informed consent disclosures

Kelly: Our IRB deals with these questions fairly often, usually involving Department of Psychology surveys of minors or abuse survivors. PIs are required to inform potential subjects (minors and adults) in writing that if evidence of suicide risk or suspected recent abuse is uncovered as a result of the subject's survey responses, the PI is obligated to report these suspicions to the appropriate authorities. In the case of minors, this information must be provided both on the consent form for the parents and the assent form for the minor. Yes, this may mean that the PI loses potential subjects; however, our primary obligation is to the safety of the research subject, not to the PI's ability to recruit subjects. Timothy P. Stratton, Ph.D., R.Ph. Associate Professor of Pharmacy Administration School of Pharmacy and Allied Health Sciences The University of Montana-Missoula Member, UM IRB ph: (406) 243-2339 fax: (406) 243-4353 e-mail: timstrat@selway.umt.edu snail mail: Pharmacy Practice 32 Campus Drive #1522 Missoula, MT 59812-1522 -----Original Message----- From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of Kelly Carroll Sent: Tuesday, July 25, 2000 3:00 PM To: mcwirb@mcwirb.org Subject: informed consent disclosures I've recently received several enquiries from PI's about the degree to which they need to disclose the following types of information to subjects in informed consent forms: if the subject reveals (through interview or questionnaire response) that they may harm themselves or others, the investigator will have to take appropriate legal steps if the investigator believes that child abuse or elder abuse has occurred, they will have to report it to the proper authorities.
timstrat@selway.umt.edu 7/26/2000 9:43:00 AM

PRIM&R and ARENA to host annual IRB meetings!

PRIM&R and ARENA to host annual IRB meetings! Paradise Point Resort, San Diego, California – October 29-31, 2000 – Enormous changes are in the air as PRIM&R and ARENA prepare for their 26th annual meetings on institutional review boards (IRBs). While hopes are high that many HHS and other new initiatives will, in fact, result in improved protections for those who participate in research, concerns are also high that IRBs are under-resourced to effectively manage their ever-increasing loads. The October meetings will help IRBs: (1) balance requirements, desires, and realities; (2) develop educational offerings; (3) better understand what can be expected from the newly relocated Office of Human Research Protection (OHRP); and (4) learn about innovative and successful ways to build a better human research protection program. Public Responsibility in Medicine and Research (PRIM&R) and Applied Research Ethics National Association (ARENA), in cooperation with the University of California at San Diego and Tufts University School of Medicine are pleased to announce PRIM&R and ARENA’s 2000 annual IRB meetings as follows: PRIM&R – IRBs: Afloat in a Sea of Change This year’s annual PRIM&R meeting on October 29 and 30, jointly sponsored by Tufts University School of Medicine and the University of California at San Diego, will focus on the evolving relationship between the newly formed HHS Office for Human Research Protection (OHRP) and the community of regulated institutions. Dr. Greg Koski, OHRP’s newly appointed Director, will deliver the keynote address, and will participate actively in the entire meeting. Dr. Bernard Schwetz, Deputy Director of the Food and Drug Administration (FDA), will deliver the second day keynote address. Other plenary speakers will be Alex Capron, of the National Bioethics Advisory Commission (NBAC), and Gregory Carroll of the Bayer Institute of Health Care Communication. There will be panels on “best practices” for IRBs, reports from the NIH, NBAC, ORI, and the Office of the Inspector General, mini-debates on legal and ethical cases that will inform and entertain, and a panel of research subjects discussing their experiences of, and attitudes toward, participating in research. In over 45 workshops, a broad range of cutting-edge problems will be discussed, including a variety of genetics research issues, IRB educational responsibilities, conflicts of interest, international research, research with special populations (including children, prisoners, and persons with mental illnesses), those in multi-center trials, compliance concerns, privacy and confidentiality, the role of central review boards (CRBs), and the ongoing search for a new paradigm of partnership between the IRB, principal investigator (PI), research participant, sponsor, and federal government. A full program and registration form are posted on the PRIM&R Web site < http://www.primr.org>. Those who desire additional information or who would prefer to receive a registration form via fax or mail may contact the PRIM&R office by telephone (617) 423-4112, fax (617) 423-1185, or email <info@primr.org>. ARENA – IRBs: New Directions in 2000 ARENA will hold its 21st Annual IRB meeting in San Diego on October 31. IRBs are experiencing increased responsibilities at a time when research is becoming more complex each day. In our 2000 meeting we plan to focus on two topics: informed consent and education. The agenda will include a number of national experts on these two topics and research participants. We look forward to discussing these exciting issues with the research community. A full program and registration form is posted on the PRIM&R Web site <http://www.primr.org>. Those who desire additional information or who would prefer to receive a registration form via fax or mail may contact the PRIM&R office by telephone can contact the PRIM&R office by telephone (617) 423-4112, fax (617) 423-1185, or email <info
Anonymous 7/26/2000 4:23:00 AM

Alternative treatments

A Consent Form Question: Has anyone seen a guidance on the appropriateness of referring a patient to his/her primary care physician for information on alternative treatments, if any, that might be advantageous. This queston arises from a conversation about discussing alternative treatments with patients who use websites and other public information to seek out clinical trials as opposed to patients who are referred to the trial by physicians who review the patient's medical history with the PI. ---------------------------------------- Kay Ryan Email: Kay.Ryan@Med.Nyu.Edu NYU Medical Center
Kay . Ryan 7/26/2000 12:08:00 PM

Alternative treatments

>>> Dale E. Hammerschmidt 07/26/00 11:37AM >>> wrote: >Kay --- There are a couple points. First, alternative treatments is really not the point, and some of the regulatory language is suboptimal. The real point is alternatives to being in the study. After all, not every study is therapeutic in intent, and treatments are not the only important alternatives that a prospective subject may need to know about. (edit) ........................................................................................................................................................... Dale's comments are, of course, right on the mark. The relevant section of our template for the Consent Document ( http://www.ihc.com/ldsh/irb/consent_template.html) uses that suggested by the NCI : http://cancertrials.nci.nih.gov/researchers/safeguards/consent/template.html This is the pertinent section from the latter : WHAT OTHER OPTIONS ARE THERE? Instead of being in this study, you have these options: [List alternatives including commonly-used therapy and No therapy at this time with care to help you feel more comfortable.] [If appropriate (for noninvestigational treatments):] You may get __________________ (STUDY TREATMENTS/DRUGS AT THIS CENTER AND OTHER CENTERS) even if you do not take part in the study. Please talk to your regular doctor about these and other options. [Reference and attach information about alternatives.] Regards, Howard
Howard Mann 7/26/2000 12:06:00 PM

Labels for IRB Actions

It is important to consider the following advice from the OPRR (now OHRP) document entitled OPRR Compliance Activities: Common Findings and Guidance (11/29/99) available on the website (ohrp.osophs.dhhs.gov/) when considering IRB approval contingent upon modifications: (5) Contingent Approval of Research with Substantive Changes and no Additional Review by the Convened IRB. OPRR finds that the IRB frequently approves research contingent upon substantive modifications or clarifications without requiring additional review by the convened IRB. OPRR recommends the following guidelines in such cases: (i) When the convened IRB requests substantive clarifications, protocol modifications, or informed consent document revisions, IRB approval of the proposed research must be deferred pending subsequent review by the convened IRB of responsive material. (ii) Only when the convened IRB stipulates specific revisions requiring simple concurrence by the investigator may the IRB Chair or designated reviewer subsequently approve the research on behalf of the IRB. 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: Workman, Don [mailto:Don.Workman@stjude.org] Sent: Tuesday, July 25, 2000 11:02 AM To: mcwirb@mcwirb.org Subject: Labels for IRB Actions At a recent conference, I became engaged in an interesting dialogue regarding the labels various IRBs use to describe the actions taken by the Committee. Most seem to agree that approval and disapproval are straightforward along with tabled, but what about those protocols and Informed Consent Forms that would be approved if only minor changes were made. It seems that some IRBs entertain motions to find the protocol and ICF approvable pending modification and then designate whether the changes are substantive (requiring it to come back to full committee) or not (allowing for Chairman review of the minor changes). Another option is to entertain a motion that minor modifications are required and indicate whether administrative approval by the Chair may be done without going back to the full committee. It seems the advantage to the label approvable pending modification is that it states full committee approval, with the contingency specified. The disadvantage is that it implies approval when approval has not yet been granted (and may be misread by the Investigator who reads too quickly and perceives what s/he wishes to read rather than what is there). The advantage of minor modification required is that it avoids the confusion of wording, but the wording does not designate approval from the full committee, implying that the Chair can give approval to studies not appropriate for expedited review. Three questions emerge in my thinking. First, is this type of action common to IRBs? Second, what wording do other IRBs use to designate this kind of action and what thoughts might be offered from MCWIRBers regarding the best practice for labeling these kinds of committee actions? And third, which date becomes the date of IRB approval; the date of the Committee action or the date of Chair review and approval? Don E. Workman, Ph.D. IRB Administrator St. Jude Children's Research Hospital 332 N. Lauderdale Memphis, TN 38101 901-495-4359 _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Evelyn Studer 7/26/2000 5:19:00 AM

Labels for IRB Actions

We need to remember that this is just advice and not codified. I think it is unworkable if interpreted too strictly. We often get restrictions from the IRB such as reconcile the 3 needle sticks mentioned in the protocol with 4 called for in the consent form. This is not something we can rephrase for a PI's simple concurrence and yet it would be absurd to delay the project a whole month because of this discrepancy (assuming, of course, that the IRB has indicated that either number is OK and they just want to eliminate the discrepancy). --Bill Sellers, Wright State University Studer, Evelyn J. wrote: > It is important to consider the following advice from the OPRR (now OHRP) > document entitled OPRR Compliance Activities: Common Findings and > Guidance (11/29/99) available on the website (ohrp.osophs.dhhs.gov/) when > considering IRB approval contingent upon modifications: > > (5) Contingent Approval of Research with Substantive Changes and no > Additional Review by the Convened IRB. OPRR finds that the IRB frequently > approves research contingent upon substantive modifications or > clarifications without requiring additional review by the convened IRB. > OPRR recommends the following guidelines in such cases: (i) When the > convened IRB requests substantive clarifications, protocol modifications, or > informed consent document revisions, IRB approval of the proposed research > must be deferred pending subsequent review by the convened IRB of responsive > material. (ii) Only when the convened IRB stipulates specific revisions > requiring simple concurrence by the investigator may the IRB Chair or > designated reviewer subsequently approve the research on behalf of the IRB.
William Sellers 7/26/2000 9:31:00 AM

(no subject)

Hi...On July 19, 2000 there was a message sent to the listserve that indicated, 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. Please be advised that this is not true. The Chair is not paid a % of the IRB application fee at the University of Miami. Steven G. Ullmann, Ph.D. Vice Provost for Faculty Affairs and University Administration and Dean of the Graduate School 305-284-2002 phone 305-284-6758 fax
Steven G . 7/26/2000 2:58:00 AM

