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Religious Institutions and IRB's

Our hospital is Catholic sponsored and hence must adhere to the Ethical and Religious Directives for Catholic health Care Facilities and all that entails. We also have an IRB which is utilized by many local physicians, (members of the medical staff) for protocols on subjects who will probably never see the inside of the hospital (unless for an unrelated reason.) You might guess an issue came up regarding a mandatory contraception statement in a protocol and informed consent document. I know this has been discussed in this forum before and I realize that you can oppose specific mandates on types of contraception without coming from a religious standpoint. Other members of our IRB felt that a change in language (warning of potential risks and advising the avoidance of pregnancy without a mandate on two forms of contraception) was watering down the prohibition on pregnancy and thus endangering potential mothers and fetuses. The discussion ultimately turned to a larger discussion of what is the duty of the IRB to its home institution vs. its duty to the community. Perhaps I should mention we are the only IRB in town, the other hospital in town does not have an IRB. Several of the physicians and community members felt strongly that although the IRB is housed at the Catholic hospital it is really a community IRB and thus should not impose Catholic doctrine on investigators and subjects, i.e. it should protect human subjects via the regs and standards set out by FDA and OPPR. The only time they felt this could be changed was if the subjects were going to be patients in the hospital, then they felt the hospital could uphold the ethical and religious directives. Personally I don't believe asking for a rewording of contraception mandates is imposing Catholic doctrine, and I do think it is in keeping with the FDA's thoughts on this matter, but I guess that is beside the point. I would be interested in the experiences of IRB's at other religiously sponsored institutions as well as the opinions of other on the obligations any IRB has to the community. Thank you in advance for any insights. Patrick McCruden Vice President, Mission Integration St. Joseph's Regional Health Center Hot Springs, AR pmccruden@htsp.smhs.com

Anonymous 6/16/2000 8:48:00 AM

Free IRB continuing education

I am pleased to announce our first-ever Free Trial Subscription offer for any MCWIRB member who would like to try our monthly newsletter (Human Research Report) for IRBs and other compliance professionals. Our new expanded 12-page format, and 4-page conference listing, is temporarily available at no cost on a limited free subscription basis—with no obligation whatsoever. I’ve never done this before, so I have no idea at all how quickly the available free subscriptions will be filled. They are on a first-come, first-served arrangement. This special Internet offer can stay open for only a few days. Details are at http://www.HumanResearchReport.com. Thank you. Sincerely, Dennis Maloney, Ph.D. Editor and Publisher Human Research Report P.O. Box 44069 Omaha, NE 68144 USA Tel: 402.895.5748 Fax: 402.895.2306 E-mail: den@deemcorp.com Web site: http://www.humansubjects.com

Anonymous 6/16/2000 7:30:00 AM

informed consent and in-vitro device testing

We recently reviewed and approved a study involving blood glucose monitoring device. Following the minimal risk guidelines, we approved the study without requiring informed consent. We have just received a similar study. Knowing that we had approved their last study without icf, the sponsor contacted me and provided information about new FDA guidelines for in-vitro device studies (issued in December 17, 1999) (www.fda.gov/cdrh/comp/ivdreg.html) and an unidentified journal article describing one investigators experience with the newly enforced guidance. During an FDA inspection, the investigator (a hospital laboratory director), was told that he should have obtained informed consent and that the samples he collected could not be correlated because the study subjects identity and medical information were not available. I am interested to hear this groups experience and advice on the subject. Thanks Gary Souders Director, Research and Regulatory Affairs St. Vincent Hospital and Health Care Center Inc. Indianapolis, IN

G Souders-Indy 6/16/2000 8:42:00 AM

Religious Institutions and IRB's

Patrick --- This is a good and (like so many good ones) difficult question. I think the answer is usually to be found in the fact that an IRB's approval is permissive rather than directive. The institution may decline to allow a study, even if it is found acceptable by the IRB, for any of a number of reasons ... ranging from resource allocation issues to ethical positions taken by the institution. So the IRB can approve something that the institution might not allow to happen on its turf. The IRB may handle this in any of a number of ways, ranging from ignoring the issue to notifying the investigator that there's a likely problem. If the IRB takes the stand that it will only approve protocols that would be fairly certain to be acceptable to the institution, then it is in a bad position to serve its more peripheral investigators, and there's a strong argument for another IRB. Conceptually, this is a bit like the protocols that might bring bad publicity to an institution. The IRB can approve them, but the institution can decide that it's not in its best interest to have them actually go on. Dale Dale Hammerschmidt Assoc Prof Med / (Hematology/Oncology/BMT) Editor., J. Lab. Clin. Med. Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455 612-626-2640; 612-626-2642 (fax) InterNet 72662,76 (CompuServe)

Dale Hammerschmidt 6/16/2000 8:48:00 AM

The creation and use of a data and DNA repository

Hi All, I would appreciate your thoughts and guidance on the following issue : It is increasingly common for physician-researchers to create customized electronic databases to facilitate research. These databases are, of course, separate from patients' medical records as maintained and controlled by the institution's medical records department. While the institution itself maintains and controls -- through the operations of an institutional information security committee --analogous databases, it may not be aware that individual researchers or clinical departments are creating such data repositories. For each of the following two scenarios, please comment on the implications with respect to disclosure to the patient, patient consent, IRB review and approval. 1. Data Repository This repository involves patients attending a heart failure clinic. Selected historical, clinical, biochemical, etc., data are entered into the database. Of course, this data is also placed in the patient's medical record, and represents data accumulated during the clinical care of the patient. Importantly, the physician-researcher may also wish to contact certain patients subsequent to the clinical encounter to ascertain additional information to be entered into the database. This database will be used for future, as yet unspecified, research activities. For example, it may be used to identify patients eligible for drug clinical trials -- parsing the electronic database with appropriate software would be a trivial exercise. This database would certainly facilitate epidemiologic research, and may subsequently be linked to other databases containing genotypic information. (At my institution, the admissions form signed by the patient mentions the possibility that medical information may be disclosed for certain, enumerated purposes, but research is not one of them) 2. Data and DNA repository The patient population in this scenario involves patients undergoing cardiac catheterization. In addition to the accumulation of the data mentioned above, a sample of blood is set aside and stored for subsequent DNA analysis -- specifically, genetic screening. Consent for the latter is ostensibly obtained, but undoubtedly in a cursory manner, simultaneous with consent for the catheterization procedure. Subsequent genetic testing may be rather casual and exploratory in nature, and not necessarily in the context of a formal research protocol. The IRB is not aware of these activities. ( I thought of these issues after reading two items concerning an analogous database involving the population of Iceland, as described here : http://www.nejm.org/content/2000/0342/0024/1827.asp http://www.nejm.org/content/2000/0342/0024/1830.asp ) Regards, Howard

Anonymous 6/16/2000 4:39:00 AM

merging IRB's

Does anyone out there have experience in merging two IRB's? that could assist me with a sample MOU? These are two Hospital IRB's that are under the same mother umbrella (i.e. SutterHealth) but currently have seperate IRB's. Deborah Mick IRB Specialist-MGH/Sutter 415/925-7965 email: mickd@sutterhealth.org

Deborah Mick 6/16/2000 11:34:00 AM

IRB Chairpersons

Does anyone typically pay IRB Chairpersons for their services? If, so, could you share how much per hour you pay? It would be most appreciated. Lynn M. Barrett-Mena email: lynn.barrett-mena@tenethealth.com

lynn barrett-mena 6/16/2000 11:52:00 AM

Religious Institutions and IRB's

At 2:31 PM -0500 6/15/00, McCruden, Patrick wrote: > Thanks for your response. In my haste I was probably unclear in my >post because I don't believe we are neglecting our duty to minimize risks >and fully inform subjects of relevant information. Certainly that would >include informing subjects of the risks of becoming pregnant or potential >harm to a developing fetus etc...stating that they should not become >pregnant etc...receive the medical counseling needed to prevent pregnancy >etc. in each of the instances posted that suggest intermediate language that the subject should be informed about methods by the investigator, how does the IRB ensure that the subjects are so informed? what happens if discussion of these methods is also contrary to the moral persuasions of the researcher? informed consent is more than a form and all that, but the IRB must ensure that subjects are informed, and the standard way to do this is ensure that the content of the consent form fulfills the legal and ethical requirements. a verbal protocol could be approved, wherein the researcher confirms that certain information will systematically be provided, but approving this would put the IRB in the same moral bind it is in with the consent form. further, the verbal protocol probably could only be approved if it satisfies §117(c). this issue comes up also with alternative treatments clauses, which rarely in my experience provide details about what the specific alternatives are. i have never felt comfortable with this, because as an IRB member i had no idea what alternatives there were, nor what alternatives would be discussed with the potential subject by the investigator. at the least, to my mind, the IRB should have been provided with that information and the written assurance by the investigator that every potential subject would be so informed (without having to ask, of course!). jon merz center for bioethics university of pennsylvania merz@mail.med.upenn.edu

