Humanitarian Device Use

Our IRB requested that I poll McWirb participants regarding CryoLife's BioGlue®. BioGlue® is not FDA approved. This product has been deemed a Humanitarian Use Device. Data are not being gathered and this is not considered research, however, the FDA requires that the PI seek IRB review and approval. It is expected that use of BioGlue will be less than 4000 subjects nationwide therefore FDA approval is not being sought. It is up to the IRB to decide whether or not to require informed consent. My questions if you have had to review this HUD: 1) Did you require an informed consent? 2) If not, did you require that the information and risks regarding this product be given to the patient? 3) Do you have any other comments regarding HUD's? Thank you. Thanks, Cindy Cindy Clukey IRB and QI Committees Coordinator Eastern Maine Medical Center (cclukey@emh.org) (207) 973-7906
Cindy Peterson 7/20/2000 10:55:00 AM

IRB response

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_01BFF290.53F1222C Content-Type: text/plain; charset=iso-8859-1 Although HERI and CIRP may not purposely misled students nor misused data, the opportunity for these things to happen is extremely high. I don't understand why identifiers are necessary. If every student was asked to participate by completing the survey on a yearly basis with the participants age and standing (i.e., freshman, sophomore, post-grad) the only identifiers, wouldn't the data be just as valuable? If they are using the incomplete questionnaires and questionnaires without identifiers now, I don't see a problem. In any case, each institution should have approval and oversight from their IRB. Joan Koenig IRB Manager Office Coordinator Banner Health Research Institute 926 E. McDowell Rd. Phoenix, AZ 85006 602-271-9018 FAX 602-271-4853 ------_=_NextPart_001_01BFF290.53F1222C Content-Type: text/html; charset=iso-8859-1 <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 4.0 Transitional//EN>   Although HERI and CIRP  may not purposely misled students nor misused data, the opportunity for these things to happen is extremely high.  I don't understand why identifiers are necessary.  If every student was asked to participate by completing the survey on a yearly basis with the participants age and standing (i.e., freshman, sophomore, post-grad) the only identifiers, wouldn't the data be just as valuable?  If t hey are using the incomplete questionnaires and questionnaires without identifiers now, I don't see a problem.  In any case, each institution should have approval  and oversight from their IRB.   Joan Koenig IRB Manager Office Coordinator Banner Health Research Institute 926 E. McDowell Rd. Phoenix, AZ  85006 602-271-9018  FAX 602-271-4853   ------_=_NextPart_001_01BFF290.53F1222C--
Joan 7/20/2000 1:18:00 PM

Clinical equipoise and the local IRB

Hi All, In a recent message, Charles Weijer reminded us that acceptable risk-benefit ratio and informed consent are separate moral requirements for research (in every document from Nuremberg to the Common Rule). Thus, a person may not consent to a study in which (a) clinical equipoise does not obtain, or (b) non-therapeutic risks have not been minimized or the risks of such procedures are not proportionate to the knowledge to be gained. It really is that simple. I heartily concur. With respect to the assurance of clinical equipoise for a phase III ( multicenter) trial, how do you verify that the former exits? Do you expect the primary reviewer -- if you use one --to summarize his analysis of existent data ( phase I/II trials)? The reviewer may or may not be a member of the community of experts pertinent to the clinical issue at hand. It is not possible to have clinical committee members representative of all medical specialities. Is it reasonable to assume that equipoise exists as the multicenter trial was conceived and designed by a subcommunity of experts ? The investigator's brochure may provide sufficient supporting information, but not always. I recognize this is part of a broader question : To what extent should a local IRB review the design of a multicenter trial ? Charles, How do you do it ? Regards, Howard
Anonymous 7/20/2000 10:52:00 AM

Humanitarian Device Use

>>> Marcus, Dr. Steven 07/20/00 01:11PM >>> wrote: Interestingly, we have been asked to review the protocol for this very same substance. There are some statements which I want clarified before I can even consider approval with or without an informed consent is developed. I would tink that any surgeon who planned on using this stuff would be a fool to not have some formal consent form developed. The risks of litigation, if the stuff fails to perform as indicated, would be too great and would be easily discovered. ........................................................................................................................................................................... Marcus, I believe you misconstrue the nature of the risks -- to patient and physician -- associated with the use of such devices. The patient is arguably at less risk as these devices are evaluated by the FDA prior to issuance of the HDE : The application, however, must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. (http://www.fda.gov/cdrh/ode/hdeinfo.html) Patients may be exposed to far greater risks when individual physicians apply innovative therapies or procedures in the context of medical care. ( Example: laparoscopic surgical procedures) We do not demand that a physician employ a written Informed Consent document in such circumstances. The application of innovative therapy is, as you know, a daily phenomenon. The use of a device made available under a HDE is , of course, analogous to innovative therapy in important respects. Thus, one may convincingly contend that innovative therapy, using a device issued under the HDE regulations, is more defensible in the context of threatened litigation consequent on a bad outcome. Regards, Howard
Howard Mann 7/20/2000 10:55:00 AM

Affiliated members

We are a not-for-profit hospital system. Is someone who has privileges at the hospital considered affiliated? Is a non-paid consultant of the hospital affiliated?
Wendy 7/20/2000 11:43:00 AM

Human Research Subjects Protection Act of 2000

I don't know about any legislative requirements for training, but I do know that NIH investigators will be required to be trained according to a Notice from NIH (June 5, 2000). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html According to that Notice, Beginning on October 1, 2000, the NIH will require education on the protection of human research participants for all investigators submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects. Since then (June 17), the Office of Research Integrity announced that ORI and the Public Health Service research agencies (such as NIH and FDA) are developing a new policy on instruction in the responsible conduct of research for institutions receiving PHS funds for research or research training. A draft of the policy was posted on the Internet July 17 (See http://ori.dhhs.gov/whatsnew.htm ) According to ORI, Following consideration of public comments and appropriate revisions, it is expected that the final policy will be announced by October 1, 2000. Under this policy PHS will expand the requirement for instruction in the responsible conduct of research from just trainees to all personnel on PHS grants, including NIH and FDA grants. The list of individuals who would be required to undergo such training is extensive and includes principal investigators, co-principal investigators, senior investigators, institutional officials who approve PHS grants, contracts, or cooperative agreements, tenure-track investigators, students, postdoctoral fellows, technicians, staff scientists, data management staff, subcontractors, consultants, clinicians, research nurses, research associates, research assistants and anyone else involved in conducting the research or who receives research training at the institution, or under the direction of the institution. Also, PHS recommends that departmental and sponsored research staff, secretarial, and other support staff receive instruction as appropriate for their jobs and roles in the research enterprise. Additionally, the proposed policy would require institutions receiving PHS funds to certify starting October 1, 2000 that: 1. The institution will establish a program of instruction that meets the requirements of this policy and a written description documenting the program by June 1, 2001. In addition to addressing the requirements of this policy and its applicability to all PHS-supported staff and those working on PHS-supported research projects, this description must address how, or whether, the program is being applied to those research staff not supported by PHS funds. 2. The institution will publish the written description of the program of instruction or otherwise make it accessible to research staff at the institution or working under the direction of the institution. 3. The institution will carry out its program of instruction. 4. Initial implementation of the program of instruction, for existing staff, will be completed by October 1, 2002. The policy lays out ten core instructional areas that such courses should include to the extent applicable. Thus, instruction should be provided, according to the notice, on such subjects as data sharing, acquisition, management, and ownership; mentoring; publication and authorship practices; peer review; collaborative science; human subjects; research involving animals; research misconduct; conflicts of interest and commitment; and compliance with federal rules. The policy does not mandate any particular instructional format or program length requirements, but notes that successful modes include workshops, lecture series, courses for academic credit, and self-study using electronic and other media, including the Internet. It is important to note that once this policy is fully implemented, it will supercede NIH's June 5, 2000 notice requiring just investigator education in the protection of human subjects. I hope that helps - I know it doesn't address your question regarding what other other IRBs doing. --------------------------------------- Christina M. Cahalan, M.H.S., J.D. Staff Attorney Vanderbilt University Office of General Counsel 305 Kirkland Hall Nashville, Tennessee 37240 (615) 343-3788 (615) 343-3930 fax Email: tina.cahalan@Vanderbilt.Edu On Thu, 20 Jul 2000 14:47:21 -0500 John McCallister wrote: > The Peoria CIRB is asking what IRBs are doing to be in > compliance with the need for documentation that IRB members > and investigators are trained in the protection of research > subjects and federal regulations. Also, where can I view a > copy of the legislation? > > Thanks in advance > > John McCallister, > Chair, CIRB > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb This e-mail, and any attachments thereto, is intended only for use by the addressee(s) named herein and may contain legally privileged and/or confidential information. If you are not the intended recipient of this e-mail, you are hereby notified that any dissemination, distribution or copying of this e-mail, and any attachments thereto, is strictly prohibited. If you have received this e-mail in error, please immediately notify me by telephone and permanently delete the original and any copy of any e-mail and any printout thereof.
Christina M 7/20/2000 11:49:00 AM

