Robert J. Levine, MD, 1934-2021

On February 25 of this year, we lost a giant in the research ethics field, a beloved member of the PRIM&R family, and a genuine force of nature, Robert J. Levine, MD. It’s hard to overstate Bob’s influence on research ethics; a blog post can hardly do justice to his many accomplishments and contributions, let alone his wonderful sense of humor, dedication to mentorship and teaching, love of life, and all-around humanity. Many of us are lucky to have our own memories of Bob, and almost all of us have been influenced by his work. Here is just a small selection of ways Bob leaves his mark on us and our world.

Bob was a major contributor to the Belmont Report. As some know, Bob was an outspoken critic of early attempts to regulate research with human subjects. However, in 1974, he was invited to join the staff of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged by the National Research Act with “identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.” Bob initially refused, saying that he wanted to be able to criticize the work of the Commission, so he was hired on as a consultant to the National Commission instead; because he was not a federal employee, he protected his ability to remain critical of the Commission and its process (though he later said he had little reason to do so).  

During National Commission meetings, Bob sat next to staff member and fellow bioethics pioneer, Tom Beauchamp. As Bob told it, Tom asked Bob for a statement on the distinctions between research, practice, and non-validated practice, and who should be responsible for review of each. The language Bob provided in response ended up comprising Part A of Belmont. Indeed, Bob always believed that one of his most important accomplishments was distinguishing non-validated practices from either research or practice, but positioning it closer to the latter.

Bob later founded IRB: Ethics and Human Research, one of the first, and still one of the most prominent, journals dedicated to human subjects research ethics and oversight, serving as its editor from 1979 to 2000. (It’s now simply called Ethics and Human Research.) In 1981, Bob released the first edition of Ethics and Regulation of Clinical Research, the seminal text for new IRB members and others in the field. A second edition, released in 1986, had even further reach. Many of Bob’s most influential writings in research ethics feature as chapters of this book.

Bob was also prominent on the international stage. He served twice as chair of steering committees charged with writing and revising the CIOMS International Ethical Guidelines of Biomedical Research Involving Human Subjects and chaired a working group for revision of the WMA’s Declaration of Helsinki. Bob was critical of the way that the Belmont Report influenced the international community, and felt strongly that the American sensibilities conveyed in Belmont—for instance the premium placed on individual autonomy—not be applied wholesale or uncritically to other parts of the world.

We can barely scratch the surface of the conceptual contributions Bob made to research ethics thinking, but here are some highlights. Bob was one of the first thinkers to introduce and take seriously the concept of vulnerability in bioethics as a special consideration relevant to subject selection. He was a proponent of understanding and communicating  ethics in a narrative form, rather than (only) in a rigidly systematic way, and he championed this by way of example: IRB: Ethics and Human Research made heavy use of case studies to explore ethical issues. Bob was an early advocate for the importance of distinguishing between harm and risk, and was influential in the formulation of risk as equivalent to the magnitude of potential harm multiplied by the likelihood of that harm, which is, of course, the conception codified in the Common Rule. He was one of the earliest bioethicists to foreground what would come to be known as the therapeutic misconception: he was adamant that research ethics thinking should engage with the fact that doctors and researchers are entrusted, simply by virtue of their positions, to act in the best interests of their patients, regardless of whether the context is research or practice. 

Bob was never shy about voicing his opinion, particularly when it came to criticizing the regulations for failing to adequately or appropriately incorporate ethical principles. He wrote extensive criticism of the regulations’ treatment of imprisoned populations for example. When Bob spoke, people listened; but he could also display an admirable intellectual humility. As you can see in this People and Perspectives interview with Alex Capron below, he is more than willing to admit what he got wrong. For instance, he acknowledged that it was a mistake not to develop separate standards for social-behavioral and biomedical research—an issue he later addressed as a member of the National Academies committee that released the influential 2014 report, Proposed Revision to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences, which sought to inform HHS’s process of revising the Common Rule.

PRIM&R was lucky enough to benefit from Bob’s participation and guidance from the early 1980s. Bob became involved with  the organization as a conference presenter in 1980, and went on to serve on the board from 1986 to 2017. In what has now become the stuff of legend, in the early years of PRIM&R’s human subjects protections conferences, Bob and Joan Rachlin, PRIM&R’s Founding executive director, would plan the whole conference agenda over the phone, just the two of them. He helped create and launch, with Ada Sue Selwitz, PRIM&R’s On the Road IRB 101 program, teaching often in the early days with Ada Sue and Susan Kornetsky. And in 2005, he was awarded PRIM&R’s Lifetime Achievement Award for Excellence in Research Ethics in recognition of his unparalleled contributions to the field.  

Bob’s immense influence and impact on the field of research ethics will live on through his scholarship; his wisdom and deep commitment to ethics will live on through the many students, scholars, scientists, and colleagues he mentored over the years. And his warmth, generosity, and humility will live on in the hearts of all who had the great privilege to know him. He touched so many in so many ways. What a legacy.

Written by Elisa A. Hurley, PhD, and Tim Badmington. Dr. Hurley is PRIM&R’s Executive Director; Badmington is PRIM&R’s Policy and Engagement Manager.