Jon Merz 6/16/2000 8:42:00 AM

Religious Institutions and IRB's

--------------B1F15AAE342648F204B34461 Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Patrick, FDA's Information Sheet concerning the Evaluation of Gender Differences in Clinical Investigations points out that Pregnancy testing is recommended, and women must be counseled about the reliable use of contraception or abstinence from intercourse while participating in the clinical trial. The Guideline does not, however, specify the type of contraception to be used because FDA believes that decisions of this nature are best left to the woman in consultation with her health care provider (emphasis mine). IRBs need not back down from their institutional standards to satisfy the birth control dictates of commercial (or other) sponsors. -Dan Patrick Mccruden wrote: > Our hospital is Catholic sponsored and hence must adhere to the Ethical and > Religious Directives for Catholic health Care Facilities and all that entails. > We also have an IRB which is utilized by many local physicians, (members of the > medical staff) for protocols on subjects who will probably never see the inside > of the hospital (unless for an unrelated reason.) > > You might guess an issue came up regarding a mandatory contraception statement > in a protocol and informed consent document. I know this has been discussed in > this forum before and I realize that you can oppose specific mandates on types > of contraception without coming from a religious standpoint. Other members of > our IRB felt that a change in language (warning of potential risks and advising > the avoidance of pregnancy without a mandate on two forms of contraception) was > watering down the prohibition on pregnancy and thus endangering potential > mothers and fetuses. > > The discussion ultimately turned to a larger discussion of what is the duty of > the IRB to its home institution vs. its duty to the community. Perhaps I should > mention we are the only IRB in town, the other hospital in town does not have > an IRB. > > Several of the physicians and community members felt strongly that although the > IRB is housed at the Catholic hospital it is really a community IRB and thus > should not impose Catholic doctrine on investigators and subjects, i.e. it > should protect human subjects via the regs and standards set out by FDA and > OPPR. The only time they felt this could be changed was if the subjects were > going to be patients in the hospital, then they felt the hospital could uphold > the ethical and religious directives. > > Personally I don't believe asking for a rewording of contraception mandates is > imposing Catholic doctrine, and I do think it is in keeping with the FDA's > thoughts on this matter, but I guess that is beside the point. > > I would be interested in the experiences of IRB's at other religiously > sponsored institutions as well as the opinions of other on the obligations any > IRB has to the community. > > Thank you in advance for any insights. > > Patrick McCruden > Vice President, Mission Integration > St. Joseph's Regional Health Center > Hot Springs, AR > pmccruden@htsp.smhs.com > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb -- Dan S. Somers IRB Coordinator School of Medicine IRB UNC Chapel Hill (919) 966-1344 dsomers@med.unc.edu --------------B1F15AAE342648F204B34461 Content-Type: text/html; charset=us-ascii Content-Transfer-Encoding: 7bit <!doctype html public -//w3c//dtd html 4.0 transitional//en> Patrick, FDA's Information Sheet concerning the Evaluation of Gender Differences in Clinical Investigations points out that Pregnancy testing is recommended, and women must be counseled about the reliable use of contraception or abstinence from intercourse while participating in the clinical trial. The Guideline does not, however, specify the type of contraception to be used because FDA believes that decisions of this nature are best left to the woman in consultation with her health care provider (emphasis mine). IRBs need not back down from their institutional standards to satisfy the birth control dictates of commercial (or other) sponsors. -Dan Patrick Mccruden wrote: Our hospital is Catholic sponsored and hence must adhere to the Ethical and Religious Directives for Catholic health Care Facilities and all that entails. We also have an IRB which is utilized by many local physicians, (members of the medical staff) for protocols on subjects who will probably never see the inside of the hospital (unless for an unrelated reason.) You might guess an issue came up regarding a mandatory contraception statement in a protocol and informed consent document. I know this has been discussed in this forum before and I realize that you can oppose specific mandates on types of contraception without coming from a religious standpoint. Other members of our IRB felt that a change in language (warning of potential risks and advising the avoidance of pregnancy without a mandate on two forms of contraception) was watering down the prohibition on pregnancy and thus endangering potential mothers and fetuses. The discussion ultimately turned to a larger discussion of what is the duty of the IRB to its home institution vs. its duty to the community. Perhaps I should mention we are the only IRB in town, the other hospital in town does not have an IRB. Several of the physicians and community members felt strongly that although the IRB is housed at the Catholic hospital it is really a community IRB and thus should not impose Catholic doctrine on investigators and subjects, i.e. it should protect human subjects via the regs and standards set out by FDA and OPPR. The only time they felt this could be changed was if the subjects were going to be patients in the hospital, then they felt the hospital could uphold the ethical and religious directives. Personally I don't believe asking for a rewording of contraception mandates is imposing Catholic doctrine, and I do think it is in keeping with the FDA's thoughts on this matter, but I guess that is beside the point. I would be interested in the experiences of IRB's at other religiously sponsored institutions as well as the opinions of other on the obligations any IRB has to the community. Thank you in advance for any insights. Patrick McCruden Vice President, Mission Integration St. Joseph's Regional Health Center Hot Springs, AR pmccruden@htsp.smhs.com _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb -- Dan S. Somers IRB Coordinator School of Medicine IRB UNC Chapel Hill (919) 966-1344 dsomers@med.unc.edu --------------B1F15AAE342648F204B34461--

Dan Somers 6/15/2000 5:14:00 AM

Religious Institutions and IRB's

I also work for a Catholic hospital and our IRB has developed this statement concerning contraception statements: Avoiding sexual activity is the only certain method to prevent pregnancy. However, if you choose to be sexually active, you must agree to use acceptable methods of birth control while in this investigational study. Your doctor will explain these methods to you and help you decide which might be best for you. The thought was with this statement, the hospital is giving the information about abstinence but also makes the decision about birth control up to the subject and the PI (or her private physican). The facility is only promoting abstinence, which was acceptable to the clergy on the Board. We have had no problem with sponsors requiring the information about specific contraception information. This was also easier for the non-Catholic research facilities to add as it does not impose the Catholic Doctrine. Sharon Hoon, RN CCRC Avera Research Institute > -----Original Message----- > From: Patrick Mccruden [SMTP:mccrudep@mercyhealth.com] > Sent: Thursday, June 15, 2000 8:38 AM > To: mcwirb@mcwirb.org > Subject: Religious Institutions and IRB's > > Our hospital is Catholic sponsored and hence must adhere to the Ethical > and > Religious Directives for Catholic health Care Facilities and all that > entails. > We also have an IRB which is utilized by many local physicians, (members > of the > medical staff) for protocols on subjects who will probably never see the > inside > of the hospital (unless for an unrelated reason.) > > You might guess an issue came up regarding a mandatory contraception > statement > in a protocol and informed consent document. I know this has been > discussed in > this forum before and I realize that you can oppose specific mandates on > types > of contraception without coming from a religious standpoint. Other members > of > our IRB felt that a change in language (warning of potential risks and > advising > the avoidance of pregnancy without a mandate on two forms of > contraception) was > watering down the prohibition on pregnancy and thus endangering potential > mothers and fetuses. > > The discussion ultimately turned to a larger discussion of what is the > duty of > the IRB to its home institution vs. its duty to the community. Perhaps I > should > mention we are the only IRB in town, the other hospital in town does not > have > an IRB. > > Several of the physicians and community members felt strongly that > although the > IRB is housed at the Catholic hospital it is really a community IRB and > thus > should not impose Catholic doctrine on investigators and subjects, i.e. > it > should protect human subjects via the regs and standards set out by FDA > and > OPPR. The only time they felt this could be changed was if the subjects > were > going to be patients in the hospital, then they felt the hospital could > uphold > the ethical and religious directives. > > Personally I don't believe asking for a rewording of contraception > mandates is > imposing Catholic doctrine, and I do think it is in keeping with the > FDA's > thoughts on this matter, but I guess that is beside the point. > > I would be interested in the experiences of IRB's at other religiously > sponsored institutions as well as the opinions of other on the obligations > any > IRB has to the community. > > Thank you in advance for any insights. > > Patrick McCruden > Vice President, Mission Integration > St. Joseph's Regional Health Center > Hot Springs, AR > pmccruden@htsp.smhs.com > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Sharon Hoon 6/15/2000 8:38:00 AM

DHHS-OIG Publications

Earlier this week the DHHS Office of the Inspector General issued 3 final inspection reports on the subject of protections for human subjects for clinical research. The full text of each of these reports may be obtained via the following links: A) Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research B) Recruiting Human Subjects: Sample Guidelines for Practice C) FDA Oversight of Clinical Investigators Doug Wilkerson, Ph.D. Assoc. V. P. for Research Voice: (419) 383-4252 Professor of Pharmacology FAX: (419) 383-4262 Research & Grants Admin. E-mail: dwilkerson@mco.edu Block Health Sci. Bldg, Rm. 148 Web: www.mco.edu/research 3035 Arlington Ave. Toledo, OH 43614-5804