Recruiting female subjects

>From 1977 until the regulations changed in 1993, the FDA banned women of childbearing potential from participation in Phase I and II clinical trials (except when the drug was for a serious or life-threatening illness) Participation in Phas III was allowed if results of reproductive toxicity testing were available. Since this testing was often done in parallel with human trials, the regulation effectively banned women of childbearing potential from nearly all trials. A good history on this is Ruth Merkatz's chapter in Women's Health Research: A Medical and Policy Primer (F.P. Haseltine and B.G. Jacobson, eds.). The Society for Women's Health Research recently held a workshop on barriers to recruitment of women into clinical trials, which included a panel on the ethical/consent issues of recruiting women of childbearing potential. We plan to publish a report on the meeting within the next couple of months, and it will be available from our website www.womens-health.com. (That is, it will if I stop typing this and get back to reviewing the draft. : ) Meanwhile, maybe Dale Hammerschmidt will give the list a sneak perview - he was one of the speakers at our workshop.) ______________________________________ Sherry A. Marts, Ph.D. Scientific Director Society for Women's Health Research 1828 L Street NW, Suite 625 Washington, DC 20036 www.womens-health.org 202-496-5019 vox 202-833-3472 fax >>From: Wainwright, Paul To: 'mcwirb@mcwirb.org' Subject: Recruiting female subjects Date: Wed, 19 Jul 2000 12:55:19 +0100 Dear List, A little while ago there was a brief correspondence concerning pregnancy (or the risks thereof) and participation in trials. A colleague and I have been thinking about the wider issues of women as trial subjects. We understand there was a time when FDA regs did not permit the inclusion of women at all - is this correct? Can anyone point to some helpful literature on this? A particular concern of mine is that trial protocols routinely insist that any women of child bearing potential must be using an acceptable form of contraception - although they rarely specify what action would be taken or advice given in the event of contraceptive failure during the trial. Does this lead to under-representation of women in trials? Any thoughts gratefully received, Paul Wainwright<< ______________________________________ Sherry A. Marts, Ph.D. Scientific Director Society for Women's Health Research 1828 L Street NW, Suite 625 Washington, DC 20036 www.womens-health.org 202-496-5019 vox 202-833-3472 fax
Sherry Marts 7/20/2000 10:49:00 AM

Humanitarian Use Device

Good Morning, Our IRB has been asked to review a device that is used as an adjunct in the surgical repair of acute thoracic aortic dissections. Actually it is a glue used in the above mentioned procedure. The CDRH has approved the HDE (Humanitarian Use Exemption), but of course before the device can be used in the hospital it must receive IRB approval. The FDA does not require an informed consent. We are being asked to expedite the review of this device. Can we, or should we expedite approval of this device? Are devices under HUD reviewed differently? Please let me know what you think. Thanks Debbie Hunsaker SLRMC - IRB Coor. slrmc_mso@sisna.com
Slrmc Medical Staff Office 7/20/2000 4:14:00 AM

Quality Assurance

Dear Members, Our central IRB is in the process of setting up internal quality assurance. Please let me know how your IRB handles this process and what has worked best for you. Any comments are appreciated. Thanks, Joanne Gross Regulatory Coordinator
Joanneg 7/19/2000 4:24:00 AM

Protocol Approval Forms

Would anyone be willing to share a copy of their format for approval of protocols? We are in the process of revising our current forms and would appreciate any help or format changes that you are willing to share. Rosemarie Alston IRB Administrative Assistant Capital Health System RAlston@chsnj.org fax 609-815-7155
Anonymous 7/19/2000 12:08:00 PM

Compensation for IRB Chair

Eileen: I actually asked this question about a month ago. In South Florida, most Chairs do not get paid. One exception, as I have been advised, is U of M, which pays the Chair a % of the IRB protocol application fee. Mercy Healthcare Sacramento pays $3500/yr for 50-60 hrs/mth ($58.33/hr) Another IRB (Couldn't tell which) pays $75 per protocol and $25 per amendment UNM pays .25 FTE equal to about $50,000/yr + fringe + $7500 bonus Boston (Mass Gen, Brigham & Women's Hospitals) pay 5%-100% of their salaries Fred Hutchinson Cancer Research Center (WA) pays 15% of salary Research Triangle Institute (NC) pays $50-$65/hr Other IRBs pay 20%, 33% or more of physician salaries A few schools pay an undisclosed stipend and course reductions. That's about all the info I can put my hands on right now. Hope it helps. Lynn M. Barrett-Mena -----Original Message----- From: Eileen Murphy [SMTP:eileen.murphy@sharp.com] Sent: Wednesday, July 19, 2000 12:45 AM To: mcwirb@mcwirb.org Subject: Compensation for IRB Chair Its budget season, and I am pushing for an increase in the financial compensation for our IRB Chair. Currently, we provide the Chair a small stipend based on the number of meetings attended per year. However, this system is not really adequate, for one, because the workload and time committment continue between meetings. Please provide the amount of financial compensation provided to your IRB Chair. I am particularly interested in responses from community hospitals, but welcome all responses. I'm hoping I can provide support for this increase from your responses. Thank you for your help. Sincerely, Eileen Murphy, B.S. IRB Coordinator Sharp HealthCare San Diego, California _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
lynn barrett-mena 7/19/2000 6:00:00 AM

