica Heath President, IRC 415-485-0717

heath 5/15/2000 9:54:00 AM

Responsibility to Report Abuse?

Who may be a mandated reporter of suspected abuse is a matter of state law. You would need to review the law applicable to the locale in which the study will take place. In Wisconsin, for example, it is my reading of the law that persons doing research are not mandated reporters. If the researcher is mandated to report in your jurisdiction, that fact must be included in the consent form as a risk of participation. Another issue entirely is whether the researcher wants to report even if not mandated to do so, after taking into consideration the effects that would have on the research and his or her personal morality. It can be extremely difficult to not report abuse when you see it. If the researcher has decided to report abuse even if not mandated to do so, I think that should also be in the consent form. Dan Daniel L. Icenogle, MD, JD Icenogle & Associates 1858 Sand Ridge Ct. Verona, WI 53593-8814 608.832.0549 (voice and fax) Electronic mail from Daniel L. Icenogle, MD, c/o Icenogle & Associates at icenogle@execpc.com. This communication is intended for the use of the addressee. It may contain information which is privileged or confidential under applicable law. If you are not the intended recipient or the agent of the recipient, you are hereby notified that any dissemination, copy or disclosure of this communication is strictly prohibited. If you have received this communication in error, please notify Icenogle & Associates at (608) 832-0549 or via return Internet electronic mail at icenogle@execpc.com and expunge this communication without making any copies. Thank you for your cooperation. -----Original Message----- From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of Matt Westbrook Sent: Monday, May 15, 2000 11:11 AM To: mcwirb@mcwirb.org Subject: Responsibility to Report Abuse? Need a little help here everyone. This question has to do with liability in research with children and adolescents in the social sciences. A solicitation of information on the methodological and ethical issues confronting researchers working with this population is in order. While researchers are obligated to maintain confidentiality of information provided by human participants (particularly those responding to open-ended interview questions addressing adolescent moral identity), there is additional concern with the safety and protection of these participants. Reporting abuse, neglect and mental illness in a research setting may be an issue if such material is presented in the interviewing process. Here are the questions: 1. Under these circumstances, would researchers be mandated to report? 2. Should this potential breech of confidentiality be included in the Informed Consent document? 3. Are there other issues concerning mandatory reporting of abuse in this type of research setting? In addition, it would be of assistance to receive feedback on whether or not researchers must expand their protocols to include more in-depth investigation of potential abuse. Whew! Have any of you had experience with this issue in a similar context? _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Daniel L . Icenogle 5/15/2000 11:17:00 AM

Responsibility to Report Abuse?

Matt, Regarding reporting child abuse in social science research: Check your state laws regarding mandatory reporters for child (and elder) abuse. In Oregon, psychologists are mandatory reporters. Research staff here at ORI are either psychologists themselves or working under the direction of a psychologist, so they are obligated to report known or suspected child abuse. Our consent form clearly states that confidentiality will be broken to report known or suspected child abuse and intent to harm self or others. Some of our consent forms also state that sex with a minor is usually considered child abuse (depending on age of child, age of actor, etc.) and must also be reported. In Oregon, sex with a child under 12 is always reportable and no consideration is given as to the age of the actor. There is a fine balance between informing the subjects of the need to break confidentiality for reporting abuse and scaring the subject away. So far, the language we've developed seems to do a good job of informing the subjects and most people are not surprised that we would report them for child abuse. Including this language hasn't been a deterrent to enrollment. If an investigator is working with a very young population, our IRB reviews that investigator's reporting protocol. Hope this helps. Kathryn Madden IRB Administrator Oregon Research Institute 1715 Franklin Blvd. Eugene, OR 97403 (541) 484-2123 kathryn@ori.org

Kathryn Madden 5/15/2000 11:20:00 AM

Washington Post CASE STUDY 1

I think Erica knows my answer already (gg). There's more room for _advance_ IRB consultation, before IRB review. As long as we view IRB review to be a post-facto regulatory hurdle to be addressed AFTER all other planning is done and the study is set in stone, this sort of scenario will occur. I'd suggest that the sponsor bring the study to the IRBs of the institutions it expects to use once it has taken shape, but has not been finalized. I'd suggest that the IRBs be open to giving such consultative (rather than approval-granting/denying) review. (I recognize that IRB resources may not be adequate, and that some mechanism for supporting this activity would have to be worked out ... one thought I've had is that a consortium IRB of a couple members from each institution's IRB could be used as consultants [recognizing that this might create a C-of-I and prevent them from being able to vote on the protocol when the time came...]) The net product, one could hope, would be a protocol which would not encounter major requests for change. It could even include a cook-book of allowable minor variations in CF and the like, to anticipate likely local preferences/rules/policies. Dale Dale E. Hammerschmidt, M.D. Associate Professor of Medicine, Univ. Minnesota Editor, J. Lab. Clin. Med. Director of Education in Research Ethics and Compliance Box 480 Mayo Building; Minneapolis 55455 612-624-0123 (voice, Heme/Onc/BMT) 612-626-2640 (voice, Journal office) 612-626-2642 (fax) hamme001@tc.umn.edu

Dale Hammerschmidt 5/15/2000 9:54:00 AM

Exculpatory Language

Cheri: Without seeing the sponsor's proposed language in question in your situation, it's a little hard to discuss the significance of the language you quoted that says You are not giving up any of your legal rights by signing this document. I assume it relates to liability for injuries etc. (you refer to a liability statement) and not to waiver of a property interest in samples. If it is the latter, you might wish to refer to a discussion in the Mcwirb forum within the past few weeks dealing with Re: Ownership of samples, in which many people talked about exculpatory language. However, I assume you are talking about liability for injuries, that sort of thing. I also assume the sponsor's liability statement you talk about attempts to say something like the subject waives any claim for injuries, compensation, and so forth. Then, if I understand what you're saying, the sponsor wants to insert the language you quote about not giving up any legal rights. Correct so far? Take a look at 45 CFR 46.116 and 21 CFR 50.20 and an OPRR Guidance Document dated 11/15/96. Both are clear in saying that a subject cannot be asked to waive, or appear to waive, any legal rights or liability on the part of the investigator, sponsor, institution, or its agents. If the liability statement you refer to does indeed attempt a waiver of liability, or appears to, then that liability statement is objectionable and should not be in the IC document, at all. It's an exculpatory clause. Take the objectionable clause out and there's no need for the other clause you quote. If the sponsor wants both clauses, then one has to ask why. Why does the sponsor want to appear to take away with one hand, and attempt to restore with the other? I would say no to the liability statement on its own if it is indeed an exculpatory clause. I would say no to both appearing in the IC document on the grounds that the first is objectionable as an exculpatory clause that may or may not be legally negated by the second, and that therefore the legal status of the first clause might be in doubt, or confused, by the second. It would not be fair to the human subject, in my opinion, to confuse him or her, or to cloud the subject's legal rights by leaving intact two seemingly contradictory clauses. I would object to the phrase You are not giving up any of your legal rights by signing this document on the further grounds that it amounts to legal advice from the sponsor to the subject. In addition, I do not believe an IRB would want to get into the awkward position of in effect approving or endorsing such language for fear that a subject might rely on the IRB's approval. Finally, if the sponsor is so (apparently) sincere about telling the subject that he/she is not giving up any rights by signing this document with the second clause in, why is it insisting upon the liability statement in the first place? The cleanest solution is to omit both clauses. 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 Cheri Rieben Sent: Monday, May 15, 2000 11:04 AM To: mcwirb@mcwirb.org Subject: Exculpatory Language I am very confused by the guidelines on exculpatory language. I understand that the guidelines state this is not something that can be in a consent document, however, can this language be in the consent document if it is immediately followed by You are not giving up any of your legal rights by signing this document?? I have had several investigators at our institution request this to be added so that their sponsor can keep their liability statement in the consent document. I would appreciate anyone's input on this matter. Thank you Cheri J. Rieben Protocol Administrator University of Utah 801-581-8236 cheri.rieben@hsc.utah.edu _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

thomas k. dalglish 5/15/2000 12:01:00 PM

Responsibility to Report Abuse?