Doug Wilkerson 6/15/2000 8:33:00 AM

Religious Institutions and IRB's

I am a very new member of the IRB although I have been corporate counsel at this Catholic hospital for several years (my co-counsel left and I inherited the IRB). But the early state of my learning curve notwithstanding, I do think I have a feel for this issue and here it is: by using the mandatory contraception statement, including specific requirements of condom and other birth control use, etc., it's not like you are requiring/providing/permitting/going along with the use of birth control while the patient is actually in the hospital. And I don't think it constitutes a Catholic health provider providing or promoting anything in violation of the ERD's. The ERD's apply to Catholic health services and the activities to which the contraception statement apply do not fall within that category. :-) Of course, this is just my opinion and not based on any official Catholic ethical pronouncement. Susan Atkinson Corporate Counsel Saint Joseph's Health System Atlanta, GA > -----Original Message----- > From: Patrick Mccruden [SMTP:mccrudep@mercyhealth.com] > Sent: Thursday, June 15, 2000 9:38 AM > To: mcwirb@mcwirb.org > Subject: Religious Institutions and IRB's > > Our hospital is Catholic sponsored and hence must adhere to the Ethical > and > Religious Directives for Catholic health Care Facilities and all that > entails. > We also have an IRB which is utilized by many local physicians, (members > of the > medical staff) for protocols on subjects who will probably never see the > inside > of the hospital (unless for an unrelated reason.) > > You might guess an issue came up regarding a mandatory contraception > statement > in a protocol and informed consent document. I know this has been > discussed in > this forum before and I realize that you can oppose specific mandates on > types > of contraception without coming from a religious standpoint. Other members > of > our IRB felt that a change in language (warning of potential risks and > advising > the avoidance of pregnancy without a mandate on two forms of > contraception) was > watering down the prohibition on pregnancy and thus endangering potential > mothers and fetuses. > > The discussion ultimately turned to a larger discussion of what is the > duty of > the IRB to its home institution vs. its duty to the community. Perhaps I > should > mention we are the only IRB in town, the other hospital in town does not > have > an IRB. > > Several of the physicians and community members felt strongly that > although the > IRB is housed at the Catholic hospital it is really a community IRB and > thus > should not impose Catholic doctrine on investigators and subjects, i.e. > it > should protect human subjects via the regs and standards set out by FDA > and > OPPR. The only time they felt this could be changed was if the subjects > were > going to be patients in the hospital, then they felt the hospital could > uphold > the ethical and religious directives. > > Personally I don't believe asking for a rewording of contraception > mandates is > imposing Catholic doctrine, and I do think it is in keeping with the > FDA's > thoughts on this matter, but I guess that is beside the point. > > I would be interested in the experiences of IRB's at other religiously > sponsored institutions as well as the opinions of other on the obligations > any > IRB has to the community. > > Thank you in advance for any insights. > > Patrick McCruden > Vice President, Mission Integration > St. Joseph's Regional Health Center > Hot Springs, AR > pmccruden@htsp.smhs.com > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Susan 6/15/2000 5:08:00 AM

Religious Institutions and IRB's

Thanks for your response. In my haste I was probably unclear in my post because I don't believe we are neglecting our duty to minimize risks and fully inform subjects of relevant information. Certainly that would include informing subjects of the risks of becoming pregnant or potential harm to a developing fetus etc...stating that they should not become pregnant etc...receive the medical counseling needed to prevent pregnancy etc. What I/we would and did object to is a mandate that sexually active women utilize two forms of artificial contraception. Women who would not accept this mandate would be excluded from the study. I felt this was incompatible with both the regs and with our adherence to the ethical and religious directives(erd). We uphold both...the regs and the (erd). I can imagine there would be some studies we simply would not review due to a conflict with the ERD e.g. a contraceptive study. Or perhaps I'm still not responding to your concerns? I also appreciate the other list participants who have shared compromise language that has been acceptable to institutional concerns while still protecting the rights of human subjects. Patrick J. McCruden Vice President, Mission Integration St. Joseph's Regional Health Center P.O. Box 29001 Hot Springs AR 71903 501-622-1135 (fax) 501-622-1199 e-mail: pmccruden@htsp.smhs.com > -----Original Message----- > From: Jon Merz [SMTP:merz@mail.med.upenn.edu] > Sent: Thursday, June 15, 2000 10:23 AM > To: mcwirb@mcwirb.org > Subject: Re: Religious Institutions and IRB's > > At 8:38 AM -0500 6/15/00, Patrick Mccruden wrote: > >... > >The discussion ultimately turned to a larger discussion of what is the > duty of > >the IRB to its home institution vs. its duty to the community. Perhaps I > >should > >mention we are the only IRB in town, the other hospital in town does not > have > >an IRB. > ... > > the duty of the IRB is simple: protection of human subjects. if you think > it is broader than that, please point me to any regulations, provisions of > your MPA, legal decisions, or any ethical writings that would expand on > that singular duty. > > under the regs, the IRB must, among other things, minimize risks to > subjects and insure that they are fully informed of all relevant > information. sounds like your IRB would fail to meet both of these > obligations. > > look too at the belmont report, which recommends that subjects be informed > about everything that would be material to a reasonable volunteer. the > standard is by what the subject requires, not by what the institution or > researcher feels safe saying (such as to insulate themselves from some > perhaps incompletely conceived notion of moral culpability for the acts of > others). > > allowing any type of institutional constraint to infect and undermine the > fundamental rights of human subjects to be fully informed about the scope > of their research participation, and in particular about means to minimize > the risks they face in that participation, is simply a violation of all > the > principles, declarations, regulations, and ethics espoused in the last 50 > years on human subjects research. > > > jon merz > center for bioethics > university of pennsylvania > merz@mail.med.upenn.edu > > > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Patrick 6/15/2000 11:51:00 AM

Charging for IRB Review

Our Institutional IRB has made the decision to begin charging for IRB Review. If anyone would be willing to share with us your policy and/or procedure for IRB review fees, it would be greatly appreciated. Thank you for your time and efforts regarding our request. Paul Sesin, Pharm.D. IRB Coordinator, Charlton Memorial Hospital, Fall River, MA 02720

Anonymous 6/15/2000 10:47:00 AM

Religious Institutions and IRB's

In response to your questions, our Catholic sponsored medical center (500 beds, tertiary care) has a very active IRB. The Research Department has developed some standard phrases regarding responsible family planning and researchers select from among those as they submit their protocols for review. We also belong to a community-wide IRB that reviews national cancer protocols. Both Catholic and non-Catholic hospitals participate in the community IRB. We have developed a page of substitute language for several of the parts of the informed consent document, including cost of care, research participant rights, and confidentiality. The Pregnancy language is as follows: There may also be risks and side effects to you (or to a developing fetus if you are pregnant) that we cannot predict. You should not become pregnant or father a baby while on the study. You should not nurse your baby while on this study. Ask about counseling and more information about avoiding pregnancy. A pregnancy test may be required before participation in this study. The physicians conducting research are expected to provide additional counseling as needed. Your hospital should be commended for providing a valuable service to the entire community. As long as the IRB is sponsored by your organization, it's my understanding that you are required to uphold the Directives. It should be possible to find some compromise language that would be satisfactory to all the hospitals you serve. Good luck as you discuss this further. Ellen Bernal, PhD Chair, Human Experimentation Committee St. Vincent Mercy Medical Center Patrick Mccruden on 06/15/2000 09:38:00 AM Please respond to mcwirb@mcwirb.org To: mcwirb@mcwirb.org cc: (bcc: Ellen W Bernal/SVMC/MHP/CHP) Subject: Religious Institutions and IRB's Our hospital is Catholic sponsored and hence must adhere to the Ethical and Religious Directives for Catholic health Care Facilities and all that entails. We also have an IRB which is utilized by many local physicians, (members of the medical staff) for protocols on subjects who will probably never see the inside of the hospital (unless for an unrelated reason.) You might guess an issue came up regarding a mandatory contraception statement in a protocol and informed consent document. I know this has been discussed in this forum before and I realize that you can oppose specific mandates on types of contraception without coming from a religious standpoint. Other members of our IRB felt that a change in language (warning of potential risks and advising the avoidance of pregnancy without a mandate on two forms of contraception) was watering down the prohibition on pregnancy and thus endangering potential mothers and fetuses. The discussion ultimately turned to a larger discussion of what is the duty of the IRB to its home institution vs. its duty to the community. Perhaps I should mention we are the only IRB in town, the other hospital in town does not have an IRB. Several of the physicians and community members felt strongly that although the IRB is housed at the Catholic hospital it is really a community IRB and thus should not impose Catholic doctrine on investigators and subjects, i.e. it should protect human subjects via the regs and standards set out by FDA and OPPR. The only time they felt this could be changed was if the subjects were going to be patients in the hospital, then they felt the hospital could uphold the ethical and religious directives. Personally I don't believe asking for a rewording of contraception mandates is imposing Catholic doctrine, and I do think it is in keeping with the FDA's thoughts on this matter, but I guess that is beside the point. I would be interested in the experiences of IRB's at other religiously sponsored institutions as well as the opinions of other on the obligations any IRB has to the community. Thank you in advance for any insights. Patrick McCruden Vice President, Mission Integration St. Joseph's Regional Health Center Hot Springs, AR pmccruden@htsp.smhs.com _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Ellen Bernal 6/15/2000 8:33:00 AM