IRB Chair compensation

As the chair of the recently referred to Mercy Healthcare Sacramento RIRB, the numbers, while not entirely correct, bring to light other questions: a. What are the responsibilities of the Chair. Does he just preside over the meeting, or does he do more (review protocols, amendments, expedited reviews, SAE's, write Policies and Procedures, etc. etc.?) b. What support staff does he have. c. Is Chair just another phrase for Chair, Director, Coordinator, and other ancillary tasks?
Md 7/19/2000 10:37:00 AM

Compensation for IRB Chair

We are a community hospital IRB, less than 50 new protocols per year. No compensation is provided to anyone, except annual $100 gift certificate to the community members. >>> eileen.murphy@sharp.com 07/18/00 10:44PM >>> Its budget season, and I am pushing for an increase in the financial compensation for our IRB Chair. Currently, we provide the Chair a small stipend based on the number of meetings attended per year. However, this system is not really adequate, for one, because the workload and time committment continue between meetings. Please provide the amount of financial compensation provided to your IRB Chair. I am particularly interested in responses from community hospitals, but welcome all responses. I'm hoping I can provide support for this increase from your responses. Thank you for your help. Sincerely, Eileen Murphy, B.S. IRB Coordinator Sharp HealthCare San Diego, California _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
David Pittman 7/19/2000 10:43:00 AM

Paid IRB members and conflict of Interest

If we pay the community or unaffiliated IRB members, should they not then be considered employees? Is there a potential conflict of interest when the paid unaffiliated IRB board member participates in discussing and voting for or against an institutional protocol? At what point does the payment, gift, stipend, or special privilege become an ethical issue for the unaffiliated board member who must consider the protocol submittted by or through the paying institution.
Anonymous 7/19/2000 5:14:00 PM

Humanitarian Device Use

>>> Clukey, Cindy 07/19/00 10:15AM >>> wrote : Our IRB requested that I poll McWirb participants regarding CryoLife's BioGlue®. BioGlue® is not FDA approved. This product has been deemed a Humanitarian Use Device. Data are not being gathered and this is not considered research, however, the FDA requires that the PI seek IRB review and approval. It is expected that use of BioGlue will be less than 4000 subjects nationwide therefore FDA approval is not being sought. It is up to the IRB to decide whether or not to require informed consent. My questions if you have had to review this HUD: 1) Did you require an informed consent? 2) If not, did you require that the information and risks regarding this product be given to the patient? We did not stipulate the use of an IRB-approved Consent Document.. We expect the surgeon to discuss the nature of the device, its use and risks with the patient in the context of acquiring consent to perform the surgical procedure. We do not require documentary evidence that he accomplished the latter. 3) Do you have any other comments regarding HUD's? Thank you. Sure. Peruse this thread from the MCWIRB archives : http://www.mcwirb.org/cgi-bin/WebX.cgi?mcwirb- Howard Mann Humanitarian Use Device 3/9/00 1:43pm Regards, Howard
Howard Mann 7/19/2000 11:22:00 AM

Compensation for IRB Chair

Some chairs are paid as consultants for each hour of work performed for the IRB, usually starting around $50/hr. Evelyn Studer, IRB Administrator Research Triangle Institute PO Box 12194 Research Triangle Park, NC 27709-2194 919-541-6442 STUDER@rti.org -----Original Message----- From: Eileen Murphy [mailto:eileen.murphy@sharp.com] Sent: Wednesday, July 19, 2000 12:45 AM To: mcwirb@mcwirb.org Subject: Compensation for IRB Chair Its budget season, and I am pushing for an increase in the financial compensation for our IRB Chair. Currently, we provide the Chair a small stipend based on the number of meetings attended per year. However, this system is not really adequate, for one, because the workload and time committment continue between meetings. Please provide the amount of financial compensation provided to your IRB Chair. I am particularly interested in responses from community hospitals, but welcome all responses. I'm hoping I can provide support for this increase from your responses. Thank you for your help. Sincerely, Eileen Murphy, B.S. IRB Coordinator Sharp HealthCare San Diego, California _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Evelyn Studer 7/19/2000 4:09:00 AM

placebo reprint

Jack -- I trust Bob would include me among those few knowledgeable commentators who disagree. Little argumentation is provided for Bob's claims, other than (1) this is the way a lot of people do it (fallacy of tradition), and (2) we get people's consent. As I said earlier an acceptable risk-benefit ratio and informed consent are separate moral requirements for research (in every document from Nuremberg to the Common Rule). Thus, a person may not consent to a study in which (a) clinical equipoise does not obtain, or (b) non-therapeutic risks have not been minimized or the risks of such procedures are not proportionate to the knowledge to be gained. It really is that simple. If anyone from the discussion group would like a pdf copy (Adobe Acrobat) of my article on this in Schizophrenia Research (1999) just write to me directly at charles.weijer@dal.ca (please don't send requests to the whole list). The file is about 100kb. Cheers, Charles.
Charles Weijer 7/19/2000 8:37:00 AM

Is it ethical to use a placebo instead of an active control?

The statistical difficulty of using an active control instead of a placebo in a study is fully recoginzed. However, are we carrying out our ethical resposibility to protect the patient when we allow the use of a placebo instead of a proven drug that works (active control). In particular, is it ethical if the potential consequences of not using that active controll item is possibly life threatening. Can we in good conscience give that hypertensive patient a placebo and a stoke instead of an active control drug? Admitedly, the patient should be told about treatment options. However, are we doing our job to protect the patient if we even allow the patient an option that could cause injury or death?
Anonymous 7/18/2000 11:01:00 AM

Is it ethical to use a placebo instead of an active control?

Jack's post quoting Bob on Helsinki, and Dale's post on economic disadvantage, move me to cite Marcia Angell's recent NEJM editorial, The Pharmaceutical Industry -- To Whom Is It Accountable? June 22, 2000, Vol. 342, No. 25, in which she suggests a more critical look at me-too drug development research, particularly with regard to placebo controls, and also suggests that the pharmaceutical industry may have social obligations with respect to drug pricing. Of course, these aren't issues that can be adequately addressed in the course of a single protocol review, but they are things that those involved in clinical research need to think hard about. Nancy M. P. King, JD Professor of Social Medicine CB# 7240 Wing D School of Medicine UNC-Chapel Hill, NC 27599-7240 DIRECT/VOICEMAIL ph 919.843.8270 DEPARTMENT ph 919.962.1136 DEPARTMENT fax 919.966.7499 nmpking@med.unc.edu How can one remember his ignorance, which growth requires, who has so often to use his knowledge? --Henry David Thoreau
Nancy M . P . King 7/18/2000 11:01:00 AM

Is it ethical to use a placebo instead of an active control?

