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Just in time grant reviews

We were quite excited, three weeks ago, to read the new rules for just in time IRB review of grant applications We just received our first request under this new provision, however, and it makes me a bit less enthusiastic. Here is a portion of the mail which was sent to our PI on April 27th: >As you are aware, the initial review of the above-referenced Grant >application has been completed. As the next step in the Just-In-Time >process, we are requesting the submission of other support documentation >for those applications that have a percentile of (30.0) or better. The >above application is among those from which final funding selections may be >made. However, please note that no funding decision has been made at this >time. Please submit the following: > > >! Other Support _ All current financial resources, as defined on Page >14 of the Public Health Service grant application kit (PHS 398), should be >submitted on Format Page 7_GG. > >! (Current certification dates for animal & human subjects) Where >appropriate. > ( Note: human assurances are valid for a 1 year period.) > >Please fax this information, identifying the grant number, to me no later >than May 5, 2000 with a cover letter countersigned by an institutional >official. Please disregard any additional requests for the same >information. Please also fax a copy of this information to the XXXXXX >program official who is xxxxxxx yyyyyyyy at fax number (301) xxx-yyzz. >. > >Again, no funding decision has been made at this time. Should your >application be selected for funding, you will receive a funding letter >indicating the XXXXX plans to fund your application. > But, you will note, as I have, that this requires an incredibly rapid turn around. There is, in fact, no way our PI would submit a protocol to the IRB, and obtain approval this quickly. As it happens, this particular proposal does not include human Ss, but if it did, this would be a problem. Maybe I just hyper-excitable on a Monday morning, but this does not look like the good news I had expected. David Hudson Assoc. VP Research

David Hudson 5/3/2000 11:35:00 AM

Will this study remain NSR?

SR/NSR determinations can certainly be difficult, but your line of thinking seems pretty reasonable. It would appear that the risk directly attributable to the device in this study is very limited (the device(s) being BP, ECG, and SP02 monitoring equipment I presume(?)). Of course, as you appear to have done, risks associated with any other aspects of the study must be considered as well. Since ancillary risks that could be considered serious and that may drive an SR determination are usually of the magnitude of an invasive surgical procedure associated with the use of the device, significant prolongation of general anesthesia, etc., I would think the probability that the exercise element could push the study over the SR threshold is low, and should be reduced further by the inc/exc criteria you propose. I'd be truly surprised if FDA would feel the need to see an IDE submission for such a study. I'd be interested in others' views on this. Mike Southworth The Cleveland Clinic ---------- > From: Linda Apholz > To: mcwirb@mcwirb.org > Subject: Will this study remain NSR? > Date: Wednesday, May 03, 2000 12:52 PM > > Hello all, > My question relates to a protocol we (a sponsor) are proposing. We want to > measure blood pressure, ECG, and SP02 on subjects that will experience a change > in blood pressure. We decided that doing this during exercise would be > preferable than during a drug induced change. Our thoughts were to target > subjects in the hospital or in a doctor's office who will be having an exercise > stress test. In addition, we want to have healthy individuals ride an exercise > bike in our company gym, monitored by a Nurse practitioner from cardiac rehab. > When discussing the procedure and inclusion/exclusion for these groups, it > occurred to me that anyone we expose to exercise who is not used to it and is > doing it solely for the purpose of the study would be exposed to SR, since > heart attack, stroke, etc. are all possible side effects of exercise. I feel > it is not an issue for the subjects undergoing the stress tests, since they are > having the procedure with or without our study. We are simply hooking up a few > extra non-invasive monitors. But for the regular population I proposed this: > we limit the protocol and inc/exc criteria to those who (for example) exercise > at a moderate to high level of exertion 3-5 times a week for 30 minutes or > more. By doing this, I believe we are not exposing them to an added risk > beyond their normal routine and risk of daily living. We will screen even > these fit subjects accordingly for risk factors and include measures for > stopping the study. We are well in accordance with all parameters for exercise > testing and cardiac rehab. Am I on track here? Would this study meet criteria > for NSR? Thank you in advance for your comments and help. > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Rac 5/3/2000 11:41:00 AM

Just in time grant reviews

kathryn, Apparently NIH has released some FAQs on this. With regard to Just in Time IRB approval, the investigator and the institutional business official who signed the application will both be notified whether or not the application is in the fundable range, with the notification of an application's rating [this is after the first peer review round, about 2-3 months before Council Review and 5-6 months before first start date]. If you are notified that an application is fundable, you would then advise the investigator to put it through the IRB. You would have 4-5 months lead time. The release date for the FAQs is May 1, 2000, Notice # OD-00-031. I assume it is on the NIH web page. Joni. At 11:42 AM 5/3/00 -0500, you wrote: >Our concern about NIH's new policy regarding when proposals need IRB review is >that we don't want to get get caught in a time crunch at the other end - we >don't want to be scrambling to get IRB review and approval because we've just >learned funding is imminent. > >My specific question is this: Does anyone know if IRB approval is required by >the time the Advisory Council meets, or just before funding? > >Any guidance will be helpful. > >Kathryn > >Kathryn Madden >IRB Administrator >Oregon Research Institute >1715 Franklin Blvd. >Eugene, Oregon 97403 >(541)484-2123 >kathryn@ori.org > > >_______________________________________________ >MCWIRB maillist - MCWIRB@mcwirb.org >http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb Jon Hart, Director, Sponsored Programs Administration The Rockefeller University 1230 York Ave.-Box 82, NY, NY 10021-6399 tel: (212) 327-8054; fax: (212) 327-8400

Jon Hart 5/3/2000 8:55:00 AM

Just in time grant reviews

A clear discussion is provided about this issue at: http://grants.nih.gov/grants/irb_review_pol.htm

Nancy Morton 5/3/2000 11:35:00 AM

Ownership

This message is in MIME format. Since your mail reader does not understand this format, some or all of this message may not be legible. ------_=_NextPart_001_01BFB536.69389300 Content-Type: text/plain Daniel Vasgird wrote Anyway I wonder if Dr. Timmons suspected this was a hornet's nest when he asked for feedback a couple weeks ago? Daniel What I expected from the McWIRB group was an informed, thoughtful, discussion with loads of different opinions. The group did not disappoint. The discussion will change my approach as our IRB considers this question in two weeks. It appears that many observers and participants will change their own approaches, too. As I intimated yesterday, the hornet's nest part made things interesting (and fun). This is one fine forum. Thank you all. Otwell Timmons, M.D. Chair, IRB B Carolinas Medical Center Charlotte, NC (The original hornet's nest) ------_=_NextPart_001_01BFB536.69389300 Content-Type: text/html Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: Ownership Daniel Vasgird wrote = " Anyway I wonder if Dr. = Timmons suspected this was a hornet's nest when he asked for feedback a = couple weeks ago? Daniel = What I expected from = the McWIRB group was an informed, thoughtful, discussion with loads of = different opinions. The group did not disappoint. The = discussion will change my approach as our IRB considers this question = in two weeks. It appears that many observers and participants = will change their own approaches, too. As I intimated yesterday, = the hornet's nest part made things interesting (and fun). This is one fine = forum. Thank you all. Otwell Timmons, = M.D. Chair, IRB B Carolinas Medical = Center Charlotte, NC (The = original hornet's nest) ------_=_NextPart_001_01BFB536.69389300--

Otwell 5/3/2000 11:42:00 AM

Will this study remain NSR?

Hello all, My question relates to a protocol we (a sponsor) are proposing. We want to measure blood pressure, ECG, and SP02 on subjects that will experience a change in blood pressure. We decided that doing this during exercise would be preferable than during a drug induced change. Our thoughts were to target subjects in the hospital or in a doctor's office who will be having an exercise stress test. In addition, we want to have healthy individuals ride an exercise bike in our company gym, monitored by a Nurse practitioner from cardiac rehab. When discussing the procedure and inclusion/exclusion for these groups, it occurred to me that anyone we expose to exercise who is not used to it and is doing it solely for the purpose of the study would be exposed to SR, since heart attack, stroke, etc. are all possible side effects of exercise. I feel it is not an issue for the subjects undergoing the stress tests, since they are having the procedure with or without our study. We are simply hooking up a few extra non-invasive monitors. But for the regular population I proposed this: we limit the protocol and inc/exc criteria to those who (for example) exercise at a moderate to high level of exertion 3-5 times a week for 30 minutes or more. By doing this, I believe we are not exposing them to an added risk beyond their normal routine and risk of daily living. We will screen even these fit subjects accordingly for risk factors and include measures for stopping the study. We are well in accordance with all parameters for exercise testing and cardiac rehab. Am I on track here? Would this study meet criteria for NSR? Thank you in advance for your comments and help.

