Dissertation Title: "The Promise and Peril of Using the Law to Promote Ethical Outcomes in Health and Healthcare"
NOTA: NOT A GOOD ACT FOR TISSUES TO FOLLOW The National Organ Transplant Act of 1984
(NOTA) articulates the U.S. federal policy for organ transplantation. It seeks to ensure equitable allocation of donor organs and strives to increase the number of organs available for transplant. A trio of ethical concerns—commodification, exploitation, and coercion—motivated passage of NOTA broadly and the prohibition on organ sales in particular. Notably, NOTA does not distinguish between organs and tissues, a devastating oversight given the differences between the two, which include: who can donate; when donation can occur; how donated items are procured, processed, and stored; who receives the donated item and why; and government oversight. Tissues are not like organs in the ways that made NOTA an appropriate legislative solution to commodification, exploitation, and coercion. Rather, NOTA failed to address tissue-specific concerns both ethical and practical in nature. Thus, there is an acute need to develop tissue-specific legislation that enhances informed consent to protect donor autonomy; sets a schedule of payments for donors and intermediaries to promote distributive justice; and improves tracking of donated tissues to address patient safety concerns.
REGULATORY UNCERTAINTY, CONCEPTUAL CONFUSION, AND A PATH FORWARD ON OFFERS OF PAYMENT TO RESEARCH PARTICIPANTS
The practice of offering payment to individuals in exchange for their participation in clinical research is widespread and longstanding. Nevertheless, such payment remains the source of substantial debate, in particular about whether or the extent to which offers of payment coerce and/or unduly induce individuals to participate. Yet, the various laws, regulations, and ethical guidelines that govern the conduct of human subjects research offer relatively little in the way of specific guidance regarding what makes a payment offer ethically acceptable. This paper systematically examines the legal and ethical dimensions of offering payment to research participants. It argues that concerns about offers of payment to research participants can be attributed to the misguided view that such offers ought to be treated differently than offers of payment in other contexts, a form of “research exceptionalism.” We show that rejection of research exceptionalism with respect to payment helps settle open debates about both how best to define coercion and undue influence, and how to understand the relation between these concepts and offers of payment. We argue for adoption of our preferred definitions, ideally by regulatory authorities, and against the conventional conservatism toward payment of research participants. Instead, we draw attention to the rarely asked, even radical, question: are research participants paid enough? We conclude by arguing that we ought to change the default to favor, rather than encourage suspicion of, offers of payment to research participants.
EBOLA & FDA: REVIEWING THE RESPONSE TO FIND LESSONS FOR THE FUTURE
In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in history. At the onset of the outbreak—as now—there were no therapies approved by the U.S. Food and Drug Administration (FDA) for prevention of, post-exposure prophylaxis against, or treatment of EVD. As a result, the outbreak spurred interest in developing novel treatments and vaccines; sparked calls to use experimental interventions in the field; and highlighted challenges to the standard approach to FDA approval of new drugs. Although the outbreak was geographically centered in West Africa, it brought to the fore issues of food and drug law and showcased FDA’s global role in drug development, approval, and access. FDA’s response to EVD highlights the panoply of Agency powers and demonstrates the flexibility of FDA’s regulatory framework. This paper evaluates the strengths and weaknesses of FDA’s response and makes policy recommendations regarding how FDA should respond to new and re-emerging public health threats going forward. The current pandemic of Zika virus infection is but one example of an emerging health threat that will require FDA involvement in order to achieve a successful response.