This is a really interesting issue - the last time my committee discussed a similar trial we were informed that the Medicines Control Agency (UK version of the FDA) required placebo data in order to issue a licence, even though the trial was a comparison with an existing established product. Any other UK or European comments? Paul Wainwright > -----Original Message----- > From: Bob Short [SMTP:zcyborg@aol.com] > Sent: Tuesday, July 18, 2000 3:03 AM > To: mcwirb@mcwirb.org > Subject: Is it ethical to use a placebo instead of an active control? > > The statistical difficulty of using an active control instead of a placebo > in a > study is fully recoginzed. However, are we carrying out our ethical > resposibility to protect the patient when we allow the use of a placebo > instead > of a proven drug that works (active control). In particular, is it > ethical if > the potential consequences of not using that active controll item is > possibly > life threatening. Can we in good conscience give that hypertensive > patient a > placebo and a stoke instead of an active control drug? > > Admitedly, the patient should be told about treatment options. However, > are we > doing our job to protect the patient if we even allow the patient an > option > that could cause injury or death? > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul 7/18/2000 4:58:00 AM

Packet to IRB members

Jill Replogle wrote: > The Agenda > The Minutes > Copies of any Informed Consents for the meeting > Full protocols go to just four of the members > Any newsletters or relevant news articles > The updated annual calendar of reviews (we may skip one or two months per year) > The Member List>> perhaps there's more to the above than meets the eye, but this implies that the only materials relating to initial submissions seen by EVERY member are consent forms (i.e. i'm admittedly reading between the two lines that refer to informed consents and full protocols to just four...). if this is the case, see more complete checklists provided by e.g. erica heath and stewart laidlaw. i believe both FDA and OHRP would frown on procedures that did not place, AT A MINIMUM, consent form and protocol summary in hand of each and every member? 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 7/18/2000 2:12:00 AM

Exempt Research

Please forgive my ignorance regarding exempt reviews, but I would appreciate clarification on a statement I read. On page 182 of the IRB 101 manual it states, If an institution does not have a Multiple Project Assurance on file with OPRR, proposed research activities cannot be reviewed using exempt procedures. We do not have an MPA at my hospital. Therefore it sounds as though we are not eligible to perform exempt reviews. Is this correct? Does this only apply to government funded studies? What about our cooperative group studies which are categorized under our CPA? Clarification would be much appreciated. Thanks. Leilani S. Price, Ph.D. IRB Administrator Cottage Health System P.O. Box 689 Santa Barbara, CA 93102-0689 ph: 805-569-8323 fx: 805-569-7875 email: lprice@cottagehealthsystem.org
Leilani Price 7/18/2000 8:16:00 AM

Assurances

Where do I find information on different types of assurances? Of special interest is multiple assurance. Thanks
Sandy 7/18/2000 11:46:00 AM

Packet to IRB members

Just curious as to your notation that the protocol is for clinicians only. What do the non-clinician members of the committee read which gives them the information they need to determine the adequacy of the consent form? -----Original Message----- From: Rebecca Eveland [mailto:reveland@hillcrest.com] Sent: Monday, July 17, 2000 4:23 PM To: mcwirb@mcwirb.org Subject: re: Packet to IRB members Our IRB requires the following: 1. Agenda 2. Minutes of the last meeting 3. New Studies: A. Protocol(clinicians only) B. IRB Application C. Consent Form (including: Patient's Bill of Rights and separate consent for anonymous genetic testing) 4. Continuing Review: A. Completed Continuing Review Form B. Research progress report C. Copies of each currently approved consent form D. Protocol 5. Amendments to Protocol A. Sponsor's cover letter regarding same B. Investigator's cover regarding same C. Copy of protocol change(s) D. Copy of protocol (when changes are numerous) 6. Amendments to Consent Form A. Sponsor's cover letter regarding same B. Investigator's cover regarding same C. Consent Form currently in use D. Newly amended Consent Form 7. Severe Adverse Events (Internal and External) A. Sponsor's cover letter regarding same B. Investigator's cover regarding same C. MedWatch Form D. Completed Severe Adverse Event reporting form 8. Education: Literature is provided regarding changes in regulations, review of regulations, and timely matters. (Due to recent developments, this month's agenda contains 13 items for review and discussion.) 9. Additional items as warranted Hope this helps. _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Susan T . 7/18/2000 2:12:00 AM

IRB relationship to Administrative review

Our IRB is small enough to have only one paid employee. He recently retired, and the Administrative reviewer for the hospital is currently performing both functions: IRB Coordinator & Administrative reviewer. Should we not allow this person to be a voting member, or does it matter?
Anonymous 7/18/2000 11:35:00 AM

(no subject)

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_01BFF0F4.BB150D4E Content-Type: text/plain Eileen, Absolutely, you should look at the consent and other issues. I believe this should be done with any amendment regardless of type of review, i.e. full board/expedited. After all, the requested protocol changes may impact on the consent - perhaps by providing new information on risks/benefits or on a individual's willingness to continue as a participant or even providing a new contact person and telephone number. Basically the entire study is again reviewed. Betty Betty L. Dunger Coordinator, Institutional Review Board Activities MetroHealth Medical Center Cleveland, OH 44109-1998 email: bdunger@research.metrohealth.org (216) 778-5459 (IRB office) (216) 778-3884 (direct) (216) 778-8720 (fax) > -----Original Message----- > From: Eileen_M_Yates@rush.edu [SMTP:Eileen_M_Yates@rush.edu] > Sent: Tuesday, July 18, 2000 12:41 PM > To: mcwirb@mcwirb.org > Subject: (no subject) > > Hello, > > In a recent IRB meeting the following issue was raised and has caused > quite > a debate, please advise: > When an amendment incorporates changes that require a full board review, > is it > appropriate to raise additional issues (other than the outlined changes, > such as > Is the consent form still appropriate?) with the study at this review? Or > should the committee only review the amendment and then at the next > scheduled > continuing review raise the issues with the investigator? It is my stance > that > any opportunity to perform a check on the progress of the study is in > the best > interest of the rights and welfare of the subjects. Please let me know > what you > think. > > Thanks, > > Eileen M. Yates > IRB Administrator > Office of Research Affairs > Rush-Presbyterian-St. Luke's Medical Center > Chicago, IL. 60612 > 312-942-5498 > Eileen_M_Yates@rush.edu > > > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb ------_=_NextPart_001_01BFF0F4.BB150D4E Content-Type: text/html Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: (no subject) Eileen, Absolutely, you = should look at the consent and other issues.  I believe this = should be done with any amendment regardless of type of review, i.e. = full board/expedited.  After all, the requested protocol changes = may impact on the consent - perhaps by providing new information on = risks/benefits or on a individual's willingness to continue as a = participant or even providing a new contact person and telephone = number.  Basically the entire study is again reviewed. Betty Betty L. Dunger Coordinator, Institutional Review = Board Activities MetroHealth Medical Center Cleveland, OH  = 44109-1998 email: = bdunger@research.metrohealth.org (216) 778-5459 (IRB office) (216) 778-3884 (direct) (216) 778-8720 (fax) -----Original Message----- From:   Eileen_M_Yates@rush.edu = [SMTP:Eileen_M_Yates@rush.edu] Sent:   Tuesday, July 18, 2000 12:41 PM To:     mcwirb@mcwirb.org Subject:        = (no subject) Hello,      In a recent = IRB meeting the following issue was raised and has caused quite a debate, please advise: When an amendment incorporates = changes that require a full board review, is it appropriate to raise additional = issues (other than the outlined changes, such as "Is the consent form still = appropriate?) with the study at this review? Or should the committee only review the = amendment and then at the next scheduled continuing review raise the issues = with the investigator? It is my stance that any opportunity to perform a = "check" on the progress of the study is in the best interest of the rights and welfare of = the subjects. Please let me know what you think. Thanks, Eileen M. Yates IRB Administrator Office of Research Affairs Rush-Presbyterian-St. Luke's Medical = Center Chicago, IL.  60612 312-942-5498 Eileen_M_Yates@rush.edu _______________________________________________ MCWIRB maillist  -  = MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb <= /FONT> ------_=_NextPart_001_01BFF0F4.BB150D4E--
Betty Dunger 7/18/2000 11:07:00 AM

Is it ethical to use a placebo instead of an active control?

