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anonymous adolescent interviews

We have a mental health provider (MD) who wants to prepare a curriculum to educate medical professionals about gay and lesbian adolescents. The proposal is to distribute literature and a video at multidisciplinary specialty staff meetings one month prior to meeting with the staff for an interactive one hour presentation, and then to follow this up by distributing literature and putting the curriculum on the staff website. 3 professionals, child and adolescent psychiatrist is the team leader; the rest of the team being one adolescent pediatrician and one social worker. to prepare the curriculum, the team will: 1. research previous medial literature 2 interview gay and lesbian teens at 3 different social groups regarding their experiences with health care. 3 interview medical personnel regarding t their experience with gay and lesbian adolescents. 4 organize the research into a meaningful curriculum. a. they will ask permission of the social groups to attend a meeting. b. they will talk with the adolescents regarding their health care experiences., they'll document the experiences with no identifiers or names, the PI does not want to use consent, in order to keep the information anonymous

Phyllis Kerr 4/5/2000 10:21:00 AM

IRB Approval of Emergency Use IND

This has always been very confusing to me, especially as an IRB chairman I have been criticized by the FDA reviewer for approving such emergency use. For one time compassionate use, the patient's physician must inform me that he/she is going to use a drug or device, show me the documentation available on the experimental device use, and assure me that the patient or family will be fully informed. In a sense, I do not approve it but acknowledge that I know that it is going to be used. These are typically emergent situations. It is also my understanding, that if the physician is likely to use drug/device again, they must get a protocol approved by the IRB. Frank Greer MD Meriter Hospital Madison, WI

M . D . 4/5/2000 12:42:00 PM

IRB Approval of Emergency Use IND

Robert Nelson asked: >>My question is what each of you is requiring of the investigator to review and approve this use... How many of you require a complete protocol and consent form (in the IRB format) when you review an intervention that was performed under an emergency IND?>> and Joel Frader responded: > I have a somewhat different take on this than most.>> Well, not different than ALL, as our stance and understanding follows yours to the letter. I was confused by Skip's question, since we don't review and approve such uses. As Skip's wording suggests, this is an intervention that WAS performed, and we're not being (or shouldn't be) asked to approve. > According to the FDA information sheets, The emergency use provision in the FDA regulations is an exemption [emphasis in original] from prior review and approval by the IRB. These treatment uses are just that, treatment. Our IRB reviews and approves (or doesn't) research, not treatment. Under the exemption as noted, we do not review and approve emergency use. We tell this to investigators and companies, tell them they may not use the drug again this way unless they submit an emergency use protocol. We also remind them that persons given the drug under this provision do not become research subjects...> Bingo! This is an after-the-fact notification, and not a prospective review and approval. > We do not think the IRB should assume any kind of responsibility for medical treatment and we do not believe the FDA requires this. Recently when a pharmaceutical manufacturer got upset with us for refusing IRB approval for emergency use, we faxed them a copy of the FDA information sheet (Emergency Use of an Investigational Drug or Biologic). Executives and lawyers reviewed the FDA statement and our position and decided we were right.>> Again you're not alone. I've dealt with more than one regulatory affairs person who was totally unaware this mechanism existed, or what it allowed. I'm batting about .500 in them deciding we were right. Following this thought, Karl Nelson asked: >> What do you do when the pharmaceutical firm won't ship the drug etc. without IRB approval and the physician is asking for that, but if you could get IRB approval at a fully convened meeting then it wouldn't be an emergency?>> Another Bingo! This is where the trouble starts (and we just spent two days wading through this exact scenario, so it's fresh in mind). As Joel and Karl both allude, sponsors create a catch-22 by insisting on prospective review in a situation in which prospective review is, by definition (see emergency), not possible. To my understanding, this is precisely the situation the emergency use exemption was meant to address. But sponsors back themselves into a corner, taking with them the IRB and the treating physician... who is likely some poor unsuspecting resident with a tough patient, who had (still has...) no intent of doing research, but now finds themselves dealing with IRBs and research protocols. Either it's research and there is time for prospective review, or it's emergency use for the benefit of an individual patient (not subject)... but you can't have it both ways. Dan Daniel K. Nelson, Director, Human Research Studies Research Associate Professor of Pediatrics and Social Medicine University of North Carolina-Chapel Hill Chapel Hill, NC 27599-7097 Phone: 919-966-1344 fax: 919-966-7879 e-mail: dnelson@med.unc.edu

Daniel Nelson 4/5/2000 2:23:00 PM

Liability in Drug Studies

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_01BF9F34.3C5FC1CC Content-Type: text/plain As a general rule, NIH will not assume liability in a grant related study, although it will allow for insurance against liability as a mater of indirect cost if the institution's indirect cost rate reflects that. If the study is a cooperative agreement rules are similar to that for a grant. Contract studies are very different and a provision for covering the cost of any medical interventions necessary to provide follow up immediate care MAY be negotiated. Nothing is automatic and NIH generally as a rule will not volunteer such coverage. Some vaccine studies have but that is another story. Check the NIH Office of Extramural Reseaarch web page for the NIH Grants Policy Handbook if this is a grant or cooperative agreement. http://grants.nih.gov/grants/policy/policy.htmI If it is a contract, ONLY the NIH contracting officer can tell you what will apply as far as NIH is concerned and that may sometimes be a matter of funds available. I do not think that a manufacturer is likely to assume liability for an approved drug. I am not certain what liability your institution might have to provide treatment or compensation to someone in the event of a serious adverse event. That is an institutional policy determination to be made by your risk manager and others and your insurance carrier. However, the informed consent form must state what the institution will do in the event of injury. Liability is really only determined after the fact. I believe you are looking to find out about indemnification. -----Original Message----- From: Rosalind Segesta [SMTP:SegestRM@MHS.PBRC.EDU] Sent: Wednesday, April 05, 2000 3:39 PM To: mcwirb@mcwirb.org Subject: Liability in Drug Studies Hello. I have a question regarding liability issues in a drug study. The scenario is as follows. A research institute plans to conduct a NIH-sponsored study using an FDA-approved drug, but using it to treat something other than what it was originally approved for. The drug's manufacturer will provide the drug to the research facility free of charge. My question is: Which entity assumes the liability in the event that a study volunteer experiences a serious adverse event? Is the research institute equally as liable as the drug's manufacturer? Is there any way to put language in the contract with NIH which would render the research institute free from liability? This question was posed to me earlier today by one of our contracts managers. I've searched the NIH and FDA sites, but am not finding pertinent information. I would appreciate any input anyone has, either from personal experience or from a regulatory standpoint. You may reply to me directly via e-mail at segestrm@pbrc.edu. Thanks in advance for your help. Rosalind Segesta Pennington Biomedical Research Center Baton Rouge, LA 70808 _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb ------_=_NextPart_001_01BF9F34.3C5FC1CC Content-Type: text/html Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: Liability in Drug Studies As a general rule, = NIH will not assume liability in a grant related study, although it = will allow for "insurance" against liability as a mater of = indirect cost if the institution's indirect cost rate reflects = that. If the study is a = "cooperative agreement" rules are similar to that for a = grant. Contract studies = are very different and a provision for covering the cost of any medical = interventions necessary to provide follow up immediate care MAY be = negotiated. Nothing is automatic and NIH generally as a rule will not = volunteer such coverage. Some vaccine studies have but that is another = story. Check the NIH Office = of Extramural Reseaarch web page for the NIH Grants Policy Handbook if = this is a grant or cooperative agreement. http://grants.nih.gov/grants/policy/policy.htmI = If it is a contract, ONLY the NIH contracting officer can tell = you what will apply as far as NIH is concerned and that may sometimes = be a matter of funds available. I do not think that a manufacturer is = likely to assume liability for an approved drug. I am not certain = what liability your institution might have to provide treatment or = compensation to someone in the event of a serious adverse event. That = is an institutional policy determination to be made by your risk = manager and others and your insurance carrier. However, the = informed consent form must state what the institution will do in the = event of injury. Liability is really = only determined after the fact. I believe you are looking to find = out about indemnification. -----Original Message----- From: Rosalind Segesta = [SMTP:SegestRM@MHS.PBRC.EDU] Sent: Wednesday, April 05, 2000 3:39 PM To: mcwirb@mcwirb.org Subject: = Liability in Drug Studies Hello. I have a question = regarding liability issues in a drug study. The scenario is as follows. A = research institute plans to conduct a NIH-sponsored study using an FDA-approved drug, but = using it to treat something other than what it was originally approved = for. The drug's manufacturer will provide the drug to the research facility free of = charge. My question is: Which entity assumes the liability in the event = that a study volunteer experiences a serious adverse event? Is the research = institute equally as liable as the drug's manufacturer? Is there any way = to put language in the contract with NIH which would render the research institute = free from liability? This question was posed to me earlier today by one of = our contracts managers. I've searched the NIH and FDA sites, but am not finding = pertinent information. I would appreciate any input anyone has, = either from personal experience or from a regulatory standpoint. You may = reply to me directly via e-mail at segestrm@pbrc.edu. Thanks in advance = for your help. Rosalind Segesta Pennington Biomedical Research = Center Baton Rouge, LA 70808 _______________________________________________ MCWIRB maillist - = MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb <= /FONT> ------_=_NextPart_001_01BF9F34.3C5FC1CC--