Religious Institutions and IRB's

At 8:38 AM -0500 6/15/00, Patrick Mccruden wrote: >... >The discussion ultimately turned to a larger discussion of what is the duty of >the IRB to its home institution vs. its duty to the community. Perhaps I >should >mention we are the only IRB in town, the other hospital in town does not have >an IRB. ... the duty of the IRB is simple: protection of human subjects. if you think it is broader than that, please point me to any regulations, provisions of your MPA, legal decisions, or any ethical writings that would expand on that singular duty. under the regs, the IRB must, among other things, minimize risks to subjects and insure that they are fully informed of all relevant information. sounds like your IRB would fail to meet both of these obligations. look too at the belmont report, which recommends that subjects be informed about everything that would be material to a reasonable volunteer. the standard is by what the subject requires, not by what the institution or researcher feels safe saying (such as to insulate themselves from some perhaps incompletely conceived notion of moral culpability for the acts of others). allowing any type of institutional constraint to infect and undermine the fundamental rights of human subjects to be fully informed about the scope of their research participation, and in particular about means to minimize the risks they face in that participation, is simply a violation of all the principles, declarations, regulations, and ethics espoused in the last 50 years on human subjects research. jon merz center for bioethics university of pennsylvania merz@mail.med.upenn.edu

Jon Merz 6/15/2000 8:33:00 AM

Responsibility For Research Files

At 03:08 PM 6/14/00 -0500, Dale E. Hammerschmidt wrote: >Generally, grants are given to an institution rather than to an individual. This is a key point. Having just attended a meeting co-sponsored by AAAS and the PHS Office of Research Integrity, the message was that ALL research data, files, equipment, etc., at least when it involves federal grants, belong to the institution, not the investigator. When one has to investigate alleged misconduct, the institution has the authority to sequester all of the above, even over the investigator's objection. In theory, data stored on the investigator's personal computer at home also belongs to the institution. However, getting access to that information without permission raises trickier legal and practical questions. Joel E. Frader, M.D. Program in Medical Ethics and Humanities Northwestern University Medical School General Academic Pediatrics Children's Memorial Hospital Mailing Address: Phone:(773) 880-8361 (CMH) General Academic Pediatrics Fax: (773) 281-4237 Children's Memorial Hospital email: j-frader@northwestern.edu 2300 Children's Plaza, #16 Chicago, IL 60614

M . D . 6/14/2000 11:50:00 AM

IRB approval letters

Is there a rule anywhere that states that IRB approval letters are required to be signed by the IRB Chairperson? A study sponsor has questioned my IRB director's signature on an approval letter. The director has always been the signitory person for all IRB corrospondence as far back as my records go. Your help would be greatly appreciated. Chris Samek Roger Williams Medical Center Providence, RI 02908 CFSamek@aol.com

Anonymous 6/14/2000 9:54:00 AM

Compassionate Use?

Actually, I'll disagree with the words well and clarified. I always find it problematic when a phrase without a regulatory definition is operationally defined in a guidance, using it in a way different from its common usage. But Howard is right that FDA, at the URL he provided, sets forth some guidance that at least makes it clear that there are single-patient compassionate uses for which FDA would not insist on full IRB approval, even though they do not involve life-and-limb-threatening emergencies. Many IRBs don't use this, because it isn't provided for in their local policies, or because the boundaries are too fuzzy for comfort. Dale Dale Hammerschmidt Assoc Prof Med / (Hematology/Oncology/BMT) Editor., J. Lab. Clin. Med. Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455 612-626-2640; 612-626-2642 (fax) InterNet 72662,76 (CompuServe)

Dale Hammerschmidt 6/14/2000 11:02:00 AM

Proposulsid Limited Access Program

I agree with Dr. Cooper's post. I believe the IRB is increasingly put into a dangerous position. Specifically, we seem to be drawn into a situation where we are considered the clearinghouse and approval body for every procedure, drug, and device that someone may have concern about regarding safety and/or liability. It may be a compliment that our approval is so sought out, but I believe we must restrict our precious time and resources reviewing true research. I believe we place ourselves in a very uncomfortable position when physicians (many of whom to not know the true purpose of the IRB) argue that It must be OK, since it's been approved by the IRB.

Md 6/14/2000 7:11:00 AM

Informed Consent Signature Lines

It has been our practice to request the following labeled signature lines for informed consent: 1)Printed and signed name of subject 2)Printed and signed name of parent/guardian 3)Printed and signed name of witness 4)Printed and signed name of investigator 5)If appropriate, child's assent I am wondering if this is reasonable or if it's overkill. I'd appreciate your comments. Ginger French, Pharm.D. Wichita, Kansas

Ginger French 6/14/2000 7:08:00 AM

IRB Policies, OPRR Reporting, Research Irregularities

> Like many of you, we are currently and constantly scrutinizing and > refining our IRB policies. I would like some opinions as to how decisions > are made to suspend or terminate research and subsequent disciplinary > actions. The obvious are relatively easy - serious harm to subjects and > overt misconduct (scientific and financial). Does anyone keep a list of > research irregularities and consequences for investigators who commit > them? (paperwork errors mostly - assume there is no subject harm) What, if > any, seemingly benign issues are being reported to the OPRR? What > constitutes a slap on the wrist? > Thanks in advance for your responses. > Kathy Johnson, RN, CCRC > Manager, Research Compliance > Children's Mercy Hospital > KC, MO > kjohnson@cmh.edu >

Kathy Johnson 6/14/2000 9:57:00 AM

Timeliness

In our cycle of IRB deadlines and meetings, a new proposal, amendment/revision, or continuing review may take between 15 and 32 days from the receipt of the materials to the PI receiving the letter of notification (depending whether it's here before or after the cut-off time). Only rarely is approval granted the first time--usually there is minor or major modification to protocol or ICF and re-review. We are about to run some numbers and determine the average and median length of time it takes for an item to move through the IRB review process to final outcome. Does anyone have benchmark numbers they are willing to share on or off list? Don E. Workman, Ph.D. IRB Administrator St. Jude Children's Research Hospital 332 N. Lauderdale Memphis, TN 38101 901-495-4359

Don Workman 6/14/2000 2:03:00 PM

Compassionate Use?

Dale wrote : >-----Original Message----- >Typical examples: > > I have a patient who would probably benefit from New Drug X, > now in phase 3 trials. No trial is active here, and I'd like to > get the drug for the patient. > > I have a patient who would probably benefit from New Drug X, > now in phase 3 trials. The trial is active here, but the patient is > ineligible for the protocol because his disease is a bit different > from the entry criteria. > >This sort of use may be allowable if it is within the >provisions of the IND (or >if the FDA grants permission for the individual patient), if >it's OK with the >sponsor, and if the IRB approves it. Roger clarified : >>I can provide a real example. The manufacturer of the Novoste system (a radioactive device for opening restenosed coronary arteries, currently under clinical trial) applied for, and received from the FDA, approval for their Compassionate Use Protocol. The CUP allows use of the device in patients who do not qualify for inclusion in the clinical trial. The CUP requires, among other things, the concurring opinions of two cardiologists that the patient is not a candidate for conventional therapy, and IRB approval. The latter requirement was, in my view, the FDA's way of distributing responsibility. The CUP (or FDA) provides no guidance about what, exactly, IRB approval means. We were advised, in an e-mail from an FDA official, that the mechanism of IRB approval of the CUP was entirely at our discretion--a letter from the chair, expedited review, or full board review all would be acceptable. As I recall, we even had the option of whether or not to require consent. (edit) ............................................................................................................................................................................... The requirements are well clarified here: http://www.fda.gov/cdrh/ode/idepolcy.html The patient protection measures are the same for the Emergency Use and Compassionate Use options ( the latter generally applies to the Novoste device) : 1. Independent assessment by an uninvolved physician. 2. IRB chairperson's concurrence. 3. Institutional clearance ( We do not have a separate institutional policy). 4. Informed consent. ( I do not necessarily equate this to the formulation and use of an Informed Consent document, per se. This is treatment, not research) A physician may treat more than one patient under the compassionate use criteria. I am involved in a request for the compassionate use of the device at present, and will report my concurrence and such use to my Committee. I shall not solicit my Committee's approval, per se. Regards, Howard

Howard Mann 6/14/2000 11:01:00 AM

IRB approval letters

The approval letter should be signed by the IRB chair or their designee. However, the investigator may insist upon rule which is more strict - as the responsible party for the clinical trial - and the IRB should comply. Here's my rule of thumb for research: Whoever has the strictest rule, rules. >>> CFSamek@aol.com 06/12/00 02:19PM >>> Is there a rule anywhere that states that IRB approval letters are required to be signed by the IRB Chairperson? A study sponsor has questioned my IRB director's signature on an approval letter. The director has always been the signitory person for all IRB corrospondence as far back as my records go. Your help would be greatly appreciated. Chris Samek Roger Williams Medical Center Providence, RI 02908 CFSamek@aol.com _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Robin Newman 6/14/2000 7:08:00 AM