Howard provides some good references. You'll find several interesting and sometimes conflicting views. The Helsinki Declaration has long stated that all participants are entitled to the best proven therapy. That's problematic on at least two fronts: -- There's pretty broad consensus that there are risks of withholding therapy that are well within the range of risks to which a person may consent; bearing the risk of an untreated stuffy nose is quite different from bearing the risk of an untreated pneumonia. -- Proven is a term with fuzzy margins, as is best. This problem is magnified when one considers therapy availability --- should the threshhold be different where the best proven therapy is unavailable to the general public from that where said therapy is in fact the standard therapy? If so, is it exploitative to do studies in a context where economic disadvantage limits therapy availability (so that placebos may seem more tolerable than they might otherwise be)? If so, how do you decide when the exploitation is either unacceptable or adequately offset by some individual or societal benefit? This is not always an easy question. But it tends for an IRB to focus on an evaluation of the risk that is posed by the period of placebo use. Dale
Dale Hammerschmidt 7/18/2000 8:19:00 AM

Is it ethical to use a placebo instead of an active control?

Dear Bob, One solution is to provide frequent (e.g., weekly) examination of the patient and switch to the proven drug if the situation warrants. However, an approach that might be of greater practical value would be to change the research question to: WHat is the effect of the experimental treatment relative to the standard treatment? Joan Sieber Bob Short wrote: > > The statistical difficulty of using an active control instead of a placebo in a > study is fully recoginzed. However, are we carrying out our ethical > resposibility to protect the patient when we allow the use of a placebo instead > of a proven drug that works (active control). In particular, is it ethical if > the potential consequences of not using that active controll item is possibly > life threatening. Can we in good conscience give that hypertensive patient a > placebo and a stoke instead of an active control drug? > > Admitedly, the patient should be told about treatment options. However, are we > doing our job to protect the patient if we even allow the patient an option > that could cause injury or death? > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Joan E . Sieber 7/18/2000 8:16:00 AM

Is it ethical to use a placebo instead of an active control?

--------------65C5F4B45989CB666D0A8D23 Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Bob -- Well said. The fundamental duty of the IRB is the protection of human subjects. An essential component of this task is ensuring that the medical treatment of subjects is not knowingly compromised as a result of study participation (clinical equipoise). Working on these premises, an IRB would have to reject a placebo-controlled trial if an effective standard therapy was available, unless the study population was restricted to those who had failed to respond to such treatment (and any standard second line treatment). Consent is not an answer in such cases, as requirements for an acceptable risk-benefit ratio and informed consent are separate moral prerequisites for research. For the record, the scientific difficulties of active controls have, in my view, been overstated. On this see: Weijer C. Placebo-controlled trials in schizophrenia: Are they ethical? Are they necessary? Schizophrenia Research 1999; 35: 211-218. Canadian guidelines (Tri-Council Policy Statement, 1998) now state that The use of placebo controls in clinical trials is generally unacceptable when standard therapies or interventions are available for a particular patient population. Be well, Charles. Bob Short wrote: > The statistical difficulty of using an active control instead of a placebo in a > study is fully recoginzed. However, are we carrying out our ethical > resposibility to protect the patient when we allow the use of a placebo instead > of a proven drug that works (active control). In particular, is it ethical if > the potential consequences of not using that active controll item is possibly > life threatening. Can we in good conscience give that hypertensive patient a > placebo and a stoke instead of an active control drug? > > Admitedly, the patient should be told about treatment options. However, are we > doing our job to protect the patient if we even allow the patient an option > that could cause injury or death? > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb --------------65C5F4B45989CB666D0A8D23 Content-Type: text/html; charset=us-ascii Content-Transfer-Encoding: 7bit <!doctype html public -//w3c//dtd html 4.0 transitional//en> Bob -- Well said. The fundamental duty of the IRB is the protection of human subjects. An essential component of this task is ensuring that the medical treatment of subjects is not knowingly compromised as a result of study participation (clinical equipoise). Working on these premises, an IRB would have to reject a placebo-controlled trial if an effective standard therapy was available, unless the study population was restricted to those who had failed to respond to such treatment (and any standard second line treatment). Consent is not an answer in such cases, as requirements for an acceptable risk-benefit ratio and informed consent are separate moral prerequisites for research. For the record, the scientific difficulties of active controls have, in my view, been overstated. On this see: Weijer C. Placebo-controlled trials in schizophrenia: Are they ethical? Are they necessary? Schizophrenia Research 1999; 35: 211-218. Canadian guidelines ( Tri-Council Policy Statement , 1998) now state that The use of placebo controls in clinical trials is generally unacceptable when standard therapies or interventions are available for a particular patient population. Be well, Charles. Bob Short wrote: The statistical difficulty of using an active control instead of a placebo in a study is fully recoginzed.  However, are we carrying out our ethical resposibility to protect the patient when we allow the use of a placebo instead of a proven drug that works (active control).  In particular, is it ethical if the potential consequences of not using that active controll item is possibly life threatening.   Can we in good conscience give that hypertensive patient a placebo and a stoke instead of an active control drug? Admitedly, the patient should be told about treatment options.  However, are we doing our job to protect the patient if we even allow the patient an option that could cause injury or death? _______________________________________________ MCWIRB maillist  -  MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb --------------65C5F4B45989CB666D0A8D23--
Charles Weijer 7/18/2000 4:58:00 AM

Packet to IRB members

Please provide information on what you include in the IRB packet to Committee members the week prior to the meeting. Thank you
Anonymous 7/18/2000 2:12:00 AM