Matt Westbrook asks: This question has to do with liability in research with children and adolescents in the social sciences. 1. Under these circumstances [revelations of abuse from minors serving as research subjects], would researchers be mandated to report? Response 1: At least in our state, when evidence of abuse, or intent to harm self or others is revealed during interviews/surveys with minors, the PI must report this information to the appropriate authorities. This applies only when the subject reporting the abuse is somehow identifiable. 2. Should this potential breech of confidentiality be included in the Informed Consent document? Response 2: Where it is possible to link specific responses to a specific respondent, we require our PIs to include a statement regarding the above-mentioned reporting obligations in both the parent's Consent Form, and in the minor's Assent Form (where child assent is appropriate). 3. Are there other issues concerning mandatory reporting of abuse in this type of research setting? Response 3: Things become sticky in cases where minors are being surveyed about illicit behaviors by themselves or by other household members, about alcohol/drug abuse in the home (which may include parental substance abuse), or when the minors are in a shelter situation. In such cases, it may not be in the minor's best interest for the parent to sign a consent form, as the parent may exert undo pressure (or worse) on the minor to learn how the minor had responded to certain questions. Our IRB has dealt with very few of these cases during my tenure, but as I recall, we prefer that such surveys be entirely anonymous so that it will not be possible for any person to trace individual responses back to a particular respondent. We have even gone so far as to waive obtaining parental consent in the most extreme of these cases involving adolescents. 4. In addition, it would be of assistance to receive feedback on whether or not researchers must expand their protocols to include more in-depth investigation of potential abuse. Response 4: We have had several instances involving anonymous surveys where we required the PI to include a list of local social service/psychological support resources to every potential respondent to enable the subject to access these services if the respondent wished. Although not a perfect solution, we feel that this provided the best balance between maintaining the subject's anonymity while providing the subject avenues to access additional support if the subject wished to do this. Timothy P. Stratton, Ph.D., R.Ph. Associate Professor of Pharmacy Administration School of Pharmacy and Allied Health Sciences The University of Montana-Missoula Member, UM IRB ph: (406) 243-2339 fax: (406) 243-4353 e-mail: timstrat@selway.umt.edu snail mail: Pharmacy Practice 32 Campus Drive #1522 Missoula, MT 59812-1522

timstrat@selway.umt.edu 5/15/2000 11:21:00 AM

Responsibility to Report Abuse?

Matt, Utah does have mandatory reporting laws which require anyone who knows of or suspects abuse, neglect or exploitation of a minor to report to either local law enforcement or local Child Protective Services (CPS). We do require IC/A documents to disclose this as a limitation of a subject's (or potential subject's) right to confidentiality. Therefore, if such abuse is disclosed during an open-ended interview, the researcher is required by state law to report; however, the researcher is NOT the appropriate individual to conduct the CPS investigation. The researcher's obligation is to let the subjects know the limits within which s/he can assure confidentiality; report any disclosed abuse, neglect or exploitation; and let the local authorities deal with the abuse report. Hope that helps, >>> Matt Westbrook 05/15 10:10 AM >>> Need a little help here everyone. This question has to do with liability in research with children and adolescents in the social sciences. A solicitation of information on the methodological and ethical issues confronting researchers working with this population is in order. While researchers are obligated to maintain confidentiality of information provided by human participants (particularly those responding to open-ended interview questions addressing adolescent moral identity), there is additional concern with the safety and protection of these participants. Reporting abuse, neglect and mental illness in a research setting may be an issue if such material is presented in the interviewing process. Here are the questions: 1. Under these circumstances, would researchers be mandated to report? 2. Should this potential breech of confidentiality be included in the Informed Consent document? 3. Are there other issues concerning mandatory reporting of abuse in this type of research setting? In addition, it would be of assistance to receive feedback on whether or not researchers must expand their protocols to include more in-depth investigation of potential abuse. Whew! Have any of you had experience with this issue in a similar context? _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb Mary M. Caputo Bureau of Internal Review and Audit (BIRA) Utah State Department of Human Services 120 North 200 West, Rm. 221 Salt Lake City, UT 84103 (801) 538-4295

Mary Caputo 5/15/2000 11:21:00 AM

Responsibility to Report Abuse?

This was discussed on the list fairly recently. You are bound by your state law, which you should get a legal opinion on (unless you are a lawyer) before you do anything else. Odds are, you have to report any suspected abuse, neglect, and possibly mental illness if it threatens the child's help. If you have to disclose, you probably should tell, and that will probably kill the study. Edward P. Richards, J.D., M.P.H. 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 > -----Original Message----- > From: Matt Westbrook [mailto:matt@fuller.edu] > Sent: Monday, May 15, 2000 11:11 AM > To: mcwirb@mcwirb.org > Subject: Responsibility to Report Abuse? > > > Need a little help here everyone. > > This question has to do with liability in research with children and > adolescents in the social sciences. A solicitation of > information on the > methodological and ethical issues confronting researchers > working with this > population is in order. > > While researchers are obligated to maintain confidentiality > of information > provided by human participants (particularly those responding > to open-ended > interview questions addressing adolescent moral identity), > there is additional > concern with the safety and protection of these participants. > Reporting abuse, > neglect and mental illness in a research setting may be an > issue if such > material is presented in the interviewing process. > > Here are the questions: > > 1. Under these circumstances, would researchers be mandated > to report? > 2. Should this potential breech of confidentiality be > included in the Informed > Consent document? > 3. Are there other issues concerning mandatory reporting of > abuse in this type > of research setting? > > In addition, it would be of assistance to receive feedback on > whether or not > researchers must expand their protocols to include more > in-depth investigation > of potential abuse. > > Whew! Have any of you had experience with this issue in a > similar context? > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb >

