Today is the 40th anniversary of the Belmont Report, the foundational document on which our federal oversight system for human subjects research is based. This milestone warrants a pause in our busy day to reflect on its impact and its legacy.
Laying out an elegant framework that is now the familiar opening of every human subjects protections training course, Belmont identified the three basic ethical principles of respect for persons, beneficence, and justice that should underlie the conduct of all biomedical and behavioral research involving human subjects. These principles are the foundation of the 1991 and revised Common Rules, and the basis for every IRB deliberation on whether proposed human subjects research should proceed.
Although the Belmont Report document emerged from a four-day meeting at the Smithsonian’s Belmont Conference Center, that landmark discussion was the culmination of almost four years of monthly discussions by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This Commission was formed in 1974 by the National Research Act, which was passed in response to the shocking public revelations in 1972 about the Tuskegee Syphilis Study. Therefore, the group’s imperative was broader and more sensitive than developing a framework for the future review of research. The Report would also have to assure communities that had been betrayed by unethical experimentation, policymakers, and the public that ethical guidelines for evaluating research could prevent such abuses. The three Belmont principles translated into the protective mechanisms of informed consent, IRB assessment and review of risks and benefits, and considerations regarding the fair selection of subjects.
Today, important questions are being asked about whether the Belmont Report’s principles are adequate to address the contemporary research enterprise. Are the report’s clearly articulated boundaries between research and practice as fixed in the context of implementation science and learning health care systems? How should we think about respect for persons in the context of collection of vast quantities of online data and biospecimens? Do we have the right equation for risk and benefit assessment when thinking about the privacy risks of “deidentified” data? Does justice require thinking just as carefully about how to ensure broad and equitable access to research and its potential benefits as about how to protect the “vulnerable” from its harms?
As discussed in a 2016 blog post, the National Academies Report “Optimizing the Nation’s Investment in Research” asked whether the framework laid out by Belmont is adequate for today’s research challenges, and called for the formation of a new national commission to consider questions like these. Commentaries this week in Nature and the New England Journal of Medicine argue that we need to engage in new ethical discussions beyond the Belmont Report to help us answer questions related to big data and health data.
It may well be time for a “Belmont 2.0.” But for today, we marvel at the impact of a single document on 40 years of research, scholarship, and regulation. In a time of increasingly rapid news cycles and barrages of information, the enduring nature of the Belmont Report speaks to the care and deliberation with which it was created. Its principles are woven into the rules we follow, the mission of PRIM&R as an organization, and the work we all do every day. And they are critical to the trust we ask of research subjects who help us advance understanding and science. The Belmont Report has served us well these past 40 years, and that deserves a moment of admiration.
Elisa A. Hurley, PhD, is the Executive Director of PRIM&R.
Heather H. Pierce, JD, MPH, currently serves as the chair of PRIM&R's Board of Directors and is the senior director for science policy and regulatory counsel at the Association of American Medical Colleges (AAMC). Read her full bio on the PRIM&R website.
As I recall, the mandate to the Commission was to examine the then current ethical framework of research. So Belmont was a report about the then current thinking. Our thinking today has been influenced by our knowledge of the three principles but I wonder what we would learn if we attempted to summarize today’s ethical standards.
Thanks for your comment, Erica. You raise an interesting question. Today we talk about transparency, community engagement, patient-centeredness, reciprocity, and good governance. These really weren’t part of the conversation about research in the middle of the 20th Century. What other ethical standards seem to be in play today?
Great job as always Elisa and Heather