Recruiting Patients

Jeanne --- This sort of recruiting practice was common when I was a trainee, and people still do it. It's because they haven't thought through the implications and because they don't know the rules. It's usually a well-intentioned mistake. But it is a mistake. And in this specific case, it's a potentially bad one, because people with positive blood cultures will disproportionately be people who are especially vulnerable and will predictably include many who cannot give consent and some who are near death with the grieving family at the bedside. Some hospitals have as part of their routine consent-to-treat process a provision that patients are asked for permission for the intramural research use of their medical records ... and very few patients object. So it MAY have been OK for the investigator to get the information. But that's qualitatively different from using the information to invade the patient's privacy. Ordinarily, it's pretty easy to do this right. The investigator approaches the physician actually caring for the patients of interest. The physician, if there's no reason for unusual concern, asks the patient if it's OK to have a researcher stop by and discuss a research study. The patient says 'yes' or the patient says 'no.' Caveat: If the institution does NOT solicit routine consent for intramural research/teaching use of clinical data, the question of the investigator's access even to the lab information gets more difficult. And of course, one may challenge such consent in any event, as patients get asked to sign a bazillion papers and may not have noticed this provision --- especially if they were frightened or in pain. (Two years ago, I was hospitalized with an esophageal laceration [I have no future as a sword-swallower], and it took great self-control to find and cross out the two provisions I objected to.) dale
Dale Hammerschmidt 7/26/2000 9:31:00 AM

informed consent disclosures

Kelly, The Florida university was the University of South Florida. The law suit did not go to trial, so USF did not lose. They settled for $3.8 million. The details should be of interest to every IRB member and administrator. I think that everyone should read the March 20, 2000 National Law Journal article. I found it archived at www.law.com. The following URL may work: http://www.law.com/cgi-bin/gx.cgi/AppLogic+FTContentServer?pagename=law/View &c=Article&cid=A19220-2000Mar21&live=true&cst=1&pc=0&pa=0 If not, search the site for informed consent. Unfortunately, it is a violation of their terms and conditions to post it to the list. This was a class action suit on behalf of several thousand women who were enrolled in various protocols during pregnancy. There was no attempt to allege any physical damage to any mother or child. The researchers had signed consent forms for every subject. The allegation was that the consent was not valid because the women did not understand what they were signing. This was considered by the plaintiffs to be a civil rights violation. Andrew Cockburn, PhD Director of Institutional Research Compliance/Biological Safety West Virginia University Morgantown, WV 26506-9006 Telephone: 304-293-7157 FAX: 304-293-4529 Email: acockbur@wvu.edu > -----Original Message----- > From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf > Of Kelly Carroll > Sent: Tuesday, July 25, 2000 5:00 PM > To: mcwirb@mcwirb.org > Subject: informed consent disclosures > > > > I've recently received several enquiries from PI's about the degree to > which they need to disclose the following types of information to > subjects > in informed consent forms: > > if the subject reveals (through interview or questionnaire response) that > they may harm themselves or others, > the investigator will have to take appropriate legal steps > > if the investigator believes that child abuse or elder abuse has > occurred, > they will have to report it to the proper authorities. > > The IRB clearly must assess risk to the subject and make sure that the > subject is fully informed of these risks before the subject consents to > participate in the study. The PI's concerns are that by > notifying subjects > of possible, but in their eyes unlikely, risks such as those mentioned > above, they will lose subjects. These are non-biomedical > protocols and in > many cases the PI's are not mandated reporters of such matters > according to > state law. Insight on how your IRB, especially non-bio medical IRB's, > handle this issue is appreciated. Also, if there are clear > guidelines for > this type of issue, legal precedent, OHRP citations concerning this, > etc. that would be helpful. > > Finally, does anyone have information on the Florida university that > recently lost a 60 million class action case for not properly obtained > informed consent from labor and delivery subjects? > > Thanks Kelly > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb >
Andrew Cockburn 7/26/2000 9:38:00 AM

Labels for IRB Actions

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_01BFF705.7E758E56 Content-Type: text/plain Don, We use 'Approved as submitted', 'Approved with the following revisions', 'Deferred', or, on rare occasion, 'Disapproved'. The following is taken from our notice form: APPROVED AS SUBMITTED (The Annual/Interim Report of the Status of Approved Human Experimentation Protocol has to be submitted for approval by the {Institutional identification} IRB NO LATER than . Due to guidelines that the IRB must follow, research CANNOT BE CONTINUED after the above date until the Annual/Interim Report is received and approved by the {Institutional identification} IRB.) APPROVED WITH THE FOLLOWING REVISIONS (If revisions are required, your study may not be undertaken until the revisions have been submitted to and have been given final approval by the {Institutional identification} IRB.) DEFERRED The IRB Chair will review revisions unless the IRB specifies subcommittee or full board review, the latter is when deferred is generally used. The approval date becomes the date final approval was given, i.e. all revisions have been made and approved by the IRB. 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: Workman, Don [SMTP:Don.Workman@stjude.org] > Sent: Tuesday, July 25, 2000 11:02 AM > To: mcwirb@mcwirb.org > Subject: Labels for IRB Actions > > At a recent conference, I became engaged in an interesting dialogue > regarding the labels various IRBs use to describe the actions taken by the > Committee. Most seem to agree that approval and disapproval are > straightforward along with tabled, but what about those protocols and > Informed Consent Forms that would be approved if only minor changes were > made. It seems that some IRBs entertain motions to find the protocol and > ICF approvable pending modification and then designate whether the > changes > are substantive (requiring it to come back to full committee) or not > (allowing for Chairman review of the minor changes). Another option is to > entertain a motion that minor modifications are required and indicate > whether administrative approval by the Chair may be done without going > back > to the full committee. > > It seems the advantage to the label approvable pending modification is > that it states full committee approval, with the contingency specified. > The > disadvantage is that it implies approval when approval has not yet been > granted (and may be misread by the Investigator who reads too quickly and > perceives what s/he wishes to read rather than what is there). The > advantage of minor modification required is that it avoids the confusion > of wording, but the wording does not designate approval from the full > committee, implying that the Chair can give approval to studies not > appropriate for expedited review. > > Three questions emerge in my thinking. First, is this type of action > common > to IRBs? Second, what wording do other IRBs use to designate this kind of > action and what thoughts might be offered from MCWIRBers regarding the > best > practice for labeling these kinds of committee actions? And third, which > date becomes the date of IRB approval; the date of the Committee action or > the date of Chair review and approval? > > Don E. Workman, Ph.D. > IRB Administrator > > St. Jude Children's Research Hospital > 332 N. Lauderdale > Memphis, TN 38101 > 901-495-4359 > > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb ------_=_NextPart_001_01BFF705.7E758E56 Content-Type: text/html Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: Labels for IRB Actions Don, We use 'Approved as = submitted', 'Approved with the following revisions', 'Deferred', or, on = rare occasion, 'Disapproved'.    The following is taken = from our notice form:         =         =         APPROVED AS SUBMITTED   (The Annual/Interim Report of the Status of = Approved Human Experimentation Protocol has to be submitted for = approval by the {Institutional identification} IRB = NO LATER = than   .  Due to guidelines that the IRB must follow, = research CANNOT BE CONTINUED after the above date until the = Annual/Interim Report is received and approved by = the {Institutional = identification}   IRB.)         =         =         APPROVED WITH THE FOLLOWING REVISIONS   (If revisions are required, your study = may not be = undertaken until the revisions have been submitted to and have been = given final approval by the {Institutional = identification}   IRB.)         =         =         DEFERRED The IRB Chair will = review revisions unless the IRB specifies subcommittee or full board = review, the latter is when deferred is generally used.  The = approval date becomes the date final approval was given, i.e. all = revisions have been made and approved by the IRB. 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:   Workman, Don = [SMTP:Don.Workman@stjude.org] Sent:   Tuesday, July 25, 2000 11:02 AM To:     mcwirb@mcwirb.org Subject:        = Labels for IRB Actions At a recent conference, I became = engaged in an interesting dialogue regarding the labels various IRBs use = to describe the actions taken by the Committee.  Most seem to agree = that "approval" and "disapproval" are straightforward along with = "tabled," but what about those protocols and Informed Consent Forms that would be = approved if only minor changes were made.  It seems that some IRBs = entertain motions to find the protocol and ICF "approvable pending = modification" and then designate whether the changes are substantive (requiring it to come = back to full committee) or not (allowing for Chairman review of the = minor changes).  Another option is to entertain a motion that "minor = modifications are required" and indicate whether administrative approval by = the Chair may be done without going back to the full committee.  It seems the advantage to the label = "approvable pending modification" is that it states full committee = approval, with the contingency specified.  The disadvantage is that it implies = approval when approval has not yet been granted (and may be misread by the = Investigator who reads too quickly and perceives what s/he wishes to read = rather than what is there).  The advantage of "minor modification = required" is that it avoids the confusion of wording, but the wording does not = designate approval from the full committee, implying that the Chair = can give approval to studies not appropriate for expedited = review. Three questions emerge in my = thinking.  First, is this type of action common to IRBs?  Second, what wording = do other IRBs use to designate this kind of action and what thoughts might be = offered from MCWIRBers regarding the "best practice" for labeling these = kinds of committee actions?  And third, which date becomes the date of IRB = approval; the date of the Committee action or the date of Chair review and = approval? Don E. Workman, Ph.D. IRB Administrator St. Jude Children's Research = Hospital 332 N. Lauderdale Memphis, TN 38101 901-495-4359 _______________________________________________ MCWIRB maillist  -  = MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb <= /FONT> ------_=_NextPart_001_01BFF705.7E758E56--
Betty Dunger 7/26/2000 4:31:00 AM

