Why Consent Is a Requirement for Ethical Research

by Jonathan J. Darrow

In a Petrie-Flom Center event last month, Dr. Alan Wertheimer raised the question of why consent is needed in ethical research.  Without commenting on his answer to the question (attendees were asked not to do so), I would like to offer two principal lenses through which an answer can be understood: one by analogy to contract, and one by analogy to tort.

First, informed consent is needed to ensure that there is a “meeting of the minds” between the researcher and the research subject.  The concept of a meeting of the minds will be familiar to all first-year law students who have taken a course on contracts, and relates to the need for each party to assent to the essential elements or terms of the contract.  See 17A Am. Jur. 2d Contracts § 30.  In lay terms, a meeting of the minds is needed in order to protect the reasonable expectations of each party.  Just as each party to a contract desires to know, in advance, what must be given and what can be expected to be received, so too must each party to a research subject agreement know what is expected of him or her and what benefits are likely to accrue.  (Because of information asymmetries, with the researcher normally knowing far more than the subject about the nature of the proposed relationship, consent need only be required of the subject).

Second, consent is needed to avoid what essentially amounts to misappropriation or conversion.  Without an understanding of what the researcher will gain from the research, the subject may feel that what was taken from him or her was wrongfully converted to the benefit of the researcher.  The feeling that one’s property has been converted to the benefit of someone else, without appropriate disclosure or compensation, seems to have been a primary motivation to bring suit in the famous case of Moore v. Regents, 793 P.2d 479 (Cal. 1990), where cells extracted from a patient became potentially valuable to the researcher. While the analogy of this second lens is to tort law, rather than contract, the underlying motivation is the same: to protect the reasonable expectations of the subject, and thereby allow the subject to make a choice that he or she is less likely to later regret.

Jonathan Darrow

Jonathan Darrow

Dr. Jonathan J. Darrow is a an Assistant Professor at Harvard Medical School and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham & Women's Hospital. He received his research doctorate (SJD) in pharmaceutical policy from Harvard University, where he completed an LLM program in intellectual property (waived), as well as degrees in genetics (BS), law (JD), and business (MBA) from Cornell University, Duke University, and Boston College. After qualifying for the California and Patent bars in 2001 and 2002, Dr. Darrow served as a senior law clerk at the U.S. Court of Appeals for the Federal Circuit, worked in private law practice at Cooley LLP and Wiley Rein LLP, taught on the faculties of four universities and for the World Intellectual Property Organization, authored several law textbooks, supported the intellectual property divisions of WHO and WTO, lectured widely on issues of FDA regulation, and published numerous articles on issues such as expanded access, the breakthrough therapy designation, competition policy, pharmaceutical patenting, gene therapies, drug efficacy, biological products, therapeutic vaccines, and expedited development and approval programs. He is an author of several textbooks, including Cyberlaw: Management & Entrepreneurship (Cengage 2012; Aspen 2015), The Legal and Ethical Environment of Business (Aspen 2014 and Wolters-Kluwer 2d ed. 2018), and Business Law and Management for Entrepreneurs (Edward Elgar, forthcoming). He has lectured widely on issues of FDA regulation, and published numerous articles on issues such as expanded access, the breakthrough therapy designation, competition policy, pharmaceutical patenting, gene therapies, drug efficacy, biological products, therapeutic vaccines, and expedited development and approval programs.

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