Charles Od 4/5/2000 12:45:00 PM

Faxed Informed Consent by LAR

Patty wrote: :I am IRB Coordinator for Sarasota Memorial Hospital and we are in the process :of making up policy and guidelines for accepting Faxed Informed Consent by a :Legally Authorized Represssentative. ( edit ) Here is a pertinent item : http://www.fda.gov/oc/oha/IRB/toc2.html#Informed Consent Process (See question 35) Summary : It is permissible . Regards, Howard Mann Chairman, IRB LDS Hospital Salt Lake City

Howard Mann 4/5/2000 12:42:00 PM

Examples

Actually Linda Apholz and Jeff Cooper have good points about another issue: when an institution has a good practice that could be useful, how could it be disseminated as a sample to the IRB community at large. It sounds like a huge undertaking, but an organized web site linking to other sites or where samples could be posted could be a terrific resource for IRBs generally. On it you could find: various institutions' procedures for handling adverse events and other practices such as under what circumstances faxed consents are allowed; application forms; Linda's and other good sample consent forms for various populations and situations; samples of approval notices, overdue renewal notices. Woops, there's another full-time job to help the discipline... _________________________________________________ Celia Walker, Regulatory Compliance Colorado State University 970-491-1563 (v) 970-491-2293 (fax) cwalker@research.colostate.edu

Celia 4/5/2000 2:00:00 PM

Cooperative Research

I have received several requests from other MCWIRBers asking me to share any information I received in response to my query concerning cooperative research agreements among IRBs. The problem is, with the exception of one person who responded to say that they didn't do cooperative research, I have not received any responses. I thought that I would re-post my original request to see if it generates any responses or any discussion among MCWIRB members: Our IRB is in the process of evaluating it's manner of participation in cooperative research activities with other institutions [we currently review for studies that are conducted by our investigators in two other facilities which have their own IRBs]. I am wondering if there are members of MCWIRB who would be willing to share their experiences [good and bad] with this type of IRB review and to also share with me copies of letters of agreement or memos of understanding [MOU] that are used in establishing cooperative research ventures between IRBs. Copies of letters of agreement or MOUs can be e-mailed to me at Gary.Dennison@arcw.org or FAXed to (414) 225-1656. Thanks for your help!

Gary Dennison 4/5/2000 10:18:00 AM

IRB Approval of Emergency Use IND

Vickie wrote : We have a written procedure and policy for emergency review which involves receiving the submission, having certain # of members review after faxing submission to them and then voting by phone or e-mail. Usually this can be done within 24 hours of receiving submission, other times (around holidays) it takes longer to find enough IRB members available to review. ................................................................................................................................................................... FAD regulations ( http://www.fda.gov/oc/oha/IRB/toc7.html) provide for the emergency use of the drug *without* the need for review and approval at a convened meeting of the IRB. Excerpt : Institutional procedures may require that the IRB be notified prior to such use, however, this notification should not be construed as an IRB approval. Notification should be used by the IRB to initiate tracking to ensure that the investigator files a report within the five day time-frame required by 21 CFR 56.104(c). The IRB should not make an investigator wait at all if emergency use is deemed necessary. ( Example: Emergency use of an investigational antibiotic if others are not efficacious ) The Sponsor may ask the FDA for authorization to ship the drug in advance of the IND submission. If the Sponsor requests a letter from the IRB, we would merely indicate that we are aware of the intended acquisition and emergency use of the investigational drug. Regards, Howard Mann Chairman IRB, LDS Hospital, Salt Lake City

Howard Mann 4/5/2000 2:00:00 PM

IRB Approval of Emergency Use IND

We have a written procedure and policy for emergency review which involves receiving the submission, having certain # of members review after faxing submission to them and then voting by phone or e-mail. Usually this can be done within 24 hours of receiving submission, other times (around holidays) it takes longer to find enough IRB members available to review.

Vickie Zimmer 4/5/2000 10:24:00 AM

IRB Coordinator Information

I would appreicate any information pertaining to job duties and salary ranges for IRB coordinators. Please send information to longd@aehn2.einstein.edu. Thank you.

Dee Long 4/5/2000 10:24:00 AM

Standard Consent Format

This is a very late response, but one that has been on the tip of my tongue for a while! I write the consent forms for my company, and have created a template that meets the 6th to 8th grade reading level. It is so simple and concise, I figured it would be an IRB's dream. We submitted this to one of our new sites, and what do they do? Replace half of the language with the IRB approved language that, among other things states I understand... many times, says I have been fully informed of the study, and I have received a signed copy of this consent form (as they haven't even signed it yet!). The language contains many larger words than our template did, yet the study coordinator says this is what is in ALL of our consents. It is so disappointing to me, a sponsor, who spent extra time creating a template that contains all of the elements yet remains reader friendly. I spent 2 years as an IRB manager, so I have seen the worst of the worst when it comes to consent forms - thus my extra effort to break this sponsor stereotype. I have requested they take out the word fully and change have received to will receive. It will remain to be seen if they are willing to change this - the study coordinator seemed to think the IRB was very comfortable with their language and would not be willing to change it. This is also the second time I have asked for the word fully to be removed from this context from an IRB template. What do you MCWIRB-ers think about this?? I mean, this is straight from the FDA information sheets - I don't understand the resistance. Linda Apholz Clinical Research Associate 813-887-2572 -----Original Message----- From: Howard Mann [mailto:ldhmann@ihc.com] Sent: Wednesday, March 22, 2000 12:52 PM To: mcwirb@mcwirb.org Subject: re: Standard Consent Format Re: Standard Consent Format Hi, As with most IRB's, we prescribe the format of the Consent Document. In my experience, the documents provided by sponsors are far too complex and typically contain language suited to contractual arrangements - for example, we've all seen the I understand... and I will... statements, which I find offensive. We too have been guided by the consent template published by the NCI. You may peruse our template at : http://www.ihc.com/ldsh/irb/consent_template.html Regards, Howard _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Linda 4/5/2000 5:44:00 AM

anonymous adolescent interviews

Maggie Frederick wrote >I am mystified as to why my fellow MCWIRBers think consent would not be >required in this case. I do not believe gay and lesbian adolescents attend >support or social groups for the purpose of helping to develop curriculum >for a local university. This is a vulnerable group, on many fronts: they >are children, they are gay/lesbian, and chances are good that they are >struggling with self-identity, and perhaps fear that parents (and others) >may find out about their orientation. Among youth, if I remember correctly, >suicide is much higher among gay/lesbian kids. (Remainder deleted) From my perspective, the issue is not whether consent is required, but whether the project is any of the IRB's business. It's not research, therefore, it's none of the IRB's business. If someone else (the institution) wants to stipulate rules for conduct of non-research projects, that's fine by me. I am against IRBs trying to regulate activities that aren't part of their mandate, however. IRBs are supposed to be concerned with research projects (as defined in the federal regulations). If an institution wants to stipulate that its IRB also oversees non-research projects that's one thing; institutions can go beyond the federal regulations if they desire. It's an entirely different kettle of fish, however, when an IRB decides for itself that it has a right to regulate non-research activities. This should not be allowed. Just my .02 Jeff Willner Jeffrey Willner, Ph.D. I speak only for myself Department of Psychology jwillner@runet.edu Box 6946, Russell Hall jwillner@james.psych.runet.edu Radford University (540) 831-5341 (voice) Radford, VA 24142-6946 (540) 831-6113 (fax)