Labels for IRB Actions

We had a similar problem -- PI's reading until they saw the one word approved -- so we use a separate, specific certification letter. Until the PI gets the certification, he or she cannot begin the project. This avoids all the confusion; if it isn't certified, it can't be started. David McGowan -----Original Message----- From: Jon Hart [mailto:hart@mail.rockefeller.edu] Sent: Wednesday, July 26, 2000 10:52 To: mcwirb@mcwirb.org; Workman, Don Subject: Re: Labels for IRB Actions In my experience, this is a common practice (in the 3 IRBs I have been a member of in the present and past). I would caution against the use of any form of the word approved in conditionally approving a protocol pending minor revisions (usually things like typos, changing some technical terms into lay language, etc.) as my experience is once an investigator spots that word, he/she stops reading. I once asked OPRR what we should use for the approval date, and was told we should use the date the final and complete approval takes place (usually by the Chair) (OHRP people: if you've changed your policy please weigh in). At one institution, we categorized this kind of committee response as Minor Modifications Needed which seemed to work well. Jon Hart At 10:01 AM 7/25/00 -0500, you wrote: >At a recent conference, I became engaged in an interesting dialogue >regarding the labels various IRBs use to describe the actions taken by the >Committee. Most seem to agree that approval and disapproval are >straightforward along with tabled, but what about those protocols and >Informed Consent Forms that would be approved if only minor changes were >made. It seems that some IRBs entertain motions to find the protocol and >ICF approvable pending modification and then designate whether the changes >are substantive (requiring it to come back to full committee) or not >(allowing for Chairman review of the minor changes). Another option is to >entertain a motion that minor modifications are required and indicate >whether administrative approval by the Chair may be done without going back >to the full committee. > >It seems the advantage to the label approvable pending modification is >that it states full committee approval, with the contingency specified. The >disadvantage is that it implies approval when approval has not yet been >granted (and may be misread by the Investigator who reads too quickly and >perceives what s/he wishes to read rather than what is there). The >advantage of minor modification required is that it avoids the confusion >of wording, but the wording does not designate approval from the full >committee, implying that the Chair can give approval to studies not >appropriate for expedited review. > >Three questions emerge in my thinking. First, is this type of action common >to IRBs? Second, what wording do other IRBs use to designate this kind of >action and what thoughts might be offered from MCWIRBers regarding the best >practice for labeling these kinds of committee actions? And third, which >date becomes the date of IRB approval; the date of the Committee action or >the date of Chair review and approval? > >Don E. Workman, Ph.D. >IRB Administrator > >St. Jude Children's Research Hospital >332 N. Lauderdale >Memphis, TN 38101 >901-495-4359 > > > >_______________________________________________ >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 _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
David G 7/26/2000 12:08:00 PM

informed consent disclosures

One case of which I am aware is the University of South Florida case, which according to the Tampa Tribune of 3/11/00 was settled for $3.8 million. Perhaps that newspaper has searchable archives that you may be able to access on-line. Elyse I. Summers, J.D. Division of Human Subjects Protection OHRP 6100 Executive Blvd., Ste. 3B01 (MSC 7507) Rockville, MD 20892-7507 ph.301-402-5559 fax.301-402-2071
Elyse Od 7/26/2000 9:43:00 AM

Alternative treatments

>>> Dale E. Hammerschmidt 07/26/00 11:37AM >>> wrote: >Kay --- There are a couple points. First, alternative treatments is really not the point, and some of the regulatory language is suboptimal. The real point is alternatives to being in the study. After all, not every study is therapeutic in intent, and treatments are not the only important alternatives that a prospective subject may need to know about. (edit) ........................................................................................................................................................... Dale's comments are, of course, right on the mark. The relevant section of our template for the Consent Document ( http://www.ihc.com/ldsh/irb/consent_template.html) uses that suggested by the NCI : http://cancertrials.nci.nih.gov/researchers/safeguards/consent/template.html This is the pertinent section from the latter : WHAT OTHER OPTIONS ARE THERE? Instead of being in this study, you have these options: [List alternatives including commonly-used therapy and No therapy at this time with care to help you feel more comfortable.] [If appropriate (for noninvestigational treatments):] You may get __________________ (STUDY TREATMENTS/DRUGS AT THIS CENTER AND OTHER CENTERS) even if you do not take part in the study. Please talk to your regular doctor about these and other options. [Reference and attach information about alternatives.] Regards, Howard
Howard Mann 7/26/2000 12:08:00 PM

Recruiting Patients

I am curious as to what is meant here by intramural research. For example, if the infection control nurse periodically reviews positive blood cultures by unit looking for pathogen or resistance trends with the aim of reducing risk of nosocomial infection, would that be considered intramural research? How about if there is an outbreak of aspergillosis on the oncology ward, and this nurse publishes her findings. Does this require IRB review and (retrospective) informed consent? Who provides the informed consent for those aspergillosis patients who died of their infection? If a county health department screened a high risk pediatric population for lead poisoning, analyzed the data by geographic region, and published the deidentified results, would that require that their parent or guardian give informed consent? Are you suggesting that epidemiology projects, quality assurance projects, healthcare community needs assessments, and healthcare improvement projects require IRB approval? If a doctor is using a palm pilot to manage his practice, and decides to calculate the mean and standard deviation of systolic blood pressures in his practice, does that require IRB approval and informed consent? How about if a munincipality notices that a certain intersection has a statistically higher risk of traffic fatalities, and they make changes and monitor them to see if fewer accidents occur. Is that intramural research? Does it require IRB review? Informed consent by the drivers? -Steven -- Steven Belknap, M.D. Assistant Professor of Clinical Pharmacology and Medicine University of Illinois College of Medicine at Peoria
Steven Belknap 7/26/2000 12:18:00 PM

Crash and recovery

Folks: I recently had a computer crash that, among other delights, destroyed my received-e-mail cache. Although I was able to rebuild the hard disk directory and recover over 99% of my files, that one remains an interesting 20+-megabyte interleaving of messages, BINHex code, UUCode and b64MIME code (it seems to have taken all attachments and interleaved them .... interesting conceptually, but...) Unfortunately, for some communications with other mcwirbers, the copy of a message in that cache was my only copy of the person's e-mail address, and may very well be my only copy of preliminary communication about speaking engagements, promised reprints, consulting visits and the like. If anybody out there is feeling grumpy because I haven't responded to something, please send me a new e-mail at your earliest convenience. And don't open any headerless e-mails (that was the event immediately preceding the crash). And Norton Filesaver really WILL rebuild your directory if it gets trashed. I went from a hard drive that was recognized as blank and unformatted to one that worked fine and had lost little in less than two hours. dale
Dale Hammerschmidt 7/26/2000 9:29:00 AM

SAE Reporting

This is a multi-part message in MIME format. ------=_NextPart_000_006D_01BFF70A.BAC5EBD0 Content-Type: text/plain; charset=iso-8859-1 Content-Transfer-Encoding: quoted-printable We are currently having a discussion (disagreement )concerning the = reformation of our IRB forms that the PIs complete when reporting SAEs. How much information is required by regulations? Is the typical = information required by a sponsor considered too much information for = the requirements of the IRB? I would appreciate all advice and/or suggestions. Thanks. Robin A. Simuncak Assistant Director IRB Medical College of Wisconsin ------=_NextPart_000_006D_01BFF70A.BAC5EBD0 Content-Type: text/html; charset=iso-8859-1 Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 4.0 Transitional//EN> We are currently having a discussion = (disagreement=20 )concerning the reformation of our IRB forms that the PIs complete = when=20 reporting SAEs.   How much information is required by=20 regulations?  Is the typical information required by a sponsor = considered=20 too much information for the requirements of the IRB?   I would appreciate all advice and/or=20 suggestions.   Thanks.   Robin A. Simuncak Assistant Director IRB Medical College of=20 Wisconsin ------=_NextPart_000_006D_01BFF70A.BAC5EBD0--
Robin Simuncak 7/26/2000 12:02:00 PM

Alternative treatments

>Kay --- There are a couple points. First, alternative treatments is really not the point, and some of the regulatory language is suboptimal. The real point is alternatives to being in the study. After all, not every study is therapeutic in intent, and treatments are not the only important alternatives that a prospective subject may need to know about. Second, the person conducting a study may have expertise in only the aspect of the disease in question that relates most directly to the study hypothesis. He may be a pharmacologist with expertise in the kinetics of HMGCoA reductase inhibitors, and the alternative treatments appropriate for a patient might be things requiring a seasoned clinician with credentials in internal medicine. Third, the appropriate alternative treatments for a group of patients may be so varied that a discussion in the CF will be either hopelessly complex or uselessly superficial. In thinking about this issue, I find it useful to get away from the unfortunate phrase alternative treatments, and try to think instead of the patient's appropriate questions: 1) What will happen or be recommended if I decide not to be in the study? --- and --- 2) If I enter the study, how will my treatment be different from what would happen if I chose to be treated without being in the study? --- and in the case of a novel therapy --- 3) Can I get the new therapy without being in the study? So what it's appropriate to say may vary a lot according to the details of the study and the patient population providing the subjects. And who ought to say it may vary according to expertise and to the nature of the relationship between the patients/subjects and the investigator. And how much belongs in the CF depends on how coherently the issues can be addressed there. Pretty often, it may turn out that it's appropriate for the CF to provide only rather broad generalities, and for the patient indeed to re-consult his or her own physician if the decision is against study participation, or if a decision cannot be reached without further input from a clinician outside of the study. Make sure those questions get answered, you'll be doing well. Dale H.
Dale Hammerschmidt 7/26/2000 9:31:00 AM

Labels for IRB Actions

In my experience, this is a common practice (in the 3 IRBs I have been a member of in the present and past). I would caution against the use of any form of the word approved in conditionally approving a protocol pending minor revisions (usually things like typos, changing some technical terms into lay language, etc.) as my experience is once an investigator spots that word, he/she stops reading. I once asked OPRR what we should use for the approval date, and was told we should use the date the final and complete approval takes place (usually by the Chair) (OHRP people: if you've changed your policy please weigh in). At one institution, we categorized this kind of committee response as Minor Modifications Needed which seemed to work well. Jon Hart At 10:01 AM 7/25/00 -0500, you wrote: >At a recent conference, I became engaged in an interesting dialogue >regarding the labels various IRBs use to describe the actions taken by the >Committee. Most seem to agree that approval and disapproval are >straightforward along with tabled, but what about those protocols and >Informed Consent Forms that would be approved if only minor changes were >made. It seems that some IRBs entertain motions to find the protocol and >ICF approvable pending modification and then designate whether the changes >are substantive (requiring it to come back to full committee) or not >(allowing for Chairman review of the minor changes). Another option is to >entertain a motion that minor modifications are required and indicate >whether administrative approval by the Chair may be done without going back >to the full committee. > >It seems the advantage to the label approvable pending modification is >that it states full committee approval, with the contingency specified. The >disadvantage is that it implies approval when approval has not yet been >granted (and may be misread by the Investigator who reads too quickly and >perceives what s/he wishes to read rather than what is there). The >advantage of minor modification required is that it avoids the confusion >of wording, but the wording does not designate approval from the full >committee, implying that the Chair can give approval to studies not >appropriate for expedited review. > >Three questions emerge in my thinking. First, is this type of action common >to IRBs? Second, what wording do other IRBs use to designate this kind of >action and what thoughts might be offered from MCWIRBers regarding the best >practice for labeling these kinds of committee actions? And third, which >date becomes the date of IRB approval; the date of the Committee action or >the date of Chair review and approval? > >Don E. Workman, Ph.D. >IRB Administrator > >St. Jude Children's Research Hospital >332 N. Lauderdale >Memphis, TN 38101 >901-495-4359 > > > >_______________________________________________ >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 7/26/2000 9:38:00 AM