Edward Richards 5/15/2000 11:56:00 AM

minimal risk

It is painful to see how much effort and energy is poured into the attempt to make quantitatively precise the concept of minimal risk. The views offered here are personal and do not reflect anything more than the views of this individual. They may only reflect a historical moment in the continuing evolution of the protection of human subjects. Certainly, OPRR may choose to define minimal risk in a way that may make the notion clearer by unilaterally altering the original sense of the definition. That will at least make for less confusion and Babel. One can only subscribe to the wisdom of that course. But as a surviving member of the original drafting committee for 45 CFR 46, Subpart A, Notice of Proposed Rule Making (NPRM) and 45 CFR 46, Subpart A, Final Rule, and The Common Rule NPRM, let me assure you that the definition intended by the drafters was in the ordinary life [of the subject.] WE had at our disposal the definition used by the National Commission for the Protection of Human Subjects and chose NOT to adopt it. The NCPHS used the absolute scale ( if you believe such a thing exists) of a healthy individual. The DHEW and its successor DHHS after careful consideration and years of public hearings and public comment with input from the scientific and lay public, from ethicists, scholars, lawyers, legislators, inside government and outside government, promulgated the definition in accordance with the ordinary life [of the subject]. A little bit of ratiocination helps explain why. 1) It makes no sense to apply the norm of healthy to people who are ill. 2) There is no agreement anywhere among experts as to what a healthy individual is. It is harder to define than minimal risk and ordinary life[of the subject]. 3) The point of the definition was to throw the determination into the capable hands of IRB members who worked with the notion on a daily basis. After all, how could a bevy of bureaucrats pin down something that after 50 years is still contentious. So guess what? IRB members and the research community wanted infallible dogma from inside the Beltway to make their tough decisions easier. A one size fits all notion of minimal risk is too rigid. The notion of minimal risk is a function of considered clinical and informed judgment of the IRB. We should no more think of exposing so-called healthy individuals to the types of risks ordinarily faced by seriously or potentially seriously ill individuals, as we would consider the substantial medically indicated risks each of us faces when illness strikes as disproportionate to the situation. It would be nice if we came to understand and utilize the notion of proportionality in our assessment of risks, rather than depend on the so-called healthy individual norm. But since we seem unable to do so, some norm is better than bewilderment.

Charles Od 5/13/2000 9:43:00 AM

Washington Post CASE STUDY 1

heath 5/13/2000 5:59:00 AM

Healthy Volunteers?

My experience with the topic of translations is that there is a certification exam. However, not everyone who does translations has passed this exam. One person I knew who had spoken Spanish since childhood did not pass the exam. In my experience, very few people who were translating (whom I worked with in the past) were certified translators. There are also companies that do translations which supply a notarized document in which the translator makes a statement that the translation is an accurate one. I've seen these documents included with consent form translations. Evelyn Studer, IRB Administrator Research Triangle Institute PO Box 12194 Research Triangle Park, NC 27709 studer@rti.org Phone: 919-541-6442 Fax: 919-541-7250 -----Original Message----- From: Peter Raich [mailto:raichp@amc.org] Sent: Monday, February 05, 2001 11:00 AM To: Goebel, Paul (OD); bmerritt@nybc.org; mcwirb@mcwirb.org Subject: RE: Healthy Volunteers? What really is a certified translation? Is there such a thing as a certified translator? The closest I have been able to come to defining this is that there are credentialed translaters. Any clarification of this issue will be greatly appreciated, since we have struggled to set standards for translations of consent documents. Peter Peter C. Raich, MD IRB Chair AMC Cancer Research Center 1600 Pierce Street Denver, CO 80214 Tel.: 303-239-3510 -----Original Message----- From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of Goebel, Paul (OD) Sent: Friday, February 02, 2001 7:53 AM To: 'bmerritt@nybc.org'; mcwirb@mcwirb.org Subject: RE: Healthy Volunteers? 1. No, they are not considered healthy. Category 2a of the Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure published in the federal register in 1998 and posted on the web at: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/expedited98.htm, applies only to individuals without a known disease and specifically, was not intended to apply to individuals who have the disease being studied. 2. See category 2b. If the amount of blood to be drawn exceeds those limits, the project is not eligible for expedited review. This does not mean the project cannot be carried out, just that it must undergo full board review. 3. Your IRB should have assurance that the translation is accurate. There is no requirement that your IRB perform a hands-on review of the translated document. There is also no regulatory requirement that the translation be certified, however, many IRBs/institutions have made certification a requirement. Paul W. Goebel, Jr. Office for Human Subject Protections Office of Public Health and Science Department of Health and Human Services 6100 Research Blvd., Suite 3B01 Rockville, Maryland 20892-7507 phone 301-402-4372 fax 301-402-4256 email pg122v@nih.gov OHRP web site http://ohrp.osophs.dhhs.gov > -----Original Message----- > From: bmerritt@nybc.org [SMTP:bmerritt@nybc.org] > Sent: Thursday, February 01, 2001 2:13 PM > To: mcwirb@mcwirb.org > Subject: Healthy Volunteers? > > My question regards the definition of healthy volunteers from whom blood > > may be drawn at certain intervals for research that can be reviewed > by expedited review. Our investigator receives unlinked blood samples > from another institution, were the samples are drawn for our > investigator's > research purposes from people who exhibit malaria symptoms. I have the > following questions: > > 1. Are people who are infected with malaria considered healthy when > they do > or don't exhibit any symptoms? > > 2. Can this protocol receive expedited review at our institution? > > 3. Our IRB has approved the consent form to be used. If it needs to be > > translated into another language by the other institution, does our IRB > > need to see the translation or, if participants cannot read or write, does > > the IRB need to approve or be informed of the consent process ? > > Thank you for your advice. > > > > _______________________________________________ > 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 _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Evelyn Studer 5/12/2000 6:46:00 AM

Requesting Info on Conflict of Interest

We have institutional policy re: COI for investigators and follow OPRR/FDA guidance re: IRB members. Our insttitutional policy for investigators is posted at: http://www.oprs.ucla.edu/human/NEWS.htm Please do not hesitate to contact me if you have any questions. -steve Steven Peckman Associate Director-Human Subjects Research Office for Protection of Research Subjects University of California, Los Angeles 310.825.5344 speckman@oprs.ucla.edu -----Original Message----- From: Kim Diccianni [mailto:kdiccianni@sbhcs.com] Sent: Thursday, May 11, 2000 12:10 PM To: mcwirb@mcwirb.org Subject: Requesting Info on Conflict of Interest Hello All- I am an IRB Coordinator for a communnity hospital. My IRB's next education topic is on Conflict of Interest of Principal Investigators and IRB Members. I'm looking for some guidance for information. I would appreciate any assistance you all could provide such as references to good articles and any policies or statements regarding conflict of interest. I would like to focus on educating members on how to identify a conflict of interest, why it seen as a conflict and ideas for policy development. If there is anything else you can recommend, I am open to suggestions. You may contact me directly at kdiccianni@sbhcs.com. Thank you for your help. _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Steven Peckman 5/12/2000 6:43:00 AM

Washington Post Editorial re:med research

I agree with Dan's comments. In fact, there is a bill that will be submitted to the House of Representatives on 17 May 2000 by DeGette and Waxman that will require that a record of previous reviews of a product be transmitted to any subsequent reviewer. Retaining this history is the only way that Shopping for an approving committee will end. Art Anderson USAMRIID artnscience@yahoo.com -----Original Message----- From: Dan Somers [mailto:dsomers@med.unc.edu] Sent: Friday, May 12, 2000 8:45 AM To: mcwirb@mcwirb.org Subject: re: Washington Post Editorial re:med research Roselyn, This is interesting. Have your local investigators encountered resistance from sponsors/CROs in seeking to obtain documentation of the determinations of other reviewing boards? Maybe I'm overly cynical (could it be?!?), but I cannot imagine a sponsor or CRO voluntarily making that information available to individual investigators in a multicenter trial, much less to their IRBs. Seems to me that in sponsors' eyes, whether or not one IRB has disapproved or required modification to a protocol is irrelevant to subsequent IRB review. My feeling is precisely the contrary - this information should be shared for the other reviewing boards to take or leave as they see fit. Anyone else have any experience with sponsors/CROs being so cooperative as to willingly share the findings of other reviewing IRBs? -Dan _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Arthur O Col Usamriid 5/12/2000 6:46:00 AM

