The Belmont Report, published 42 years ago, is the seminal document credited with creating the ethical foundation for research involving human participants in the United States. But new technologies have transformed the research world since then. Does the Belmont Report remain relevant today?
What Led to Development of the Belmont Report?
The Tuskegee Study of “Untreated Syphilis in the Negro Male,” conducted by the U.S. Public Health Service and the Centers for Disease Control and Prevention between 1932-1972, was designed to observe the effects of syphilis when left untreated. The men participating in the study were not informed about its purpose, and over 100 of the 400 subjects died from syphilis or its complications, despite the availability of penicillin by 1947 to effectively treat their disease. It has been cited as “arguably the most infamous biomedical research study in U.S. history”(1).
The Tuskegee Experiment led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, charged with identifying the basic ethical principles for the conduct of research involving human participants. After nearly four years of meetings and discussions, the Commission released the Belmont Report (named for the conference center site of a key meeting) in 1979.
The ethical principles outlined in the Belmont Report were used to develop the federal regulations for the protection of human subjects now referred to as the Common Rule. Most considerations of ethical issues in human subjects research today are examined through the lens of the Belmont Report principles. Indeed, our human subjects research courses, HSRT and HSRT SBER, are organized around the three main Belmont Report principles of Respect, Beneficence, and Justice.
Is the Belmont Report Still Relevant Today?
Society and science have evolved significantly in the 40-plus years since the Belmont Report was published. For example, the proliferation of detailed data about individuals from health care and other sources along with analytic methods and computer technology to handle large data sets; the widespread use of the internet, personal computer technology, and electronic devices; and the use of complex imaging modalities for disease diagnosis and treatment have transformed biomedical and behavioral research. Current clinical trials are usually multi-site, are often designed to change as a trial progresses, take advantage of virtual and electronic methods, and can involve randomization at a group level (practice or facility) rather than at the individual level. Work done to improve health care delivery has led to debates about what is research and what is quality improvement. The evolution of genetic technologies has raised a number of ethical issues such as the meaning of identifiability for human specimens.
Because of this evolution in research technologies, there are questions about whether the Belmont Report principles are still relevant for guiding current research ethics. Some have called for a complete re-do of the Report while others believe the framework just needs some modernization (2,3). We believe that the main Belmont Report principles are still very relevant but there needs to be continued discussion of how to apply them to research as it evolves.
How Could the Belmont Report Be Updated to Meet Today’s Research Challenges?
The Belmont Report was conceived in response to studies like Tuskegee where individuals were clearly mistreated. Thus, the Belmont Report principles are primarily focused on the rights of individuals in research. As Friesen and her colleagues argue, one area where the Belmont Report may fall short is in consideration of societal or community harms which may not be addressed by the Report’s primary focus on individual subjects’ rights (such as voluntariness and informed consent) (4). For example, the experience of the Havasupai tribe in the early 2000’s in which de-identified data from the tribe was used in other research that the tribe did not approve, demonstrated the failure of the Common Rule definition of research to consider cultural norms and wishes. Although the principle of Justice does address some aspects of community considerations, this is an area that may need further ethical development.
We believe that the Belmont Report has proven to be remarkably robust, largely because of its focus on underlying ethical principles that can be broadly applied. But we also endorse continued ethical discussion to determine how to apply the Belmont Report principles in the future and whether additional principles are needed.
References:
1. Katz, Ralph V.; Green, B. Lee; Kressin, Nancy R.; Kegeles, S. Stephen; Wang, Min Qi; James, Sherman A.; Russell, Stefanie L.; Claudio, Cristina; McCallum, Jan M. The legacy of the Tuskegee Syphilis Study: assessing its impact on willingness to participate in biomedical studies. Journal of Health Care for the Poor and Underserved. 2008 Nov: 19(4):1168–1180.
2. Raymond N. Safeguards for human studies can’t cope with big data. Nature World View April 15, 2019.
3. Brothers, KB, et al. A Belmont Reboot: Building a normative foundation for human research in the 21st century. J. Law Med. Ethics. 2019 Mar:47(1): 165-172.
4. Friesen, P, et al. Rethinking the Belmont Report? Amer. J. Bioethics. 2017 17(7): 15-21.