Labels for IRB Actions

It is important to consider the following advice from the OPRR (now OHRP) document entitled OPRR Compliance Activities: Common Findings and Guidance (11/29/99) available on the website (ohrp.osophs.dhhs.gov/) when considering IRB approval contingent upon modifications: (5) Contingent Approval of Research with Substantive Changes and no Additional Review by the Convened IRB. OPRR finds that the IRB frequently approves research contingent upon substantive modifications or clarifications without requiring additional review by the convened IRB. OPRR recommends the following guidelines in such cases: (i) When the convened IRB requests substantive clarifications, protocol modifications, or informed consent document revisions, IRB approval of the proposed research must be deferred pending subsequent review by the convened IRB of responsive material. (ii) Only when the convened IRB stipulates specific revisions requiring simple concurrence by the investigator may the IRB Chair or designated reviewer subsequently approve the research on behalf of the IRB. Evelyn Studer, IRB Administrator Research Triangle Institute PO Box 12194 Research Triangle Park, NC 27709-2194 Phone: 919-541-6442 Fax: 919-541-7250 STUDER@rti.org
Evelyn Studer 7/26/2000 9:58:00 AM

Recruiting Patients

It is common to recruit patients for studies in somewhat similar ways. However, IMHO, what must happen is that someone who has the authority to review the chart/lab/whatever does so in order to identify the patients who would qualify for the study and then that person also broaches the subject of the study to the patient. The investigator, who has no privilege to the identity of the patient, cannot make contact until the patient has agreed to learn more about the study and agrees to meet with the investigator. Only then can the identity of the patient be revealed to the investigator. 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 Dan_Icenogle@icenogle.net. 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 Dan_Icenogle@icenogle.net 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 Gaffney, Jeanne Sent: Tuesday, July 25, 2000 3:22 PM To: 'mcwirb@mcwirb.org' Subject: Recruiting Patients I am Coordinator for the IRB of a hospital system (11 hospitals). The following situation just came to my attention today. If this scenario has been recently discussed on list, please forgive. It seems that a physician/researcher (pulmonologist) at one of our hospitals is recruiting patients for a sepsis study. This study currently has IRB approval by our local IRB. The question of recruiting practice did not come up at the meeting when the study was approved. It was assumed that he would be using his own practice patients. Today I received a call from the Micro Lab Director. It seems that the PI has requested from our microbiology lab, the names of hospital patients that have a positive blood culture, then approaches them about the study. I have been assured by our Quality Improvement Director that this is a breach of confidentially and that any information on/about the patient should be shared only with the attending physician. Since this has come up, I have found that at least one other physician within our system that is using this recruiting tool. Is this type of recruiting common practice within the hospital setting? Some departments within the hospital have access to patient's medical information/labwork, etc., via MIDAS and other software programs. Does it make a difference if the physician/researcher is a hospital employee? Jeanne Gaffney Human Research Review Board Baptist Health System Birmingham, AL 205/592-5700 205/592-5094 fax jeanne.gaffney@bhsala.com _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Icenogle & Associates 7/26/2000 9:32:00 AM

Labels for IRB Actions

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_01BFF705.7E758E56 Content-Type: text/plain Don, We use 'Approved as submitted', 'Approved with the following revisions', 'Deferred', or, on rare occasion, 'Disapproved'. The following is taken from our notice form: APPROVED AS SUBMITTED (The Annual/Interim Report of the Status of Approved Human Experimentation Protocol has to be submitted for approval by the {Institutional identification} IRB NO LATER than . Due to guidelines that the IRB must follow, research CANNOT BE CONTINUED after the above date until the Annual/Interim Report is received and approved by the {Institutional identification} IRB.) APPROVED WITH THE FOLLOWING REVISIONS (If revisions are required, your study may not be undertaken until the revisions have been submitted to and have been given final approval by the {Institutional identification} IRB.) DEFERRED The IRB Chair will review revisions unless the IRB specifies subcommittee or full board review, the latter is when deferred is generally used. The approval date becomes the date final approval was given, i.e. all revisions have been made and approved by the IRB. 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: Workman, Don [SMTP:Don.Workman@stjude.org] > Sent: Tuesday, July 25, 2000 11:02 AM > To: mcwirb@mcwirb.org > Subject: Labels for IRB Actions > > At a recent conference, I became engaged in an interesting dialogue > regarding the labels various IRBs use to describe the actions taken by the > Committee. Most seem to agree that approval and disapproval are > straightforward along with tabled, but what about those protocols and > Informed Consent Forms that would be approved if only minor changes were > made. It seems that some IRBs entertain motions to find the protocol and > ICF approvable pending modification and then designate whether the > changes > are substantive (requiring it to come back to full committee) or not > (allowing for Chairman review of the minor changes). Another option is to > entertain a motion that minor modifications are required and indicate > whether administrative approval by the Chair may be done without going > back > to the full committee. > > It seems the advantage to the label approvable pending modification is > that it states full committee approval, with the contingency specified. > The > disadvantage is that it implies approval when approval has not yet been > granted (and may be misread by the Investigator who reads too quickly and > perceives what s/he wishes to read rather than what is there). The > advantage of minor modification required is that it avoids the confusion > of wording, but the wording does not designate approval from the full > committee, implying that the Chair can give approval to studies not > appropriate for expedited review. > > Three questions emerge in my thinking. First, is this type of action > common > to IRBs? Second, what wording do other IRBs use to designate this kind of > action and what thoughts might be offered from MCWIRBers regarding the > best > practice for labeling these kinds of committee actions? And third, which > date becomes the date of IRB approval; the date of the Committee action or > the date of Chair review and approval? > > Don E. Workman, Ph.D. > IRB Administrator > > St. Jude Children's Research Hospital > 332 N. Lauderdale > Memphis, TN 38101 > 901-495-4359 > > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb ------_=_NextPart_001_01BFF705.7E758E56 Content-Type: text/html Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: Labels for IRB Actions Don, We use 'Approved as = submitted', 'Approved with the following revisions', 'Deferred', or, on = rare occasion, 'Disapproved'.    The following is taken = from our notice form:         =         =         APPROVED AS SUBMITTED   (The Annual/Interim Report of the Status of = Approved Human Experimentation Protocol has to be submitted for = approval by the {Institutional identification} IRB = NO LATER = than   .  Due to guidelines that the IRB must follow, = research CANNOT BE CONTINUED after the above date until the = Annual/Interim Report is received and approved by = the {Institutional = identification}   IRB.)         =         =         APPROVED WITH THE FOLLOWING REVISIONS   (If revisions are required, your study = may not be = undertaken until the revisions have been submitted to and have been = given final approval by the {Institutional = identification}   IRB.)         =         =         DEFERRED The IRB Chair will = review revisions unless the IRB specifies subcommittee or full board = review, the latter is when deferred is generally used.  The = approval date becomes the date final approval was given, i.e. all = revisions have been made and approved by the IRB. 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:   Workman, Don = [SMTP:Don.Workman@stjude.org] Sent:   Tuesday, July 25, 2000 11:02 AM To:     mcwirb@mcwirb.org Subject:        = Labels for IRB Actions At a recent conference, I became = engaged in an interesting dialogue regarding the labels various IRBs use = to describe the actions taken by the Committee.  Most seem to agree = that "approval" and "disapproval" are straightforward along with = "tabled," but what about those protocols and Informed Consent Forms that would be = approved if only minor changes were made.  It seems that some IRBs = entertain motions to find the protocol and ICF "approvable pending = modification" and then designate whether the changes are substantive (requiring it to come = back to full committee) or not (allowing for Chairman review of the = minor changes).  Another option is to entertain a motion that "minor = modifications are required" and indicate whether administrative approval by = the Chair may be done without going back to the full committee.  It seems the advantage to the label = "approvable pending modification" is that it states full committee = approval, with the contingency specified.  The disadvantage is that it implies = approval when approval has not yet been granted (and may be misread by the = Investigator who reads too quickly and perceives what s/he wishes to read = rather than what is there).  The advantage of "minor modification = required" is that it avoids the confusion of wording, but the wording does not = designate approval from the full committee, implying that the Chair = can give approval to studies not appropriate for expedited = review. Three questions emerge in my = thinking.  First, is this type of action common to IRBs?  Second, what wording = do other IRBs use to designate this kind of action and what thoughts might be = offered from MCWIRBers regarding the "best practice" for labeling these = kinds of committee actions?  And third, which date becomes the date of IRB = approval; the date of the Committee action or the date of Chair review and = approval? Don E. Workman, Ph.D. IRB Administrator St. Jude Children's Research = Hospital 332 N. Lauderdale Memphis, TN 38101 901-495-4359 _______________________________________________ MCWIRB maillist  -  = MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb <= /FONT> ------_=_NextPart_001_01BFF705.7E758E56--
Betty Dunger 7/26/2000 4:33:00 AM

Labels for IRB Actions

The OPRR guidelines seem to imply that there must be a "convened" IRB to review modifications to protocols and informed consent forms.  Since we are in the e-commerce age and since we find it difficult to schedule meetings of our IRB because of people's full calendars, we try to use email to do business where we can.  (We do not have regularly scheduled IRB meetings because of the small number of cases we process.)  A typical situation here:  The IRB meets in person to consider a case.  We develop a list of concerns and convey in writing to the PI as explicitly as possible what those concerns are and what would need to be done to satisfy the IRB.  As Chair, I usually make a follow-up call to the PI to ensure that he/she understands all the points in the letter.  Our PIs tend to be highly responsive [fortunately], and so when the PI sends back a revised protocol and informed consent form, more often than not it is fully satisfactory to the IRB.  When I receive the revised documents, I email them to the IRB members and ask them whether they feel that the PI has successfully addressed all of the concerns of the Board.  If the members all email a "yes" back to me, then it seems that there is no need for another face to face meeting.  At that point I can prepare and process the approval, (keeping on file copies of the emails to verify that the Board approved the modifications).  If one or more members of the Board feel that the PI has not adequately addressed the Board's concerns, then we can call a meeting and discuss it, but if we can handle most of the modified protocols/ICFs by email, we can act much more quickly than if we must "convene" follow-up meetings to review these documents. Brian Belanger IRB Chair, Natl. Institute of Standards and Technology brian.belanger@nist.gov At 01:29 PM 7/25/00 -0400, you wrote: >It is important to consider the following advice from the OPRR (now OHRP) >document entitled "OPRR Compliance Activities:  Common Findings and >Guidance" (11/29/99) available on the website (ohrp.osophs.dhhs.gov/) when >considering IRB approval contingent upon modifications: > >"(5) Contingent Approval of Research with Substantive Changes and no >Additional Review by the Convened IRB. OPRR finds that the IRB frequently >approves research contingent upon substantive modifications or >clarifications without requiring additional review by the convened IRB. >OPRR recommends the following guidelines in such cases: (i) When the >convened IRB requests substantive clarifications, protocol modifications, or >informed consent document revisions, IRB approval of the proposed research >must be deferred pending subsequent review by the convened IRB of responsive >material. (ii) Only when the convened IRB stipulates specific revisions >requiring simple concurrence by the investigator may the IRB Chair or >designated reviewer subsequently approve the research on behalf of the IRB." > >Evelyn Studer, IRB Administrator >Research Triangle Institute >PO Box 12194 >Research Triangle Park, NC  27709-2194 >919-541-6442 >STUDER@rti.org
Brian Belanger 7/26/2000 12:09:00 PM

Help Wanted!