community representatives

At 01:02 PM 7/14/2000 -0400, MacKay, Charles (OD) wrote: > Commendable civic virtue. A fine list. But to force the position on someone > by not offering adequate remuneration blunts their civic zeal. It is really > a greater contribution if you are shown how much value the organization > places on your effort and you decline it or donate the payment to charity. At 11:57 AM 7/14/2000 -0400, MacKay, Charles (OD) wrote: > I repeat that it is inequitable to expect individuals to give of their time > and valuable view points without fair remuneration. Abe Lincoln used to have > the motto up that A lawyer is only paid for his time and advice. Sounds > fair to me. Not to compensate such members is exploitation, pure and > simple. I can find much sympathy for the desire to give people their just due. In the past, I too have argued against exploitation, like the exploitation of medical residents. So, I can also find sympathy for the political view that we should find better ways of acquiring personnel resources, such as increasing the pay of those who are in high demand and short supply, whether hospital residents or IRB members. I can also find heaps of sympathy for wanting to pay those who really need the income. But I do not believe this issue is, in fact, all quite so pure and simple. In fact from the size of my response below, one will ascertain that I believe it is quite a complex issue, and one worth spending some time to address. So, please forgive the lack of tightness of my arguments and whatever else warrants forgiveness--I don't want to spend more time rewriting it. Sorry, but much of the logic of the opposing argument here escapes me. This argument would seem to me to be appropriately characterized as a no pay, no work, or tit only for tat argument--one of do no more good for others than they do for you. I am not aware of a foundation in either medical ethics or general ethics for such a position. But perhaps I am in error. Perhaps the reality is that my having devoted extensive time to non-profit and government boards and activities for many years has warped my thinking. Regardless, I think that those of us who are able, have a duty to give to the community, to society, beyond our immediate family and friends. It appears to me the opposing argument here, as formulated, if carried to its logical conclusion in implementation, would destroy volunteerism. If generalized to human relationships, it would destroy much more. Applied consistently in IRBs, the result would be the end of research as we know it, because research is dependent upon volunteers. If it valid to declare, Not to compensate such members is exploitation, pure and simple, then I fail to understand how it would not be equally (actually more so) appropriate to aver that not to compensate research subjects is exploitation, pure and simple. And if that is so, then as IRBs, we could rarely approve the research that we currently approve. Aside from the methodological problems that paying research subjects would cause with research process and validity, the compensation for research subjects would be incredibly more expensive than that of compensating IRB members. For me, it is inconsistent to expect to be paid for my relatively small and generally riskless role in the approval of research, and to expect the research subjects to offer not only their time for free, but their bodies, their personalities, their personal histories, medical and otherwise--accepting all the risks associated with being a research subject, of which most IRB members will probably be much more knowledgeable than most research subjects. Granted, utility alone is not sufficient basis upon which to base the argument--so, perhaps research subjects should be compensated. But, if there is remuneration that should be provided in this system, then as IRB members with our primary charge being the protection of human subjects, it seems to me that before we start trying to put more into our own pockets, it is research subjects for whom we should first be seeking remuneration. If we win that battle, then, maybe we ought to reconsider remuneration for community IRB members who are willing, even happy, to volunteer their time, effort, and resources. Regarding the comment of to force the position on someone, I am not familiar with any experiences in which force has been used to put people into positions on IRBs--I only know of them as positions in which people get to exercise their free will to choose to be or not to be on the IRB. Nor am I supporting any such potential experiences on IRBs or anything else. Those who do not want to volunteer their time and effort shouldn't. If they want to do this kind of work, but only if they get paid for it, I do not begrudge them the opportunity to find a commercial IRB or one that wants to pay--or they can create one. But if one can acquire services, or products, for less than fair market value, is it exploitation to do so? Not necessarily. There are numerous examples of instances when commercial enterprises and individuals acquire things for less than fair market value. Regarding the comment that not offering adequate remuneration blunts their civic zeal, I do not believe that most of our reasonably well-paid politicians in Washington and the state houses have any more civic zeal than those who do it for free, or who at least certainly do it for much less, as mayors, commissioners, volunteers, etc. in their little towns and counties. Nor do I believe that they tend to have more civic zeal than those who work for free as Red Cross volunteers or as volunteers in the thousands of other non-profit organizations that depend on volunteers for their existence to provide free and low cost benefits to the community. Or those who do it for free on Federal and State Boards, Blue Ribbon Panels, and Commissions. I have observed situations in which those who were getting paid were far less productive, far less qualified, far less prepared, and sporting far worse attitudes than even most of those who did the work without pay. It is not civic zeal in my experience that is enhanced by money--that is financial zeal. I believe there is also a significant problem with the general idea of adequate remuneration in the context of civic virtue or civic duty. What is adequate remuneration in this context? What are the criteria for determining adequate remuneration? Is the criterion one of time spent on task? Or of showing up for a meeting? Of being on time? Of how well-prepared for the meeting? Or of what the market pays that individual for time, or for task, or for credentials? Do we deduct for those who nodded off during the meeting, or those who said not a word, or those who wasted everyone else's time asking questions already covered before their late arrival? Or do we employ some combination of these and other criteria? So, does a physician who volunteers get remunerated the same as the volunteer nurse, or the minister, priest, rabbi, or nun? Does the new attending get remunerated the same as the physician who is earning $500,000/year. Does a lawyer who normally gets $300 an hour get remunerated the same as a retired science teacher. Does a $20,000-a-day management consultant and a millionaire biotech entrepreneur get remunerated the same as the relatively poorer $300-an-hour lawyer or the poorer $500,000-a-year physician? Is any one member just as valuable to the IRB as any other? That seems highly unlikely to me. Other discussions in this forum have indicated that some believe that not all are equally valuable, equally productive, equally educated or qualified, etc. If all are not equal, then to avoid exploiting some, we should develop scales indicating how much to pay volunteers based on. . . , based on what--their education, experience, credentials, earning power? But, developing such scales are very resource intensive--expensive--if done properly, that is, working diligently to ensure that no one is exploited from an inadequately considered or poorly developed scale. Are some not being exploited if they are all getting the same amount? But, using another criterion as primary, someone might argue that they, as members of an IRB, are all doing the same work, so they should all be paid the same. Is that the acceptable conclusion? So, it is no longer exploitation as long as they are being paid? Being paid something? Being paid anything? $250? $100? $5. Where is the line? Their individual value, experience, education, ability to contribute do not matter? If that is so regarding community representatives, then should the same not apply to employees? If community volunteer nurses are to be paid the same as physician volunteers and millionaire biotech entrepreneur volunteers, why do employed nurses not get paid by their employers at the same wage rate as physicians for their time on IRBs? How do we ameliorate that inequity, that exploitation? Do we insist that employers pay the nurses more? Or since a nurse or someone with a master's degree or even a bachelor degree can perform the function, perhaps we should reduce the wages of physicians for the time that they spend doing IRB work? We know how far that brick will fly. Frankly, there are some people for whom there could never be adequate remuneration provided by IRBs, ethics committees, and many other organizations--these organizations cannot afford to pay what some volunteers are worth. Following the line of reasoning as presented in the original argument that stimulated these current words, that people should not do this work without adequate remuneration, and given that it is not possible for some to be adequately remunerated, then those who cannot be adequately remunerated would be freed from the responsibility of civic duty. I think not. I do not expect the Bill Gates of the world to volunteer for IRBs, but I do expect them to do other things for the benefit of society. Thank goodness Gates did not demand adequate remuneration for the $20 billion or so that he put into foundations. For whatever motive, he decided to give back some of his good fortune to the community. Also, how can it possibly be a greater contribution if you are given something in return for the contribution? The IRS has never to my knowledge accepted that argument. In fact, if I give $500 to my symphony or public broadcasting corporation, the IRS does not let me ADD the value of any tickets or gift that I might receive. Quite the opposite, they insist that I DEDUCT that value from my declared contribution. Finally, and probably less significant, even if I am given adequate remuneration and choose to donate it, that can detract from the altruistic spirit of the good intention because I can take a tax deduction for it and get 39.6% of it back on my IRS return and another chuck from my state. Sorry, but I think the exploitation argument does not have much solid grounding. It also suffers from one of the same problems of which utilitarianism is often accused. Its calculus becomes, if not impossible, too complex to be worth the extensive effort for the lesser benefit. I certainly do not claim to have all the answers, but for me at least, we do far better to encourage altruism. Thus, my general argument is for the encouragement of greater altruism, specifically in IRBs and ethics committees, that may help to move us just slightly toward a less Hobbesian brutish society. Perhaps I am bucking a normal trend and getting more idealistic in my advancing age, but for me, Peace Corps, Job Corps, the American Association of Retired People, Red Cross, and similar kinds of organizations and activities that encourage our citizens, young and old, to develop a sense of responsibility to give unselfishly to others are doing wholesome work. Bravo to those organizations that demonstrate their appreciation in one form or another to those who volunteer, but if they can continue to find qualified and motivated people who will do the work without requiring a tit for tat pecuniary reward, well. . . , I think Abe Lincoln would not object, for he also said each of the following: I have just tried to do my very best each and every day. You cannot bring about prosperity by discouraging thrift. Wanting to work is so rare a merit that it should be encouraged. You cannot build character and courage by taking away men's initiative and independence. Best regards to all, Phillip Michaels
Phillip Michaels 7/17/2000 11:28:00 AM