Jeff Willner 4/5/2000 10:21:00 AM

Faxed Informed Consent by LAR

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_01BF9F36.1312E41E Content-Type: text/plain You mean faxing of the documentation of informed consent? If you can assume that there is a process of informed consent preceding the signing of a document faxed back to you, the fax generally is able to withstand tests of document authenticity, although most places would want the original to follow since there is no way to assure that the signatures affixed to the document have not been somehow deviously added. -----Original Message----- From: Patty Rensing [SMTP:patty_rensing@smh.com] Sent: Wednesday, April 05, 2000 3:27 PM To: mcwirb@mcwirb.org Subject: Faxed Informed Consent by LAR I am IRB Coordinator for Sarasota Memorial Hospital and we are in the process of making up policy and guidelines for accepting Faxed Informed Consent by a Legally Authorized Represssentative. We have had two study sponsor make this request in the last month. We are finding more and more sponsor requesting this. We approved one study and disapproved the other study. If anyone would has a current policy or has worked with setting up guidelines regarding faxed consent,I would appreciated a copy of your policy or any input regarding this subject. You can reply off line if you like. Thanks in advance. Patty Rensing SMH IRB Coordinator patty-rensing@smh.com 941-917-6268 _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb ------_=_NextPart_001_01BF9F36.1312E41E Content-Type: text/html Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: Faxed Informed Consent by LAR You mean faxing of = the " documentation of informed = consent?" If you can assume = that there is a process of informed consent preceding the = "signing" of a document faxed back to you, the fax generally = is able to withstand tests of document authenticity, although most = places would want the original to follow since there is no way to = assure that the signatures affixed to the document have not been = somehow deviously = added. -----Original Message----- From: Patty Rensing = [SMTP:patty_rensing@smh.com] Sent: Wednesday, April 05, 2000 3:27 PM To: mcwirb@mcwirb.org Subject: = Faxed Informed Consent by LAR I am IRB Coordinator for Sarasota = Memorial Hospital and we are in the process of making up policy and guidelines = for accepting Faxed Informed Consent by a Legally Authorized Represssentative. = We have had two study sponsor make this request in the last month. We are = finding more and more sponsor requesting this. We approved one study and = disapproved the other study. If anyone would has a current policy or has worked = with setting up guidelines regarding faxed consent,I would appreciated a copy of = your policy or any input regarding this subject. You can reply off line if = you like. Thanks in advance. Patty Rensing SMH IRB Coordinator patty-rensing@smh.com = 941-917-6268 _______________________________________________ MCWIRB maillist - = MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb <= /FONT> ------_=_NextPart_001_01BF9F36.1312E41E--

Charles Od 4/5/2000 12:45:00 PM

Liability in Drug Studies

Hello. I have a question regarding liability issues in a drug study. The scenario is as follows. A research institute plans to conduct a NIH-sponsored study using an FDA-approved drug, but using it to treat something other than what it was originally approved for. The drug's manufacturer will provide the drug to the research facility free of charge. My question is: Which entity assumes the liability in the event that a study volunteer experiences a serious adverse event? Is the research institute equally as liable as the drug's manufacturer? Is there any way to put language in the contract with NIH which would render the research institute free from liability? This question was posed to me earlier today by one of our contracts managers. I've searched the NIH and FDA sites, but am not finding pertinent information. I would appreciate any input anyone has, either from personal experience or from a regulatory standpoint. You may reply to me directly via e-mail at segestrm@pbrc.edu. Thanks in advance for your help. Rosalind Segesta Pennington Biomedical Research Center Baton Rouge, LA 70808

Anonymous 4/5/2000 12:45:00 PM

Costs of injuries resulting from medical research

The fundamental rule for HCFA is to not pay for care that is not reasonable or necessary and experimental care is felt to be not reasonable or necessary. By extension, the care related to injuries suffered in the course of experimental therapy is not reasonable or necessary. However, I asked this question on another listserv dealing with healthcare compliance issues and was told there is a caveat. 42 CFR 405.207(a) and (b) state that although Medicare won't pay for devices that are not 'reasonable' or 'necessary' or are otherwise excluded from coverage, Medicare may pay for services that are ordinarily covered by Medicare even if the services are to treat a condition or complication that arises because of the use of a non-covered device or from the furnishing of related non-covered services. Therefore, it seems there is a possibility that Medicare may cover the costs, it is not a sure bet. The language is permissive. I don't know how you can structure the payment request to maximize the likelihood of obtaining reimbursement. Dan Daniel L. Icenogle, MD, JD Icenogle & Associates 1858 Sand Ridge Ct. Verona, WI 53593-8814 608.832.0549 (voice and fax) Electronic mail from Daniel L. Icenogle, MD, c/o Icenogle & Associates at icenogle@execpc.com. This communication is intended for the use of the addressee. It may contain information which is privileged or confidential under applicable law. If you are not the intended recipient or the agent of the recipient, you are hereby notified that any dissemination, copy or disclosure of this communication is strictly prohibited. If you have received this communication in error, please notify Icenogle & Associates at (608) 832-0549 or via return Internet electronic mail at icenogle@execpc.com and expunge this communication without making any copies. Thank you for your cooperation.

Daniel L . Icenogle 4/4/2000 9:33:00 AM

anonymous adolescent interviews

I am mystified as to why my fellow MCWIRBers think consent would not be required in this case. I do not believe gay and lesbian adolescents attend support or social groups for the purpose of helping to develop curriculum for a local university. This is a vulnerable group, on many fronts: they are children, they are gay/lesbian, and chances are good that they are struggling with self-identity, and perhaps fear that parents (and others) may find out about their orientation. Among youth, if I remember correctly, suicide is much higher among gay/lesbian kids. Consent is absolutely essential, whether or not this is considered as research. How could it be done otherwise??? I do think a case can be made for not seeking prior consent of parents (whether or not it is research), as parents may not know their child is gay/lesbian, may have strong negative reactions if they were to find out, etc. I think (hope) what you mean is waiver of documentation of informed consent of kids, not skipping consent entirely. The kids could provide consent to be interviewed, but would not sign their names to a consent document, although they would receive a copy. I really doubt that community agencies that serve gay/lesbian youth would even allow the facility to participate in the activity otherwise. The interviews are not truly anonymous as interviewers would be asking questions face-to-face to kids. I think we need to be careful about discussions of research/non-research and the terminology used. If an activity is not research, that does not mean that consent of individuals is not a requirement. Even QA/QI activities that involve contact with patients/clients/enrollees, etc. require some form of consent. (E.g., if Joe Schmoe doesn't fill out that survey about the quality of his health care visit, then he didn't give consent, declined to respond, or however you want to phrase it.) Maggie Maggie Frederick, MPH Review Coordinator DSHS Human Research Review Section P.O. Box 45205 Olympia, WA. 98504-5205 (360) 902-8075 FAX: (360) 902-0705 Email: fredem@dshs.wa.gov

Maggie 4/4/2000 1:15:00 PM

Limits on amt and frequency of blood drawing

Would anyone be willing to share guidelines on the amount of blood that can be drawn over time and the number of times subjects can be stuck for research? Some of our subject/patients who have unusual conditions or rare substances in their blood are in danger of being bled out in the name of research! We apply Blood Bank guidelines for one-time draws, but lately, it is both the frequency and total volume that have become worrisome. Usually the problem arises when three or four investigators identify the same subject and all want some blood. Alert nurses worry that we might be drawing too much blood. How much is too much? How about 22 draws in 2 1/2 months, for a total of 800 ml? What guidelines would you apply? I'm afraid that relying on the clinical judgment of our investigators may not be possible because many of them really do not take care of patients; they are basic scientists. Thank you.