In order to help institutions and IRBs develop institutional guidelines, IRB operating procedures, and investigator education programs, OHRP would like to put together a resource list of such documents that institutions could utilize as acceptable samples. If your institution would like to contribute to this undertaking, and if your institution has documents in electronic form that it is willing to share freely with the IRB community, please e-mail me directly (NOT THRU MCWIRB) at tp10y@nih.gov, including the to-be-shared documents via attachment or website link. Thanks very much! Tom Puglisi, PhD Director, Human Subject Protections Office for Human Research Protections tp10y@nih.gov / 301-402-5189
Tom Od 7/26/2000 3:46:00 AM

informed consent disclosures

I've recently received several enquiries from PI's about the degree to which they need to disclose the following types of information to subjects in informed consent forms: if the subject reveals (through interview or questionnaire response) that they may harm themselves or others, the investigator will have to take appropriate legal steps if the investigator believes that child abuse or elder abuse has occurred, they will have to report it to the proper authorities. The IRB clearly must assess risk to the subject and make sure that the subject is fully informed of these risks before the subject consents to participate in the study. The PI's concerns are that by notifying subjects of possible, but in their eyes unlikely, risks such as those mentioned above, they will lose subjects. These are non-biomedical protocols and in many cases the PI's are not mandated reporters of such matters according to state law. Insight on how your IRB, especially non-bio medical IRB's, handle this issue is appreciated. Also, if there are clear guidelines for this type of issue, legal precedent, OHRP citations concerning this, etc. that would be helpful. Finally, does anyone have information on the Florida university that recently lost a 60 million class action case for not properly obtained informed consent from labor and delivery subjects? Thanks Kelly
Kelly Carroll 7/26/2000 4:42:00 AM

Labels for IRB Actions

We had a similar problem -- PI's reading until they saw the one word approved -- so we use a separate, specific certification letter. Until the PI gets the certification, he or she cannot begin the project. This avoids all the confusion; if it isn't certified, it can't be started. David McGowan -----Original Message----- From: Jon Hart [mailto:hart@mail.rockefeller.edu] Sent: Wednesday, July 26, 2000 10:52 To: mcwirb@mcwirb.org; Workman, Don Subject: Re: Labels for IRB Actions In my experience, this is a common practice (in the 3 IRBs I have been a member of in the present and past). I would caution against the use of any form of the word approved in conditionally approving a protocol pending minor revisions (usually things like typos, changing some technical terms into lay language, etc.) as my experience is once an investigator spots that word, he/she stops reading. I once asked OPRR what we should use for the approval date, and was told we should use the date the final and complete approval takes place (usually by the Chair) (OHRP people: if you've changed your policy please weigh in). At one institution, we categorized this kind of committee response as Minor Modifications Needed which seemed to work well. Jon Hart At 10:01 AM 7/25/00 -0500, you wrote: >At a recent conference, I became engaged in an interesting dialogue >regarding the labels various IRBs use to describe the actions taken by the >Committee. Most seem to agree that approval and disapproval are >straightforward along with tabled, but what about those protocols and >Informed Consent Forms that would be approved if only minor changes were >made. It seems that some IRBs entertain motions to find the protocol and >ICF approvable pending modification and then designate whether the changes >are substantive (requiring it to come back to full committee) or not >(allowing for Chairman review of the minor changes). Another option is to >entertain a motion that minor modifications are required and indicate >whether administrative approval by the Chair may be done without going back >to the full committee. > >It seems the advantage to the label approvable pending modification is >that it states full committee approval, with the contingency specified. The >disadvantage is that it implies approval when approval has not yet been >granted (and may be misread by the Investigator who reads too quickly and >perceives what s/he wishes to read rather than what is there). The >advantage of minor modification required is that it avoids the confusion >of wording, but the wording does not designate approval from the full >committee, implying that the Chair can give approval to studies not >appropriate for expedited review. > >Three questions emerge in my thinking. First, is this type of action common >to IRBs? Second, what wording do other IRBs use to designate this kind of >action and what thoughts might be offered from MCWIRBers regarding the best >practice for labeling these kinds of committee actions? And third, which >date becomes the date of IRB approval; the date of the Committee action or >the date of Chair review and approval? > >Don E. Workman, Ph.D. >IRB Administrator > >St. Jude Children's Research Hospital >332 N. Lauderdale >Memphis, TN 38101 >901-495-4359 > > > >_______________________________________________ >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 _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
David G 7/26/2000 12:06:00 PM

Human Research Subjects Protection Act of 2000

I have developed a two part training program for our IRB members. The first part explains the IRB from an historical perspective and provides an overview of applicable federal regulations. The second part focuses on the actual operation of the IRB and includes several practical exercises. A part of the training also explains the role of the IRB in the correctional setting. I utilize the OHRP videotapes in the training. Since we are just getting started and have not begun to review protocols, I have not addressed PI training. (Mr.) Lanue B. Ryan, MA Senior Management Analyst & Executive Director Institutional Review Board Office of Health Services Florida Department of Corrections 2601 Blair Stone Road Tallahassee, FL  32399-2500 Phone: 850.922.6645 Fax: 850.487.8082 -----Original Message----- From: LaRusso, Sandra ARMC-Prof Svcs [mailto:LaRussoS@armc.co.san-bernardino.ca.us] Sent: Friday, July 21, 2000 4:09 PM To: 'mcwirb@mcwirb.org' Subject: RE: Human Research Subjects Protection Act of 2000 Wendy: We spend the first few minutes of each IRB meeting on an educational topic. I have also developed a newsletter that goes out to all IRB members, principal investigators, and department chairs. On a more formal note, I am in the process of putting together an educational binder for the IRB members. It will contain resource information and several self study modules. I do one-on-one orientations with all new IRB members. I have not started to work on anything specific for P.I.s as yet. Our standard operating procedures apply regardless of the funding source. > -----Original Message----- > From: Wendy Westling [SMTP:MSJ.CIAMXW@memo.msj.org] > Sent: Friday, July 21, 2000 11:33 AM > To: mcwirb@mcwirb.org > Subject: re: Human Research Subjects Protection Act of 2000 > > I would be interested in finding out what organizations without federally > funded studies are doing regarding providing education for PIs and IRB > members. > It does not appear that as yet, there are any federal educational > requirements > for PIs or others conducting human subject research that is industry > sponsored. > I would like to know what kind of educational programs are being offered > by > such organizations. Thank you for your response. > > Wendy Westling > IRB Chairperson > Mission St. Joseph's Health System > Asheville, NC > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Anonymous User 7/25/2000 7:29:00 AM

Human Research Subjects Protection Act of 2000

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
Anonymous 7/25/2000 7:29:00 AM

? about informed consent

I was absolutely sure that I had read somewhere that conducting interviews could be considered, in some instances, to be like questionaires; i.e., that if no identifying characteristics were collected and no harm could come to the subjects, then informed consent was not necessary. The idea was that the simple act of answering the questions was equivalent to giving informed consent. Now I can't find where I had read this information. Am I just imagining having read this in some guidelines (could be US or Canadian), or does someone have a reference. This would help greatly with a paper I am currently writing. Thanks, Janice
Janice Singer 7/25/2000 6:15:00 AM

Survey of College Freshmen

This question is directed at university IRBs. It involves the Cooperative Institutional Research Program survey that is given to all incoming university freshmen at (we are told) over 200 universities. Results are tabulated at UCLA and published for the academic community. The survey was exempted by UCLA's IRB several years ago although the questions change from year-to-year. We at Georgia Tech began examining this survey a year ago after a parent complained that her 17 year-old daughter was required to take the survey in order to register for college, that parental permission was not sought, and that it contained sensitive questions. Our IRB had never been sent an application because the survey was declared exempt at its source and our local PI thought that eliminated need for local review. Our IRB just received a protocol for this year's survey and again have serious problems with it. (At our IRB's direction, students under 18 are now excluded from the survey here.) The survey is still claimed to be exempt. CIRP still claims that there are no sensitive questions -- yet it asks students about their alcohol consumption (a crime), whether they suffer from depression (a health problem that could affect future employability and insurability), their political and moral views, and family history. They must provide their full name and social security number to allow followup. At our insistence, the survey forms given to Georgia Tech freshmen must emphasize that completion of any or all questions is voluntary. Yet, proctors are told to convince the reluctant students to complete the forms. It's hard to imagine a group more vulnerable to coercion than college freshmen on their first day away from home. I'd like to hear from other university IRBs about their knowledge and handling of this national survey. I'm told that we're the only IRB that has voiced any concerns about the survey. Thanks for your comments. Mike Kelly IRB Chair Georgia Tech
Mike Kelly 7/25/2000 6:25:00 AM

Web-based Surveys

>From our local newspaper last week: Fifty-five percent of employers are monitoring their workers' Internet use, and 38 percent examine workers' e-mail messages, according to a survey by the American Management Association. Another survey by Angus Reid Group found 73 percent of employees agreed with their employers' right to minotor their e-mail and Internet use at work. However, 46 percent admitted they surf the Web for personal reasons at work, and 55 percent sent and [received personal e-mails]. If you access the American Management Association web page, there are additional research results posted that indicate on average employees are informed of such monitoring about 83.5% of the time in the sectors AMA queried (mfg, finan. Svcs, wholesale/retail, bus/prof services, public adm, other non-profit). Among other significant issues associated with research conducted on the web remains the question of confidentiality. When aspects of the research relate to matters which could influence insurability, employability, or reputation within the organization if the personal information became known, one may need to ask whether the web is the medium of choice. _________________________________________________________ Celia S. Walker Director, Regulatory Compliance 410 University Services Center Colorado State University Fort Collins, CO 80523-2046 970-491-1563 (v) 970-491-2293 (fax) cwalker@research.colostate.edu Regulatory Compliance web site: http://www.research.colostate.edu/regulatory
Celia 7/24/2000 8:41:00 AM

genetic samples/long-term use

Our Independent Ethics Committee is seeing increasing numbers of pharmacogenetic sub-studies tacked on to clinical drug trials. These are generally to search for genes or genetic markers involved in the disease of interest, or response to treatments for the specific disease. In most cases, the samples remain linked to identifying information for some specified duration related to exploration of the specific disease/treatment that is the focus of the clinical trial. Request is commonly made for separate consent to then destroy the linkage (annonymize the sample) and keep the annonymous sample indefinitely for research into other diseases and treatments. Recently, however, we reviewed a protocol wishing to keep the sample linked for 50 years, to study the disease/treatment related to the trial, and then other diseases/treatments. Subjects would retain the right to have their sample destroyed at any time. We had a big problem with this (among other things, without further input about what research was taking place over time, how would subjects know when to exercise their right to withdraw their sample?) and requested a study design more in line with the format described above. Of course the sponsor is not happy with our stand. Has anyone else encountered such a design? What was your response? Thanks, Nancy Ondrusek
Nancy Ondrusek 7/24/2000 11:47:00 AM

placebos

If anyone is still following this debate, the following reference is worth looking at. It is a review paper by Aspinall and Goodman, from the BMJ in 1995, looking at placebo controlled trials of Ondansetron for control of post-operative nausea and vomiting, a condition for which there was clearly an alternative treatment available. By the authors' estimate, some 2180 patients had been given placebo as prophylaxis and 440 had been given placebo when already experiencing postoperative nausea or vomiting. http://www.bmj.com/cgi/content/full/311/7009/844 Paul Wainwright
Paul 7/24/2000 8:39:00 AM