Emergency IND applicability

Our expectation is that, if a patient on a study is admitted for a complication of a study, or if a patient is admitted and must continue study participation while admitted, our IRB should be notified and our IRB should get to make the call as to whether jurisdictional lines have been crossed. A subject does not cease to be a subject because s/he has also become a patient. A scenario: Investigator decides he's tired of dealing with regulatory apparatus of institution and sets up shop on his own, using an intramural IRB he creates or using a freestanding (I)RB. He continues to hospitalize his patients at the same hospital, but no longer uses their IRB. All actual administrations of experimental drugs occur at his own clinic, even if it means transporting patients by cab from the hospital to his clinic and back again. HE has decided this is OK, and that he doesn't have to deal with the hospital's IRB even if there are in-hospital study-related deaths. His rationale is that the study participation is happening elsewhere, and only medical care is happening in the hospital. (I didn't make this one up; it's an allegation under investigation by the credentials committee of a hospital where I know the IRB staff) -------------------------------- I agree that, if a patient in a trial of an antihypertensive drug is hospitalized for something unrelated, it seems a bit much always and automatically to require full IRB review by the hospital's IRB. But the IRB should be notified, because human subjects' research is going on on their turf. And maybe -- just maybe -- that hip fracture happened because the study med made the subject dizzy and caused a fall...... Dale Dale E. Hammerschmidt, M.D. Associate Professor of Medicine, Univ. Minnesota Editor, J. Lab. Clin. Med. Director of Education in Research Ethics and Compliance Box 480 Mayo Building; Minneapolis 55455 612-624-0123 (voice, Heme/Onc/BMT) 612-626-2640 (voice, Journal office) 612-626-2642 (fax) hamme001@tc.umn.edu

Dale Hammerschmidt 5/12/2000 4:10:00 AM

Requesting Info on Conflict of Interest

Hello All- My IRB's next education topic is on Conflict of Interest of Principal Investigators and IRB Members. I'm looking for some guidance for information. I would appreciate any assistance you all could provide such as references to good articles and any policies or statements regarding conflict of interest. I would like to focus on educating members on how to identify a conflict of interest, why it seen as a conflict and ideas for policy development for our hospital. If there is anything else you can recommend, I am open to suggestions. You may contact me directly at kdiccianni@sbhcs.com. Thank you for your help.

Anonymous 5/12/2000 6:43:00 AM

Emergency IND applicability

A geriatric physician whose practice is limited to patients in nursing homes serves as PI on several drug studies. The studies are on drugs currently marketed for specific groups, but not for the geriatric population. The studies have NOT been submitted through a local IRB, approval was obtained from a large central IRB. Our institution requires local review of all studies involving subjects at our institution. The age group and residence of the subjects generally places them at higher risk for hospitalization and such hospitalization may not be related to the study. The PI doesn't want to submit all his studies to our IRB for what he believes will amount to only a rare admission of a study participant. Obviously there will be an issue in the near future...but my question is how other IRB's handle this type of circumstance. Subject on a study drug (like an IV antibiotic), the protocol has not been reviewed by the IRB, subject falls and fractures hip and requires admission. PI wishes to continue study drug. I would appreciate details on or off-line on how other IRB's handle this. Exerpts from policies or procedures addressing this would also be greatly appreciated. Dulce Bramblett, IRB Manager, Deaconess Hospital, Oklahoma City, OK 405-604-4298 dulceb@deaconessokc.com

Anonymous 5/12/2000 4:10:00 AM

Nitric oxide protocol

We have an approved treatment protocol for use of nitric oxide with adult lung transplant patients. The company that supplies this gas has indicated that it will no longer supply it to investigators unless they are using it in a research (rather than treatment) protocol. The protocol may have to close for lack of supply. The FDA has approved it only for pediatric use. The transplant physicians have asked me to inquire whether there are any approved experimental protocols using nitric oxide in adults at other institutions. There is great interest in joining in a multi-site trial or at least building on the experience at other institutions. If you have information relevant to this request, please contact me privately. Thanks. Chris Christina M. Gullion, Ph.D. Biostatistician/Senior Scientist Department of Clinical Research Medical City Dallas Hospital 7777 Forest Lane, Suite C-740 Dallas TX 75230 phone: 972-566-4718, fax: 972-566-4715

Gullion Christina 5/12/2000 6:46:00 AM

Regarding Info on Conflict of Interest

Howard Mann gave a wonderful reference list (my favorite by far is the Understanding Financial Conflicts of Interest) Several more of my favorite (and one non-favorite for the lawyer-types) references for use when lecturing on coi-type things: Wall Street Journal article New York, Mar 19, 1998 by Thomas B. Burton: Urodollars: a prostate researcher tested firm's product and sat on its board; case, while extreme, shows problem medicine has with conflict of interest - options and honorariums Conflict of Interest Guidelines for a multicenter clinical trial of treatment after coronary artery bypass graft surgery. NEJM 320(14): 949-951, 1989 (note that this predates the federal research integrity guidelines and articulates the policy developed by the researchers themselves) Draft Guidance from the FDA - financial disclosure by clinical investigators http://www.fda.gov/oc/guidance/financialdis.html (my take is that if FDA requires disclosure, one can assume that there is a potential conflict that may taint the data) for the lawyers : Conflict of Interest and Informed consent in Industry-Sponsored Clinical Trials. D. S. Shimm and R. G. Spece, Jr. The Journal of Legal medicine 12: 477-513, 1991. (much probably covered in reference 1 in Howard's list). I also find it useful to cruise the professional societies to which the audience members may belong for their policies re: coi. For example the new policy from the American Society of Gene Therapy (http://www.asgt.org/policy/index.html Lynne E. Olson Professor and Research Integrity Officer The Ohio State University 320 Research Foundation 1960 Kenny Rd. Columbus, OH 43210-1063 phone: 614-292-1840 fax: 614-688-0366 email: olson.3@osu.edu