Anonymous 5/3/2000 11:41:00 AM

Courses at the University of Washington

The Department of Medical History and Ethics of the University of Washington announces the following courses. June 12-16, 2000 ETHICS OF RESEARCH WITH HUMANS: PAST, PRESENT, AND FUTURE This one-week course is an intensive introduction to ethical issues in research with humans. The course reviews the origins and development of the ethics and regulation of human research, examines the current federal regulations and their applications, and explores the emerging issues in research with humans that ethics and regulation must take into account. Link: http://depts.washington.edu/mhedept/conedu/rsethc/index-re.html Registration is limited, and fee waivers are awarded on a first-come, first-served basis, so hurry! CERTIFICATE PROGRAM IN ETHICS OF RESEARCH WITH HUMANS Open to participants who successfully complete the Ethics of Research with Humans course. This is a one-year correspondence program of advanced study in human research ethics. Link: http://depts.washington.edu/mhedept/conedu/rscert/indx-rcp.html July 31-August 4, 2000 SUMMER SEMINAR IN HEALTH CARE ETHICS Offered annually since 1988 and open to practicing health care professionals, this is an intensive one-week Seminar designed to familiarize participants with basic definitions and arguments in each of the major topics of clinical ethics. The open, non-judgmental atmosphere of the Seminar, the diverse group of participants, as well as lectures, panel discussions, case analyses, and mock ethics committees, combine to make this a lively, intellectually stimulating, and enjoyable course. Link: http://depts.washington.edu/mhedept/conedu/sumsem/index-ss.html For more information, go to the website or contact: Continuing Education Manager: Marilyn J. Barnard Email: mbarnard@u.washington.edu Phone: (206) 616 - 1864 Fax: (206) 685 - 7515

Anonymous 5/3/2000 12:51:00 PM

Post-mortem use of tissue in research

Dan Icenogle wrote: >I have a question about tissue samples and other material (not whole body or >whole organs) that originated with people who are now dead. It is my >understanding from the federal regs that human research, hence IRB >involvement, requires the potential participant be alive. That is, that no >consent is needed to use tissue and other materials which are derived from >someone who is now dead. Is my understanding correct? Or are the rules for >establishing whether material is residual and anonymous material applicable >post-mortem? as the VCU case makes abundantly clear, it all depends on what information is gathered along with the decedent's sample. if there is any information by which the investigator could identify living relatives, and the information gathered or generated in the research may be considered private (in the sense of familial medical information, for example), then those living persons may be human subjects. this is particularly true in genetics studies, and OPRR and I believe the NBAC both have flagged this issue for attention by researchers and IRBs. jon merz center for bioethics university of pennsylvania merz@mail.med.upenn.edu

Jon Merz 5/3/2000 6:29:00 AM

Post-mortem use of tissue in research

Assume a living subject gave consent for use of tissue in research, then dies, leaving the tissue under the control of the investigator: there should, of course, be IRB review of the research in which the living subject's consent was obtained, but since consent is a process and continuing, death functions as a withdrawal from research. I'd advise the investigator to get consent of personal representative, next of kin etc. before going ahead with any research use of the now deceased subject's tissue. You might want to look at the local jurisdiction's version of the Uniform Anatomical Gift Act (passed in all 50 states). In Washington State RCW Chapter 68.50 et seq defines part of a body to include tissue, blood, fluid or other portion. , and also lists in order of preference those with authority to decide upon the disposition of the remains. (There is also law in Washington, and I suspect in most states, that deals with the authority of representatives of deceased patients to consent to the disclosure of health care information, including tissue and specimen slides, of the patient, and you may wish to double check the local version of this type of law.) In any case, I do not believe that IRB review is required by federal regs of the use of a decedent's tissue, since no living human subject is involved. See 45 CFR 46.102(f). I suppose a local institution could require IRB review of such a use and I don't think there would be any prohibition against it. I would use the same analysis with respect to any tissue of an identifiable decedent, even if there had not been a previously approved research protocol involving the decedent prior to death. If the remains, tissue, part, are identifiable, if provenance leads you back to someone, then I would check local law to determine who has the power to authorize what use of the material. But the federal regs would not kick in to require IRB review of a research use, though local law or local discretion might. Tom Dalglish Community Representative, Committee C University of Washington (206)543-0098(University) (206)706-1000(Office) From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of Daniel L. Icenogle Sent: Tuesday, May 02, 2000 1:31 PM To: mcwirb@mcwirb.org Subject: Post-mortem use of tissue in research I have a question about tissue samples and other material (not whole body or whole organs) that originated with people who are now dead. It is my understanding from the federal regs that human research, hence IRB involvement, requires the potential participant be alive. That is, that no consent is needed to use tissue and other materials which are derived from someone who is now dead. Is my understanding correct? Or are the rules for establishing whether material is residual and anonymous material applicable post-mortem? Thanks for the info. I hope the subject does not offend anyone, but when a client asks a question, you've got to find out the answer. 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. _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

thomas k. dalglish 5/3/2000 6:29:00 AM

Ownership

This message is in MIME format. Since your mail reader does not understand this format, some or all of this message may not be legible. ------_=_NextPart_001_01BFB449.9704230A Content-Type: text/plain; charset=iso-8859-1 Tom Dalglish wrote earlier: ...In other words, while we talk over here - in reference to human subjects - about charity, donations, the right to participate in research or to contribute to science, and the desire to benefit all humankind, over there in the world beyond the human subject people are patenting everything in sight, launching IPOs, and so forth. In addition Dan Icenogle wrote: ...In this void, the question of the payment of royalties becomes a philosophical or justice issue. These 2 excerpts cut to the heart of the matter from my perspective. Yes, that is what we are doing is arguing philosophically while the system in place keeps rolling on. Like Dan Icenogle I hope someday some plaintiff and court will decide to take it to another level integrating the changes (both biological and philosophical) which have taken place over the last ten years and perhaps making some substantive changes. Right now though what rankles me is that the patent people Tom refers to seem to want their cake and eat it too. Hardly a day goes by (I live in NYC so it's the Times I primarily refer to) that I don't find some hyperbolic exaltation of the American economic system and an excoriation of anything remotely attempting to challenge it (just look at the recent IMF and World Bank coverage). Ownership is a principle free enterprise advocates are in love with except when it comes to someone else not in the top 5% SES category perhaps claiming some entitlement. Anyway I wonder if Dr. Timmons suspected this was a hornet's nest when he asked for feedback a couple weeks ago? Daniel Daniel R. Vasgird, PhD Office of Research Compliance Research Foundation of CUNY 30 West Broadway, 11th Floor New York, NY 10007 Ph: 212-4178485 Fax: 212-4178479 email: Daniel_Vasgird@rfcuny.org ------_=_NextPart_001_01BFB449.9704230A Content-Type: text/html; charset=iso-8859-1 Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> Ownership Tom Dalglish wrote earlier: = "...In other words, while we talk over here - in reference to = human subjects - about charity, donations, the right to participate in = research or to contribute to science, and the desire to benefit all = humankind, over there in the world beyond the human subject people are = patenting everything in sight, launching IPOs, and so = forth." In addition Dan Icenogle wrote: = "...In this void, the question of the payment of royalties becomes = a philosophical or justice issue." These 2 excerpts cut to the heart of = the matter from my perspective. Yes, that is what we are doing is = arguing philosophically while the system in place keeps rolling on. = Like Dan Icenogle I hope someday some plaintiff and court will decide = to take it to another level integrating the changes (both biological = and philosophical) which have taken place over the last ten years and = perhaps making some substantive changes. Right now though what rankles = me is that the "patent people" Tom refers to seem to want = their cake and eat it too. Hardly a day goes by (I live in NYC so it's = the Times I primarily refer to) that I don't find some = hyperbolic exaltation of the American economic system and an = excoriation of anything remotely attempting to challenge it (just look = at the recent IMF and World Bank coverage). Ownership is a principle = free enterprise advocates are in love with except when it comes to = someone else not in the top 5% SES category perhaps claiming some = entitlement. Anyway I wonder if Dr. Timmons = suspected this was a hornet's nest when he asked for feedback a couple = weeks ago? Daniel Daniel R. Vasgird, = PhD Office of Research = Compliance Research Foundation = of CUNY 30 West Broadway, = 11th Floor New York, NY = 10007 Ph: = 212-4178485 Fax: = 212-4178479 email: = Daniel_Vasgird@rfcuny.org ------_=_NextPart_001_01BFB449.9704230A--

