Against One-Size-Fits-All Research Ethics
Michelle N. Meyer
Harvard Law School
September 1, 2010
Michelle N. Meyer, Against One-Size-Fits-All Research Ethics, Hastings Center Report, 10–11, Sept.-Oct. 2010
This short article in a leading bioethics journal examines the merits of one of the first decisions made under the NIH's new Guidelines governing whether existing stem cell lines are eligible for federal funding (the origins of which I discuss here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2103417).
Individuals undergoing in vitro fertilization (IVF) for reproductive purposes who find themselves with "spare" embryos after they have completed their families are often given the opportunity to donate those embryos rather than destroying them or donating them to another couple. Under the Guidelines, research using existing stem cell lines derived from such embryos is eligible for federal funding if the IVF patients gave their voluntary, informed consent to the donation. The NIH rejected several important, disease-specific cell lines because donors were required to waive any legal claims arising from the research, finding that the “use of exculpatory language . . . was inconsistent with the basic ethical principle of voluntary consent."
I consider the possibility that the waiver undermined the voluntariness of the donations by being coercive. Assuming, arguendo, that this is an apt characterization of the waiver, I argue that the appropriate response would have been to sever the waiver term from the rest of the agreement, not to invalidate the agreement as a whole, thus impeding both important science and the donors' intent.
I then defend a more provocative claim: namely, that the waiver was an ethically acceptable part of a take-it-or-leave-it offer which did not exploit the donors.
Number of Pages in PDF File: 2
Keywords: Stem cell research, embryo, waiver, informed consent, exculpatory clauseAccepted Paper Series
Date posted: July 13, 2012
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