Lynne Olson 5/12/2000 10:45:00 AM

A Neurosurgical Study at The University of Florida

A reporter for The Gainesville Sun (Carrie Miller) is seeking individuals to provide comment/background on a story she is working on. In rejecting her request for admission to the list, I did offer to post her questions to the list. If anyone wants to contact her, call 352-338-3103 or use e-mail at . All the below information is from the reporter and has not been confirmed, so please treat it as simply her version of the story. BACKGROUND I am working on a story about a spinal surgery experiment going on at the University of Florida in which patients with progressive syringomyelia have their syrinxs, or cysts, drained of cerebrospinal fluid an implanted with fetal nerve tissue. I have been communicating with one of the patients (he contacted the paper) who participated in the study and who has told me about several things which have happenned which seem to go against the protocol of the study. His complaints have been reviewed by the university IRB and with the exception of one point — the investigator's failure to convene a 5-person oversight committee made up of neurosurgeons and spinal specialists which was to meet twice a year, review all adverse reports and prepare an annual report - they have sided with the investigators. At this point, it doesn't look like anything is going to happen to the investigators because of the failure to convene the oversight committee. This is a non-randomized, single-blinded, one-armed prospective study to find out if it's safe to implant fetal tissue in the spinal cord, and to find out if the tissue would grow to fill the cyst. It initially was designed to be performed on paralyzed subjects, but part-way through the investigators expanded it to include subjects with incomplete motor function — using the rationale that it was hard to find enough paralyzed subjects to participate. I'm requesting copies of the IRB minutes, but looks like the committee let that change go through without discussion. The subject I'm talking to was stable and walking before the surgery (according to him and to a report written by his previous doctor months before the experimental sugery) but is now paralyzed. QUESTIONS: 1. Would be unusual to change midstream the protocol for an experimental spinal surgery involving fetal tissue implantation from only including paralyzed patients to operating on patients who can walk. What kind of review would that need — merely a protocol revision approved by the I.R.B.? I'm wondering if such a seemingly major change in the protocol ought to be reviewed by someone with spinal/neurological experience rather than this IRB which is headed by a pharmacist? Would that have been something that this planned oversight committee would have reviewed? 2. In single-blind experiments, can investigators share the results of previous patients and speculate to a patient that they have a better chance of having successful results? This man says the investigators showed him copies of tests that were performed on another non-paralyzed subject who was operated on just before him. He said they told him she improved dramatically and was able to drive for the first time in 25 years. He said they told him she was 300 pounds and that since he was in much better physical shape they expected the surgery to be even more beneficial to him. This sound like coercion to me or at least not right. Are the investigators allowed to tell him what has happened with other patients if the study is single-blind? 3. How common is it for patients to exaggerate their symptoms to gain admission to experimental treatments/studies? The man I'm talking to, although his doctor advised him that he was stable and did not need conventional surgery, said he wrote a letter to the study portraying his symptoms as getting progressively worse. He said an administrative aide told him writing a letter would help his cause in getting involved in the study. His doctors reports and his MRIs showed that his syrinx had not changed in size since he was first injured in 1985 — an expanding syrinx was one of the inclusion criteria. In his response to the IRB, the investigator wrote that since it is irrational for a patient to exaggerate his/her symptoms to obtain surgery for no reason, it is generally one's best clinical judgement to believe that the patient is in fact telling you the truth and that their symptoms are progressing...one's most prudent decision is to treat the patient and not the MRI. I have asked two neurosurgeons versed in traumatic syringomyelia, via e-mail, about the likelihood of a syrinx expanding in size 15 years after it first appears, and they say the longer it remains unchanged in size, the more likely it is to continue that way. 4. In a protocol for a surgical experiment to implant fetal tissue into human spinal cords, the investigators say they will convene an oversight committee comprised of five memebers with expertise in medical ethics, spinal cord injury, fetal neural tissue transplants and/or clinical trials. They are to get quarterly reports from the experiment's biostatistician and data manager. Their role is to periodically monitor the study data for adverse effects, problems with the consent process and to recommend whether the study should be continued, modified or halted. They are to meet at least twice a year and produce an annual report. This oversight committee is never convened during the 3-4 years the study goes on. How big of a protocol violation is that? Is it unusual/unethical to say you'll have an oversight committee and then let it slide? Thanks, Carrie Miller The Gainesville Sun 352-338-3103 millerc@gvillesun.com

Anonymous 5/12/2000 9:59:00 AM

Results of reviews being passd on to other reviewers

Greetings from New Zealand! This problem is not just limited within jurisdictions. We have also had the situation where a procedure was judged unethical in New Zealand and the applicants took their case to an Australian reviewing committee and had it accepted. So we need international communication and safeguards as well as national ones. We have also had cases recently, where two committees out of four agreed with a proposal and two others rejected it. After hearing of the outcome, one of the pro committees reversed its decision. So communication works if it happens. Frank Gaze Chair Taranaki Ethics Committee New Zealand

Frank And Margaret Gaze 5/12/2000 12:24:00 PM

Washington Post Editorial re:med research

FYI... Medical Research on People Friday , May 5, 2000 ; A26 MEDICAL PROGRESS depends to a rarely appreciated degree on clinical trials done on patients. In recent years, though, as medical research seems to take on a more frenetic pace, concern has mounted as to whether the safety of patients in clinical studies is being adequately protected. Two years ago the inspector general of the Department of Health and Human Services found disturbing inadequacies across the system intended to guard patients' safety. It called for major improvements in the system's mainstay, the institutional review boards that oversee clinical trials at individual research institutions. Now a sharp follow-up report says that hardly any of the 1998 recommendations has been carried out. The review boards remain overworked and sometimes unqualified for the crucial task before them; many, the report says, don't even question the safety of an ongoing study unless someone dies. The government has not pushed the boards to track trials in progress rather than, as now, simply vetting experiment designs before they begin. It has not required the boards to oversee the way patients are recruited for clinical trials, though the recipe for trouble is there when doctors eager to fill out a roster meet patients who may be desperate for a cure that the study isn't really offering. Nor has the government come up with promised rules that would set educational requirements for review board members and curb potential conflicts of interest--for instance, by barring those with a financial interest in a drug's success from serving on review boards for trials of that drug. These are not abstract issues. Many of them were dramatized last fall in the tragic death of 18-year-old Jesse Gelsinger in a gene therapy trial that was subsequently accused of just such shortcomings, from overzealous recruitment to inadequate tracking once it began. Most recently, a Food and Drug Administration warning letter alleged that the death of a volunteer went unreported and others may have been endangered in a gene therapy trial by a Tufts University researcher. And gene therapy, though under a stronger spotlight, is only a tiny corner of the research landscape. Left untended, the problem could worsen in the next few years, if only in sheer scale. More medical research is taking place in the private sector, where oversight is scarce. Meanwhile, the promise of more biological breakthroughs around the corner has led to pressure to double or triple the number of patients enrolled in trials; some research groups are lobbying to have more of the costs of these trials covered through patients' insurance. More clinical trials may in fact be called for if, as many believe, we are on the brink of incredible medical breakthroughs in every direction. But the system ought to be shored up if it is to be so heavily loaded. 2000 The Washington Post Company Sheri Alpert Institute of Public Policy George Mason University Fairfax, VA

Sheri Alpert 5/12/2000 6:46:00 AM

IRB training /education

I can't tell what organization you are from, but if you have a relationship with other IRBs in the area, especially if you either similar or related in any way, sometimes you can get a group to come as a courtesy. I don't know how big your IRB is or how many people you are thinking should come so this may not work for you, but I know that I and others I know have done performed this service for a lunch and travel costs. If you have to pay, I have no idea how much it would cost but I would guess the more people involved the more you would pay. The FDA for official audits usually has one person over a couple three days. OPRR for big audits may have up to six people for a day and a half. Good luck. At 08:03 AM 5/10/00 -0500, you wrote: >Hello, >We would like to hire a team of consultants to do an audit of our IRB and IRB >office. Can anyone refer me to who does this and also give a ballpark on >cost? >Thank you. > > >_______________________________________________ >MCWIRB maillist - MCWIRB@mcwirb.org >http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb Sharon K. Friend Director Research Subjects Protection Committees Office of Research Administration Box 0962 tel: 415/476-9839 San Francisco, CA 94118 fax: 415/502-1347 sfriend@itsa.ucsf.edu

Sharon Friend 5/11/2000 5:36:00 PM

IRB training /education

In keeping with the spirit of training and education, our yearly retreat is built around educating the IRB. This year I would like to schedule a mock IRB for our group, we usually invite local institution research administration/IRB members to participate. A few months back a mcwirb message discussed this type of agenda. I would appreciate any feed back on this subject. What worked what did not work. We are a small HMO with approximately 200 active projects. Small staff, Grants managers pre and Post awards, myself the coordinator, and 1 part time admin. assistant. Mcwirb is a real blessing for small institutions. I need to move on this agenda fairly quick , My fax # 617 421-6871 if anyone is willing to share information. Our tentative agenda is: Mock IRB FDA local field representative. Question and answer period What's new