Anonymous 4/4/2000 9:37:00 AM

Cooperative project assurances

In answering Karen Swenson's question about CPAs and drug studies, Jon Hart wrote: > Simply put: yes, of course. The CPA is an assurance with DHHS/OPRR that > you will abide by the federal regulations and gives a blanket assurance > that makes it unnecessary for you to get a separate assurance (Single > Project Assurance) for each clinical trial you review which falls under the > CPA group. Your IRB can, should and must review all protocols at your > institution which come under its purview....>> At first blush, Jon's response seemed to contradict my own (No... CPA doesn't extend beyond its defined coverage), but I think we're just coming at this from two different angles. As Jon notes, the blanket covers each clinical trial you review WHICH FALLS UNDER THE CPA GROUP. I also agree with his next sentence, confirming that IRB is responsible for all studies at its institution. My message was that CPA does not extend to non-cooperative studies, but it certainly does not limit an IRB to reviewing ONLY those studies. The CPA is for a defined group of studies from a defined source... and if we're lucky, OPRR will soon overhaul the entire assurance system, and we can learn a whole new set of (simplified...) parameters!? Dan Daniel K. Nelson, Director, Human Research Studies Research Associate Professor of Pediatrics and Social Medicine University of North Carolina-Chapel Hill Chapel Hill, NC 27599-7097 Phone: 919-966-1344 fax: 919-966-7879 e-mail: dnelson@med.unc.edu

Daniel Nelson 4/4/2000 1:21:00 PM

IRB oversight of research in workplace

> Was this research or training? If the purpose of this project > was to identify > students who are poorly trained in auscultation so that they > could get remedial > training, I don't think it is research. I would like to echo this. There is a push by some IRBs to expand the notion of research in ways that will paralyze institutions. Training, skills assessment, and the like are not research, any more than examinations in classes are research. Employers, supervisors, peer reviewers, and quality control people have a lot of latitude to collect information without triggering research regs. Publication does not affect the classification as research, but it may trigger other concerns such as privacy protection. Under all federal regs and international codes, the primary value in research in voluntariness - which makes a research model fairly useless in institutional quality control. Ed Edward P. Richards Owner - LAWPROF (Registered Service Mark) List Owner - HEALTHLAW-L Professor - UMKC Law School (816)235-2370 Fax (816)235-5276 richardse@umkc.edu http://plague.law.umkc.edu

Edward Richards 4/4/2000 5:39:00 AM

Cooperative project assurances

Hello, My question is if the institution has a cpa, can the IRB review protocols other than cooperative group studies such as pharmaceutical studies conducted in physicians offices that are afiliated with the institution? Thank you.

Anonymous 4/4/2000 1:21:00 PM

Limits on amt and frequency of blood drawing

Without minimizing the issue of discomfort secondary to frequency of blood draws, I would have to respectfully disagree with Dr. Laidlaw: I believe that the volume of blood taken would more appropriately be of greater concern to the IRB, since this directly relates to volunteer safety. Although the frequency of blood draws might potentially impact safety (e.g. if so excessively frequent/chronic that veins become sclerosed), it is probably much more potentially causative of discomfort at the frequency described. As such, one might argue that the IRB's concern regarding the issue of frequency is to ensure 1) that the frequency/chronicity is not so excessive that safety becomes a significant concern, and 2) that the individual patient/subject is apprised that discomfort is reasonably anticipated; it might even be reasonably construed as paternalistic (or parentalistic) if the IRB does not allow a fair degree of latitude for an individual to decide what amount of discomfort he/she wants to tolerate (especially considering that there is MUCH individual variability in the degree of perceived discomfort suffered secondary to blood draws). Just as a matter of perspective regarding frequency of blood draws, subjects volunteering for phase I trials often undergo very frequent blood sampling for pharmacokinetic purposes (not uncommonly 20-30 blood draws during a trial, some of which might be concluded within as short a time frame as several days or a week); it is common for these individuals, when offered the option of having an indwelling catheter to avoid frequent needle sticks, to prefer to avoid the discomfort of the catheter if the phlebotomists are good. Obviously, it is imperative that subjects know up front how often as well as how much blood will be taken, and the IRB should be diligent about making sure that this information is provided. I might also add that this type of trial virtually always prohibits other blood donation or participation in another clinical trial for 30-90 days, depending primarily upon the blood volume taken. Perhaps the IRB's more relevant safety concern would be that of iron-deficiency anemia (please bear in mind that I am not a hematologist), as blood volume is far quicker to be replenished than red blood cell production can take place (a good source for this information is http://www.aabb.org/docs/facts.html; this site states that whole blood can be donated once every eight weeks, ASSUMING that the patient/subject passes basic screening which typically includes a rough check of hemoglobin/hematocrit status; the amount allowed to be taken over this time frame is typically a unit, or around 450 mL). As with everything in medicine, however, discretion must be used with respect to an individual patient/subject when applying general guidelines, as individual health status (and considerations such as dietary/supplemental iron intake, whether or not the patient/subject is a menstruating female, etc.) can vary considerably. As far as multiple draws of smaller amounts of blood over time, it seems reasonable to me that applying the limits set for drawing less frequent but larger volumes should be a relatively conservative approach, assuming that someone is actually paying attention to the cumulative amount that is drawn over a certain time frame (this may be a BIG assumption). The problem with the scenario described, as I see it, is that individual volunteers are getting involved with multiple trials (and thus multiple researchers), such that it becomes difficult to advise a volunteer re: his/her safety unless someone is looking at the overall picture for that individual. Obviously, the most prudent thing to do would be to periodically assess the individual's serum iron and overall health status; this might most appropriately become the concern of the personal clinician for any individual volunteering to participate in multiple trials. I hope this is of some help. Joan Collison Joan M. T. Collison, M.D. -----Original Message----- From: Stewart Laidlaw Phd [mailto:slaidlaw@rei.edu] Sent: Monday, April 03, 2000 11:21 AM To: mcwirb@mcwirb.org Subject: Re: Limits on amt and frequency of blood drawing barbara the issue it seems to me is not the volume but the frequency of the draws. being stuck 22 times in 2.5 months is a lot for anybody and particularly if the subjects are volunteering. the issue would seem to be respect for the persons who are volunteering. just because an investigator needs the blood doesnt necessarily mean they should get the blood. the irb should take a stand on this. you should consult your lay members perhaps as to what they would consider reasonable, given the discomfort and inconvenience involved. stewart laidlaw Barbara Bigby wrote: > Would anyone be willing to share guidelines on the amount of blood that can be > drawn over time and the number of times subjects can be stuck for research? > Some of our subject/patients who have unusual conditions or rare substances in > their blood are in danger of being bled out in the name of research! We apply > Blood Bank guidelines for one-time draws, but lately, it is both the frequency > and total volume that have become worrisome. Usually the problem arises when > three or four investigators identify the same subject and all want some blood. > Alert nurses worry that we might be drawing too much blood. How much is too > much? How about 22 draws in 2 1/2 months, for a total of 800 ml? What > guidelines would you apply? I'm afraid that relying on the clinical judgment > of our investigators may not be possible because many of them really do not > take care of patients; they are basic scientists. Thank you. > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Joan M . T . 4/4/2000 9:37:00 AM