Daniel 5/3/2000 11:42:00 AM

Just in time grant reviews

David Hudson wrote: > We were quite excited, three weeks ago, to read the new rules for just in time IRB review of grant applications. We just received our first request under this new provision, however, and it makes me a bit less enthusiastic. Here is a portion of the mail which was sent to our PI on April 27th:.... There is, in fact, no way our PI would submit a protocol to the IRB, and obtain approval this quickly. As it happens, this particular proposal does not include human Ss, but if it did, this would be a problem. Maybe I just hyper-excitable on a Monday morning, but this does not look like the good news I had expected.>> a few comments, based on reading (1) the final policy statement that NIH just released yesterday, and (2) between the lines in your description of circumstances. the policy change goes into effect for applications submitted for the january 2001 council round, which generally means those submitted for june/july 2000 receipt dates. is there a chance that you and/or your investigator are still playing under the old rules, by virtue of timing (i.e. revision not yet in effect)? i see nothing in the revised policy that indicates expected/required turnaround time for obtaining IRB approval of applications determined to fall in the fundable range. there certainly is nothing to indicate that you or investigator will be put under the gun to produce instant approval, which makes me wonder if something special going on with this particular grant? finally, you note no human subjects. the policy change applies only to IRBs, and not to research with animals. IACUC approvals will still be required at the time of submission or within 60 days. if any of these impact on your reading of this particular situation, perhaps your enthusiasm is still warranted... albeit delayed, until the policy change for IRB review of human subjects research actually kicks in? 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 5/2/2000 9:48:00 AM

Ownership of samples

Daniel Icenogle (responding to your 5/1/00 message): I don't read the OPRR Guidance Document 11/15/96 as requiring the use of statement of fact language. Rather, the Guidance Document is just that: interpretive guidance by the giving of examples, not mandate. What is prohibited (mandatorily) is exculpatory language, by CFR rules as elaborated upon by the Examples of Exculpatory Language given in the Guidance Document. The same Guidance Document then gives Examples of Acceptable Language that include just one (only!) example of statement of fact language pertaining to future patenting and commercial use and subject compensation , but that single example 1)is not based on any CFR, 2)is isolated and different in content from all other so-called acceptable examples, 3)is unrelated to the research activity or to correlative treatment, and 4)is emphatically not mandated or required, just permitted. So, I wouldn't worry about the wrath of OPRR if you fail to use statement of fact language. In fact, I wouldn't be surprised if OPRR rethought the whole idea of approving statement of fact language through the use of a single example in a Guidance Document, especially in respect to the momentous issue of the disposition of possible property/ownership interests of subjects. Sincerely, 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 Daniel L. Icenogle Sent: Monday, May 01, 2000 2:48 PM To: MCWIRB@mcwirb.org Subject: RE: Ownership of samples In my opinion, the real problem here is the crabbed language required of us (IRBs) by OPRR. Although there is a difference of opinion among those of us on this list, as well as by others, whether justice requires any compensation be given those whose material in some way contributes to the development of a commercially viable product, OPRR requires us to use the language of fact, as opposed to the language of exculpation. The end result of either is, to most English speaking people, is much the same. The end result, to OPRR, is different. There is nothing to stop someone from suing to recover compensation for his or her role in the development of some wildly successful product. As discussed here, there are reasons to believe that the language of the consent form will not serve as a bar to the success of such a suit. In fact, what I expect is that someone is going to do just that, and then the legal questions surrounding property interests in this setting will begin to be settled. Because that question has not yet been settled, I suppose you could then infer that the participant may have some property interest, if only in the sense that some court some day in some setting may decide they do. Today, we have two facts. One, the language of fact required by OPRR must be used or you risk the wrath of OPRR. Two, any IRB is free to require whatever other language of the possible they want to include, as long as the edicts of OPRR and the federal rules are not violated. How you would accomplish that is unclear to me. We also have the ongoing debate about the justice of this issue. I, for one, will enjoy the discussion. 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. _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

thomas k. dalglish 5/2/2000 3:27:00 AM

Thank you re: Ownership of samples

This message is in MIME format. Since your mail reader does not understand this format, some or all of this message may not be legible. ------_=_NextPart_001_01BFB3BB.33E2EFB0 Content-Type: text/plain McWirbers, Thank you for the varied and well-considered opinions related to my question regarding ownership of samples. I am glad that no black or white answer exists; if one did, the discussion would not have been as fun. Owing to the quality of the exchange , the local investigator, our IRB, and I are now much better informed. We, and I suspect other IRBs, will make a better decision on this issue. Otwell Timmons, M.D. Chair, IRB B Carolinas Healthcare System ------_=_NextPart_001_01BFB3BB.33E2EFB0 Content-Type: text/html Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> Thank you re: Ownership of samples McWirbers, Thank you for the varied and = well-considered opinions related to my question regarding ownership of = samples. I am glad that no black or white answer exists; if one = did, the discussion would not have been as fun. Owing to the = quality of the exchange , the local investigator, our IRB, and I are = now much better informed. We, and I suspect other IRBs, will make = a better decision on this issue. Otwell Timmons, M.D. Chair, IRB B Carolinas Healthcare System ------_=_NextPart_001_01BFB3BB.33E2EFB0--

Otwell 5/2/2000 3:27:00 AM

OTHER IRBs

> 2. A patient is admitted to the hospital, but is temporarily taken off > his research protocol (no medications, no lab tests to monitor the > protocol, no investigator evaluations) for the duration of his > hospitalization. Not obvious to me that any IRB involvement is needed, here. 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 5/2/2000 9:19:00 AM

Surgical side effects

Dear Karena, You might take a look at the device regulations, 21 CFR part 812, and follow the way FDA handles reporting for anticipated versus unanticipated adverse events for medical devices. In practice, it works like this: an adverse event or complication is considered anticipated if is listed in the protocol and/or investigator's brochure and in the consent form. Then, the case report forms are set up to ask about the anticipated adverse event (complication) at periodic intervals (whatever makes sense, maybe every day following the surgery for as long as the patient is in the hospital.) This allows you to report severity and frequency of the event. Anticipated adverse events are reported to the IRB in the annual report. Unanticipated adverse events are all adverse events not listed in the protocol/IB nor the consent form. They are reported when they occur, if serious; in the annual report, if not serious. For devices, this whole discussion deals ONLY with device related adverse events. Non-device related adverse events--anticipated or not--are not reported. Nancy J Stark, President Clinical Design Group ----- Original Message ----- From: Karena Cooper To: Sent: Monday, May 01, 2000 2:56 PM Subject: Surgical side effects > My IRB is struggling to refine a SOP for adverse event reporting of surgical > side effects for biomedical studies that involve surgery. > > The debate at the moment is whether expected as well as unexpected surgical > side effects should be reported to the IRB. > > And who determines which effects are expected vs. unexpected? > > Any guidance, including links to relevant web sites, would be appreciated. > Thank you. > > Karena Cooper, M.S.W. > IRB Administrator > Saint John's Health Center > Santa Monica, CA > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Nancy J Stark 5/2/2000 3:25:00 AM