Phyllis Kerr 5/11/2000 5:36:00 PM

Washington Post Editorial re:med research

I assume that there may be differences in antipodean law. My Committee's application form includes a question about the trial being presented to other Commitees, the outcome and, if necessary calls for documentary evidence. if this question is not answered and the Committee has concerns, the Investigator is contacted and additional information is sought. Approval to proceed is not given unless this is done if required. Roselyn Drake South Eastern Sydney Area Health Service Ethics Committee St George Hospital Kogarah 2217 AUSTRALIA > -----Original Message----- > From: Dan Somers [SMTP:dsomers@med.unc.edu] > Sent: Thursday, 11 May 2000 3:14 > To: mcwirb@mcwirb.org > Subject: re: Washington Post Editorial re:med research > > Joan Volin commented that our not approving... [a particular multicenter > trial] may have an effect (sic) on the sponsor - or on some other IRB... > > The effect on the sponsor is that they have to shop around for an IRB that > will > approve the project. There is no effect on other reviewing IRBs. When an > IRB > dispproves a multicenter trial, there is no mechanism for sharing that > decision > and the reasons for it with the other IRBs reviewing the same trial - > sponsors > certainly are not going to share that information on our behalf. We might > be > tempted to post something about it on MCWIRB, but we'd better not identify > either the sponsor or the title of the study - doing so will earn you the > dubious honor of being sued, or at least threatened. > > I believe that a mechanism for sharing that information is right and > appropriate. Others may disagree. My opinion is that there's no harm in > sharing > the information, and it may potentially aid the review process at the next > shop > to deliberate over the protocol. The prerogative of each reviewing IRB to > make > its own ethical decision should be maintained, but what's the harm in > letting > them know which issues the other reviewing boards found to be > dealbreakers? Is > the proposed information sharing a threat to IRB autonomy, or is it a > threat to > the practice of IRB shopping? > > -Dan > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb ********************************************************************** South East Health This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. This footnote also confirms that this email message has been virus-scanned and no computer viruses were detected. **********************************************************************

draker@sesahs.nsw.gov.au 5/11/2000 5:36:00 PM

Washington Post Editorial re:med research

At 06:22 PM 5/10/2000 -0500, Gullion Christina wrote: >I agree that a mechanism is needed. I've tried posting a request for input >from other IRBs off line, and did get some response. Actually, that is when >I started forming the opinion that we have very limited powers. When I >pointed out my IRB's concern about an aspect of the protocol, the response >often was, we can't do anything about it--it's a big multicenter study. On 5/5/00 I provided a fairly long posting under this same subject heading. It's focus was leadership in our work--of courage, of being proactive, of not going with the flow when our sensitivities and sensibilities are aroused by research that just doesn't feel quite right to us. The leadership issue did not seem to elicit much interest here. So, I won't repeat all of that, but I will take the limited power issue as an opportunity to try again. I think some of us might be surprised at the impact we can have if we stand up and say, No! That is not acceptable here, or even if just one of us stands up and says, No! That is not acceptable to me! Reviewers of research will in fact have very limited powers if they think and act as if they have very limited power. However, such an act is an abrogation of power. If they recognize their regulatory authority, grounded in law, and act with courage and the intention to protect the rights of research subjects, they can have a positive impact, at least in their own local environment, and perhaps even in the larger system. We cannot allow this young and evolving field to evolve in the wrong direction. Someone will want the power. And even if we don't want it, we have the obligation to protect subjects from those who will reap the benefits and profits from research, whether they be honorable or not. Joan Volin stated earlier today: When we are told that every other IRB in the country has approved the study, we've learned to take it with a grain (or more) of salt - if we get the names of some of the other IRBs that are reviewing it, we often find that they haven't approved it yet, possibly for the very reason that we don't want to approve it. Bravo, Joan!! We should strive for that grain of salt attitude to become a standard. People generally hate to hear the reference to Nuremberg, because of course, we are not like that. But going along with others, following orders, wasn't okay then, and it is not okay now to minimize or relinquish the legal authority and duty we have to protect research subjects. Multcenter study be hanged--if it is wrongly supported elsewhere, it is wrongly supported, and we must reject it at our centers of influence. We can potentially have our greatest influence in educating IRBs and improving the status of research subjects in multicenter studies. When it gets rejected somewhere, anywhere, there is potential for impact, for review, for dialogue. I agree that a mechanism is needed. The lack of one appears to be a serious flaw in the process. Going to a second or third IRB for approval seems to me to be an unethical response that ought to be defined as illegal. Such a response certainly seems to be outside the spirit and intention of the current law. Regards, Phillip Michaels

Phillip Michaels 5/11/2000 5:33:00 PM

Washington Post Editorial re:med research

Phillip Michaels 5/11/2000 5:36:00 PM

Washington Post Editorial re:med research

We actually have, on a very few occasions, managed to convince drug companies to change the design of a study. We have also rejected studies of drugs that were later pulled by the FDA. But I agree that it's probably impossible to change a cooperative group study; they seem to be immutable. I think it's very important not to approve a study if the IRB does not theink that it should be approved. That, after all, is why we're here. And possibly our not approving it may have an effect on the sponsor - or on some other IRB that is considering the study, so the effect may well go further than protecting local subjects. When we are told that every other IRB in the country has approved the study, we've learned to take it with a grain (or more) of salt - if we get the names of some of the other IRBs that are reviewing it, we often find that they haven't approved it yet, possibly for the very reason that we don't want to approve it. Joan Volin Columbia-Presybterian Medical Center > Date: Tue, 09 May 2000 16:36:10 -0500 > To: > To: > To: mcwirb@mcwirb.org > From: Bambi Grilley > Subject: RE: Washington Post Editorial re:med research > I agree with Christina M. Gullion, as an IRB administrator some of the most > frustrating (and fruitless) battles I fought were related to studies > developed by cooperative groups or in conjunction with federal regulatory > agencies. > > Trying to do the right thing results in: > a) anger from the local PI > b) potential loss of the study > c) a lost battle. > > I have yet to see a situation where a local IRB made a substantial > scientific change to a protocol that was developed by a pharmaceutical > company or a cooperative group such as POG. > > In my opinion, having OPRR serve as an ombudsman for the IRBs would be VERY > helpful. Then, there would be some real teeth in the negotiation > process. Currently, as Christina G states, IRBs are left on their own to > try and figure out whether or not other IRBs have approved a study, decide > if the decisions made by those other IRBs were correct, and ultimately > decide whether the issue is of enough importance that the study should not > be approved at the local site. The sad thing is that not approving the > protocol locally only decreases the risk to local participants, ultimately > the same number of participants will be subjected to risk (just at other > sites). > > Something's got to give! I think that IRBs are full of hard working people > devoting an incredible amount of time to reviewing studies and protecting > patients. Unfortunately, I do not think that the current system can work > effectively. Some sort of restructuring will have to occur. > > Bambi Grilley, RPh, CCRC, CCRA > > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb >

