Ethical and Legal Implications
of Stored Tissue Samples
Summer 1996
Co-Directors: Jeffrey Murray, (Pediatrics and Biology) and Robert Weir, (Medical Ethics)
This seminar explored issues which now have substantially greater significance with the advent of the recently-cloned sheep "Dolly" from the DNA of a tissue sample. Beginning with experts in the biomedical scientists, the team included social scientists, ethicists, and legal experts in order to adequately address this multi-valent issue. The project was envisioned not only as an effort to collate views on the topic, but also to provide guidance to various institutions and agencies on how to more comprehensively and appropriately address matters of policy in this area. In particular, the seminar focused upon three key lines regarding the importance of the handling of tissue samples.
First, there is the matter of biomedical collections of tissue samples from humans which have been ongoing for a number of years. Originally undertaken in pathological studies related to disease, these collections now raise additional questions as the possible uses of them are expanding with recent innovations.
Secondly, once these samples are collected, the usage of them has to be specified and limited. With advances in DNA research, cell lines can be transformed and subsequently transferred to other laborities for other uses. Often these "other uses" might well be at odds with the original intents of the donors from whom they were collected. This second concern, then, addressed the issue of "secondary use." Additionally, the nature of the samples stored is now changing. It is no longer simply blood or muscle tissue, or scrapings from inside a cheek. Now there are pre-embryo samples and other reproductive-related issues whose controversiality has been noted nationally by the media and even by President Clinton.
Thirdly, the seminar provided a timely examination of the topic as ethicists, health-law attorneys, behavioral and scoial scientists, biomedical investigators, and members of the public are all beginning to work to form policy and procedure on this issue. Governmental examination of this complex situation has begun across a range of departments, from the FBI Forensic Data Base, to the Center for Disease Control, to the Department of Energy. Additionally, professional journals are becoming prolific with the topic.
Already the conference has produced a group response to the National Center for Human Genome Research (NCHGR) based upon the NCHGR's draft "Policy on Human Subjects Issues in large-Scale DNA Sequencing." The scholars have joined in a signed commentary upon the draft which called for policies to be imposed for maintaining anonymity in DNA sequencing, parameters for imposing and designing such a policy, and suggestions for addressing the issue of anonymity procedurally.
Participants
Mary Ann Gardell-Cutter (Philosophy, University of Colorado) -
William L. Freeman (Indian Health Service, Albuquerque, New Mexico) - Karen Gottlieb (BioLaw, Nederland, Colorado)
Kenneth Kipnis (Philosophy, University of Hawaii at Manoa) - Michael J. Kozal (Internal Medicine, The University of Iowa) - Susan Lawrence (History, The University of Iowa) - Jon F. Merz (Bioethics Cellular and Molecular Engineering, University of Pennsylvania) - Isaac D. Montoya (Health Care Management, Our Lady of the Lake University) -
Amy Sparks (Iowa In Vitro Fertilization-Reproductive Testing Labs, Obstetrics-Gynecology, The University of Iowa) - Joanne Tobacman (Internal Medicine, The University of Iowa) -
Dorothy E. Vawter (Minnesota Center for Health Care Ethics, College of St. Catherine)
Visiting Speakers
Scott Bottenfield (LifeNet Transplant Services) - Jane Getchell, (Associate Director of The University of Iowa Hygienic Laboratory) - Henry Greely, (Law, Stanford University) - John Hicks (Deputy Director of the Alabama Department of Forensic Sciences) - Richard Lynch, (Pathology, The University of Iowa) - Bartha Maria Knoppers, (Law, University of Montreal) - Jean McEwen, (Law, Boston College) - Mark Sobel, (Laboratory of Pathology, National Cancer Institute, NIH) - Karen Steinberg, (Division of Environmental Health Lab. Sciences Center for Disease Control) - Ronald Strauss, (Pathology and Pediatrics, The University of Iowa) - Victor Weedn, (Chief Deputy Medical Examiner Armed Forces Institute of Pathology)