Looking for out of print book

Hi, I hope someone can help me. I am currently searching for Faden, King, & Beauchamp's, A history and theory of informed consent., and Sieber's, Planning ethically responsible research. If you have a copy you would like to sell, please contact me. (I can only lend them from my library for 2 weeks at a time, and that is never long enough!). Janice Singer janice.singer@nrc.ca
Janice Singer 7/24/2000 8:41:00 AM

Human Research Subjects Protection Act of 2000

The University of Pennsylvania has been working on and will institute mid-August a 4 hour web based educational program for researchers performing clinical trials.  It contains four modules (ethics, IRB, GCP, Conflict of Interest).  At 01:32 PM 7/21/00 -0500, you wrote: >I would be interested in finding out what organizations without federally >funded studies are doing regarding providing education for PIs and IRB members. > It does not appear that as yet, there are any federal educational requirements >for PIs or others conducting human subject research that is industry sponsored. >I would like to know what kind of educational programs are being offered by >such organizations.  Thank you for your response. > >Wendy Westling >IRB Chairperson >Mission St. Joseph's Health System >Asheville, NC > > >_______________________________________________ >MCWIRB maillist  -  MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb > +++++++++++++++++++++++++++++++++++++++++++++++++++++ Marcia D. Markowitz, Director     Phone:    (215)662-4253 Office of Clinical Trials                     Fax:    (215)662-4939 University of Pennsylvania                  E-mail:     mmarkowi@mail. 3620 Hamilton Walk 151 Anatomy/Chemistry Philadelphia, PA 19104-6061 +++++++++++++++++++++++++++++++++++++++++++++++++++++
Marcia D . Markowitz 7/24/2000 2:41:00 AM

Web-based Surveys

>From our local newspaper last week: Fifty-five percent of employers are monitoring their workers' Internet use, and 38 percent examine workers' e-mail messages, according to a survey by the American Management Association. Another survey by Angus Reid Group found 73 percent of employees agreed with their employers' right to minotor their e-mail and Internet use at work. However, 46 percent admitted they surf the Web for personal reasons at work, and 55 percent sent and [received personal e-mails]. If you access the American Management Association web page, there are additional research results posted that indicate on average employees are informed of such monitoring about 83.5% of the time in the sectors AMA queried (mfg, finan. Svcs, wholesale/retail, bus/prof services, public adm, other non-profit). Among other significant issues associated with research conducted on the web remains the question of confidentiality. When aspects of the research relate to matters which could influence insurability, employability, or reputation within the organization if the personal information became known, one may need to ask whether the web is the medium of choice. _________________________________________________________ Celia S. Walker Director, Regulatory Compliance 410 University Services Center Colorado State University Fort Collins, CO 80523-2046 970-491-1563 (v) 970-491-2293 (fax) cwalker@research.colostate.edu Regulatory Compliance web site: http://www.research.colostate.edu/regulatory
Celia 7/24/2000 8:41:00 AM

Affiliated Board Member?

From a university IRB perspective, what is the affiliation classification of an IRB Board Member that is also a student (part and full time if there is a difference)? What about a volunteer?
Anonymous 7/24/2000 2:40:00 PM

(no subject)

Subject: Web-based surveys I am wondering if anyone can direct me to sources about confidentiality issues and Web-based surveys - if there are any guidelines or accepted conventions about confidentiality. While the researcher will gather consent in person, a longitudinal survey study is proposed, whereby participants will complete Web-based surveys 4 times over 2 years. These surveys include information about depression (Beck) and eating disorders (using other standardized instruments. The participant will be assigned a code number at the beginning of their participation and will use this throughout the 4 waves. Data will be sent to the PI's university-based, email account. The PI will be the only one with the links between names and code numbers. Any advice or thoughts about issues the IRB should be thinking about? Thanks in advance. Sincerely, Leslie B. Alexander, Ph.D., PRofessor and Chair Bryn Mawr College IRB
Leslie Alexander 7/24/2000 2:41:00 AM

placebos

If anyone is still following this debate, the following reference is worth looking at. It is a review paper by Aspinall and Goodman, from the BMJ in 1995, looking at placebo controlled trials of Ondansetron for control of post-operative nausea and vomiting, a condition for which there was clearly an alternative treatment available. By the authors' estimate, some 2180 patients had been given placebo as prophylaxis and 440 had been given placebo when already experiencing postoperative nausea or vomiting. http://www.bmj.com/cgi/content/full/311/7009/844 Paul Wainwright
Paul 7/24/2000 8:41:00 AM

placebos

--------------DAB9CA5812A4644B9D790447 Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Jack -- First off let me say that I think it is great to have an impassioned argument on MCW-IRB. I'd like to see more issues of substance debated in this way on the list serve. Jack thinks I am being paternalistic and he is right. When IRBs are doing their job they are acting paternalistically. This is the case because IRBs are a social oversight mechanism designed to protect research subjects. By requiring that every research study has an acceptable risk-benefit ratio, they in fact ensure that no research subject is presented with an unreasonable choice. To suggest that consent might somehow make up for a study whose risks exceed its benefits is simply an abnegation of the IRB's responsibilities. If all we were talking about were placebo controlled trials of nasal steroids or skin creams I doubt I would bother writing about the issue. The real problem cases here are circumstances in which patients are being deprived of needed medical treatment. The most common violator here is the placebo controlled trial in psychiatric research. New drugs in psychiatry are often tested against placebo, despite they fact that effective treatment exists for schizophrenia, depression, obsessive compulsive disorder, panic attacks, generalized anxiety and so on. Such trials not only violate the ethics of research, the lead to needless suffering of vulnerable persons. IRBs all too often approve such studies due to a variety of reasons: (1) pressure from the institution and the investigator as such trials may be reimbursed at $7000 per patient or more; (2) lack of a clear understand of their responsibilities, including risk-benefit analysis; or (3) capitulation to questionable claims that good science or the FDA requires a placebo control. None of these is a sufficient reason to approve a placebo control when standard therapy exists. I think you rather overstate the murkiness of standard therapy. If it were really so nebulous, doctors would spend their days in a state of perpetual confusion -- and of course they don't. It is true that it is rare for their to be a single standard therapy for a medical condition -- many may exist. This presents choice for an active control arm, but not a justification for a placebo control arm. The IRB may establish whether a standard treatment exists for a particular condition in a number of ways: (1) consultation with an impartial expert practitioner (she must in no way be involved with the study of the trial investigators); (2) review of Medline for randomized controlled trials demonstrating the efficacy of particular treatment; and (3) definitive review articles (such as ones in the New England Journal of Medicine). In general, if a standard treatment exists, a placebo controlled trial is prohibited. Ironically enough, a greater proportion of psychiatric treatments are backed up by RCT results -- fully 65% -- than any other area of medicine (Quality in Health Care 1996; 5: 215-217.). Go figure. It makes one wonder what is driving the frenzy of placebo controlled trials in psychiatry. Could it be the tremendous corporate profits that may be reaped with another me-too SSRI or antipsychotic drug? Be well, Charles. --------------DAB9CA5812A4644B9D790447 Content-Type: text/html; charset=us-ascii Content-Transfer-Encoding: 7bit <!doctype html public -//w3c//dtd html 4.0 transitional//en> Jack -- First off let me say that I think it is great to have an impassioned argument on MCW-IRB. I'd like to see more issues of substance debated in this way on the list serve. Jack thinks I am being paternalistic and he is right. When IRBs are doing their job they are acting paternalistically. This is the case because IRBs are a social oversight mechanism designed to protect research subjects. By requiring that every research study has an acceptable risk-benefit ratio, they in fact ensure that no research subject is presented with an unreasonable choice . To suggest that consent might somehow make up for a study whose risks exceed its benefits is simply an abnegation of the IRB's responsibilities. If all we were talking about were placebo controlled trials of nasal steroids or skin creams I doubt I would bother writing about the issue. The real problem cases here are circumstances in which patients are being deprived of needed medical treatment. The most common violator here is the placebo controlled trial in psychiatric research. New drugs in psychiatry are often tested against placebo, despite they fact that effective treatment exists for schizophrenia, depression, obsessive compulsive disorder, panic attacks, generalized anxiety and so on. Such trials not only violate the ethics of research, the lead to needless suffering of vulnerable persons. IRBs all too often approve such studies due to a variety of reasons: (1) pressure from the institution and the investigator as such trials may be reimbursed at $7000 per patient or more; (2) lack of a clear understand of their responsibilities, including risk-benefit analysis; or (3) capitulation to questionable claims that good science or the FDA requires a placebo control. None of these is a sufficient reason to approve a placebo control when standard therapy exists. I think you rather overstate the murkiness of standard therapy. If it were really so nebulous, doctors would spend their days in a state of perpetual confusion -- and of course they don't. It is true that it is rare for their to be a single standard therapy for a medical condition -- many may exist. This presents choice for an active control arm, but not a justification for a placebo control arm. The IRB may establish whether a standard treatment exists for a particular condition in a number of ways: (1) consultation with an impartial expert practitioner (she must in no way be involved with the study of the trial investigators); (2) review of Medline for randomized controlled trials demonstrating the efficacy of particular treatment; and (3) definitive review articles (such as ones in the New England Journal of Medicine ). In general, if a standard treatment exists, a placebo controlled trial is prohibited. Ironically enough, a greater proportion of psychiatric treatments are backed up by RCT results -- fully 65% -- than any other area of medicine (Quality in Health Care 1996; 5: 215-217.). Go figure. It makes one wonder what is driving the frenzy of placebo controlled trials in psychiatry. Could it be the tremendous corporate profits that may be reaped with another me-too SSRI or antipsychotic drug? Be well, Charles. --------------DAB9CA5812A4644B9D790447--
Charles Weijer 7/24/2000 8:41:00 AM

Looking for out of print book

Hi, I hope someone can help me. I am currently searching for Faden, King, & Beauchamp's, A history and theory of informed consent., and Sieber's, Planning ethically responsible research. If you have a copy you would like to sell, please contact me. (I can only lend them from my library for 2 weeks at a time, and that is never long enough!). Janice Singer janice.singer@nrc.ca
Janice Singer 7/24/2000 8:41:00 AM