OTHER IRBs

> 1. A different IRB approves a protocol for research intended to be > conducted entirely in an outpatient setting, e.g. in a physician's > office. However in the course of the research a patient has to be > admitted to our hospital and the research protocol regimen needs to be > continued during the hospitalization. First, there are jurisdictional issues. Was this physician, by virtue of being on your staff, required to use your IRB? Or was he someone who was perfectly free to use a freestanding RB or his clinic's IRB if your hospital's involvement were not foreseen? Second, there's the foreseeability issue. It it could be reasonbly foreseen that this would come up, he should have run the protocol past your IRB. Third, there's a fundamental precept: Don't let the subject suffer. If this occurred as a quite unexpected hospitalization for someone who incidentally was participating in a drug trial, and if abrupt drug cessation would endanger the person, I'd think the appropriate thing for the PI to do would be to notify the hospital's IRB of the event. The IRB can then decide if the risk or the likelihood of recurrent episodes is great enough that they need to review the protocol formally. Analog: Patient on chemotherapy protocol, wishes to take vacation during segment not requiring hospitalization; need arises for me to give a dose of a licensed drug or to check blood counts. I notify the IRB of such events, rather than seeking approval of the whole protocol. OTOH, when such a patient came to Minnesota as a graduate student and I was going to be her provider for eight months out of every year, I submitted a formal application for approval. 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 5/2/2000 9:19:00 AM

Ownership of samples

I wonder if we’re not talking about a loophole in the rules (45 CFR 46.116, 21 CFR 50.20) here, whereby a sought objective (the waiver of a legal right) is prohibited from being secured directly by one means but is allowed to be secured indirectly by another. Assume that “statement of fact” language (telling the subjects they have no property rights in the blood or tissue etc., for example) is not, in words at least, the same as exculpatory language. Assume that “statement of fact” language is permitted by the rules, but exculpatory language is not. Assume further that blood and tumor samples are “things” whose relationship to the person from whom they are taken is best characterized by language that connotes possession, that is that there is a property relationship between a subject and his/her blood and tumor samples. Assume that recognizing or extinguishing such a property relationship invokes notions of legal right. (Put the literal implications of Moore in a box in the air here, for a moment.) “Statement of fact” language, which some would argue is now allowed by the rules, could quite plausibly discourage a subject from bringing a property rights claim in the first place, or lead to the defeat of such a claim in litigation. The argument, made by a hypothetical lawyer for any interest holder (e.g. the commercially viable product) other than the subject, might go something like this: The subject was told he had no property interest. He read the consent document. He was even given a copy of it. He had the right to ask questions. He knew whom to call if he did have any. He signed the document. He testified that was his signature. He never objected. He never raised a claim at the time he signed, or at any time thereafter. He participated fully in the research. He benefited from treatment. Furthermore, this document was reviewed and approved by an impartial committee at the institution, and those folks made sure that the rights and welfare of the subject were protected and that there wouldn’t be language in the document that could waive the subject’s rights. In fact, this committee approved the consent document here and found nothing wrong with it. I’m guessing there’s a real risk the subject would lose the case, because of the adverse effect on his/her claim of the “statement of fact” language. Legal theories brought into battle might include implied contract, estoppel, or waiver. I suspect that it would also be argued that the “statement of fact” language discharges any fiduciary duty (see Moore) on the part of the sponsor or non-subject interest holder, or actually secures the subject’s consent (Moore too?). In short, “statement of fact” language exploits a loophole in the rules and accomplishes, perhaps by indirection, what the precluded exculpatory language was not allowed to do directly. The practical effect is the same. To be consistent with the spirit and intention of the rules – to preclude a waiver of rights by the subject in a consent form -- it seems to me “statement of fact” language, just like exculpatory clauses, should not appear in the consent form. It is not a “statement of fact” anyhow, but rather a “position statement” taken by a sponsor or other interest holder with the purpose in mind, I would argue, of stripping the subject of any later claimed property right or, more subtly, of discouraging the subject from going to the trouble and expense of asserting one in the first place. As for whether a “property” interest in blood and tissue samples exists, I suspect that the trend, Moore notwithstanding, is clearly in that direction. Oregon has a statute that states “…an individual’s genetic information and DNA are the property of the individual except when the information or sample is used in anonymous research [Emphasis added].” See ORS 659.715. (Anonymous research, interestingly, is defined to include any research that complies with federal rules protecting human subjects and is reviewed by an IRB.) To read the statute (which deals with privacy and genetic information) in its entirety see www.findlaw.com, click “Laws: Cases & Codes,” then scroll and click “US State Laws: Cases and Codes,” then click Oregon, then click Oregon Revised Statutes, then ORS Chapter 626-692, then scroll to and click ORS Chapter 659, then scroll way, way down to the full text of ORS 659,715. There is also an interesting treatment of biological materials as property in a COGR (Council on Government Relations) brochure entitled “Materials Transfer In Academia.” See www.cogr.edu/mta.htm. The brochure discusses at length many of the issues in the ongoing debate between commercial and academic laboratories in their competition over the ownership and use of biological materials. Even if one doesn’t consider that the human subject in research has a “property” or “ownership” interest in his or her own biological materials, it is clear that commercial and academic laboratories, in their dealings with each other, most emphatically believe that property and ownership interests are at stake, and act accordingly. Jon Merz’s story on 4/27/00 in this discussion portrayed a researcher and hospital owner with patent or property interests they were asserting. In other words, while we talk over here – in reference to human subjects – about charity, donations, the right to participate in research or to contribute to science, and the desire to benefit all humankind, over there in the world beyond the human subject people are patenting everything in sight, launching IPOs, and so forth. Even more specifically, a given university might very aggressively be asserting a property interest in biological materials in a dispute with commercial laboratory, while at the same time an IRB at that institution might be approving so-called “statement of fact” language in a consent form. Is this a conflict of interest? Does it raise questions as to the institution’s discharge of a fiduciary duty (through an IRB) to protect the human subject in research? The Moore court saw a shadow and ran like hell away from validating a “conversion” theory that could, in the court’s view (using hyperbole to make its point), require “scientists to investigate the consensual pedigree of each human cell sample used in research.” Moore, 51 Cal 3rd at 135. What is interesting is that the Moore court didn’t identify the legal character of John Moore’s blood, tissue, and other samples (let’s call them “things”), at least not that I could find. Perhaps others more familiar than I with Moore can point out what these “things” should be called in the world of commerce, if not “property.” What I did notice in Moore was mention of “raw materials” in presumed reference to Moore’s “things.” See Moore, 51 Cal 3rd at144 and 147. Maybe something like a meta-trust theory in reference to such “raw materials” would help us divvy up the competing interests, so that as we pie chart the resources that go into the production and the proceeds that flow from the use of such “raw materials” we come to a more equitable sharing than is now implied by “statement of fact” language in a consent-for-research document. Finally, I wonder how the Moore court would decide the case now. What if a hypothetical National Association for Human Subjects had filed an amicus brief? What if such an organization existed and had input in rule-making and could comment upon 45 CFR 46.116 or 21 CFR 50.20? Or could be routinely represented in clinical ethics decision-making at the IRB level? Tom Dalglish J.D., Ph.D. Community Representative, Committee C University of Washington (206) 543-0098 (University) (206) 706-1000 (Office)

thomas k. dalglish 5/2/2000 3:30:00 AM

Ownership of samples

Mcwirbers, I would appreciate opinions on the following situation: A commercial sponsor plans to take blood and tumor samples for unspecified future testing, possibly genetic. Their sample consent contains the statement if a commercially viable product results from use of this specimen, you will not have any ownership rights of proceeds. We refused to allow that language; no informed consent, whether oral or written, may include any exculpatory language to which the subject or the representative is made to waive or appear to waive any of the subjects rights...... (FDA Info Sheets). We proposed language that states that no current arrangement exists that would allow a subject to share in any profit generated from the use of his or her sample. The sponsor refuses the change. Our local investigator asked me to pursue other approaches. Did we blow this out of proportion? Are we correct that the sponsor is asking subjects to waive a right? Should we stand our ground? Many thanks. Otwell Timmons, M.D. Chair, IRB B Carolinas Healthcare System otimmons@carolinas.org