Informed Consent Signature Lines

The time of informed consent is not an FDA requirement at this time. It may be an imposed requirement - making the rule more strict than the current requirement - and if this is done, the site will be held accountable for documentation of time. Timing is only an issue when we must clearly show that consent was obtained prior to initiating therapy or changing the patient's health care or treatment for the purpose of research. The classic situation when the time of consent would be important is the interventional cardiology study where a patient will be premedicated prior to determining eligibility for the trial. In this case, the consent form will document that the patient gave consent to research enrollment prior to receiving premeds - a very important issue with the FDA. >>> Ryan, Lanue 06/12/00 03:12PM >>> >From a recent conference I attended of IRB Managers, it was also pointed out that the consent document contain the time the document was signed. -----Original Message----- From: GFFrench@aol.com [mailto:GFFrench@aol.com] Sent: Monday, June 12, 2000 2:09 PM To: mcwirb@mcwirb.org Subject: Informed Consent Signature Lines It has been our practice to request the following labeled signature lines for informed consent: 1)Printed and signed name of subject 2)Printed and signed name of parent/guardian 3)Printed and signed name of witness 4)Printed and signed name of investigator 5)If appropriate, child's assent I am wondering if this is reasonable or if it's overkill. I'd appreciate your comments. Ginger French, Pharm.D. Wichita, Kansas _______________________________________________ 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

Robin Newman 6/14/2000 7:08:00 AM

IRB approval letters

Robin Newman 6/14/2000 7:05:00 AM

Responsibility For Research Files

I would like to pose a hypothetical question: Who has ownership of research files? Consider a situation in which an investigator (not the P.I.) becomes incapacitated, but refuses to relinquish research files. Does the P.I. of the research program have the right to obtain these files? Does the IRB have jurisdiction over the files? How about the institution? The refusal to relinquish the files is compromising data submission and patient care. Both the P.I. and the IRB have suspended the investigator's ability to enter new patients on trials, and he is on a leave of absence, but ownership of the files continues to be an issue. Advice?

Nancy Morton 6/14/2000 11:50:00 AM

Responsibility For Research Files

Generally, grants are given to an institution rather than to an individual. The PI generally is held to exercise control over study records, with the institution having right of audit and right to a true copy. A Co-I or trainee is in a less clear position, generally being held to have not a lot of right to the data (but sometimes argued to have the right to a true copy in order to be able to have defense against fraud). The rules may be set forth more explicitly in an institution's code of conduct or in the terms of a research contract. When we looked into this for a responsible conduct of research course a few years back, we were surprised that this is often left unsaid, and the rules of engagement are oral tradition that each trainee is expected to acquire by osmosis. Our biggest message in the course was that research teams should discuss data ownership and publication conventions right away at the beginning of a project or association, so that bitter fights did not happen later. The suggested scenario is not one I've dealt with specifically (though I often worry about who protects confidentiality of records when the PI retires or dies); my initial thought would be that the PI should take control of the files, and the institution should back him(her) up. The IRB's role would be, as usual, to think about risk and benefit. If the files have identifiers and the squabble poses a confidentiality risk, that's an IRB concern. If the files contain information that should go back to subjects, and that information transfer might be compromised, that could be an IRB concern. I'll be interested to see how others respond. Dale Dale Hammerschmidt Assoc Prof Med / (Hematology/Oncology/BMT) Editor., J. Lab. Clin. Med. Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455 612-626-2640; 612-626-2642 (fax) InterNet 72662,76 (CompuServe)

Dale Hammerschmidt 6/14/2000 11:02:00 AM

Compassionate Use?

Message posted for Jeanne Gaffney Lynne Moffitt's posting regarding Charging for IRB Review caught my eye, not for the obvious, but because she made reference to waiving the fee for compassionate use protocols. Recently, I had a conversation with Paul Goebel regarding this topic. He simply stated that the FDA does not recognize this term. But it seems to continue to surface on this site. What does it mean when someone states, The drug has been approved for compassionate use? Jeanne Gaffney Human Research Review Board Baptist Health System, Inc. Birmingham, AL

Anonymous 6/14/2000 11:02:00 AM

Proposulsid Limited Access Program

I just returned from DIA and in picking up my mail felt I would like to respond to this one. This is a very astute pick up. For an investigator to argue that something is medically, scientifically or ethically acceptable because it is IRB approved is a way of passing the responsibility buck - something, by the way, that a clinical investigator cannot legally do. As the PI, the physician investigator is held 100% responsible for the clinical trial conduct just as in the role of doctor they are held responsible for the medical decisions they make or delegate. They are held responsible for the contents of an informed consent document and for proper communication and dialogue with the IRB. The IRB's role in the protection of human subjects does not substitute for the physician's responsibility in this matter. This does not mean that an IRB does not have accountability to GCP. Among their many responsibilities, the IRB must still review studies for scientific integrity as it relates to patient protection and the risk:benefit ratio. The IRB should also be aware of what the essential elements of an informed consent document are and review each one submitted for proper content, format and appropriateness of disclosure. This oversight function, however, does not absolve the physician conducting research from responsibility. It seems as though this should be intuitive, but many investigators have no formal GCP training and may be quite unaware of what their role in research entails - they may not fully understand the difference between medical practice and clinical research. When I train physicians engaged in research, I always emphasize that they may delegate away the authority to manage certain tasks in clinical research, but they may not delegate away their responsibility. I think it is prudent of the IRB to remind them of this as well. >>> Craig Weiner, MD 06/11/00 10:43PM >>> I agree with Dr. Cooper's post. I believe the IRB is increasingly put into a dangerous position. Specifically, we seem to be drawn into a situation where we are considered the clearinghouse and approval body for every procedure, drug, and device that someone may have concern about regarding safety and/or liability. It may be a compliment that our approval is so sought out, but I believe we must restrict our precious time and resources reviewing true research. I believe we place ourselves in a very uncomfortable position when physicians (many of whom to not know the true purpose of the IRB) argue that It must be OK, since it's been approved by the IRB. _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Robin Newman 6/14/2000 7:11:00 AM