Joan Volin 5/10/2000 6:05:00 AM

Risk Terminology Survey

Dear Colleagues, Request for help in clarifying the meanings of words doctors use to define risks for patients and their families. I am interested in surveying a wide variety of people involved in the healthcare professions (and in risk assessment and risk communication) with the view of trying to gain a consensus of what odds are suggested or intended by the words commonly used to characterize risks for patients. I anticipate that different likelihoods are actually intended by doctors from different specialties when they speak of high, moderate, low, very low, minimal, or negligible risks. Please consider participating in the survey in one of two ways. Please reply to this e-mail off-list (i.e. mail it to jpaling@aol.com), complete the form below and send it to us. Please respond to any or all of the questions as you choose. If you choose, include your e-mail address below and we will send you the results when we have completed the survey and compiled the responses. Your address will only be used to return the results of the survey to you. When I hear a physician speak of a High risk I think that means a range between about 1 in ________ and 1 in ________. When I hear a physician speak of a Moderate risk I think that means a range between about 1 in ________ and 1 in ________. When I hear a physician speak of a Low risk I think that means a range between about 1 in ________ and 1 in ________. When I hear a physician speak of a Very Low risk I think that means a range between about 1 in ________ and 1 in ________. When I hear a physician speak of a Minimal risk I think that means a range between about 1 in ________ and 1 in ________. When I hear a physician speak of a Negligible risk I think that means a range between about 1 in ________ and 1 in ________. What is your job title, or how would you describe your area of expertise? Do you have any questions or comments about this survey? If you would like to receive the results of this survey via e-mail, please enter your e-mail address: Thank you for your time and cooperation. John John Paling, M.A., Ph.D. John Paling & Co. Inc. Helping Patients Understanding Risks 5822 NW 91 Blvd. Gainesville, FL 32653 1-877-JPALING jpaling@aol.com http://healthcarespeaker.com

jpaling@aol.com 5/10/2000 1:18:00 PM

What type of injury do you want to exculpate?

Putting aside the federal regulations on exculpatory language for a moment, I am curious about type of injury we are talking about. More specifically, negligent or non-negligent injury: a) are we concerned about compensation when the investigator commits malpractice, or b) when a known (and disclosed) complication occurs or when an unknown complication occurs? I have been assuming we are talking about b, rather than a, but realized that since it makes a HUGE legal difference, I should check as to what others are thinking. If we are talking malpractice, then it does not matter what the federal regs say, no court is going to enforce the exculpatory language and the sponsor is going to lose points with the jury for even asking. If it is b, however, then the patient is not going to have a legal claim for compensation because, in the absence of negligence, the only cause of action is failure of informed consent. If the risk is disclosed or unknown, then there can be no failure of informed consent and the patient is out of luck. (Putting aside using publicity to extort a settlement.) If the consent form is defective, I would probably sue the IRB as well as the sponsor, just to make life exciting and increase the chance of extorting a settlement. Ed Edward P. Richards, J.D., M.P.H. 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 5/10/2000 4:52:00 PM

requirement for IRB to inspect a site in Massachusetts

Does anyone have any information on a Massachusetts requirement that the IRB of record inspect the clinical site conducting a study in the state of Massachusetts?

jwatson@pdanc.com 5/10/2000 6:06:00 AM

Washington Post Editorial re:med research

At 09:01 AM 05/05/2000 -1000, Phillip Michaels wrote: >Just this week, one of the major news networks covered the case of a >physician who was found doing unethical research, and had had it >terminated. There were multiple problems--harm to subjects, conflict of >interest, ownership in the potential profits of a positive research outcome. Does anyone have any information about this story? Where it aired? When? Who was involved? Was it published elsewhere? I'd like more details for a paper I am writing. Many thanks. Steve Steven S. Clark, Ph.D. Associate Professor of Human Oncology and Member, UW Comprehensive Cancer Center University of Wisconsin School of Medicine 600 Highland Ave, K4/432 Madison, WI 53792 Office: (608) 263-9137 FAX: (608) 263-4226 ssclark@facstaff.widc.edu http://www1.bocklabs.wisc.edu/profiles/Clark,Steven.html

Steve Clark 5/10/2000 1:18:00 PM

Washington Post Editorial re:med research

I agree that a mechanism is needed. I've tried posting a request for input from other IRBs off line, and did get some response. Actually, that is when I started forming the opinion that we have very limited powers. When I pointed out my IRB's concern about an aspect of the protocol, the response often was, we can't do anything about it--it's a big multicenter study. > -----Original Message----- > From: Dan Somers [SMTP:dsomers@med.unc.edu] > Sent: Wednesday, May 10, 2000 12:14 PM > To: mcwirb@mcwirb.org > Subject: re: Washington Post Editorial re:med research > > Joan Volin commented that our not approving... [a particular multicenter > trial] may have an effect (sic) on the sponsor - or on some other IRB... > > The effect on the sponsor is that they have to shop around for an IRB that > will > approve the project. There is no effect on other reviewing IRBs. When an > IRB > dispproves a multicenter trial, there is no mechanism for sharing that > decision > and the reasons for it with the other IRBs reviewing the same trial - > sponsors > certainly are not going to share that information on our behalf. We might > be > tempted to post something about it on MCWIRB, but we'd better not identify > either the sponsor or the title of the study - doing so will earn you the > dubious honor of being sued, or at least threatened. > > I believe that a mechanism for sharing that information is right and > appropriate. Others may disagree. My opinion is that there's no harm in > sharing > the information, and it may potentially aid the review process at the next > shop > to deliberate over the protocol. The prerogative of each reviewing IRB to > make > its own ethical decision should be maintained, but what's the harm in > letting > them know which issues the other reviewing boards found to be > dealbreakers? Is > the proposed information sharing a threat to IRB autonomy, or is it a > threat to > the practice of IRB shopping? > > -Dan > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Gullion Christina 5/10/2000 1:49:00 PM

What type of injury do you want to exculpate?

Important points, Ed. I think most of us have been thinking about both a and b. An enduring concern is that CFs often contain language that could imply a complete waiver of the right to seek redress, even in case a, when the real information to be conveyed is Here's what we've set up against possibility 'b.' Dale Dale E. Hammerschmidt, M.D. Associate Professor of Medicine, Univ. Minnesota Editor, J. Lab. Clin. Med. Director of Education in Research Ethics and Compliance Box 480 Mayo Building; Minneapolis 55455 612-624-0123 (voice, Heme/Onc/BMT) 612-626-2640 (voice, Journal office) 612-626-2642 (fax) hamme001@tc.umn.edu

Dale Hammerschmidt 5/10/2000 5:58:00 AM

Appearance of waiver of legal rights

We have approved language as follows: In the unlikely event that you are injured as a direct result of participating in this research project, medical treatment will be made available to you for that injury at your own cost. You will not receive any injury compensation, only medical care. You should understand that this is not a waiver or release of your legal rights. You should discuss this issue thoroughly with the Principal Investigator before you enroll in this project. We also provide contacts for further explanations of the consent form and the rights of the participants. Tryn Stimart AMC Cancer Research Center Regulatory Officer -----Original Message----- From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of Dan Somers Sent: Monday, May 08, 2000 7:26 PM To: mcwirb@mcwirb.org Subject: re: Appearance of waiver of legal rights Liz, I'd like to see something like this: It is not the regular policy of Company X, the sponsor of this research study, to provide compensation for injury beyond what is stated in the above paragraph. You still have all of your legal rights to seek other compensation... I'm not sure whether you should mention specific other claims like lost wages or discomfort. Anyone have any thoughts on this? Might sponsors' lawyers object if that's brought up outside the framework of WE ABSOLUTELY DO NOT PAY FOR... ? Also, I do think that sometimes Joe/Jane Q. Research Participant might take the sponsor's preferred language as precisely that waiver which is specifically disallowed. Which message would you take home? I think the part that says WE WILL PAY NO MORE SO DON'T EVEN BOTHER shouts louder than the part saying, none of your existing legal rights is affected... My two cents. -Dan Dan Somers IRB Coordinator School of Medicine UNC-CH dsomers@med.unc.edu _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Tryn Stimart 5/9/2000 6:55:00 AM