IRB SOPs on line

Dear mcwirbers, I would would be very grateful if anyone could tell me whether there are Independant IRB SOPs to be read on line. Do Independant IRBs make SOPs public for customers who may wish to read them before submitting their protocol to them? You can respond privately, if you wish. Many thanks, Anne Blanchard Argentina
Anne 7/17/2000 2:34:00 AM

Students on IRB

As a third and forth year medical student, I was a student IRB member at the University of Cincinnati Medical Center, 1973-1975. It was the early days of IRB's. It was very educaitonal for me, and I felt I contributed my share to the review process. Toby Acheson MD TriHealth IRB Cincinnati
Toby Acheson 7/17/2000 2:37:00 AM

Packet to IRB members

We send: Agenda Minutes of last meeting Educational Information An update on regulatory information, if any Primary, secondary reviewer and Chair will receive: Human Protocol Proceessing form Internal Review from with Signature of PI, Chair and Hospital CEO The protocol summary If it is a clinical trial, complete invetigator's brochure Consent/permission/Assent Any pertinent publication or regulation that may concern that research project Conflict of Interest form for all investigators and coinvestigators Adverstisements, if any All other reviewers will receive everything except Investigator's brochure. Sree Murthy Associate VP for Ressearch Drexel and MCP Hahnemann Universities s.murthy@drexel.edu -----Original Message----- From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of Sandy Richmond Sent: Friday, July 14, 2000 5:08 PM To: mcwirb@mcwirb.org Subject: Packet to IRB members Please provide information on what you include in the IRB packet to Committee members the week prior to the meeting. Thank you _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Sreekant Murthy 7/17/2000 9:25:00 AM

A Subject's Right to Withdraw Collected Research Data?

Howard --- I agree fundamentally with your points about there being circumstances where there might be an argument for a subject's right to demand removal of samples or data already collected. However, I am concerned about the practical implementation, and I think the far better way is to handle the issues up front: -- minimizing the risks -- disclosing the risks -- getting consent for the accurately-portrayed risks -- including in that process a frank discussion of the liability to or protection from use of the samples/data for purposes other than that for which consent is sought. The biggest argument for a right of removal comes in the circumstance when disclosure has not been frank, and there's a change either in confidentiality risk or in the type of research being done. But you are absolutely right that people may wish to support some sorts of research and not others, and there ARE genuine concerns about respect for autonomy when one gets consent for study A and then uses the samples for study 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 7/17/2000 8:26:00 AM

Recruiting community members

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_01BFECEE.F8408414 Content-Type: text/plain It was suggested by a fellow mcwirb member (thanks Sandra) that I put this issue out as a separate discussion item. (I had included it in a response to a related discussion.) Therefore... As an additional discussion item...how do you/fellow mcwirb participants recruit community members? To date we have done it, for the most part, by word of mouth, contacting local churches/groups or press release. We are especially interested in targeting minority groups for representation. Any thoughts/comments would be appreciated. Thank you. Betty Betty L. Dunger Coordinator, Institutional Review Board Activities MetroHealth Medical Center Cleveland, OH 44109-1998 email: bdunger@research.metrohealth.org (216) 778-5459 (IRB office) (216) 778-3884 (direct) (216) 778-8720 (fax) ------_=_NextPart_001_01BFECEE.F8408414 Content-Type: text/html Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> Recruiting community members It was suggested by a fellow mcwirb = member (thanks Sandra) that I put this issue out as a separate = discussion item.  (I had included it in a response to a related = discussion.)  Therefore... As an additional = discussion item...how do you/fellow mcwirb participants recruit = community members?  To date we have done it, for the most part, by = word of mouth, contacting local churches/groups or press release.  = We are especially interested in targeting minority groups for = representation.  Any thoughts/comments would be = appreciated. Thank = you. Betty Betty L. Dunger Coordinator, Institutional Review = Board Activities MetroHealth Medical Center Cleveland, OH  = 44109-1998 email: = bdunger@research.metrohealth.org (216) 778-5459 (IRB office) (216) 778-3884 (direct) (216) 778-8720 (fax) ------_=_NextPart_001_01BFECEE.F8408414--
Betty Dunger 7/17/2000 2:34:00 AM

Packet to IRB members

lets see for new proposals - a summary of the proposal (we call it the submission form - six pages) prepared by the PI and addressing all the hot button issues (inclusion of women, risks, mitigation thereof, etc) - the abstract from the proposal - the consent form (omitting the boilerplate sections for higher risk new proposals - also the protocol in full for continuing review - the continuing review form (two pages) - the consent form (truncated as above) for amendments - the PI cover letter - the text of the amendment - the new consent form (if there is one, truncated as before) for adverse events - the PI cover letter - the text of the adverse event report (truncated as much as possible) other stuff, like information items, etc that enough detail? if not, I would be happy to expand Sandy Richmond wrote: > Please provide information on what you include in the IRB packet to Committee > members the week prior to the meeting. > > Thank you > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Stewart Laidlaw Phd 7/17/2000 2:34:00 AM

Students on IRB

I served as a full voting member of a University Medical IRB for 3 years in the early 80's while completing a doctorate in a health sciences field. It was a wondeful experience for me while at the same time I feel I contributed to the IRB. I was a conscientious reviewer and presenter and spent many many hours reviewing proposals. A mature student can offer considerable expertise. My experience has stayed with me all these years and I am now Chairperson of our newly forming health department IRB. Richard Danila, Ph.D., M.P.H. Acting State Epidemiologist and Acting Section Manager Acute Disease Epidemiology Section Minnesota Department of Health 717 SE Delaware St. SE Minneapolis, MN 55414 Voice: (612) 676-5414 FAX: (612) 676-5743 richard.danila@health.state.mn.us
Richard Danila 7/17/2000 2:37:00 AM

A Subject's Right to Withdraw Collected Research Data?