Otwell 5/2/2000 3:30:00 AM

Post-mortem use of tissue in research

When the Genetic Privacy model law was drafted in 1995, with funding from the Ethical, Legal, and Social Implications program of the Human Genome Project, the investigators chose the following formulation for dealing with such samples: Sec. 133. EXCEPTION FOR DNA SAMPLES PREVIOUSLY COLLECTED FROM DECEASED PERSONS (a) ANALYSIS PERMISSIBLE. -- Notwithstanding the provisions of section 131, an individually identifiable DNA sample which was collected from a sample source who died prior to the effective date of this Act may be analyzed as part of a research project, but no individually identifiable genetic information may be disclosed without the authorization of the sample source's representative. (b) DISCLOSURE TO RELATIVES. -- If the analysis of a DNA sample permitted by subsection (a) determines that a relative of a deceased sample source is at risk for a genetic disease which in reasonable medical judgment can be effectively ameliorated, prevented, or treated, nothing in this Act shall be construed as prohibiting researchers from contacting such relatives and informing them of such risk provided that private genetic information about the sample source is not disclosed. While this is not law (as far as I know), I think it is helpful in thinking about the human subjects issues. If you're interested, the full text of the model act with commentary can be seen at http://www.ornl.gov/hgmis/resource/privacy/privacy1.html. 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 5/2/2000 3:18:00 PM

OTHER IRBs

I would appreciate suggestions and guidance as to the role and responsibility of our hospital IRB in relationship to research protocols approved by other IRBs, as illustrated by the hypothetical scenarios below. We have no relationship with these other IRBs, and the circumstances I am asking about may make formal relationships impracticable. There are several scenarios (below), but all have the common theme of a patient participating in an approved protocol who is admitted to our hospital for reasons that are not related to the protocol or at least not primarily related to it. What is the role and responsibility of our hospital IRB in these situations? 1. A different IRB approves a protocol for research intended to be conducted entirely in an outpatient setting, e.g. in a physician's office. However in the course of the research a patient has to be admitted to our hospital and the research protocol regimen needs to be continued during the hospitalization. Assume the admitting physician has privileges at our hospital and is an approved investigator on the research protocol. (Would it matter if the admission were entirely coincidental to the research, or was necessitated as a complication of it?) 2. A patient is admitted to the hospital, but is temporarily taken off his research protocol (no medications, no lab tests to monitor the protocol, no investigator evaluations) for the duration of his hospitalization. 3. A patient is admitted because of an effect of a research protocol, but all study medications were stopped prior to hospitalization and are not going to be restarted (or at least not restarted during the hospitalization). That is, a complication of the research protocol is being treated in the hospital using conventional (i.e. non-investigational) treatment, but the research protocol itself is not conducted during the hospitalization. 4. The research patient's only purpose for coming to the hospital is to receive standard diagnostic tests (e.g. CBC, barium enema, bone scan) that are only available at the hospital. (Would it matter whether the patient had to be admitted for these tests as opposed to having them done as an outpatient? Would it matter whether the tests were required by the protocol as part of its monitoring effort, or were entirely coincidental to the research?) Thank you for any assistance you can provide. S. William Berg, MD, MPH Hampton (VA) Health Department

Swberg 5/2/2000 9:19:00 AM

Location of consent forms

I would volunteer for the road trip, depending on the location. I believe the important thing here is that the outside institution had their IRB approve the study and the particular consent form used. You have no jurisdiction over them, but your faculty cannot use those samples unless they were obtained with approval from the other institution (with the exeption of samples without identifiers) Italo |--------+-----------------------> | | Tim Sparklin | | | | | | | | | 05/01/2000 | | | 08:26 AM | | | | |--------+-----------------------> >----------------------------------------------------------------| | | | To: IRB listserv - MCW | | cc: (bcc: Italo Biaggioni/VUMC/Vanderbilt) | | Subject: Location of consent forms | >----------------------------------------------------------------| Hi all I'm in the middle of reviewing protocol files for compliance (ie an audit) per our MPA. Among the items for review is the match of the IRB approved consent form to the one actually used in the study. The one thing I insist upon with researchers is to physically match the approved consent on file with each form signed by the participant (pools are large but pretty manageable). Here's the issue: the PI for a particular study conducted interviews and obtained consent from subjects in another country. The forms are kept in the research office at that institution, while the PI returned back to the USA, with the collected data, to use for analysis. Can I rely on the word of the PI (in a written memo) that the approved forms were used? I figure it's that or a road trip. Thanks in advance for advice. Tim

Italo Biaggioni 5/1/2000 12:58:00 PM

PATIENT/SUBJECT REQUEST FOR RESEARCH PROTOCOL

Recently we have had a patient/subject request a copy of the protocol which they were enrolled on, a request that rarely occurs. Initially the subject was given a summary of the study, but evidently obtained a full copy of the protocol (from an unknown source). I would like to get the collective's opinion and rationale for how this would be/has been handled at their institution when such requests have been made. (I do have my own biases on the issue, but would like to others to respond first.) Thanks, Gwenn Oki City of Hope National Medical Center/ Beckman Research Institute Duarte, California

Gwenn Oki 5/1/2000 12:54:00 PM

OPRR Rules on Witnesses

I have just re-read OPRR regulations on documentation of informed consent (45CFR46.117) under (b) two examples are given. The first is a written consent document which may be read to the subject. The second is the short form example which requires a witness to the oral presentation. Signatures of a witness and the person obtaining consent are required on the short form and/or the summary of what is said to the subject. My question is this: Can the person obtaining consent also be the witness? (In cases where the consent form itself, not the short form, is read to the subject.) In the past, I've always thought they had to be two separate people and sign in two separate places. However, the regulations seem to mention the witness only when the short form is used. Thanks in advance for any information on this. Evelyn Studer, IRB Administrator Research Triangle Institute PO Box 12194 Research Triangle Park, NC 27709-2194 919-541-6442 STUDER@rti.org

Evelyn Studer 5/1/2000 12:46:00 PM

Location of consent forms

Hi all I'm in the middle of reviewing protocol files for compliance (ie an audit) per our MPA. Among the items for review is the match of the IRB approved consent form to the one actually used in the study. The one thing I insist upon with researchers is to physically match the approved consent on file with each form signed by the participant (pools are large but pretty manageable). Here's the issue: the PI for a particular study conducted interviews and obtained consent from subjects in another country. The forms are kept in the research office at that institution, while the PI returned back to the USA, with the collected data, to use for analysis. Can I rely on the word of the PI (in a written memo) that the approved forms were used? I figure it's that or a road trip. Thanks in advance for advice. Tim

Timothy Sparklin 5/1/2000 1:00:00 PM

Ownership of samples

In response to Jerry Minikoff: The point is not whether or not they have property rights. The point is that it is not using exculpatory language to inform them that they do not. Naturally you do not tell people that they have no property rights when they do. But the passage in the regulations that was being discussed precludes only the use of exculpatory language. Bob Levine

Robert J . Levine 5/1/2000 11:18:00 AM

Ownership of samples

Perhaps I can restate this issue, add some details, and highlight the problems that I have encountered in attempts to resolve language in consent forms: 1. In at least some circumstances (see below), it is less than crystal clear, as a legal matter, when a company might need the consent of a person whose tissue it is using, in order to patent and/or market a commercial product that is somehow derived from that tissue. 2. Assume that in a particular circumstance, as a legal matter, a company does indeed require that consent in order to do such patenting/marketing. If so, how does the company get that consent? In particular, is it OK to tell the subjects in the consent form that they have no rights in the commercial product? In that circumstance, it would seem the company is doing more than just informing them of a legal fact; rather, it would seem to be getting the subjects to acknowledge that they have consented to such use. And that consent, when gotten as part of the informed consent process, would seem to perhaps violate the OPRR/FDA rules against waiver of rights. (Unless, perhaps, it is OK to require the subject to allow the commercial use of the cells, so long as the subject can still sue/bargain for a share of the profits?) 3. To put this in a real context, as I noted in a previous message, our IRB previously discussed this issue in the context of the numerous protocols presented to us by one of the regional oncology groups. (Thus, we are not even really dealing with a private entity, but rather with a group that has a close tie to the federal research establishment.) They had begun including in consent forms the type of statement of fact language referred to in previous messages in this thread, telling subjects that their tissue might be used to produce a commercial product and thus might make profits for various entities. We thought it was appropriate for the subjects to know that they would not be getting any of this profit. (At the time, I was not even aware of the waiver issue in terms of OPRR/FDA rules, so I was assuming it was OK for the subjects to be required to give up all profit interests as a precondition to participating in the research.) So we asked for the inclusion of a single extra sentence, stating, e.g., I am agreeing to give up any share of the economic benefits that may result from these activities. After months of review, the oncology group said this sentence could not be included. The following was the response we got from the oncology group: The paragraph is meant to inform the patient that there may be an economic benefit resulting from research and development done on the tissue submitted, but it is not the intent of the paragraph to ask the patient to give up their share of this possible economic benefit. Also, even though the patient could be entitled to a benefit, we have no realistic way of knowing at this time what that benefit might be, and thus are unable to describe it in the informed consent document as you have suggested. The current wording has been approved by the Group's attorneys and by the National Cancer Institute, and there are no plans to change the paragraph at this time. Now, maybe I am just very confused, but it seems as if this oncology group (and the NCI!) is saying that the subject may indeed have a right to a portion of the profits--otherwise, why are they talking about the subject giving up their share of the profits? (Is the government merely deciding to make a purely altruistic gift of some profits to the subjects?) Indeed, I assume their problems with the language we suggested is precisely because it might be viewed as inconsistent with the waiver rules imposed by FDA/OPRR. And if the subjects have a possible right--as the federal government seems to be acknowledging, given its reluctance to NOT allow us to tell the subjects they have no rights--then it would seem incorrect to be telling the subjects in the consent form that they have no rights. We should at least warn them that they might have some rights (and that even the federal government believes this), so they have a chance to perhaps attempt to exercise those rights. (Sorry for the somewhat lengthy discussion here.) Jerry Menikoff University of Kansas

