HUM-MOLGEN archive: ETHI: consent/specimens

We have received multiple responses to this inquiry. Those which are not apparently duplicative are included with this message. I have also appended a message on roughly the same subject which was posted to another newsgroup several months ago. Obviously this is a hot issue right now. If somebody from NIH will send me a copy of the proposed NIH-OPPR rules, I shall post them to HUM-MOLGEN's www site. It is also interesting to note that despite the fact that we have subscribers from 58 or so countries, the responses came from only two countries, France and the US. Presumably archival specimens are being used or have been protected in other countries and it would be appreciated if those from other countries with knowledge of the appropriate regulations, rules or discusions would forward them. Hans Goerl ETHI editor ***************************************************************************** *********** Moshe, I have had some experience with this issue here at the genome center and in an American Society of Human Genetics subcommittee on informed consent. I refer you to the document that resulted from an NIH-CDC conference on informed consent for research on stored samples. (Clayton-Wright, et al. JAMA 1995 274(22) 1786-92) This paper discusses the issue quite thorougly though it has been controversial. For your study, the bottom line is that it is reasonable to use such material for studies like you describe if the samples are anonymized prior to analysis. The Clayton-Wright paper gives a rigorous (and in my view, correct) definintion of anonymous and anonymized. There are two caveats, however. If you completely consume the specimens some would argue that you are destroying a resourse of potential value to the patient from whom it was drawn. Since it was drawn for clinical (not research) purposes, you could be foreclosing future clinical use that might be of benefit. The second argument is if the research deals with a sensitive issue and it is conceivable that a significant cohort of the "subjects" might object. Race and IQ, for example. From a scientific point of view, anonymizing or stripping identifiers and forgoing consent offers a potential advantage as consent can bias gene frequency studies. If particular subgroups (ethnic, geographic, socioeconomic, etc) participate have different participation rates, it could possibly distort your data. I recommend that you put together a proposal to anonymize the specimens and present that to your IRB (or equivalent) in light of the paper noted above. In addition you may wish to review the statement by the American Board of Medical Genetics on this topic (Am J Hum Genet 1995, 57:1499-1500). If there are other problems or issues with this approach, I would welcome further direct discussions with you. With warm regards, Les Leslie Biesecker, MD National Institutes of Health National Center for Human Genome Research Building 49 Room 4A80 Bethesda, MD 20892-4470 Telephone: 301-402-2041 Fax: 301-402-2170 ************************************************************* In my view, using newborn screening samples for research is highly problematic since they were obtained for an entirely different reason. If you are going to retain identifiers, you must obtain informed consent. If you remove identifiers irretrievably, then it is more acceptable to use the samples without obtaining consent. There is some controversy about what is meant by irretrievable removal, but the main point is that no one should be able to identify the particular baby. In particular, it is completely inappropriate to do the study and then go contact the family with specific informationa bout their child. Ellen Wright Clayton Vanderbilt University ********************************************************************* In France, such studies have been strictly forbidden by the National Ethics Committee, on the basis of the idea tha no informed consent could be obtained. Segolene Ayme ****************************************************************** This issue of whether and how previously collected tissue samples can be used for genetic research has become quite controversial in the United States. A CDC/NIH Task Force completed a report on the question, which was published in the December 13, 1995 issue of the Journal of the American Medical Association (Clayton, et al.). This report would make it difficult to use previously collected samples for such research. The report prompted a great deal of concern and was the subject of a special meeting at NIH, reported in a news story in the January 26, 1996 issue of Science (Marshall). It seems to me that the three main questions are as follows: 1. Must a researcher get additional informed consent to use truly anonymous (not linkable to an individual by anyone, on the current research or not) previously collected samples for genetic research? 2. Must a researcher get additional informed consent to "anonymize" previously collected samples and then use them for genetic research? 3. For newly collected samples, can a research get general informed consent for future research or must the informed consent be limited to only those particular and specific investigations foreseen (and described) at the time? These issues are important and I cannot make an informed guess about how they will be resolved. Professor Robert Weir and Jeffrey Murray at the University of Iowa are holding a two week seminar on just these issues at Iowa this June. They might be able to provide you with more references, information, or ideas. Professor Murray's e mail address is jmurray@genome6.ped-gen.uiowa.edu. I don't mean to imply by this answer that the US experience is the only relevant experience, but it is the only experience I know anything about. I hope this is of some help. Hank Greely Professor of Law Stanford University ***************************************************************************** I serve on the IRB for the University of Pittsburgh Medical Center as well as on a task force addressing IRB concerns for genetics studies. If all identifiers are stripped from the samples, they can be used for mutation screening studies. Under these circumstances, informed consent is not necessary. Your IRB should receive a protocol from you so that they are informed of the study, but it should be made clear that your study design is conforming to the most recent recommendations of OPRR which do not require informed consent when the samples are completely anonymous. Michael B. Gorin, M.D. Ph.D. Assistant Professor Departments of Ophthalmology and Human Genetics University of Pittsburgh Sch. of Medicine and Grad. Sch. of Public Health Mail address: Dept. of Ophthalmol. - 8th floor, The Eye & Ear Institute Building 203 Lothrop Street, Pittsburgh, PA 15213 Office: (412) 647-2211 FAX: (412) 647-5880 *************************************************************************** X-Sender: raspritz@facstaff.wisc.edu Dear Dr. Frydman, In fact, in the U.S. there are new NIH OPRR rules for using stored or banked specimens. I will be attending a special NIH workshop later this month to consider how these new rules can be implemented. I just received the packet of materials today, and so I have not read the new rules yet. However, I would suggest that, at least in the U.S., new rules may render prior experiences with IRBs obsolete. Richard A. Spritz Professor Medical Genetics and Pediatrics University of Wisconsin ***************************************************************************** ****** EDITORS NOTE: The message below was sent to another newsgroup several months ago in response to a comment about about using archived, specimens for research. Since the original sender did not post it to this list, I have not identified him or her. I know that there are probably stacks of lawyers who will disagree with me ... after all, by disagreeing with me they create a market for their services ... but when it comes toi archived specimens, unless they are sold or used for commercial production purposes (e.g., in the case of a cell line), I don't consider informed consent necessary for unforeseen clinical testing purposes. While such testing may be for the validation of a new commercial product, the archived specimen is normally of no further use to the patient. He or she can't sell it ... they'd have no idea of how or to whom ... and who would buy it? And who can value the 100 or 200 microliters that may be used for a clinical trial. It really has no significant commercial value. Additionally, the specimen has essentially been abandoned by the patient anyway. I know that there will always be somebody seeing something sinister in the use of these specimens .... or trying to derive some material gain from them .... but with the vast majority of patients, there is no issue here ... only with their attorneys. Again, however, there are cases, such as those where the material is a cell line used to provide a commercial product, or in the case of materials from a miscarried baby, and other extremes, where informed consent is important. Routinely, however, only ambulance chasers will make an issue.