IRB oversight of research in workplace

Related to this discussion - I just spoke with a doctor yesterday about a project to compare aptitude in using a stethoscope in one of my hospitals. He was asking about doing a survey which required identification of the residents/subjects and follow up training for those who did not do well. The continuing education department was getting involved and wanted to require every resident to do this. We had a discussion about the voluntariness of research being an ethical cornerstone and that residents would have the same protections that a patient would when involved in research. It's amazing to me that these concepts seem foreign to many of physicians/administrators/etc in our hospitals and universities. I now use the opportunity of employee involvement in research to teach the researchers about the ethical issues we deal with every day. And I assume that the researchers in these situations do not know about these ethical standards, so as not to put employees at risk of coercion or retaliation in the research setting. Do any of you have a specific training program for this issue? If so, how is it working and what does it involve? Any feedback is appreciated! Rebecca M. Clark Scripps Health/Children's Hospital IRBs San Diego, CA (858) 576-4008 rebcaclark@aol.com

Rebecca M. Clark 4/4/2000 1:15:00 PM

IRB oversight of research in workplace

Jeff, The physician approached me calling this research, but through discussion with him I determined that it should really be part of their training, to identify those who weren't proficient in order to provide necessary training. After this has been done, the physician who initially approached me will come back to request approval for a retrospective review of the findings of this training program in order to publish the results. Does this clear it up for you? Thanks for your comments Rebecca M. Clark Scripps Health/Children's Hospital IRBs San Diego, CA (858) 576-4008 rebcaclark@aol.com

Rebecca M. Clark 4/4/2000 1:15:00 PM

Cooperative project assurances

Simply put: yes, of course. The CPA is an assurance with DHHS/OPRR that you will abide by the federal regulations and gives a blanket assurance that makes it unnecessary for you to get a separate assurance (Single Project Assurance) for each clinical trial you review which falls under the CPA group. Your IRB can, should and must review all protocols at your institution which come under its purview. If you review other federally sponsored research (grants, contracts, clinical trials not covered by the CPA) you would have to obtain a Single Project Assurance for each one. See the OPRR web site for information on the different kinds of assurances and when they are required: http://grants.nih.gov/grants/oprr/oprr.htm Jon Hart At 01:35 PM 4/2/00 -0500, you wrote: >Hello, > My question is if the institution has a cpa, can the IRB review protocols >other than cooperative group studies such as pharmaceutical studies conducted >in physicians offices that are afiliated with the institution? >Thank you. > > >_______________________________________________ >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 4/3/2000 7:53:00 AM

New FDA web page

I just got a call from Ron Wilson at the FDA. He has set up a new web page on clinical investigator education. It is under the CDER home page and the small business division which he directs, so it takes a little looking for. The direct url is: http://www.fda.gov/cder/about/smallbiz/clinical_investigator.htm It has links to the IRB regs, IND regs and guidance documents like DSMB guidance etc. It's worth a look! Gary Chadwick, Univ. of Rochester 716-275-2398 gary_chadwick@urmc.rochester.edu

Anonymous 4/3/2000 5:51:00 AM

Limits on amt and frequency of blood drawing

barbara the issue it seems to me is not the volume but the frequency of the draws. being stuck 22 times in 2.5 months is a lot for anybody and particularly if the subjects are volunteering. the issue would seem to be respect for the persons who are volunteering. just because an investigator needs the blood doesnt necessarily mean they should get the blood. the irb should take a stand on this. you should consult your lay members perhaps as to what they would consider reasonable, given the discomfort and inconvenience involved. stewart laidlaw Barbara Bigby wrote: > Would anyone be willing to share guidelines on the amount of blood that can be > drawn over time and the number of times subjects can be stuck for research? > Some of our subject/patients who have unusual conditions or rare substances in > their blood are in danger of being bled out in the name of research! We apply > Blood Bank guidelines for one-time draws, but lately, it is both the frequency > and total volume that have become worrisome. Usually the problem arises when > three or four investigators identify the same subject and all want some blood. > Alert nurses worry that we might be drawing too much blood. How much is too > much? How about 22 draws in 2 1/2 months, for a total of 800 ml? What > guidelines would you apply? I'm afraid that relying on the clinical judgment > of our investigators may not be possible because many of them really do not > take care of patients; they are basic scientists. Thank you. > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Stewart Laidlaw Phd 4/3/2000 10:46:00 AM

injury compensation question

Is anyone familiar with this regualation? ---------------------- Forwarded by Phyllis Kerr/CORP/HPHC on 04/03/2000 11:03 AM --------------------------- Laurie Kunches on 04/03/2000 08:18:19 AM To: Phyllis Kerr/CORP/HPHC@HPHC cc: Subject: injury compensation question Phyllis: thanks for mailing and faxing info on this point. The question you asked to erica heath isn't t exactly the point I was told.... It was that, according to the US Inspector General, it is illegal to charge health insurers (in particular the public ones, like Medicaid or Medicare, but private plans as well) for costs of medical care required to treat a research-related injury. I understand that an IRB and a study sponsor can set their own policies, but if that policy starts with the assumption that health insurers will cover all or part of the care, this aspect would be illegal. Hope that is clear-er. You could just forward this on to the email list if you like...thanks.

Phyllis Kerr 4/3/2000 8:13:00 AM

Cooperative project assurances

Karen Swenson asks: > My question is if the institution has a cpa, can the IRB review protocols other than cooperative group studies such as pharmaceutical studies conducted in physicians offices that are afiliated with the institution?> I won't pretend to speak for OPRR (i.e. you should get a direct ruling, if this question has much riding on it...), but my understanding is that CPA only covers OPRR-recognized Cooperative Protocol Research Programs (CPRPs). Thus, the CPA does not provide the broader umbrella of the MPA, and does not extend to cover non-CPRP protocols. You can find more details in OPRR's CPA info sheet, dated Nov 1999: Having said that, I'm wondering why you're wondering about assurances for pharmaceutical studies conducted in affiliated physicians offices. FDA regulations do not require assurance mechanisms. Unless these studies are sponsored through DHHS, an assurance (be it SPA, CPA or MPA) is not required for you to review FDA-regulated drug studies. Or am I missing something? Daniel K. Nelson, Director, Human Research Studies Research Associate Professor of Pediatrics and Social Medicine University of North Carolina-Chapel Hill Chapel Hill, NC 27599-7097 Phone: 919-966-1344 fax: 919-966-7879 e-mail: dnelson@med.unc.edu

Daniel Nelson 4/3/2000 10:44:00 AM

Videos shown to study participants

Dulce, Yes, the videos are part of the ongoing informed consent process and have to be reviewed by the IRB. For the study closed to accrual, would not a letter suffice on the new contact numbers? This is presumably merely an administrative update, not a change in information that would affect the subjects' willingness to continue in the study, unless there is something I am missing here, so would not really require their concurrence. Jon Hart At 10:53 AM 3/31/00 -0600, you wrote: >Two questions for the group: > >1) Can anyone direct me to documentation regarding whether IRB approval of >videos to be viewed by subjects is required? I just learned this study has >included three videos that subjects have been viewing for some time. Two were >information regarding updates on the study (per the coordinator) and one is >information regarding the importance of undergoing the biopsy agreed to in the >consent. > >2) We will be conducting continuing review on this study that has been closed >to patient accrual for over three years. The number listed in the consent for >questions regarding rights as a research subject lists the number where the IRB >office WAS. (The IRB office was in the cancer center. It recently moved, >although the number listed is still valid for the cancer center.) Question: > Do we need to require a change in the consent? It would not be informative >unless we required reconsenting of subjects. *An amendment to the study for >addional blood collection, also being reviewed, will require additional >informed consent. We could identify the new IRB phone number in this consent >but it may not actually reach all subjects of the study should some decline >participation in this additional blood collection. Suggestions? > >It may be helpful to identify the study. SWOG 9217-Chemoprevention of Prostate >Cancer with Finasteride (Proscar)..... > >Advice and direction on these matters is appreciated. > >Dulce Bramblett >IRB Manager >Deaconess Hospital >Oklahoma City, OK >dulceb@deaconessokc.com > > >_______________________________________________ >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 4/2/2000 7:36:00 AM

Adverse Event Review

We've had similar discussions along this line but maybe not this particular issue. How do various IRBs handle the actual review of adverse events? At my institution, we send them to our physician IRB members for review. They either sign off or refer the report to the full IRB. The physician members are getting a little cranky because of the additional workload. Any ideas? Deb Barnard Senior IRB Administrator Rush-Presbyterian-St. Luke's Mecical Center Chicago, IL 60612