Washington Post Editorial re:med research

I agree with Christina M. Gullion, as an IRB administrator some of the most frustrating (and fruitless) battles I fought were related to studies developed by cooperative groups or in conjunction with federal regulatory agencies. Trying to do the right thing results in: a) anger from the local PI b) potential loss of the study c) a lost battle. I have yet to see a situation where a local IRB made a substantial scientific change to a protocol that was developed by a pharmaceutical company or a cooperative group such as POG. In my opinion, having OPRR serve as an ombudsman for the IRBs would be VERY helpful. Then, there would be some real teeth in the negotiation process. Currently, as Christina G states, IRBs are left on their own to try and figure out whether or not other IRBs have approved a study, decide if the decisions made by those other IRBs were correct, and ultimately decide whether the issue is of enough importance that the study should not be approved at the local site. The sad thing is that not approving the protocol locally only decreases the risk to local participants, ultimately the same number of participants will be subjected to risk (just at other sites). Something's got to give! I think that IRBs are full of hard working people devoting an incredible amount of time to reviewing studies and protecting patients. Unfortunately, I do not think that the current system can work effectively. Some sort of restructuring will have to occur. Bambi Grilley, RPh, CCRC, CCRA

Bambi Grilley 5/9/2000 4:14:00 PM

Appearance of waiver of legal rights

Attached is the response I received from Ellie Braverman about the appearance of waiver of a subject's legal rights, which I think others on MCWIRB might be interested in. Liz Liz Schell Associate General Counsel Carilion Health System Phone: 540-224-5064 Fax: 540-224-5793 Fax: 540-224-5793

Liz Schell 5/9/2000 6:55:00 AM

Adverse Event Reports

> As with IND studies, adverse events in a Phase IV-type study > should be reported > to your IRB in the usual fashion. That is, serious and > unexpected adverse > events, related to the drug under surveillance, should be > reported to the > Sponsor and the IRB . > > I am not aware of a waiver of this requirement in the context of a > post-marketing study. The requirement does not pertain to > other medications > that patient-subject concurrently may be taking . Except that a post-market study is often just tracking ordinary medicinal use by the patient's physician. There are FDA reporting requirements, but I do not think this would require an IRB report, and probably not even IRB approval if confidentiality was protected. Edward P. Richards, J.D., M.P.H. 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 > -----Original Message----- > From: Howard Mann [mailto:ldhmann@ihc.com] > Sent: Monday, May 08, 2000 11:25 PM > To: mcwirb@mcwirb.org > Subject: re: Adverse Event Reports > > > Re: Adverse Event Reports > > Hi, > > > Overall, the intent is to facilitate the detection of adverse > events that were > not apparent in the pre-marketing phase. This phenomenon is , > of course, not > uncommon. > > Regards, > > Howard > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb >

Edward Richards 5/9/2000 4:06:00 AM

Washington Post Editorial re:med research

>>> Gullion Christina 05/09/00 11:56AM >>> >What is even more >disturbing is that protocols supported by NCI and/or carried out on an >FDA-issued IND may raise serious ethical concerns, viz., the POG protocols >requiring submission of tissue samples in order to qualify for treatment >studies. How do these protocols get past review at these agencies? I'm with a CRO/consulting company, and in my experience with the FDA at least, these studies aren't really reviewed from an ethical or protection of human subjects standpoint this early in the process. In pre-study meetings the clinical science and statistics are reviewed and discussed, but the ethics etc. are not addressed unless it's something pretty blatant. Maybe FDA should start including someone who specializes in these issues on the review teams. Kenneth Malcolm, MS, RAC IdeaMed, LLC

Kenneth Malcolm 5/9/2000 4:14:00 PM

Adverse Event Reports

Dr. Banks: It may help to refer to the regulations. 21 CFR 312.3(b) defines a clinical investigation as any experiment in which a drug is ... used involving one or more human subjects. ... an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. Your message indicates you are the principal investigator of a study. 21 CFR 312.2(b)(iv) requires compliance with the Part 50 and Part 56 informed consent and IRB regulations as one of the five conditions for conducting a study with a marketed drug without obtaining an IND. Comment 3 in the preamble to the 1987 IND rewrite states: The agency believes that a postapproval study of an indication contained in the marketed product's labeling is, and should be, subject to all relevant requirements governing the investigational use of drugs, including the requirements of Part 312. All studies, including those involving use of a marketed drug for a labeled indication, pose risks that patients' interests will be subordinated to the interests of the study, and therefore implicate FDA's responsibilities for the rights and safety of human subjects. To clarify the agency's view that it has jurisdiction over all clinical studies, the definition of investigational new drug has been revised to make clear that it includes any drug used in a clinical investigation. It should be emphasized that even though a study of a marketed drug involving an indication contained in the product's approved labeling would be subject to all relevant requirements governing the use of investigational drugs, such a study would, like a study of a marketed drug for an unlabeled indication, be exempt from IND submission requirements if it met all conditions of paragraph 312.2. Federal Register, Vol. 52, page 8801, March 19, 1987. Once a use of a drug is defined as a study, the IRB review and informed consent requirements must be met. The IRB requirements include reporting AEs to the IRB. However, not all AEs need to be reviewed at a convened meeting of the IRB. The IRB can establish a procedure for handling AEs. See the FDA Information Sheet Continuing Review Aster Study Approval. The section on Process for Dealing with Reports of Adverse Reactions and Unexpected Events states the level and promptness of review may depend upon factors such as the seriousness of the event, whether the event is described in the study protocol and consent and whether the event occurred at a location for which the IRB is the IRB of record. This is not an official OPRR statement. Paul W. Goebel, Jr. Division of Human Subject Protections Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, suite 3B01, MSC-7507 Rockville, MD 20892-7507 Phone: 301-402-4372 email: pg122v@nih.gov Fax: 301-402-4256 OPRR url: http://grants.nih.gov/grants/oprr/oprr.htm >

Paul Od 5/9/2000 3:42:00 AM

Appearance of waiver of legal rights

Tryn Stimart 5/9/2000 4:14:00 PM

PICC line upper ext. DVT--outcome

> The Committee also rejected the idea of > getting the physician's permission to enroll the patient in a study and to > share the information. We felt this was burdensome and unnecessary. Did I miss something in the original posting? Are patients to be enrolled as subjects without the physicians' knowledge and approval?? Yowp!! Would I be P-O-ed if one of my neutropenic chemotherapy patients (a high proportion of PICC users) were taken away from the leukemia ward for a study without my knowledge and consent! The ultrasound procedure per se may be of trivial risk, but the care interruption may not be. Moreover, if I have or a consultant has made a special trip to the hospital to see the patient, and the patient is unexpectedly gone..... I remember a case in which a very depressed patient was enrolled (without my knowledge or consent) in a study of a surveillance test to try to detect early relapse of his disease. His take on it was that he'd probably been selected for the study because we suspected him to be in early relapse and hadn't yet told him. This made the difference between outpatient depression and inpatient depression. Put simply, there ARE patients who shouldn't be recruited to studies, and there ARE patients for whom extra precautions are necessary. There's a fair overlap between those groups and PICC users. Then of course, there's the question of how care continuity and patient privacy and data confidentiality are being maintained in the recruitment, if the care-giving physician is not involved.... 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 5/9/2000 4:12:00 AM

Appearance of waiver of legal rights

Liz Schell 5/9/2000 4:14:00 PM

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