Federal Register Notice

[Federal Register: June 13, 2000 (Volume 65, Number 114)] [Notices] [Page 37136-37137] >From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr13jn00-74] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Office of Public Health and Science, and National Institutes of Health, Office of the Director; Statement of Organization, Functions, and Delegations of Authority Part A, Office of the Secretary (OS) of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (DHHS), Chapter AC, Office of Public Health and Science (OPHS), the Immediate Office (ACA) as last amended at 62 FR 5009-10, dated February 3, 1997; and Part N, the National Institutes of Health, Office of the Director (NA), Office of Extramural Research (NA3), Office for Protection from Research Risks, as last amended at 65 FR 11792, March 6, 2000, are being amended to reflect the transfer of the human research protection functions from the NIH to the newly established Office for Human Research Protections (OHRP), OPHS, within the OS. The OHRP will be headed by a Director who will report to the Assistant Secretary for Health. The changes are as follows: I. Under Part N, National Institutes of Health, Chapter NA, Office of Director, Office of Extramural Research (NA3), make the following changes: A. Delete the ``Office of Extramural Research (NA3)'' in its entirety and replace with the following: Office of Extramural Research (NA3)--(1) Acts on behalf of the NIH Director to provide guidance to the research institutes on the development and management of extramural (grant and cooperative agreement) research and training programs; (2) advises the NIH Director and staff on issues relating to extramural research activities; and (3) oversees the proper care and use of laboratory animals on behalf of the entire U.S. Public Health Service. B. Delete the ``Office for Protection from Research Risks (NA33)'' in its entirety. II. Under Part A, Chapter AC, Office of Public Health and Science, make the following changes: A. Delete Section AC.10 Organization in its entirety and replace with the following: Section AC.10 Organization. The Office of Public Health and Science (AC) is under the direction of the Assistant Secretary for Health and consists of the following components: A. Immediate Office (ACA) B. Office on Women's Health (ACB) C. Office of Minority Health (ACC) D. Office of the President's Council on Physical Fitness and Sports (ACE) E. Office of Research Integrity (ACF) F. Office of Population Affairs (ACG) G. Office of International and Refugee Health (ACH) H. Office of HIV/AIDS Policy (ACJ) I. Office of Emergency Preparedness (ACK) J. Office of Disease Prevention and Health Promotion (ACL) K. Office of the Surgeon General (ACM) L. Office for Human Research Protections (ACN) B. Amend Chapter AC.20 Functions, paragraph A, ``Office of Public Health and Science,'' paragraph titled, ``The Immediate Office (ACA)'' by adding the following new clause: (m) Responsible for overseeing human research subjects protections functions and related functions where research involves the use of human subjects. [[Page 37137]] C. Under Section AC.20 Functions, add paragraph ``L. Office for Human Research Protections (ACN),'' to read as follows: L. Office for Human Research Protections (ACN)--The Office for Human Research Protections (OHRP) fulfills responsibilities set forth in the Public Health Service Act. These include: (1) Developing and monitoring as well as exercising compliance oversight relative to HHS Regulations for the protection of human subjects in research conducted or supported by any component of the Department of Health and Human Services; (2) coordinating appropriate HHS regulations, policies, and procedures both within HHS and in coordination with other Departments and Agencies in the Federal Government; (3) establishing criteria for and negotiation of Assurances of Compliance with institutions engaged in HHS-conducted or--supported research involving human subjects; (4) conducting programs of clarification and guidance for both the Federal and non-Federal sectors with respect to the involvement of humans in research; and directing the development and implementation of educational and instructional programs and generating educational resource materials; (5) evaluating the effectiveness of HHS policies and programs for the protection of human subjects; (6) serving as liaison to Presidential, Departmental, Congressional, interagency, and non-governmental commissions and boards established to examine ethical issues in medicine and research and exercises leadership in identifying and addressing such ethical issues; and (7) promoting the development of approaches to enhance and improve methods to avoid unwarranted risks to humans participating as subjects in research covered by applicable statutes and regulations. 1. Office of the Director (ACN1)--The Office of the Director reports to the Assistant Secretary for Health, supervises and manages the development and promulgation of policies, procedures, and plans for meeting the responsibilities set forth above. Additionally, staff of this office advise the Secretary, Assistant Secretary for Health and other HHS officials on ethnical issues pertaining to medicine and biomedical and behavioral research, including all issues relative to the implementation of HHS Regulations for the Protection of Human Subjects. Directs the development, implementation, and compliance oversight activities for HHS Regulations and for the Protection of Human Subjects; exercises oversight and negotiates Assurances of Compliance in all areas of human subject research; maintains liaison and coordinates policy implementation with components throughout HHS that conduct or support research involving human subjects; and directs the development and implement of educational and instructional programs and generates resource materials relating to the responsibilities of the research community for the protection of human subjects. 2. Division of Policy and Assurance (ACN 2)--(1) Negotiates Assurances of Compliance with research entities; (2) provides liaison, guidance, and regulatory interpretation to research entities, investigators, Federal officials, and the public; (3) maintains existing assurance mechanisms; and (4) develops and implements new procedures to ensure that HHS human subjects protection regulations are appropriately and effectively applied to the changing needs of the research community. 3. Division of Compliance Oversight (ACN 3)--(1) Conducts inquiries and investigations into alleged noncompliance with HHS Regulations for Protection of Human Subjects; (2) prepares inquiry and investigative reports; (3) recommends remedial or corrective action as necessary to agency or Department officials as appropriate; and (4) conducts a program of oversight of awardee institution implementation of HHS Regulations for the Protection of Human Subjects. 4. Division of Education and Development (ACN 4)--(1) Produces and coordinates conferences and workshops focusing on issues in human subjects protection; (2) promotes cooperative education and development efforts among external groups and consortia to improve human subjects protections and related processes; (3) promptly responds to requests for clarification and guidance regarding ethnical issues in biomedical and behavioral research involving human subjects; (4) provides technical assistance to institutions engaged in HHS-conducted or - sponsored research involving human subjects; and, (5) maintains, promulgates, and updates educational and institutional review guidance materials. D. Continuation of Policy: Except as inconsistent with this reorganization, all statements of policy and interpretations with respect to the National Institutes of Health and the Office of the Secretary heretofore issued and in effect prior to this reorganization are continued in full force and effect. E. Delegation of Authority: All delegations and redelegations of authority made officials and employees of affected organizational components will continue in them or their successors pending further redelegation, provided they are consistent with this reorganization. F. Funds, Personnel, and Equipment: Transfer or organizations and functions affected by this reorganization shall be accompanied by direct and support funds, positions, personnel, records, equipment, supplies and other resources. G. Effective Date: The effective date of this reorganization is June 18, 2000. Donna E. Shalala, Secretary. [FR Doc. 00-14803 Filed 6-12-00; 8:45 am] BILLING CODE 4150-04-M

rachlinj@aol.com 6/14/2000 7:14:00 AM

Informed Consent Signature Lines

Robin Newman 6/14/2000 7:05:00 AM

IRB approval letters

Robin Newman 6/14/2000 7:08:00 AM

Compassionate Use?

Howard Mann 6/14/2000 11:00:00 AM

IRB approval letters

Hi all I have never felt comfortable signing the approval letters - either previously as an admin or now as president. I believe that it is the duty of the chair. The chair is the person who should be interpreting committee action and conveying it on behalf of the group. Also, if we were to write, sign and file, there might be misstatements that would not be caught in time. Now, in reality, we draft the letters in the office and fax them to the chair. She edits, adds, comments and returns. Then, when the letter is ready to her satisfaction, I sign her name to it. But in the files, there is the backup. Also, I have a written signature authority from her. Our policy has a section on duties of the chair and responsibillity for the letters is assigned to the chair. The administration simply makes her job easier for her; it does not substitute. Erica >Is there a rule anywhere that states that IRB approval letters are required to >be signed by the IRB Chairperson? A study sponsor has questioned my IRB >director's signature on an approval letter. The director has always been the >signitory person for all IRB corrospondence as far back as my records go. Your >help would be greatly appreciated. > >Chris Samek >Roger Williams Medical Center >Providence, RI 02908 >CFSamek@aol.com > > >_______________________________________________ >MCWIRB maillist - MCWIRB@mcwirb.org >http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb Erica Heath President, IRC 415-485-0717

heath 6/14/2000 7:08:00 AM

IRB approval letters

I agree with Erica on who should sign. I feel the person who signs should have a broad professional knowledge base in Biology and Medicine (a real understanding of science and the practice of medicine not just terminology), Regulatory Affairs (knows the meaning of subject protection regulations) and Ethics (understands and uses the concepts and methods of ethical deliberation). If you can't say you are capable of doing all these, you shouldn't sign and take responsibility for the action. Art Anderson USAMRIID artnscience@yahoo.com -----Original Message----- From: ejheath@batnet.com [mailto:ejheath@batnet.com] Sent: Wednesday, June 14, 2000 11:40 AM To: mcwirb@mcwirb.org Subject: Re: IRB approval letters Hi all I have never felt comfortable signing the approval letters - either previously as an admin or now as president. I believe that it is the duty of the chair. The chair is the person who should be interpreting committee action and conveying it on behalf of the group. Also, if we were to write, sign and file, there might be misstatements that would not be caught in time. Now, in reality, we draft the letters in the office and fax them to the chair. She edits, adds, comments and returns. Then, when the letter is ready to her satisfaction, I sign her name to it. But in the files, there is the backup. Also, I have a written signature authority from her. Our policy has a section on duties of the chair and responsibillity for the letters is assigned to the chair. The administration simply makes her job easier for her; it does not substitute. Erica >Is there a rule anywhere that states that IRB approval letters are required to >be signed by the IRB Chairperson? A study sponsor has questioned my IRB >director's signature on an approval letter. The director has always been the >signitory person for all IRB corrospondence as far back as my records go. Your >help would be greatly appreciated. > >Chris Samek >Roger Williams Medical Center >Providence, RI 02908 >CFSamek@aol.com > > >_______________________________________________ >MCWIRB maillist - MCWIRB@mcwirb.org >http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb Erica Heath President, IRC 415-485-0717 _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Arthur O Col Usamriid 6/14/2000 9:54:00 AM

Compassionate Use?

>-----Original Message----- >Typical examples: > > I have a patient who would probably benefit from New Drug X, > now in phase 3 trials. No trial is active here, and I'd like to > get the drug for the patient. > > I have a patient who would probably benefit from New Drug X, > now in phase 3 trials. The trial is active here, but the patient is > ineligible for the protocol because his disease is a bit different > from the entry criteria. > >This sort of use may be allowable if it is within the >provisions of the IND (or >if the FDA grants permission for the individual patient), if >it's OK with the >sponsor, and if the IRB approves it. I can provide a real example. The manufacturer of the Novoste system (a radioactive device for opening restenosed coronary arteries, currently under clinical trial) applied for, and received from the FDA, approval for their Compassionate Use Protocol. The CUP allows use of the device in patients who do not qualify for inclusion in the clinical trial. The CUP requires, among other things, the concurring opinions of two cardiologists that the patient is not a candidate for conventional therapy, and IRB approval. The latter requirement was, in my view, the FDA's way of distributing responsibility. The CUP (or FDA) provides no guidance about what, exactly, IRB approval means. We were advised, in an e-mail from an FDA official, that the mechanism of IRB approval of the CUP was entirely at our discretion--a letter from the chair, expedited review, or full board review all would be acceptable. As I recall, we even had the option of whether or not to require consent. We have had several requests for the CUP involving this Novoste device, and in response we usually issue a letter from the chair indicating approval once all of the required elements are provided. We requested that the PI ammend the study protocol to include the CUP, and the ammendment was debated and approved by the full board. Subsequently, we include individual instances of the CUP as informational (non-voting) items in our meeting agenda. We also issue a single-use consent form, with the patient's name typed in, for each CUP occurrence. Incidently, in their letter to the manufacturer in which approval of the CUP is granted, the FDA mentioned neither Treatment Use nor Emergency Use, which have specific regulatory definitions. Roger Bertholf Chair, IRB-03 Univ of Fla Health Sci Cntr/Jax

Roger 6/14/2000 7:08:00 AM

Compassionate Use?