Jerry Menikoff 5/1/2000 12:58:00 PM

Ownership of samples

In my opinion, the real problem here is the crabbed language required of us (IRBs) by OPRR. Although there is a difference of opinion among those of us on this list, as well as by others, whether justice requires any compensation be given those whose material in some way contributes to the development of a commercially viable product, OPRR requires us to use the language of fact, as opposed to the language of exculpation. The end result of either is, to most English speaking people, is much the same. The end result, to OPRR, is different. There is nothing to stop someone from suing to recover compensation for his or her role in the development of some wildly successful product. As discussed here, there are reasons to believe that the language of the consent form will not serve as a bar to the success of such a suit. In fact, what I expect is that someone is going to do just that, and then the legal questions surrounding property interests in this setting will begin to be settled. Because that question has not yet been settled, I suppose you could then infer that the participant may have some property interest, if only in the sense that some court some day in some setting may decide they do. Today, we have two facts. One, the language of fact required by OPRR must be used or you risk the wrath of OPRR. Two, any IRB is free to require whatever other language of the possible they want to include, as long as the edicts of OPRR and the federal rules are not violated. How you would accomplish that is unclear to me. We also have the ongoing debate about the justice of this issue. I, for one, will enjoy the discussion. 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.

Daniel L . Icenogle 5/1/2000 1:27:00 PM

Location of consent forms

Italo Biaggioni 5/1/2000 1:00:00 PM

Ownership of samples

> The issue of ownership of or commercial gain from traffic in > human genes is > surely entirely analogous to chattel slavery and the > trafficking in human > body parts. > > This was outlawed throughout the then British Empire in 1834, > and in the US > some time and a civil war later. US law seems to prevent selling organs for transplantion, but it certainly permits selling of tissue - look in any major city's alternative press and you will see ads for plasma centers paying for plasma and intermediaries buying human eggs for several thousand dollars, if you have the right phenotype. 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 5/1/2000 11:24:00 AM

Ownership of samples

Jerry Menikoff 5/1/2000 1:00:00 PM

Ownership of samples

Am I missing something? The issue of ownership of or commercial gain from traffic in human genes is surely entirely analogous to chattel slavery and the trafficking in human body parts. This was outlawed throughout the then British Empire in 1834, and in the US some time and a civil war later. Richard Doehring Consultant Medical Microbiologist P O Box 5152 New Plymouth, New Zealand doehring@taranaki.ac.nz

Doehring 5/1/2000 9:09:00 AM

IRB Work Flow Computer Applications?

Ken, We (Illinois State University's IRB) have been working on a system for the last year, and have implemented the first part of it quite successfully. The system is web based, meaning that anyone (IRB committee members, the chair, and approved others) who have access to a web browser (in this version Internet Explorer 4.x or later) can access information about in-review, pending, approved, and expired protocols. They can read specific information and, if their access rights permit, add information to the database (including changing the protocol's status, approval dates, etc.) or write the PI one of several standard letters. The system is password protected, and runs on a secure server. This first part has been in daily operation since January, and has been working quite well. We are beta-testing an extension of this which would allow for first, PI electronic submissions, as well as on-line reviews. While the software has been developed and works OK for this second part, we are having somewhat other concerns about getting our folks wanting/trained/capable of using it. The PI's really want this, but our departmental reps (we distribute first-level reviews to our department folks) are mixed in their desires. Until we get that ironed out, or modify our procedures somehow, this one will stay in beta. I'm hopeful, though, that we can get these issues worked out before the start of the next school year. I would be interested to hear what other folks have put together! - Jeff Hecht Chairperson, ISU IRB At 12:20 AM 4/28/00 -0500, you wrote: >I am interested to hear of any complete, active, or proposed projects to >automate IRB work flow. Do any organizations allow applications to be >submitted online, and then use custom developed software for managing the IRB >distribution, approval, and archive process? What about integration of >desktop >videoconferencing? > >Kenneth Berg > > >_______________________________________________ >MCWIRB maillist - MCWIRB@mcwirb.org >http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb ---------------------------------------------------------------------------- ------------------ Dr. Jeffrey B. Hecht Office: (309) 438-5585 Campus Box 5900 FAX: (309) 438-8683 Illinois State University E-mail: jbhecht@tierlab.ilstu.edu Normal, IL 61790-5900 http://tierlab.ilstu.edu ---------------------------------------------------------------------------- ------------------

Dr . Jeffrey B . Hecht 4/30/2000 5:43:00 AM

IRB Work Flow Computer Applications?

Would like to draw your attention to the Website for PRO_IRB. A database application designed specifically to assist in managing the IRB administrative workflow process. The site has a demonstration feature which will give you a flavor for the functionality. The application is currently in use by several Hospitals in the Tampa Bay area and evaluation of Web enabled features is underway. While I support read only access to a Database of Protocols either open or archived, I am in principal opposed to allowing changes other than through pre-designed transactions. One of the distinguishing features of PRO_IRB is the ability to produce an audit trail identifying each document/transaction which in any way altered or updated the information stored for a particular Study. http://www.proirb.com/ If your interested in discussing the product send me an Email Dick@proirb.com Thanks, Dick ----- Original Message ----- From: Kenneth Berg To: Sent: April 28, 2000 1:20 AM Subject: IRB Work Flow Computer Applications? > I am interested to hear of any complete, active, or proposed projects to > automate IRB work flow. Do any organizations allow applications to be > submitted online, and then use custom developed software for managing the IRB > distribution, approval, and archive process? What about integration of desktop > videoconferencing? > > Kenneth Berg > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Dick Fluegel 4/30/2000 2:22:00 PM

FDA Clinical Trials & Consent

The American Association for Clinical Chemistry does monitor information about IVD trials. They are hosting an audio conference: http://www.aacc.org/meetings/fda/index.stm There also is a headline summary of the action and a link to the document on the Government Affairs Update: http://www.aacc.org/govt/gau/gau_toc.stm David E. Uddin, PhD, DABCC duddin@mvh.org

David Uddin, PhD 4/30/2000 5:43:00 AM

IRB Work Flow Computer Applications?

