13 July 2012

Lab Rat Rights

Past posts in this blog have noted works such as The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects (Durham: Duke University Press 2010), History and theory of human experimentation: the Declaration of Helsinki and modern medical ethics (Stuttgart: Franz Steiner 2007) by Ulf Schmidt & Andreas Frewer, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects (Princeton: Princeton University Press 2009) by Adriana Petryna.

 It is interesting to see the short and robustly contrarian 'The Subject–Researcher Relationship: In Defense of Contracting Around Default Rules' by Michelle Meyer in 11(4) American Journal of Bioethics (2011) 27-30.

Meyer states that as "part of a broader project of rethinking the way we govern human subjects research" -
I consider a proposal to improve the quantity, quality and speed of research by requiring subjects to contractually agree not to withdraw from research, at least without good reason. That proposal would require altering the current regulations governing human subjects research, which provide subjects with an inalienable right to withdraw from the research at any time, for any reason, without penalty or loss of benefit to which they would otherwise be entitled. 
I argue that the gains sought by this particular proposal would likely be swamped by the costs of enforcing such contracts and by the chilling effect they would have on subject recruitment. But I agree that we should explore the role of contract in rethinking the way we govern human subjects research. Doing that in any significant way, however, requires an understanding of the subject-researcher relationship that is not fiduciary. In this article, I defend the claim that this relationship is in fact not fiduciary, cannot coherently be made fiduciary, and ought not to be fiduciary. I then defend the role of contract not only in the efficient conduct of research, but also, and more importantly, in serving the interests and welfare of research subjects.
She asks how can contract benefit subjects?
 First, subjects can use and have used contract to secure benefits that they are not owed under the applicable default rules. Too often it is assumed that contracting around default rules entails contracting down from them. Contract can be a way for those whom the law regards as legal strangers, such as same-sex partners, to establish legal commitments to one another. Even where the law already recognizes a relationship as imposing rights and obligations, contract can be used as easily to heighten as to lower those duties of care. For example, the current default rule is that researchers have no duty to provide subjects with post-trial access to a beneficial trial intervention (Kraemer-Katz v. U.S. Public Health Service). Subjects have been able to secure that benefit only through contract (Dahl v. HEM Pharmaceuticals Corp.; Abney v. Amgen, Inc.). Similarly, the general default rule is that tissue contributors have no property interests in the tissue they contribute to research. But through contract, tissue contributors have conditioned their gifts in a variety of ways, such as by requiring data to be shared with other researchers or negotiating intellectual property arrangements that would ensure the accessibility of any resulting diagnostics or treatments to patients (Skloot 2006). Similar gaps between what the regulations require and what bioethicists believe subjects are owed — such as compensation for research-related injuries and receipt of individual research results — could be bridged through contract. 
Second, and less obviously, subjects sometimes have an interest in waiving their legal rights — that is, in choosing not to be protected — in order to secure benefits or outcomes that they value more highly. Unless subjects are permitted to make binding promises to researchers, the promises that researchers make to them will remain largely empty. Under classical contract doctrine, a researcher’s promise to pay (or otherwise compensate) a subject in exchange for the subject completing the study—the unilateral contract that De Ville (2011) wants to preserve — does not become a contract binding on either party until the moment the subject accepts the researcher’s offer by completing the study. Until then, the researcher may revoke his or her offer (as often occurs when a trial is halted; Abney v. Amgen, Inc.) without penalty, and the subject, who may have completed 99% of the study, will be entitled neither to the promised benefits nor to recoup any out-of-pocket costs. Given the unfairness that can result from unilateral contracts, courts have found various ways to enforce the offeror’s promise over his or her attempts at revocation, at least where the offeree has initiated performance. For present purposes, the point is that it is the subject’s inability to bind him- or herself that permits this unfairness, and the subject’s ability to “lock in” the offered benefit at enrollment by making a binding promise to complete the study that would prevent it. 
Similarly, the federal regulations not only permit a subject to withdraw at any time, but also permit a researcher to terminate a subject’s participation without his or her consent (45 CFR §46.116(b)(2); Kraemer-Katz v. U.S. Public Health Service). Yet while the researcher may alienate that right by making a binding promise to the subject not to terminate the subject’s participation for trivial reasons, the regulations prohibit subjects from including that offer by reciprocating with a binding promise not to withdraw for trivial reasons. Although the inalienable right to withdraw undoubtedly protects subjects in some ways, it also deprives them of something of value that they might willingly exchange for something they regard as more valuable. 
Those queasy about allowing subjects to waive their legal rights should recall that the very institutions of medicine and clinical research could not exist without permitting patients and subjects to waive their legal rights. Informed consent transforms what would otherwise be battery into treatment or volunteerism, respectively. The real question, then, is not whether to allow subjects to waive their legal rights, but which rights they ought to be permitted to waive, and who decides.