Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research. This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991. Since then, there have been no major changes to the regulations – until now. After a five-year process and thousands of comments, the new “final rule” was released on January 19^th, 2017. The July 2017 issue of the American Journal of Bioethics addresses these changes. In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.

by Danish Zaidi, MTS, MBE and Spencer Hey, Ph.D.

According to Friesen et al., the Belmont Report (hereafter “Belmont”) is in need of a “tune-up” or “overhaul.”¹ On their view, Belmont fails to acknowledge harms to communities, inadequately accommodates the need for transparency in research, overemphasizes protectionism, and implies a deductive relationship between its principles and their applications that is too narrow.

However, the force of Friesen et al.’s argument depends on a particular interpretation of Belmont’s function within the research enterprise. If Belmont is supposed to function as an exhaustive account of the principles and concepts that govern the ethics of research, then the flaws outlined in Friesen et al.’s article are indeed problematic. However, if Belmont is interpreted as a “living document,” which articulates a small subset of the principles necessary for ethical research, then an “overhaul” is not necessarily the appropriate course of action in response to the document’s shortcomings. Instead, the prudent course may be to supplement and extend Belmont toward new documents, arguments, principles, and concepts as are needed to meet the challenges facing the current biomedical research enterprise.

There are at least two reasons to favor the “living document” interpretation. First, Belmont does not present a means to weigh its three principles – respect for persons, beneficence, and justice – against one another. The responsibility of balancing the principles against one other and determining how they should be applied in the case of particular research protocols instead falls to the institutional review boards (IRBs). IRBs have thus interpreted Belmont in the years since it was drafted in such a way that it can be applied to new questions in research ethics. This is similar to how federal judges interpret the U. S. Constitution in light of conditions that could not reasonably have been foreseen by its authors.

Second, it is impractical to develop a document that could exhaust all areas of research ethics, as the area of biomedical research is constantly expanding and raising new issues. Anticipating this challenge, the authors of Belmont intended for it to be a compass to guide researchers by way of prima facie ethical principles. Indeed, Belmont acknowledges this early on, when it states that “[b]roader ethical principles will provide a basis on which specific rules may be formulated, criticized, and interpreted.” In other words, Belmont’s authors deliberately wrote the document in such a way that it allowed room for further development and reapplication. It served as an introduction to principles of research ethics, not as an exhaustive guideline that could stand on its own. This is similar to the concept of a “living document,” as outlined by Thurgood Marshall: A text that that is constantly updated, reinterpreted, and expanded based on pragmatism and changing contexts.

We therefore find that Belmont is best understood as a living document. It is a valuable primer on principles that should be considered in research ethics. But it is neither exhaustive nor inflexible. Thus, we think it is important to moderate the critique of Friesen and colleagues. We agree with them that a Belmont Report, understood as a static set of principles to which all challenges in research ethics must relate, will indeed come up short. Belmont is not particularly well equipped to guide us on transparency, cultural humility, and protectionism. However, a “living document” understanding would find that the Belmont serves simply as a prolegomena – an introductory framework for research ethics that demands constant expansion and reinterpretation to suit the needs of changing contexts in the area of biomedical research.