I am interested to hear of any complete, active, or proposed projects to automate IRB work flow. Do any organizations allow applications to be submitted online, and then use custom developed software for managing the IRB distribution, approval, and archive process? What about integration of desktop videoconferencing? Kenneth Berg

Anonymous 4/30/2000 2:22:00 PM

Ownership of samples

> Thus, under your > argument, it would still seem as if the Moore case itself > represented a case (perhaps, as you say, not common) in which > a unique DNA arrangement was indeed commercially important. >From my limited knowledge of patent law on DNA, it is not the DNA sequence that is patented. The patent is for figuring out the sequence and putting it to work, which usually means modifying it or expressing it in an artificial system. Thus Moore could not have just sent in a sample to the patent office and said, this is a great tumor for making stuff - give me a patent. At best, Moore had an interesting feedstock. The real dilemma with cases like Moore is that the rational solution is to pay research subjects a fee that captures their chance at contributing to an important discovery. Lawyers and economists would have done this in a second, but the ethos of research has been to limit payments. The result is that the subject gets nothing, but we keep wondering if that is fair. Ed Edward P. Richards Center for Public Health Law Professor - UMKC Law School (816)235-2370 Fax (816)235-5276 richardse@umkc.edu http://plague.law.umkc.edu

Edward Richards 4/30/2000 5:40:00 AM

Ownership of samples

I don't know that Moore's hairy cell leukemia was due to a unique pattern of DNA, or if an oncogene we all may have was induced by an outside agent, or a suppressor cell was turned off, or what. Regardless, I have never argued that Moore should not have been compensated. In fact, he demonstrates that rare individual who has a unique characteristic that is required for me to consider compensation to the source a proper matter. The point remains, Moore, and cases like him, are the rare exception. What genetic technology is all about is the identity of markers of disease, the products of genes that are critical to gene function and the effort to correct a deficient state or to turn off a pathologically active gene. These all require the use of the normal gene or gene product which all whose function is normal have, or the use of gene markers which are common to all who have a particular disease. It is this commonality that makes the people whose genetic material, etc. is used in this research non-unique. None of us have a unique gene unto ourselves that will somehow be useful to insert in all the rest of us. 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 Jerry Menikoff Sent: Friday, April 28, 2000 4:59 PM To: MCWIRB@mcwirb.org Subject: Re: Ownership of samples Daniel Icenogle wrote: Moore, for example, had no unique DNA-he had a leukemia that produced huge numbers of abnormally functioning white blood cells, ones that made huge quantities of a material each of us has. Moore was a factory of a substance generally found in minuscule amounts. That's what made him valuable. And that leukemia--part of Moore's body, a genetic variation in some of his own cells--itself represented a unique pattern of DNA in those cancerous cells, which instructed for continued cell division and the production of the lymphokines in question. That is what turned Moore into a factory for producing that substance. Thus, under your argument, it would still seem as if the Moore case itself represented a case (perhaps, as you say, not common) in which a unique DNA arrangement was indeed commercially important. Jerry Menikoff University of Kansas _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Daniel L . Icenogle 4/30/2000 5:38:00 AM

Ownership of samples

Daniel Icenogle wrote: Moore, for example, had no unique DNA-he had a leukemia that produced huge numbers of abnormally functioning white blood cells, ones that made huge quantities of a material each of us has. Moore was a factory of a substance generally found in minuscule amounts. That's what made him valuable. And that leukemia--part of Moore's body, a genetic variation in some of his own cells--itself represented a unique pattern of DNA in those cancerous cells, which instructed for continued cell division and the production of the lymphokines in question. That is what turned Moore into a factory for producing that substance. Thus, under your argument, it would still seem as if the Moore case itself represented a case (perhaps, as you say, not common) in which a unique DNA arrangement was indeed commercially important. Jerry Menikoff University of Kansas

Jerry Menikoff 4/29/2000 7:48:00 AM

Ownership of samples

Robert Levine writes: Telling people they have no property rights to anything is not exculpatory language and not proscribed by regulations. This would only be the case if it were TRUE that they had no property rights. If the key element of a commercial product is a unique genetic sequence that was derived from the DNA of a particular patient, then it well may be the case that the researcher needed the consent of the patient to legally make and sell that product. There is only one case, Moore, that says otherwise. Given the dramatic developments in the field of intellectual property and related fields of law in recent years, I think it would be inappropriate to say that there is an absolutely clear answer on this. We may all have a right to say how our DNA is used, just as we can say how our image, etc., is used. Jerry Menikoff University of Kansas

Jerry Menikoff 4/28/2000 10:44:00 AM

Disclosure of payments to investigators

Good morning, To the best of my knowledge the disclosure of financial information is not illegal as per the FDA, it just is not required by the FDA. I'm sure the sponsor/CRO feel the financial info is confidential. To date we have not required the payments to physicians to be listed in the consent document, but the IRB needs to know. Any one else? > ---------- > From: Howard Mann[SMTP:ldhmann@ihc.com] > Reply To: mcwirb@mcwirb.org > Sent: Thursday, April 27, 2000 7:33 PM > To: mcwirb@mcwirb.org > Subject: Disclosure of payments to investigators > > Hi All, > > In the context of a drug study involving a Contract Research Organization, > we > have requested disclosure of the amount paid to the clinician-investigator > per > enrolled subject. We have requested disclosure in the Application for > Research > and in the Consent Document. > > The P.I./CRO have declined to do so, stating : As you are aware, all > regulatory documents, including IRB correspondence must be filed and is > subject > to FDA audit. It is against FDA regulations for any financial information > to be > included into these documents. > > They have included the following in the Consent Document : > > Your doctor will be paid by [ CRO's name ] for the additional study > related > procedures and office visit not associated with your usual clinical care, > but > necessary for the conduct of this study. > > Have any of you encountered this response before? > > Is any one aware of a FDA regulation that proscribes --as unlawful-- > disclosure > of the financial information as alleged above ? > > If so, would you provide me with relevant references for such regulation, > including Internet-based references if possible. > > Thanks. > > Regards, > > Howard > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb >

Raffy 4/28/2000 4:03:00 AM

AAMC Compliance Web Site

To Subscribers of MCWIRB and PRIMR_ARENA_LIST: The AAMC is developing a research compliance Web site to accumulate links to institutional compliance programs, regulatory information, educational modules, and any other material and resources that can be of assistance to institutional administrators and scientists. The emphasis is on human subjects compliance in particular, and we would thus be very interested in receiving links to elements of your own institutional or federal agency Web pages that we might ought to feature here. If you would like to draw our attention to such material, please send an e-mail to our staffer, Stephen Heinig, who has been putting this together. He can be reached at . The basic outline of the site can be seen at: Many thanks for your assistance!

Allan Shipp 4/28/2000 12:34:00 PM

Disclosure of payments to investigators

Hi All, In the context of a drug study involving a Contract Research Organization, we have requested disclosure of the amount paid to the clinician-investigator per enrolled subject. We have requested disclosure in the Application for Research and in the Consent Document. The P.I./CRO have declined to do so, stating : As you are aware, all regulatory documents, including IRB correspondence must be filed and is subject to FDA audit. It is against FDA regulations for any financial information to be included into these documents. They have included the following in the Consent Document : Your doctor will be paid by [ CRO's name ] for the additional study related procedures and office visit not associated with your usual clinical care, but necessary for the conduct of this study. Have any of you encountered this response before? Is any one aware of a FDA regulation that proscribes --as unlawful-- disclosure of the financial information as alleged above ? If so, would you provide me with relevant references for such regulation, including Internet-based references if possible. Thanks. Regards, Howard

Anonymous 4/28/2000 5:45:00 AM

Proxy voting

Is proxy voting permissible? At our meeting yesterday, a member had to leave early and gave his proxy to another member to vote how he saw fit. I can not find any reference to this in the regulations. Any help would be appreciated. Thanks! Tracy Smart Arwood Regulatory Compliance Administrator Mississippi State University 302 Bowen Hall Mailstop 9564 662-325-3994 662-325-8776 fax tarwood@spa.msstate.edu

Tracy Arwood 4/28/2000 10:49:00 AM

Presentation : Critical situations in Clinical Trial Monitoring

This is a multi-part message in MIME format. ------=_NextPart_000_0030_01BFB10C.6FB63800 Content-Type: text/plain; charset=iso-8859-1 Content-Transfer-Encoding: quoted-printable I am preparing a presentation to show how critical role of a monitor = for Clinical trials is and how difficult situations may present in some = cases. Do you have any idea on where I could check on the internet for typical = conflicting situations where PIs fail to comply with regulations (GCPs, = federal) and this puts CRAs in difficult situations as they are to make = sure trial is carried out according to regulations? I thought of having access to a black list of Doctors where I could = check why these people were penealized and withdrawn the possibility of = continuing to participate in Clinical Trials. By looking at what = happened in the past I may focused at some examples so that they are not = repeated in the future. Thanks for reading, any contribution will be greatly appreciated. Anne Blanchard Argentina ------=_NextPart_000_0030_01BFB10C.6FB63800 Content-Type: text/html; charset=iso-8859-1 Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD W3 HTML//EN> I am preparing a presentation to show how critical role of a = monitor=20 for Clinical trials is and how difficult situations may present in some=20 cases. Do you have any idea on where I could check on the internet for = typical=20 conflicting situations where PIs fail to comply with regulations (GCPs, = federal)=20 and this puts CRAs in difficult situations as they are to make sure = trial is=20 carried out according to regulations? I thought of having = access to a=20 black list of Doctors where I could check why these people were = penealized and=20 withdrawn the possibility of continuing to participate in Clinical = Trials. By=20 looking at what happened in the past I may focused at some examples so = that they=20 are not repeated in the future. Thanks for reading, any contribution will be greatly=20 appreciated. Anne=20 Blanchard Argentina ------=_NextPart_000_0030_01BFB10C.6FB63800--