Anonymous 4/2/2000 7:36:00 AM

Limits on amt and frequency of blood drawing

I'm addressing the issue of how much blood you could ask a patient/subject to give up in a 2 1/2 month period. Simple, maybe overly simple answer: **IF** the patient/subject is relatively healthy to begin with, the patient will go no higher than Denver, and the blood, though rare, works normally, then I would think that a hematocrit drop of less than 3% would be well tolerated. ROUGHLY, the drop one would expect from donating a unit of blood) From my worm's eye view of the world, the main function of blood is to carry oxygen from the lungs to the rest of the body. I'm not even considering loss of other blood componenets. Fe loss could be a problem, especially if you concatenate several 2 1/2 month periods. For a more complicated answer, you might try contacting Dale Hammerschmidt, our hematologist colleague. Ron Low

Ronald Low 4/2/2000 7:36:00 AM

Limits on amt and frequency of blood drawing

Ronald Low 4/2/2000 7:33:00 AM

Videos shown to study participants

Two questions for the group: 1) Can anyone direct me to documentation regarding whether IRB approval of videos to be viewed by subjects is required? I just learned this study has included three videos that subjects have been viewing for some time. Two were information regarding updates on the study (per the coordinator) and one is information regarding the importance of undergoing the biopsy agreed to in the consent. 2) We will be conducting continuing review on this study that has been closed to patient accrual for over three years. The number listed in the consent for questions regarding rights as a research subject lists the number where the IRB office WAS. (The IRB office was in the cancer center. It recently moved, although the number listed is still valid for the cancer center.) Question: Do we need to require a change in the consent? It would not be informative unless we required reconsenting of subjects. *An amendment to the study for addional blood collection, also being reviewed, will require additional informed consent. We could identify the new IRB phone number in this consent but it may not actually reach all subjects of the study should some decline participation in this additional blood collection. Suggestions? It may be helpful to identify the study. SWOG 9217-Chemoprevention of Prostate Cancer with Finasteride (Proscar)..... Advice and direction on these matters is appreciated. Dulce Bramblett IRB Manager Deaconess Hospital Oklahoma City, OK dulceb@deaconessokc.com

Anonymous 4/2/2000 7:39:00 AM

Videos shown to study participants

>Two questions for the group: > >1) Can anyone direct me to documentation regarding whether IRB approval of >videos to be viewed by subjects is required? I just learned this study has >included three videos that subjects have been viewing for some time. Two were >information regarding updates on the study (per the coordinator) and one is >information regarding the importance of undergoing the biopsy agreed to in the >consent. My response is yes although you will never find it in any reg. The regs speak of informed consent (process & document) and equitable selection. Using these criteria, those in the seats of power who determine what we do said that advertising shall be reviewed. (good thought but introduced by fiat.) In the years since the review of advertising was introduced, the concept has been expanding - exponentially it seems. At first IRBs reviewed print ads for the newspapers and flyers for the bulletin boards. Now we review recruitment materials in all forms except (a) those targeting referral sources only that will not be seen by potential subjects and (b) those that go onto internet database listings although which ones is being debated. Something about the importance of undergoing anything suggests a message that may be more aggressive than that approved in the consent form. Something about Updates suggests information the IRB hasn't been given? Erica Erica Heath President, IRC 415-485-0717

heath 4/2/2000 7:33:00 AM

Videos shown to study participants

heath 4/2/2000 7:36:00 AM

Videos shown to study participants

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_01BF9B56.0364CD36 Content-Type: text/plain; charset=iso-8859-1 Just a quick note - remember that consent is a process as you have probably heard often before. That means anything involved in the consent process should be reviewed by the IRB including videos that are used to inform. This includes information that might effect whether a subject joins or continues in a study. It is not unusual for boards I have worked on to have videos brought before them for review. However to insure a fair appraisal of risks and benefits, it was also not unusual for those Boards to request editing (sometimes major) prior to approval. Videos can be positive when used as part of the process to inform but you need to be sure they are objective and not simple propaganda tools for the research project. Remember, to paraphrase Spike Lee, that your role is to make sure that the right thing gets done. -----Original Message----- From: Dulce Bramblett [mailto:dulceb@deaconessokc.com] Sent: Friday, March 31, 2000 11:54 AM To: mcwirb@mcwirb.org Subject: Videos shown to study participants Two questions for the group: 1) Can anyone direct me to documentation regarding whether IRB approval of videos to be viewed by subjects is required? I just learned this study has included three videos that subjects have been viewing for some time. Two were information regarding updates on the study (per the coordinator) and one is information regarding the importance of undergoing the biopsy agreed to in the consent. 2) We will be conducting continuing review on this study that has been closed to patient accrual for over three years. The number listed in the consent for questions regarding rights as a research subject lists the number where the IRB office WAS. (The IRB office was in the cancer center. It recently moved, although the number listed is still valid for the cancer center.) Question: Do we need to require a change in the consent? It would not be informative unless we required reconsenting of subjects. *An amendment to the study for addional blood collection, also being reviewed, will require additional informed consent. We could identify the new IRB phone number in this consent but it may not actually reach all subjects of the study should some decline participation in this additional blood collection. Suggestions? It may be helpful to identify the study. SWOG 9217-Chemoprevention of Prostate Cancer with Finasteride (Proscar)..... Advice and direction on these matters is appreciated. Dulce Bramblett IRB Manager Deaconess Hospital Oklahoma City, OK dulceb@deaconessokc.com ------_=_NextPart_001_01BF9B56.0364CD36 Content-Type: text/html; charset=iso-8859-1 Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: Videos shown to study participants Just a quick note - remember that consent is a = "process" as you have probably heard often before. That means = anything involved in the consent process should be reviewed by the IRB = including videos that are used to inform. This includes information = that might effect whether a subject joins or continues in a study. It = is not unusual for boards I have worked on to have videos brought = before them for review. However to insure a fair appraisal of risks and = benefits, it was also not unusual for those Boards to request editing = (sometimes major) prior to approval. Videos can be positive when used = as part of the process to inform but you need to be sure they are = objective and not simple propaganda tools for the research project. = Remember, to paraphrase Spike Lee, that your role is to make sure that = the right thing gets done. -----Original Message----- From: Dulce Bramblett [ mailto:dulceb@deaconessokc.com</= A>] Sent: Friday, March 31, 2000 11:54 AM To: mcwirb@mcwirb.org Subject: Videos shown to study participants Two questions for the group: 1) Can anyone direct me to documentation = regarding whether IRB approval of videos to be viewed by subjects is required? I = just learned this study has included three videos that subjects have been = viewing for some time. Two were information regarding "updates on the = study" (per the coordinator) and one is information regarding the importance of undergoing = the biopsy agreed to in the consent. 2) We will be conducting continuing review on this = study that has been closed to patient accrual for over three years. The = number listed in the consent for questions regarding rights as a research subject = lists the number where the IRB office WAS. (The IRB office was in the cancer = center. It recently moved, although the number listed is still valid for the = cancer center.) Question: Do we need to require a change in the = consent? It would not be informative unless we required reconsenting of subjects. = *An amendment to the study for addional blood collection, also being reviewed, will = require additional informed consent. We could identify the new = IRB phone number in this consent but it may not actually reach all subjects of the = study should some decline participation in this additional blood = collection. Suggestions? It may be helpful to identify the study. SWOG = 9217-Chemoprevention of Prostate Cancer with Finasteride (Proscar)..... Advice and direction on these matters is = appreciated. Dulce Bramblett IRB Manager Deaconess Hospital Oklahoma City, OK dulceb@deaconessokc.com _______________________________________________ = MCWIRB maillist - = MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb <= /FONT> ------_=_NextPart_001_01BF9B56.0364CD36-- _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Daniel 4/2/2000 7:39:00 AM