Possibility of misuse of longitudinal files

A recent posting on this list said: 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. Longitudinal studies of aging and human development, in which respondents are followed over time, are essential to research in many academic fields. There are numerous such studies, some of which, like HERI's have yielded hundreds of publications. Obtaining enough identifying information to follow subjects is essential to the success of the research and, in my experience, poses extremely low risks to subjects. As the recent HERI/CIRP posting indicated, analysis files never contain direct identifiers of subjects. In order for subjects to be compromised, it would require either a deliberate act on the part of a member of the investigator's staff or a deliberate and illegal intrusion into carefully guarded data files by an outsider. Neither of these events is likely. I have worked with many such data sets for the past 30 years. I don't know of a single documented instance in which data have been misused or in which respondents to a major national longitudinal study have been identified or compromised in any way. I would be interested in any documented examples that readers of this list can provide. Richard T. Campbell Dcamp@uic.edu Professor of Sociology Phone: 312.413.0480 Director, Research Methods Core Fax: 312.996-2703 Health Research and Policy Centers web: wwww.uic.edu/~dcamp University of Illinois at Chicago Address on web page
Dick Campbell 7/21/2000 9:23:00 AM

Human Research Subjects Protection Act of 2000

Wendy: We spend the first few minutes of each IRB meeting on an educational topic. I have also developed a newsletter that goes out to all IRB members, principal investigators, and department chairs. On a more formal note, I am in the process of putting together an educational binder for the IRB members. It will contain resource information and several self study modules. I do one-on-one orientations with all new IRB members. I have not started to work on anything specific for P.I.s as yet. Our standard operating procedures apply regardless of the funding source. > -----Original Message----- > From: Wendy Westling [SMTP:MSJ.CIAMXW@memo.msj.org] > Sent: Friday, July 21, 2000 11:33 AM > To: mcwirb@mcwirb.org > Subject: re: Human Research Subjects Protection Act of 2000 > > I would be interested in finding out what organizations without federally > funded studies are doing regarding providing education for PIs and IRB > members. > It does not appear that as yet, there are any federal educational > requirements > for PIs or others conducting human subject research that is industry > sponsored. > I would like to know what kind of educational programs are being offered > by > such organizations. Thank you for your response. > > Wendy Westling > IRB Chairperson > Mission St. Joseph's Health System > Asheville, NC > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Sandra Armc-Prof Svcs 7/21/2000 11:41:00 AM

Remuneration for IRB members

Hi all, We are a community IRB, financially supported by two hospitals, with a volunteer membership. Our board has in the past discussed and dismissed the idea of monetary remuneration for any volunteer. One volunteer drives 60 miles each way and once came to town the night before a snowstorm and stayed in a hotel, in order not to miss the meeting. Attendance and commitment of these volunteers is commendable. Still, I am testing ways of enhancing member participation at IRB meetings. What are the best ways to motivate IRB members? For institutional IRB members, I believe Dr. Gary Ellis had a big part of the answer, which is that IRB membership should be highly valued by senior instititional leadership. (1) I wonder about several aspects of volunteer behavior: 1. There's a perception that you can't push a volunteer, that expectations should be lower than those for an employee. Does volunteer status convey a defense against demands for extending extra time and effort? My perception is that volunteers, even more than employees, must be lead, that is, motivated by appeals to their interest and innate sense of commitment. Offer the carrot, hold the stick. Our IRB attempts to motivate members through regular distribution of interesting/inspiring articles about research (carrot), in addition to the scarey ones about noncompliance, instititions being shut down, etc.(stick). To continue with the equine metaphor, we lead them to water....but we can't MAKE them read...(And to be fair, the volume of printed material from the IRB makes reading prioritization necessary.) On the other hand, does paying IRB members make them more productive or reliable or committed? Is there a positive association between level of remuneration and members' time and effort put into preparation/participation? What effect, if any, does the addition of money have in the equation? 2. My recollection of cognitive dissonance from undergraduate days is that providing an external reward decreases internal justification for behavior. That is, students NOT given a small monetary award for a task found more intrinsic value in performing the task than did the awarded students. Based on this, I wonder if even a small amount of money devalues the IRB member's intrinsic sense of contribution. 3) It would be interesting to test these ideas on IRB members who were and were not remunerated, by evaluating objective measures such as productivity and attendance and having them estimate their preparation time and self-rate the value of their service. A hypothetical model would have a continuum between the volunteer at one end whose motivation is purely intrinsic and internal, and the highly paid IRB member (employee) at the other. Would there be a difference? Stephanie Fofonoff, Coordinator Inter-Institutional Review Board of Billings Billings, Montana 406/245-8528 sfofonoff@billingsclinic.org (1) Ellis, G. (1999). Keeping research subjects out of harm's way. JAMA. 282(20), 1963-1964.
Stephanie Fofonoff 7/20/2000 1:53:00 AM

IRB response

--=====================_700371390==_.ALT Content-Type: text/plain; charset=us-ascii > > It has come to our attention that Institutional Review Boards around the > nation have begun a discussion of various aspects of the Cooperative > Institutional Research Program (CIRP) at UCLA. We at the Higher Education > Research Institute (which houses the CIRP) would like to take this > opportunity to address some of those issues. Before doing so, however, we > would like to raise one general point. > > HERI supports the efforts of Institutional Review Boards to protect the > safety and rights of human subjects, and we would like to address their > concerns about our survey programs. But quite apart from that, apart from > the laws and guidelines governing research on human subjects, and even apart > from the personal moral commitment the entire staff of HERI has to protect > our respondents, there are practical research reasons why we believe the > protection of CIRP respondents is a vital issue. Quite simply, the validity > of our results depends on the voluntary cooperation of respondents to give > accurate and honest answers to our questions. If respondents believe that > their responses are not kept in confidence, or if they feel that they have > been coerced into making those responses, it is less likely that they will > cooperate, and our results will suffer accordingly. > > To address the specific issues: > (1) Does the CIRP have IRB approval? > In past years, the IRB at UCLA had exempted CIRP from regular review. This > exemption was last renewed in 1997. However, due to changing guidelines and > inquiries from other IRBs, UCLA’s IRB conducted a formal review of the 2000 > survey and its protocols. We are pleased to announce that the 2000 CIRP has > been officially approved. For your reference, the approval # is > G00-06-053-01. > (2) How does HERI preserve confidentiality? > HERI does request identifying information from the respondents (name, > address, date of birth, etc.). Collecting this information is the only way > in which students can be followed-up at later points in their college careers > or after they have graduated. HERI stores this identifying information > separately from the students’ responses to the survey, and keeps it in a > secure location accessible only to the Associate Director for Operations. > The only link between the file containing responses and the file containing > the identifying information is an arbitrary 6-digit sequence number which is > useless for the purposes of identification without access to the secure file. > > We should point out that in 35 years of administering the CIRP to over 10 > million students at over 1,700 institutions, we do not know of a single > instance in which a respondent’s confidentiality had been violated. > (3) Item content > There has been some discussion that certain questions in the CIRP survey are > “sensitive,” insofar as students’ responses to those questions somehow could > be used against them. To the extent that such questions exist in the CIRP > (and opinions on which questions those might be vary widely), students would > only be at risk if responses to those questions could be tied to the > individual making them. Since this cannot happen with the data files kept at > HERI, we believe that the risk to students in this regard is extremely > minimal. > (4) Voluntary survey completion > As we mentioned before, freedom from coercion is an important factor in > obtaining the cooperation of respondents. To ensure this, institutions > participating in the survey are directed to read to their students a > statement that explains the purpose of the survey, emphasizes its voluntary > nature, and guarantees the confidentiality of their responses. Among other > things, the students are told “Your participation is voluntary and will not > affect your standing at (name of campus).” > > Some have commented that our instructions do not specifically emphasize the > student’s right to refuse to respond to any question. Yet, an analysis of > the most recent CIRP survey suggests that the students understand their > rights quite well. Examining the responses of almost 370,000 students to 241 > items on the survey, we find that over 86% did not respond to at least one > question, over 52% did not respond to at least five questions, and over 42% > did not respond to at least ten questions. Moreover, 11% of the respondents > did not provide a Social Security Number, and a similar percentage did not > provide their name or address. > > Nonetheless, we would be more than willing to add language to our statement > specifically indicating that survey participation is not only voluntary, but > that response to any particular question is also voluntary. > (5) Respondents under 18 years of age > There is some concern about whether the CIRP should be administered to > freshmen under the age of 18. At many institutions, college students under > the age of 18 are considered “emancipated minors” and need not be excluded > from this type of research. At UCLA, for example, the IRB informs > investigators that “students under 18 years of age may be considered adults > for the purpose of participating in a research project with no more than > minimal risk” (UCLA Investigator’s Manual for the Protection of Human > Subjects, p. 4-22). Indeed, given the voluntary and confidential nature of > the CIRP data collection and data storage process (described above), > completing the CIRP survey involves no more than minimal risk to the student. > > Finally, we would like to add a few words about the use of CIRP data. One of > the principal motives underlying the founding of CIRP was to encourage > college officials to take a greater interest in their students and in how > they were developing over time. Much of what we now know about the impact of > college on students has come from CIRP data, and the findings from this > research continue to be used as a basis for strengthening undergraduate > programs. Hundreds of institutions have used the CIRP survey to improve > their educational programs and services to their students. CIRP data enable > institutions not only to get a comprehensive portrait of their new freshmen, > but also to compare their students to students at similar institutions, to > compare student cohorts over time, and to obtain baseline data for measuring > student change and development during college. Dozens of organizations, > including Ford, Kellogg, and Mellon Foundations, the National Science > Foundation, the U.S. Department of Education, the National Institutes of > Health, and others, have used results from the CIRP to inform their > discussion and implementation of national policy concerning higher education. > > We welcome your inquiries on our CIRP survey procedures. For further > information, please contact the Higher Education Research Institute directly > at (310) 825-1925 or email heri@ucla.edu. > > Prof. Alexander W. Astin, Director > Higher Education Research Institute > > Prof. Linda J. Sax, Director, > Cooperative Institutional Research Program ************************************************************** William S. Korn, Associate Director for Operations Higher Education Research Institute Graduate School of Education & Information Studies University of California, Los Angeles 3005 Moore Hall/Mailbox 951521 Los Angeles, CA 90095-1521 (310) 825-1925 (voice) (310) 206-2228 (FAX) wkorn@ucla.edu ************************************************************** --=====================_700371390==_.ALT Content-Type: text/html; charset=iso-8859-1 Content-Transfer-Encoding: quoted-printable It has come to our attention that Institutional Review Boards around the nation have begun a discussion of various aspects of the Cooperative Institutional Research Program (CIRP) at UCLA.  We at the Higher Education Research Institute (which houses the CIRP) would like to take this opportunity to address some of those issues.  Before doing so, however, we would like to raise one general point. HERI supports the efforts of Institutional Review Boards to protect the safety and rights of human subjects, and we would like to address their concerns about our survey programs.  But quite apart from that, apart from the laws and guidelines governing research on human subjects, and even apart from the personal moral commitment the entire staff of HERI has to protect our respondents, there are practical research reasons why we believe the protection of CIRP respondents is a vital issue.  Quite simply, the validity of our results depends on the voluntary cooperation of respondents to give accurate and honest answers to our questions.  If respondents believe that their responses are not kept in confidence, or if they feel that they have been coerced into making those responses, it is less likely that they will cooperate, and our results will suffer accordingly. To address the specific issues: (1)       Does the CIRP have IRB approval? In past years, the IRB at UCLA had exempted CIRP from regular review.  This exemption was last renewed in 1997. However, due to changing guidelines and inquiries from other IRBs, UCLA=92s IRB conducted a formal review of the 2000 survey and its protocols.  We are pleased to announce that the 2000 CIRP has been officially approved.  For your reference, the approval # is G00-06-053-01. (2)       How does HERI preserve confidentiality? HERI does request identifying information from the respondents (name, address, date of birth, etc.).  Collecting this information is the only way in which students can be followed-up at later points in their college careers or after they have graduated.  HERI stores this identifying information separately from the students=92 responses to the survey, and keeps it in a secure location accessible only to the Associate Director for Operations.  The only link between the file containing responses and the file containing the identifying information is an arbitrary 6-digit sequence number which is useless for the purposes of identification without access to the secure file. We should point out that in 35 years of administering the CIRP to over 10 million students at over 1,700 institutions, we do not know of a single instance in which a respondent=92s confidentiality had been violated. (3)       Item content There has been some discussion that certain questions in the CIRP survey are =93sensitive,=94 insofar as students=92 responses to those questi= ons somehow could be used against them.  To the extent that such questions exist in the CIRP (and opinions on which questions those might be vary widely), students would only be at risk if responses to those questions could be tied to the individual making them.  Since this cannot happen with the data files kept at HERI, we believe that the risk to students in this regard is extremely minimal. (4)       Voluntary survey completion As we mentioned before, freedom from coercion is an important factor in obtaining the cooperation of respondents.  To ensure this, institutions participating in the survey are directed to read to their students a statement that explains the purpose of the survey, emphasizes its voluntary nature, and guarantees the confidentiality of their responses.  Among other things, the students are told =93Your participation is voluntary and will not affect your standing at (name of campus) .=94 Some have commented that our instructions do not specifically emphasize the student=92s right to refuse to respond to any question.  Yet, an analysis of the most recent CIRP survey suggests that the students understand their rights quite well.  Examining the responses of almost 370,000 students to 241 items on the survey, we find that over 86% did not respond to at least one question, over 52% did not respond to at least five questions, and over 42% did not respond to at least ten questions.  Moreover, 11% of the respondents did not provide a Social Security Number, and a similar percentage did not provide their name or address. Nonetheless, we would be more than willing to add language to our statement specifically indicating that survey participation is not only voluntary, but that response to any particular question is also voluntary. (5)       Respondents under 18 years of age There is some concern about whether the CIRP should be administered to freshmen under the age of 18.  At many institutions, college students under the age of 18 are considered =93emancipated minors=94 and nee= d not be excluded from this type of research.  At UCLA, for example, the IRB informs investigators that =93students under 18 years of age may be considered adults for the purpose of participating in a research project with no more than minimal risk=94 (UCLA Investigator=92s Manual for the Protection of Human Subjects, p.  4-22).  Indeed, given the voluntary and confidential nature of the CIRP data collection and data storage process (described above), completing the CIRP survey involves no more than minimal risk to the student. Finally, we would like to add a few words about the use of CIRP data.  One of the principal motives underlying the founding of CIRP was to encourage college officials to take a greater interest in their students and in how they were developing over time.  Much of what we now know about the impact of college on students has come from CIRP data, and the findings from this research continue to be used as a basis for strengthening undergraduate programs.  Hundreds of institutions have used the CIRP survey to improve their educational programs and services to their students.  CIRP data enable institutions not only to get a comprehensive portrait of their new freshmen, but also to compare their students to students at similar institutions, to compare student cohorts over time, and to obtain baseline data for measuring student change and development during college.  Dozens of organizations, including Ford, Kellogg, and Mellon Foundations, the National Science Foundation, the U.S. Department of Education, the National Institutes of Health, and others, have used results from the CIRP to inform their discussion and implementation of national policy concerning higher education. We welcome your inquiries on our CIRP survey procedures.  For further information, please contact the Higher Education Research Institute directly at (310) 825-1925 or email heri@ucla.edu . Prof. Alexander W. Astin, Director Higher Education Research Institute Prof. Linda J. Sax, Director, Cooperative Institutional Research Program ************************************************************** William S. Korn, Associate Director for Operations Higher Education Research Institute Graduate School of Education & Information Studies University of California, Los Angeles 3005 Moore Hall/Mailbox 951521 Los Angeles, CA  90095-1521 (310) 825-1925 (voice)       (310) 206-2228 (FAX) wkorn@ucla.edu ************************************************************** --=====================_700371390==_.ALT--
William S . Korn 7/20/2000 1:18:00 PM