Dale Hammerschmidt 6/14/2000 11:01:00 AM

Audit process

I would like advice from mcwirb members regarding investigator audits by the IRB office. Our IRB has reason to suspect that improper consent is being obtained by an investigator. The investigator has the approval of two separate IRB's and we believe that they have been using the wrong consent form to consent patients at our institution. We are planning to audit the investigator files and will probably suspend the study (with proper notification to the sponsor and FDA) until the audit is completed. Has anyone else had this experience and how did you handle the situation. Are we on the right track? DonnaSchoenfelder IRB Coordinator INTEGRIS Baptist Medical Center schods@integris-health.com (405) 951-2958

Donna S . 6/14/2000 7:08:00 AM

Conflict of Interest: A provocative notion

Hi All, You may be interested in this item, issued by the NIH : FINANCIAL CONFLICTS OF INTEREST AND RESEARCH OBJECTIVITY: ISSUES FOR INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS [ http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-040.html] It contains this notion : o Ask investigators to complete a short questionnaire in which they are asked “whether they or any other person responsible for the design, conduct, or reporting of this research has an economic interest in, or acts as an officer or a director of any outside entity whose financial interests would reasonably appear to be affected by, the research.” We increasingly review industry-sponsored research protocols in which intermediaries (CROs) recruit physicians in private practice -- physicians without any experience in clinical research -- as investigators for drug trials. With respect to the design, conduct, analysis and reporting of data, they are distant and passive. These elements are entirely the responsibility of the Sponsor and its representatives. This has dire implications for the conduct of research, and obvious implications with respect to notions of conflict of interest. This is well explicated in a recent article and editorial published in the NEJM: [http://www.nejm.org/content/2000/0342/0020/1539.asp] [http://www.nejm.org/content/2000/0342/0020/1516.asp] I urge you to read these. What is an IRB to do ? Regards, Howard

Anonymous 6/14/2000 11:24:00 AM

Liability of IRB members

Gullion Christina M 06/09/00 08:41AM wrote: >>The question has come up here of whether IRB members need to worry about personal liability. Two possible situations come to mind--one is if a fine is levied by OHRP/HHS against an institution because of its IRB's failings. The second is a lawsuit that determines an IRB was negligent in protecting a human subject--which doesn't seem totally farfetched to us, with the major advances in tort law that we've seen in this country. >>While hospital and university employees would probably be covered by their institution's liability insurance, what is the status of physicians in private practice and community members who served on an IRB? ................................................................................................................................................................................ Christina, Your institution should have an identifiable indemnification policy that covers the members of the IRB. At my institution, IRB members act as Officers of the Corporation with respect to their IRB duties. Here is a relevant excerpt from my Institution's bylaws : ARTICLE VII INDEMNIFICATION Section 7.01. Indemnification. To the maximum extent permitted by law, no Trustee or officer of the Corporation shall be personally liable for any obligations of the Corporation or for any duties or obligations arising out of any acts or conduct of any such Trustee or officer performed for or on behalf of the Corporation. The Corporation shall and does hereby indemnify and hold harmless each person and his or her heirs and administrators who shall serve at any time hereafter as a Trustee or officer of the Corporation... Regards, Howard

Howard Mann 6/13/2000 4:58:00 AM

Office for Human Research Protections

Is the new Office for Human Research Protections, where Dr. Koski is the new director, meant to be THE NEW Office for Protection of Research Subjects in the office of the Secretary of Health and Human Services as promulgated by Section 401, Title IV - (Federal Oversight) of the proposed Human Research Subject Protection Act 2000? Or is the OHRP an entirely different office in addition to what is promulgated in Section 401 as referenced above?

Anonymous 6/13/2000 3:18:00 AM

Informed Consent Signature Lines

ginger french wrote: > It has been our practice to request the following labeled signature lines for > informed consent: > 1)Printed and signed name of subject > 2)Printed and signed name of parent/guardian > 3)Printed and signed name of witness > 4)Printed and signed name of investigator > 5)If appropriate, child's assent > I am wondering if this is reasonable or if it's overkill.>> whether it's reasonable or overkill or required may all be separate questions. i'll only tackle the last of those, by cutting and pasting something i wrote as guidance on this question: ------------------------------------------------------------------------- Who must sign the informed consent document according to FDA/OPRR regulations? By ICH guidelines? JCAHO requirements? FDA regulations require only that an IRB approved consent form be signed and dated by the subject or the subject's legally authorized representative (LAR), unless a short form is used to document a verbal presentation (as provided under 21 CFR 50.27(b)(2)). In this case, the subject or LAR must sign the short form, while the person obtaining consent must sign a summary of the verbal information, and a witness to the presentation must sign both the short form and the written summary. The subject or LAR should be given copies of both the short form and summary. OPRR regulations largely follow those of the FDA, except that the signature of the subject or LAR on the full written consent form is not required to be dated. 45 CFR 46.117(b)(2) provides for the same short form approach described above, when a verbal presentation is used. International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice (Guideline E6, section 4.8.8) require that the written consent document be signed and personally dated by the subject or LAR, and by the person who conducted the informed consent discussion. JCAHO standards (R1.3.1) require that consent forms indicate the name of the person who provided the information and the date the form was signed. * NOTE that these policies and regulations provide minimal requirements which may be exceeded, particularly if a study is subject to multiple, overlapping authorities. * NOTE that there is no requirement under any of these policies or regulations that the principal investigator must personally sign a consent form, although individual sponsors or IRBs may choose to require this. In this case, it may be appropriate that this be a third signature, if the PI delegates this responsibility in practice (i.e. PI does not take place of person who actually conducted the informed consent process). * NOTE that there is no requirement that a third party witness sign a consent form, except under the short form scenario allowed by FDA and OPRR, although industry sponsors and/or IRBs are increasingly choosing to impose this additional requirement. ------------------------------------------------------------------------- to the above, i'd add that everyone should be clear what the witness is witnessing, if that additional signature is required (by the IRB). in my personal opinion, this shouldn't be a notary public sort of function (i.e. yes, the subject actually signed), but rather an independent observation of the consent process. and i bet few witnesses actually serve that purpose(?). having said all the above, we require two signatures for most research on adults: that of the subject (or LAR, when appropriate), and that of the person obtaining consent. 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 6/13/2000 7:55:00 AM

Response to Removal of Gary Ellis

Tuesday, June 13, 2000/The Plain Dealer (Cleveland OH) By SABRINA EATON WASHINGTON -Gary B. Ellis was one of the government's top medical research cops, a job he took seriously. That's why, some researchers and congressmen say, the government last week shunted aside the University Heights native - for being too tough in ferreting out questionable practices in experiments on humans. He investigated University of California at Irvine fertility researchers who implanted embryos in women without revealing that they were not their own. At the West Los Angeles Veterans Affair Medical Center, Ellis' office sanctioned cardiologists who performed heart research on patients against their wishes. And at Rush-Presbyterian-St. Luke's Medical Center in Chicago, his staff faulted researchers for enrolling patients in stroke research when their symptoms made participation risky. In the past two years, he suspended clinical research at seven facilities until they improved protections for their human subjects. But the research community grew angry with Ellis, 45, who headed the National Institutes for Health's division responsible for protecting human subjects. It was unheard of to suspend funding to universities before he came on the scene, said Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics and an Ellis supporter, who said he has heard plenty of researchers grumble. Any academic institution would be mightily distressed to have questions raised as to whether it is doing its job to protect human subjects, said Dr. John Mather, who heads the Veterans Administration office that oversees compliance with research standards. Health and Human Services Secretary Donna E. Shalala last week announced that oversight of human research will shift to a new HHS office, where Ellis will have no role. Many of Ellis' supporters saw it as payback from disgruntled researchers. Representatives of research institutions disciplined by Ellis' Office for Protection from Research Risks (OPRR) and HHS spokesman Damon Thompson denied that they lobbied HHS to push Ellis out. Shalala announced that Harvard Medical School anesthesia professor Dr. E. Greg Koski will head the new Office for Research Protections. Ellis was moved to an education position at an NIH research hospital in Bethesda, Md., which is conducting studies on such topics as shingles and teen obesity. But Ellis was not told what he will be doing there. Koski, a medical doctor, is considered well-qualified for the new post, said Association of American Medical Colleges President Jordan J. Cohen. Koski currently oversees protection of research subjects at a consortium of hospitals, including Massachusetts General Hospital and Brigham and Women's Hospital. In shifting protection of research subjects to a new office, Thompson said, the government will be better able to monitor experiments conducted by other agencies besides NIH. The secretary not only appreciated the record of accomplishment that Gary Ellis brought to OPRR, but has said plainly that we intend to build upon and expand on those accomplishments, Thompson said. But not everyone accepts that the shift was made to expand upon Ellis' accomplishments. Marian Secundy, director of the National Center for Bioethics in Research and Health Care at Tuskegee University in Alabama, believes Ellis was shoved aside because his aggressive enforcement vexed members of the scientific community. I believe strongly that Gary Ellis would have made certain this new office would have continued to function effectively and positively, said Secundy, whose institution was created by President Clinton as a way to apologize for an infamous 40-year government study of syphilis at Tuskegee, in which doctors didn't treat 400 black men for the disease. Gary Ellis did his job too well and is being shunted aside, said Madison Rep. Steve LaTourette, a classmate o