Videos shown to study participants

Dulce- In reference to the video question. I recently worked on a study that included a patient education video. We submitted it as part of the protocol and, although I can't site you a reference, the IRB considered it as part of advertising. Kathi Redding, RNC, CCRA Dulce Bramblett wrote: > Two questions for the group: > > 1) Can anyone direct me to documentation regarding whether IRB approval of > videos to be viewed by subjects is required? I just learned this study has > included three videos that subjects have been viewing for some time. Two were > information regarding updates on the study (per the coordinator) and one is > information regarding the importance of undergoing the biopsy agreed to in the > consent. > > 2) We will be conducting continuing review on this study that has been closed > to patient accrual for over three years. The number listed in the consent for > questions regarding rights as a research subject lists the number where the IRB > office WAS. (The IRB office was in the cancer center. It recently moved, > although the number listed is still valid for the cancer center.) Question: > Do we need to require a change in the consent? It would not be informative > unless we required reconsenting of subjects. *An amendment to the study for > addional blood collection, also being reviewed, will require additional > informed consent. We could identify the new IRB phone number in this consent > but it may not actually reach all subjects of the study should some decline > participation in this additional blood collection. Suggestions? > > It may be helpful to identify the study. SWOG 9217-Chemoprevention of Prostate > Cancer with Finasteride (Proscar)..... > > Advice and direction on these matters is appreciated. > > Dulce Bramblett > IRB Manager > Deaconess Hospital > Oklahoma City, OK > dulceb@deaconessokc.com > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Katherine Redding 4/2/2000 7:36:00 AM

Adverse Event Review

> -----Original Message----- > From: Deborah Barnard [mailto:Deborah_L_Barnard@rush.edu] > How do various IRBs handle the actual review of adverse events? At my > institution, we send them to our physician IRB members for > review. What do you do if you think there has been an adverse event? Edward P. Richards Owner - LAWPROF (Registered Service Mark) List Owner - HEALTHLAW-L Professor - UMKC Law School (816)235-2370 Fax (816)235-5276 richardse@umkc.edu http://plague.law.umkc.edu

Edward Richards 4/2/2000 7:36:00 AM

NAT Research Study, Consents

This is a study of an additional test of blood donations for HIV and HCA. (NAT = Nucleic Acid Amplification Technology). The longer name is Protocol ABC//GEN-Probe/Chiron Hiv-1/HCV 001: Pooled Donor Plasma Testing for the Detection of HIV-1 and HCV Using Gen-Probe TMA Technology. The initial test is done on all donated blood, you cannot donate blood without it going to this research study (over and above all the other testing that's done). In the protocol, no consent is required when the initial donation is made. There is a NAT Research Study Information Sheet that is to be handed out. It states We are asking you to participate in a research study that will evaluate. . . The Sheet also contains some information that is typically contained in consents -- Benefits, Risks, Confidentiality. However, there is no signature required. The real consent forms aren't used until a person is id'd by this test as having HIV or HCA. Then they are asked to enroll to give further blood for testing, etc. This protocol has been reviewed and approved by the Western Institutional Review Board in Olympia, Washington. Can anyone help with an explanation as to why this Information Sheet is sufficient at the front end of the study with no signature requirement or other record being kept to show that the donor did actually receive and review that sheet? Thank you. Mary L. Crumbaker Administrative Director Saccomanno Research Institute St. Mary's Hospital; Grand Junction, CO Ph: 970-244-2497; Fx: 970-241-4366

mcrumbaker@stmarygj.com 3/31/2000 9:59:00 AM

NAT Research Study, Consents

In response to Mary Crumbaker, Howard Mann wrote: > I presume I understand the process correctly : > > 1. The individual donates blood. Mandatory testing for the presence of the HIV is performed. 2. Individuals who test positive are potential research subjects. ( What do you mean by ... you cannot donate blood without it going to this research study...?)....>> It's a bit more complicated than all this, as that last parenthetical implies. Assuming we're talking about the Red Cross NAT protocol, this is a mandatory program that has caused much confusion and/or consternation on the part of IRBs, blood banks, et al. This confusion and/or consternation led to multiple discussions on this forum. Rather than repeat any of it here (not that I'm sure I ever understood enough to repeat...), I would refer you to the MCWIRB website, where you can search the archives using keywords like NAT and Red Cross. There you will find much background, if not resolution. Dan Daniel K. Nelson, Director, Human Research Studies Research Associate Professor of Pediatrics and Social Medicine University of North Carolina-Chapel Hill Chapel Hill, NC 27599-7097 Phone: 919-966-1344 fax: 919-966-7879 e-mail: dnelson@med.unc.edu

Daniel Nelson 3/31/2000 9:59:00 AM

Training Materials

One of my colleagues recently received a brochure from Barnett International Clinical Training Group advertising six book training series relative to clinical studies including ICH guidelines,and information relative to clinical research, IRBs and informed consent.a clinical practice training among other topics. Is anyone familiar with this organization or does anyone have information relative to their publications. If so, please respond to me directly. thanks (Mr.) Lanue B. Ryan, MA 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 E-Mail: ryan.lanue@mail.dc.state.fl.us

Anonymous User 3/31/2000 11:02:00 AM

Transfer of protocols Re-Consent

Subjects who have already consented at a previous institution would probably benefit from receiving at least a patient information sheet with the current POC names and phone numbers. The subjects should have the PIs current phone number and the Human Subjects Chairman's name and phone number. This way if they have any questions about their participation they have access to answers. -----Original Message----- From: David Guinn [mailto:deg@prchfe.org] Sent: Thursday, March 30, 2000 6:17 AM To: mcwirb@mcwirb.org Subject: re: Transfer of protocols Re-Consent >>> Paul Roby <pvroby@halcyon.com> 03/29 12:09 PM >>> ............................. If the purpose of the form is to document the consent process, and the study has already begun (in our case it was actually begun and completed), what is being documented by the original form text? Isn't after-the-fact consent coerced, in that there is no option to withhold permission to initiate study procedures? >>> I think the point is that the consent form not only documents consent, but also documents that the subject has been given all relevant information. If the original consent process was flawed, this is an opportunity to remedy that. Moreover, as previously suggested, consent is a process not a single event. The subjects, by continuing to participate in the research, are in effect regularly reaffirming their consent to participate. If the original disclosure was incomplete or failed to include necessary information (such as the right to withdraw from the research without penalty) then it is important for the new organization to make sure that ongoing subjects are given this information as a way of affirming the integrity of the ongoing consent of the subjects. I would, however, agree that the consent agreements for current participants should probably be drafted in a way which recognizes their current status as participants rather then simply reciting the boilerplate that is included at enrollment. David David E. Guinn, JD, PhD The Park Ridge Center 211 E. Ontario, Suite 800 Chicago, IL 60611 deg@prchfe.org (312) 266-2222 (312)266-6086 (fax) web page: www.prchfe.org _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Lynda J Civ 3/30/2000 10:06:00 AM

Whose subjects are they?