Clinical equipoise and the local IRB

Howard asked, in a MCWIRB response to Charles: > >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 ? > Q. To what extent should the local IRB review the design of a multicenter trial? A. As much as is necessary to know if you want grant approval so your institution can take part. May I suggest that there is clinical equipoise and local clinical equipoise. For instance, a study may have equipoise in a large academic center that has available alternatives and knowledge but have less equipoise in a rural center in which the options are quite limited. We reviewed a randomized trial that was put out for the university centers and seemed to be universally accepted by their IRBs. But in the search for more recruitment, the study center broadened the number of sites to some with fewer resources. At the center(s) we reviewed it was clear that the equipoise was much more tenuous. They could offer much less and could do only one of the arms well. Erica Aside: this could sound like an argument for local review. To short-circuit that (repeat) discussion I would counter that it would make a good argument except that, even though we were remote, we were also aware of it and were questioning it. And we also had to fight the 77 other IRB argument with an academic study coordinator who did not understand the concept of equipoise. Erica Heath President, IRC 415-485-0717
heath 7/20/2000 10:52:00 AM

No blanket prohibition against placebo control

There should be no blanket prohibition against placebo controlled trials. They should be evaluated on a case-by-case basis. Take the following hypothetical research proposal: A sub-population of depressed patients has mild symptoms that persist despite good diet and exercise, but the patients forego standard pharmacological treatment because they want to avoid the risk of potential side-effects--such as delayed sexual climax. It is hypothesized that a zinc dietary supplement, with no known sexual side-effects, will be effective for this population. This population is willing to take zinc supplements (but unwilling to take standard drugs that carry risk of sexual side-effects). The experimenter design a placebo-controlled study to test the effects of zinc on depression, in this specific sub-population of depressed patients. Clearly, it would be wrong for an IRB to reject such a proposal simply because it includes a placebo control group. >If all we were talking about were placebo controlled trials of nasal steroids or >skin creams I doubt I would bother writing about the issue. The real problem cases >here are circumstances in which patients are being deprived of needed medical >treatment. The most common violator here is the placebo controlled trial in >psychiatric research. New drugs in psychiatry are often tested against placebo, >despite they fact that effective treatment exists for schizophrenia, depression, >obsessive compulsive disorder, panic attacks, generalized anxiety and so on. -- RICHARD B. ANDERSON Bowling Green State University randers@bgnet.bgsu.edu http://personal.bgsu.edu/~randers
Richard Anderson 7/20/2000 1:42:00 PM

Humanitarian Device Use

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. -----Original Message----- From: Howard Mann [mailto:LDHMANN@ihc.com] Sent: Wednesday, July 19, 2000 4:38 PM To: cclukey@emh.org; mcwirb@mcwirb.org Subject: Re: 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- Debbie Hunsaker Humanitarian Use Device 7/20/00 9:14am 2 Regards, Howard _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Dr . Steven 7/20/2000 10:55:00 AM

placbos

Charles, Jack, and all, Some comments on the recent discussion. 1.) I don't read the codes as Charles does. The US CFR says reasonable in relation to anticipated benefits, if any, and the importance of the knowledge Nuremberg says risk should never exceed humanitarian importance of the problem In both cases it seems to me they are allowing high risk to the subject if the total benefit justifies it AND there is informed consent. 2.) This seems reasonable enough to me. Yes IRBs were set up to protect vulnerable populations but I suspect they also reflect the long standing paternalism of the profession. The horrible thing about Tuskegee was not that the subjects were black and poor all on its own but that they were in no position to make an informed choice. When subjects can make a fully informed choice without coercion, I see no reason to condemn placebo controlled trials. Such acts are commendable on my view and the system depends importantly on their virtue. 3.) The problem that bothers me is not placebos per se. The real issues seems to me to be inferior treatment without informed consent. That can happen when we have good reason to believe the experimental treatment is better--for example when we repeat Phase III trials such as in ECMO. No placebo here but same problem. And as Charles points out, we can also know the experimental treatment is probably inferior--so even those getting treatment in placebo controlled trials may be getting inferior treatment. Similar situations arise when data comes in during a trial but we do not inform patients of what can be gleaned from them. Here the ethical issues run into statistical issues of Bayesians vs frequentists. The former think we can reasonably look at all times at the data as it comes in. This may seem an esoteric topic, but it has huge ethical implications that IRBs are pretty much completely unaware of. Cheers, Harold Harold Kincaid Professor and Director, Center for Ethics and Values in the Sciences Department of Philosophy University of Alabama at Birmingham 900 13th St. So. Birmingham, AL 35294-1260 205 934 8797 205 975 6639 (fax) kincaid@uab.edu http://www.uab.edu/philosophy/faculty/kincaid http://www.uab.edu/ethicscenter
Harold Kincaid 7/20/2000 7:08:00 AM

Recruiting female subjects

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
Paul 7/20/2000 11:49:00 AM

Recruiting female subjects

As an attorney, and the co-author with Ruth Merkatz on that article, I feel the need to clarify that what the FDA issued in 1993 was a new Guideline on the inclusion of women of childbearing potential in clinical trials, which replaced an outdated Guideline published sometime in the 1970s. For what it's worth, neither is or was a regulation. From a legal standpoint, the difference between a guideline and a regulation may or may not be be viewed as an important distinction in terms of what may actually be required of a clinical trial sponsor. Just thought I'd point that out. Elyse I. Summers, J.D. Division of Human Subjects Protection OHRP 6100 Executive Blvd., Ste. 3B01 (MSC 7507) Rockville, MD 20892-7507 ph.301-402-5559 fax.301-402-2071
Elyse Od 7/20/2000 11:49:00 AM
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