Anonymous 6/13/2000 10:04:00 AM

Response to Removal of Gary Ellis

We will all have to wait and see if big money and politics replaces protection of human subjects as the main focus of this office. If it is becomes a gelding or already is gelded, then we will know. -----Original Message----- From: Steven Peckman [SMTP:SPECKMAN@oprs.ucla.edu] Sent: Tuesday, June 13, 2000 11:46 AM To: mcwirb@mcwirb.org Subject: re: Response to Removal of Gary Ellis Cleveland Plain Dealer Part II Gary Ellis did his job too well and is being shunted aside, said Madison Rep. Steve LaTourette, a classmate of Ellis' at both Cleveland Heights High School and the University of Michigan. LaTourette, upset when Shalala announced she was seeking someone from outside government for the new post, thereby excluding Ellis, wrote a letter of complaint to the secretary, as did House Government Reform and Oversight Committee Chairman Dan Burton of Indiana. More than anyone else in the government, he was dedicated to protecting human research subjects, Cleveland Rep. Dennis Kucinich, who serves on the Government Reform and Oversight Committee with LaTourette and Burton, said of Ellis. He made it uncomfortable for some of the university research interests, who weren't interested in the human side of the equation. For all the complaining, even critics doubt that at this stage Shalala's decision can be reversed. Most of Ellis' 25 former employees are expected to move to the new office, and Ellis is hoping he can at least serve there in another capacity. No reason was given for my removal, Ellis said, and so the cause is open for speculation. _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

John 6/13/2000 10:04:00 AM

Financial disclosure in the informed consent

I don't think this is done routinely. The pharmaceutical companies often are asking for this information and signed by the investigators, but it may not be universally requested. >>> ldhmann@ihc.com 06/13/00 02:22PM >>> Hi, We recently adopted a policy concerning investigator financial conflict of interest. It is essentially that described by John La Puma : How Much Do You Get Paid IF I Volunteer? Suggested Institutional Policy on Reward, Consent and Research (see pages 197-199) J. Hospital and Health Services Administration 39:2, 1994 We require disclosure of the source, mechanism and amount of funding in the Application for Research and Consent Document. We also ask about any ownership interests, etc., the investigator may have in the sponsoring company, and a similar query concerning the investigator's institution. If you would like to see the former, it is a Wordperfect document: http://www.ihc.com/ldsh/irb/forms/application.wpd The relevant section of our Consent Document template is : http://www.ihc.com/ldsh/irb/consent_template.html#SPONSOR Regards, Howard _______________________________________________ MCWIRB maillist - MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb

Greg Wise 6/13/2000 10:43:00 AM

A simple question of length

I've been presented a consent for a trial utilizing a new pacemaker device. The consent is somewhat disjointed, and difficult to understand, even for someone with a background in medicine. That represents one problem. The other is that this consent form runs 13 (thirteen) pages in length (and with rather small font size as well). If we are really going to do justice to the PROCESS of consent, does anyone agree with me that 13 pages is a significant hinderance to proper disclosure, and that merely by its length, most potential subjects will either refuse the trial, or sign it merely on the basis that they trust their doctor. Even a great consent is just words on paper if no one reads it. Thanks for your thoughts. Craig Weiner, MD Chair Mercy Healthcare Sacramento Regional IRB craig@the-most.com

Md 6/13/2000 10:43:00 AM

Liability of IRB members

Christina: I wouldn't worry a bit, as I suspect your own counsel, whom you should consult for reassurance, will probably tell you. Anyone, whether employee or outside or community member, serving on an IRB was presumably appointed to membership by an official of the parent institution with authority to make such appointments. Decisions by members of the IRB acting in their capacity as members, would be decisions made in the course of their official duties and on behalf of the parent institution. Members of whatever type (e.g. physicians in private practice, community members) would probably be viewed as agents, if not employees, of the institution. If some IRB-approved research project went bad and suit were brought, I have no doubt the institution (or its insurer if any), and not the individual IRB member(s), would be on the hook if the claimant were able to prove liability. That said, anyone with the money to pay a court filing fee (probably in the range of two hundred dollars or so, plus or minus) could sue anyone naming anyone, and you cannot prevent such things from happening. It would be up to the courts to dismiss frivolous claims, with perhaps (depending on state law) discretionary authority to impose sanctions on anyone who filed a really frivolous claim in bad faith for improper (e.g. harassment) purposes. Don't fear what you call advances in tort law (e.g. think of asbestos and tobacco litigation), or a system of civil fines. There are two ways to regulate an activity. One is by writing an increasing number of more and more detailed rules, to anticipate nuance, and to try to control and monitor very sophisticated human activities in advance, in order to prevent any harm from ever occurring. This is what we have done thusfar in attempting to protect human subjects. We may have reached a saturation point, however, in which there are now, or soon will be, more rules than anyone can be expected to remember, understand, or apply. The second way is to develop some general principles that define a duty, which we expect people to adhere to. Presumably people will try to meet their duty, and act reasonably and free of negligence, if for no other reason than fear that if they fail to do so they might be held liable (through a dreaded lawsuit), or fined. I favor a mix of both approaches. The first tends to rely upon legislative and administrative power, the second upon judicial power, for enforcement of principles. In my view, IRB members, individually, will never in a million years be held personally liable for research gone bad, or be required personally to pay money damages or civil fines (assuming a system of fines ever gets established in the first place). They or the IRB itself might get named as defendants in a lawsuit, a possibility that cannot really be prevented as noted above, but they should not be afraid, as their actions are likely considered to be taken or not taken as agents of the institution. I strongly suspect the parent institution would step forward, provide IRB members a defense, pay for legal expenses, and pay any damages that might be assessed for research gone wrong. Check with your own counsel on this, however. Finally, for what it may be worth, as a community member of an IRB I am not in the slightest bit concerned about personal liability, and never expect to be. Good luck, Tom Dalglish J.D., Ph.D. Community Representative, Committee C University of Washington (206) 543-0098 (University) (206) 706-1000 (Office) -----Original Message----- From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of Gullion Christina M Sent: Friday, June 09, 2000 7:41 AM To: 'mcwirb@mcwirb.org' Subject: Liability of IRB members

thomas k. dalglish 6/13/2000 4:55:00 AM

Informed Consent Signature Lines

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_01BFD55B.BA3311B4 Content-Type: text/plain Ginger, If you are JACHO accredited, you may wish to consider adding (or changing your 'witness signature' to) signature of person obtaining informed consent. We no longer use witness. We also do not require the PI to sign (unless (s)he is the individual obtaining the IC), however, many consent documents include this information at the PI's or sponsor's request. In terms of patent/guardian, minor assent...these are only included if applicable to the specific study. 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: GFFrench@aol.com [SMTP:GFFrench@aol.com] > Sent: Monday, June 12, 2000 2:09 PM > To: mcwirb@mcwirb.org > Subject: Informed Consent Signature Lines > > It has been our practice to request the following labeled signature lines > for > informed consent: > 1)Printed and signed name of subject > 2)Printed and signed name of parent/guardian > 3)Printed and signed name of witness > 4)Printed and signed name of investigator > 5)If appropriate, child's assent > I am wondering if this is reasonable or if it's overkill. I'd appreciate > your comments. > Ginger French, Pharm.D. > Wichita, Kansas > > > _______________________________________________ > MCWIRB maillist - MCWIRB@mcwirb.org > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb ------_=_NextPart_001_01BFD55B.BA3311B4 Content-Type: text/html Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: Informed Consent Signature Lines Ginger, If you are JACHO = accredited, you may wish to consider adding (or changing your 'witness = signature' to) "signature of person obtaining informed = consent". We no longer use witness. We also do not = require the PI to sign (unless (s)he is the individual obtaining the = IC), however, many consent documents include this information at the = PI's or sponsor's request. In terms of patent/guardian, minor = assent...these are only included if applicable to the specific = study. 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: GFFrench@aol.com [SMTP:GFFrench@aol.com] Sent: Monday, June 12, 2000 2:09 PM To: mcwirb@mcwirb.org Subject: = Informed Consent Signature = Lines It has been our practice to request = the following labeled signature lines for informed consent: 1)Printed and signed name of = subject 2)Printed and signed name of = parent/guardian 3)Printed and signed name of = witness 4)Printed and signed name of = investigator 5)If appropriate, child's = assent I am wondering if this is reasonable = or if it's overkill. I'd appreciate your comments. Ginger French, Pharm.D. Wichita, Kansas _______________________________________________ MCWIRB maillist - = MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb <= /FONT> ------_=_NextPart_001_01BFD55B.BA3311B4--

Betty Dunger 6/13/2000 10:34:00 AM

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