We have a behavorial study in which extensive data was collected over the course of several years. There were simple physical assessments, but these were limited to blood pressure, balance adn the like--nothing invasive. From time to time an investigator came along who wished to look at sub-sets of the subjects for various substudies. Most of these worked for the sponsor, came through the IRB and proceeded routinely. One study, however, was with an outside entity. The IRB approved a mailout to the cohort, informing subjects that they were being contacted as a result of their participation in the previous study, telling them aobut the new study and who to contact if they were interested in participating. Those interested went over, were consented, and participated in the new study. Now the folks in the new study wish to expand the horizon by adding QOL questionnaires and additional physical assessments that were not included when the original study was outlined. Their IRB sees this as a routine amendment, but the original sponsor is concerned about this. The new material duplicates some of the behavorial material in the original study; the sponsor is considering a follow-up study of the cohort and is concerned about too many trips to the well. They feel very strongly that the outside study could jeopardize continued participation by their own cohort. Does the original sponsor have any interest in the study changes if folks have involved themselves voluntarily through a new consent? Could (should) the sponsor approach the other IRB and plead their case? What are your thoughts about this sort of issue in the future? Thanks for your help. Kathy Schulz Regulatory Affairs Coordinator Buck Cen

Anonymous 3/30/2000 10:05:00 AM

Transfer of protocols Re-Consent

> 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. --MS_Mac_OE_3037169357_4315248_MIME_Part Content-type: text/plain; charset=US-ASCII Content-transfer-encoding: 7bit In addition to other administrative details, Charlotte E. Pacheco wrote: We required all existing participants be Re-Consented using our approved Consent Form. I recall a study in which our on-site people physically lost a stack of signed consent documents after an all-day study of about 50 people (they had undergone abdominal ultrasound to screen for and measure aortic aneurysms). The forms were later found (they had fallen behind a file cabinet), but prior to their recovery, the IRB chairman demanded that the subjects be contacted and re-consented. I resisted doing this, because re-consent seemed meaningless. If the purpose of the form is to document the consent process, and the study has already begun (in our case it was actually begun and completed), what is being documented by the original form text? Isn't after-the-fact consent coerced, in that there is no option to withhold permission to initiate study procedures? Is anyone aware of specific regulatory or scholarly guidance on these sorts of backfill consent documents? I could see some sort of documentation of the subjects' understanding their ability to withdraw consent, or of a statement that the subject recalls the original consent process, but re-administering a pre-study consent form after study procedures have started seems to hold the paper appearance of consent above the reality of consent. Paul V. Roby, MD Consultant in Medical Device Development Seattle --MS_Mac_OE_3037169357_4315248_MIME_Part Content-type: text/html; charset=US-ASCII Content-transfer-encoding: quoted-printable RE: Transfer of protocols "Re-Consent" In addition to other administrative details, Charlotte E. Pacheco wrote= : "We required all existing participants be Re-Consented using our appr= oved Consent Form." I recall a study in which our on-site people physically lost a stack of sig= ned consent documents after an all-day study of about 50 people (they had un= dergone abdominal ultrasound to screen for and measure aortic aneurysms). &n= bsp;The forms were later found (they had fallen behind a file cabinet), but = prior to their recovery, the IRB chairman demanded that the subjects be cont= acted and "re-consented." I resisted doing this, because &qu= ot;re-consent" seemed meaningless. If the purpose of the form is = to document the consent process, and the study has already begun (in our cas= e it was actually begun and completed), what is being documented by the orig= inal form text? Isn't after-the-fact "consent" coerced, in t= hat there is no option to withhold permission to initiate study procedures?<= BR> Is anyone aware of specific regulatory or scholarly guidance on these sorts= of "backfill" consent documents? I could see some sort of d= ocumentation of the subjects' understanding their ability to withdraw consen= t, or of a statement that the subject recalls the original consent process, = but "re-administering" a pre-study consent form after study proced= ures have started seems to hold the paper appearance of consent above the re= ality of consent. Paul V. Roby, MD Consultant in Medical Device Development Seattle --MS_Mac_OE_3037169357_4315248_MIME_Part--

Paul Roby 3/30/2000 10:06:00 AM

Adverse Event Review

Deb - At my institution, most of the AEs that we get are related to drug studies, so we have our Pharmacy rep review these. He is an employee of the institution, and IRB participation is considered part of his (as opposed to physicians who are not employees of the institution). He writes a monthly report that is distributed to the committee with the meeting agenda, and he reports his findings at the meeting. The committee members are then given the opportunity to discuss or question his findings. If I receive an AE that is outside his expertise, I have the chair review it, or give it to another member that has the necessary experience to review it. This has worked well for us. I hope this helps. -- Lori Roesch IACUC/IRB Administrator Aurora Health Care, Inc., Applied Research Division Sinai Samaritan Medical Center Deborah Barnard wrote: > We've had similar discussions along this line but maybe not this particular > issue. > > How do various IRBs handle the actual review of adverse events? At my > institution, we send them to our physician IRB members for review. They either > sign off or refer the report to the full IRB. The physician members are getting > a little cranky because of the additional > workload. Any ideas? > > Deb Barnard > Senior IRB Administrator > Rush-Presbyterian-St. Luke's Mecical Center > Chicago, IL 60612 > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Lori Roesch 3/30/2000 9:14:00 AM

Transfer of protocols Re-Consent

Lynda J Civ 3/30/2000 9:41:00 AM

IRB chair job description

Our hospital has finally gone big time by funding the position of IRB chair. Is anyone willing to share their job description? If confidentiality is a problem, no informed consent will be sent but I would be happy to receive it directly rather than having it posted on the listserve. Norman A. Leopold Chairman IRB Crozer-Chester Medical Center

Norman Leopold 3/30/2000 4:00:00 AM

IRB oversight of investigational device use in workplace

No and Yes No. 21 CFR 56.103(a) requires IRB review of any clinical investigation which must meet the requirements for prior submission to the FDA. What you are describing is more a feasibility study preparatory to the clinical investigation. If there is no way that it will be included in a 510K submission, then part 56 does not apply. Maybe. 21 CFR 50.20 requires that no investigator may involve a human being as a subject in research covered by these regulations without consent. Is the study being done covered in these regulations? I suspect they refer to 812.2. Yes Helsinki and ICH both require outside review of clinical studies and require consent. My choice, were I in your shoes, would be to require IRB review, protocol, consent, the whole nine yards. Questions an IRB might raise would involve the risk to employee subjects who (a) chose not to participate or (b) who are found to have a funny result. Is there a risk to employment? Who sees the information? How is it recorded? What is the local condition like? Does it foster compliance or refusal? Erica >Dear MCWIRB members: >I am looking for guidance on whether or not we need to go through IRB and/or >obtain informed consent for the following scenario: >Our company, a medical device manufacturer, usually does bench testing during >the early development of our NSR devices, prior to the IRB covered testing done >with human subjects. Our engineering department recently started requesting >that instead of using the bench simulators for some of these early performance >tests, we do them on people in the company. This would involve setting up an >area where people can stop by to have their blood pressure, temperature, etc. >taken by the device with the results recorded, or wheeling the device set-up >around to people's offices to see if they have a minute to take some >measurements. Again, these are simply performance measurements to test for a >working algorithm. No claims are made based on these, and the monitor does not >go on the market until testing in the clinical arena is done (under IRB >approval). Do we need a protocol, consent form, IRB approval or any >combination of these to perform these measurements? My guess is that we do, >but I wanted to hear it from the experts...Thank you in advance for your >guidance! Please feel free to reply to me directly if you prefer. > > >_______________________________________________ >MCWIRB maillist - MCWIRB@mcwirb.org >http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb Erica Heath President, IRC 415-485-0717

heath 3/29/2000 4:26:00 PM

Investigators present during vote

Please give me information about the presence/absence of investigators (IRB member or non-member) during the voting process of a study. Is it OPRR or FDA guidelines to have the PI absent from the room, and is it followed? Thank you, Peggy IRB Specialist Covenant HealthCare Pbruns-hahn@chs-mi.com

Peggy Bruns-Hahn 3/29/2000 9:43:00 AM

IRB oversight of investigational device use in workplace

Dear MCWIRB members: I am looking for guidance on whether or not we need to go through IRB and/or obtain informed consent for the following scenario: Our company, a medical device manufacturer, usually does bench testing during the early development of our NSR devices, prior to the IRB covered testing done with human subjects. Our engineering department recently started requesting that instead of using the bench simulators for some of these early performance tests, we do them on people in the company. This would involve setting up an area where people can stop by to have their blood pressure, temperature, etc. taken by the device with the results recorded, or wheeling the device set-up around to people's offices to see if they have a minute to take some measurements. Again, these are simply performance measurements to test for a working algorithm. No claims are made based on these, and the monitor does not go on the market until testing in the clinical arena is done (under IRB approval). Do we need a protocol, consent form, IRB approval or any combination of these to perform these measurements? My guess is that we do, but I wanted to hear it from the experts...Thank you in advance for your guidance! Please feel free to reply to me directly if you prefer.

Anonymous 3/29/2000 4:26:00 PM

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