Blanchard Anne 4/28/2000 8:05:00 AM

Ownership of samples

-----Original Message----- From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of Jerry Menikoff Sent: Friday, April 28, 2000 11:50 AM To: MCWIRB@mcwirb.org Subject: Re: Ownership of samples Robert Levine writes: Telling people they have no property rights to anything is not exculpatory language and not proscribed by regulations. This would only be the case if it were TRUE that they had no property rights. If the key element of a commercial product is a unique genetic sequence that was derived from the DNA of a particular patient, then it well may be the case that the researcher needed the consent of the patient to legally make and sell that product. There is only one case, Moore, that says otherwise. Given the dramatic developments in the field of intellectual property and related fields of law in recent years, I think it would be inappropriate to say that there is an absolutely clear answer on this. We may all have a right to say how our DNA is used, just as we can say how our image, etc., is used. Jerry Menikoff University of Kansas This captures, or misses, depending on your point of view, my entire point throughout this entire thread. It is EXTREMELY UNLIKELY that there will be any viable commercial product that takes advantage of some of the tiny, tiny amount of your DNA that is unique. A great deal of your DNA is identical to everyone else, a portion is like many others (this is often the case with the mutations for which markers are sought, as described in Jon Merz' example yesterday), and a very little amount is unique. Since the point of most commercial products that use DNA or other genetic material is that the gene or the marker or whatever is involved IS found in others-and therefore this product can be useful for other persons in terms of disease diagnosis or treatment, completely unique DNA has little commercial value. The unique components of DNA are used in identity testing, but that is a different story. Moore, for example, had no unique DNA-he had a leukemia that produced huge numbers of abnormally functioning white blood cells, ones that made huge quantities of a material each of us has. Moore was a factory of a substance generally found in minuscule amounts. That's what made him valuable. The source of DNA used to produce a product, DNA that is identical to mine and yours, is no more entitled to special status than the people whose blood was used to create and calibrate machines that determine hemoglobins. 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. _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Daniel L . Icenogle 4/28/2000 12:22:00 PM

Proxy voting

> Is proxy voting permissible? At our meeting yesterday, a member had to leave > early and gave his proxy to another member to vote how he saw fit. I can > not find any reference to this in the regulations. Tracy -- I can't say that I've ever seen this issue raised before, though we've discussed the parallel question whether a member may, after reviewing the materials, cast a vote in absentia if s/he cannot be present at the time of the actual vote. The answer there is no, because the absent person has not participated in the deliberations (which may have changed the vote, or even the precise question on the table). At an intuitive level, it doesn't seem to pass the sniff test. Why should one member's absence give another member -- chosen by the departing member -- an extra vote? OTOH, there is precedent in the usual procedural rules for stockholders' meetings. One substantive difference, though, is that stockholders have one vote PER SHARE rather than one vote PER PERSON --- ceding control over a number of shares somehow seems less odd than does giving a personal proxy. If I were sitting as chair, I'd rule the proxy out of order as allowing a person to sit simultaneously as a member and as an alternate for the leaving member. I'll bet that's how the feds would see it, too. A more interesting question would be whether, if your written procedures specifically allowed for this practice, clarified the quorum implications, etc., etc, is there anything that directly forbids it? That might take a bit more thought. Dale Dale Hammerschmidt Assoc Prof Med / (Hematology/Oncology/BMT) Editor., J. Lab. Clin. Med. Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455 612-626-2640; 612-626-2642 (fax) InterNet 72662,76 (CompuServe)

Dale Hammerschmidt 4/28/2000 8:00:00 AM

Proxy voting

Tracy wrote : >Is proxy voting permissible? At our meeting yesterday, a member had to leave early and gave his proxy >to another member to vote how he saw fit. I can not find any reference to this in the regulations. Hi, Here is my (terse !) answer : This is illicit. ( A legalist might add the modifier per se :-)) Look, for additional pointers, at Section E of this item : http://www.fda.gov/oc/oha/IRB/toc11.html#A Self-evaluation Checklist for IRBs Regards, Howard Mann, M.D. LDS Hospital, Salt Lake City

Howard Mann 4/28/2000 10:47:00 AM

Proxy voting

See the FDA Information Sheets, Q & A number 14. No. ... ad hoc substitutes are not permissible.... In the old days, FDA wrote many letters stating that proxy voting was not permissible. Also see Q & A number 15, formally appointed alternate members. A substitute (alternate) is not appropriate unless the substitute is listed in the membership roster as an alternate for that member. Another way of looking at the situation is when a voting member leaves, the quorum count goes down and the number of eligible voters goes down unless a designated alternate is present. Oh yes, unofficial. 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 4/28/2000 10:49:00 AM

Proxy voting

I would assume it is not permitted. If not expressly prohibited, it goes against the spirit of the regulations, both in terms of the quorum and the need to participate in the discussion to decide how to vote. Italo Biaggioni |--------+-------------------------> | | Tracy Arwood | | | | | | | | | 04/28/2000 | | | 09:32 AM | | | | |--------+-------------------------> >----------------------------------------------------------------| | | | To: Mcwirb@mcwirb.org | | cc: primr_arena_list@aamcinfo.aamc.org, (bcc: Italo | | Biaggioni/VUMC/Vanderbilt) | | Subject: Proxy voting | >----------------------------------------------------------------| Is proxy voting permissible? At our meeting yesterday, a member had to leave early and gave his proxy to another member to vote how he saw fit. I can not find any reference to this in the regulations. Any help would be appreciated. Thanks! Tracy Smart Arwood Regulatory Compliance Administrator Mississippi State University 302 Bowen Hall Mailstop 9564 662-325-3994 662-325-8776 fax tarwood@spa.msstate.edu _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Italo Biaggioni 4/28/2000 8:00:00 AM

Disclosure of payments to investigators

All, I am unaware of any FDA regulations prohibiting disclosure of compensation to the investigators Typically, financial information is kept in a separate folder and is routinely pulled from trial master folders prior to audits. My experience with several IRBs is that the boards will not release study approval until they have seen the contract/budget for the study...thus, it information does not become part of the IRB correspondence documentation that is subject to audit. The generic investigator compensation clause is typically part of the IC. With the recent financial disclosure regulation (21CFR54), it appears the FDA is trying to get at least a broad view of compensation that is not available in the essential documents collected for a study. Nancy P. Ponton, B.S., MT(ASCP) PRA International -----Original Message----- From: Howard Mann [mailto:ldhmann@ihc.com] Sent: Thursday, April 27, 2000 7:33 PM To: mcwirb@mcwirb.org Subject: Disclosure of payments to investigators Hi All, In the context of a drug study involving a Contract Research Organization, we have requested disclosure of the amount paid to the clinician-investigator per enrolled subject. We have requested disclosure in the Application for Research and in the Consent Document. The P.I./CRO have declined to do so, stating : As you are aware, all regulatory documents, including IRB correspondence must be filed and is subject to FDA audit. It is against FDA regulations for any financial information to be included into these documents. They have included the following in the Consent Document : Your doctor will be paid by [ CRO's name ] for the additional study related procedures and office visit not associated with your usual clinical care, but necessary for the conduct of this study. Have any of you encountered this response before? Is any one aware of a FDA regulation that proscribes --as unlawful-- disclosure of the financial information as alleged above ? If so, would you provide me with relevant references for such regulation, including Internet-based references if possible. Thanks. Regards, Howard _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Nancy 4/28/2000 5:45:00 AM

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