Dear McWirbers, Your insight and assistance regarding the following would be helpful. SCENARIO i. A subject enrolls in a research project that includes medical record data extraction and questionnaires regarding medical care for X disease. Full written informed consent is provided. The informed consent form indicates that the subject may withdraw from the research without penalty. ii. The research procedures are performed. The data is obtained using standard instruments. There are 95 total subjects. The study is now closed to accrual and statistical analysis is performed. iii. The subject returns 2 months later and requests to be withdrawn from the study. Part of the request is the removal of her data from the project. iv. It would require a significant expenditure of time and resources for the investigator to identify the data, redact it, and re-do data analysis. QUESTIONS: 1. When a subject withdraws from the research should her/his research information also be withdrawn? a. What should be the reasonable expectation placed on the investigator? b. What if the data can be deidentified? 2. At what point is it impracticable to remove data/specimens from a project. 3. What if the removal of such information negatively impacts the statistical analysis of the entire project? For example, the 1 out of 95 could be a significant percentage, depending on the information. The OPRR Guidebook discussing the development of cell lines states: ...the underlying principle would be that withdrawal releases the subject from providing further information or tissue samples, and perhaps requires the removal of the subject's identity from all research records, but does not require the investigator to eliminate the resulting data from the study or to destroy the cell line. [p5-48 - 5-49] thank you for your help. -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
Anonymous 7/17/2000 8:26:00 AM

student representative

We are currently filling vacancies on our IRB. Since many of the subjects tend to be students, we are looking at the possibility of having a student serve on the board. Do any institutions have a student representative on the IRB? If so, in what capacity (voting or non-voting). What are some of the pros and cons of having a student serve? Thanks in advance. Susie Hayes Compliance Coordinator University of Memphis slhayes@cc.memphis.edu
Anonymous 7/17/2000 8:24:00 AM

IRB PACKET

Interesting question. Our IRB receives a consent agenda (amoung other documents) 10 days prior to the meeting. This consent agenda includes alot of housekeeping material, including the progress reports, some SAE's, and annual reports. ANY item can be extracted for discussion and a separate vote. Otherwise, the consent agenda is voted on as one item (with appropriate abstentions noted). HOWEVER, the FDA auditor, which concluded her interview last Wednesday, didn't like this one vote on numerous matters function, suggesting that each item be voted on separately (which could be time consuming for ? gain). Does anyone else use a consent agenda? If so, how? Thanks, Craig Weiner, MD Chair Mercy Healthcare Sacramento Regional IRB
Craig Weiner 7/17/2000 11:04:00 AM

Packet to IRB members

The Agenda The Minutes Copies of any Informed Consents for the meeting Full protocols go to just four of the members Any newsletters or relevant news articles The updated annual calendar of reviews (we may skip one or two months per year) The Member List -----Original Message----- From: Sandy Richmond [mailto:srichmond@shc.org] Sent: Friday, July 14, 2000 4:08 PM To: mcwirb@mcwirb.org Subject: Packet to IRB members Please provide information on what you include in the IRB packet to Committee members the week prior to the meeting. Thank you _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Jill 7/17/2000 2:34:00 AM

community representatives

We are a small board and review 45 new protocols a year, meeting 1.25 hr. once a month. We have two community representatives and give them $100 gift certificates once a year. Dr. Pittman >>> fitp@aol.com 07/12/00 07:41PM >>> ,Our IRB is seeking advice on how much to pay our community representatives. They provide an invaluable service and are a necessary and insightful component of the Board. I have spoken with administrators of several Boards and the honorarium ranges from $100/meeting to $50/hour including several hours of preparation time. Any advice would be appreciated. _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
David Pittman 7/17/2000 8:24:00 AM

Packet to IRB members

Sandy, For my IRBs, we send each member: - the meeting agenda - a report called the Coordinators Report that lists all activity being presented at the current meeting (continuing/final study reports, amendments, serious AEs,INDs), expedited matters, info items, and pertinent correspondence to investigators (your study is closed because you didn't submit a request to renew your approval) - new study information that includes a full protocol, full application form (ours is a few pages long) and an informed consent in our institutions format - materials to the subcommittees. We have a Continuing/Final report committee, AEs/INDs committee and Amendment Committee. They review copies of all the materials the IRB Office gets in for these areas. Rebecca Rebecca M. Clark Scripps Health/Children's Hospital IRBs San Diego, CA (858) 576-4008 rebcaclark@aol.com
Rebecca M. Clark 7/17/2000 2:37:00 AM

Packet to IRB members

An attendance notice, agenda, minutes from previous meeting, one full protocol for review, partial (missing the sponsor's protocol) protocols to be reviewed, annual, continuation, and final reports, any articles of interest. >>> srichmond@shc.org 07/14/00 05:07PM >>> Please provide information on what you include in the IRB packet to Committee members the week prior to the meeting. Thank you _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Dee Long 7/17/2000 2:40:00 AM

student representative

We have a graduate student from psychology serve as a voting member on a one year appointment. Nanci Stewart Woods, Ph.D. Associate Professor of Psychology Coordinator, Undergraduate Psychology Austin Peay State University Clarkville, TN 37044 931-221-7236 woodsn@apsu.edu -----Original Message----- From: Susie Hayes [mailto:slhayes@msuvx2.memphis.edu] Sent: Friday, July 14, 2000 11:48 AM To: mcwirb@mcwirb.org Subject: student representative We are currently filling vacancies on our IRB. Since many of the subjects tend to be students, we are looking at the possibility of having a student serve on the board. Do any institutions have a student representative on the IRB? If so, in what capacity (voting or non-voting). What are some of the pros and cons of having a student serve? Thanks in advance. Susie Hayes Compliance Coordinator University of Memphis slhayes@cc.memphis.edu _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Nanci Woods 7/17/2000 8:24:00 AM

community representatives

,Our IRB is seeking advice on how much to pay our community representatives. They provide an invaluable service and are a necessary and insightful component of the Board. I have spoken with administrators of several Boards and the honorarium ranges from $100/meeting to $50/hour including several hours of preparation time. Any advice would be appreciated.
Anonymous 7/17/2000 11:28:00 AM

Packet to IRB members

This is the short and simple. To every short & simple rule there is an exception. Erica 1. Agenda 2. Minutes of prior meeting 3. Discussion Items 3a Journal articles etc for continuing ed. 3b Reports 3bi Expedited reviews conducted 3bii Adverse events 3biii ad nauseum 4. Initial reviews 5. Continuing reviews 6. Major modifications 7. Returns from prior meetings Initial Reviews Protocol, consent document, CRFs, IB, ads and recruitment materials etc. Everyone gets full protocol and consent. Selected people get the rest unless it is of a manageable size. Continuing review CR report form, summary letter/report consent document used for the most recent enrollment. Selected people get the prior protocol. Erica >Please provide information on what you include in the IRB packet to Committee >members the week prior to the meeting. > >Thank you > > >_______________________________________________ >MCWIRB maillist - MCWIRB@mcwirb.org >http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb Erica Heath President, IRC 415-485-0717
heath 7/17/2000 2:41:00 AM

Recruiting community members

Dear Betty, Could study participants be consulted while entering a study if they are interested in participating for future IRB meetings? Perhaps as guests, in the same way some investigators may be invited to make comments but abstain from voting? I think experience from subjects is a delicate issue, anyway. But although they may be biased by their experience, they may provide a valid insight to the trial. Regards, Anne Blanchard Argentina
Anne 7/17/2000 2:34:00 AM

Archival data collection

Dear Members, Our IRB has been struggling with some aspects of archival data collection and we would like to pose the topic to the list-serv for input. What do institutional review boards consider archival data collection that requires the Board's review for exemption? Do they require investigators to go through a review if: a) they are new professors and brought data that was already collected and reviewed by another IRB with them to the new institution or b) they come on board as a collaborator/author after the data was reviewed and collected at another university. In both cases there is no active data collection from the archival data files. Thanks in advance for your help. Elisa Gaucher Florida Atlantic University
Anonymous 7/14/2000 5:01:00 AM
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