Last month brought the 40^th anniversary of the publishing of the Belmont Report, and along with that milestone came a reflection on how its values, conclusions, and imperatives have changed in the intervening years. A celebration of its durability has been accompanied by a necessary reckoning with the ways that a 40-year-old document may be ill-equipped to process the ethical issues brought about by technological, cultural, and political changes. Here, we’ve gathered a range of resources that look back on 40 years of the Belmont Report.

Safeguards for human studies can’t cope with big data
Nature
This provocative piece explores the ways in which the Belmont Report is insufficient for dealing with revolutionary digital technologies, arguing that “data science overlooks risks to human participants by default” and that it is “past time for a Belmont 2.0.” That new summit, the author argues, would need to engage with the currently “poorly understood risks and harms” that big data researches poses to humans.

A Belmont Report for Health Data (abstract available)
The New England Journal of Medicine
HIPAA offers robust protection of a limited range of data, but in 2019, the demands on humans’ health data come from far more directions than the 1996 legislation could anticipate. The authors of this NEJM piece call for a coordinated expansion of the scope of ethical review of the gathering, use, and manipulation of health data to account for sources such as “social-media platforms, health and wellness apps, smartphones [and] life insurers,” citing concerns about reidentification of deidentified data, discrimination, health profiling, and more.

A Belmont Reboot: Building a Normative Foundation for Human Research in the 21st Century (abstract available)
The Journal of Law, Medicine & Ethics
This piece, authored in part by PRIM&R Board Member Suzanne M. Rivera, PhD, takes the position that the drawn-out process for revising the Common Rule was indicative of the ways that the 40-year-old report is an insufficient guidepost for modern ethical problems. The authors call for not only a reevaluation of the three main Belmont principles, but also “empirical research and public engagement activities” to gauge stakeholder perspectives on research ethics principles, and an improved process by which those principles can be “translated into policy and practice.”

The Belmont Report at 40 – A Moment of Admiration
Ampersand
Here on our blog, we take time to acknowledge that, though its limitations are substantial and worth engaging, the Belmont Report created an elegant framework for thinking about research ethics that was not only acutely necessary at the time, but that also can provide meaningful guidance for rethinking of the field’s ethical issues moving forward.

The Belmont Report at 40: Reckoning With Time (abstract available)
American Journal of Public Health
The Commission set up to explore the ethics of human subjects research was novel in scope and mandate, and further notable for the extent to which its conclusions are “[inculcated]…in government policy overseeing human subject research.” According to this paper’s authors, the close association between the findings of the original Belmont Commission and the existing federal regulations is a testament to the durability of its ideas.

Though granting full weight to the breadth of impact the Report has had, the authors acknowledge the need for its reappraisal, especially in areas such as emergent technologies, the adequacy of “3 unordered abstract principles” for resolving ethical dilemmas, a possible overemphasis on protectionism, the document’s lack of a feminist framework, and more.

This piece was published in 2018, which was 40 years after the Belmont Report was issued. The Report was published in the Federal Register the following year, in 1979.

As we come across other resources that explore this perspective, we will update this post. If you have any other such resources we should know about, contact Tim Badmington, Marketing and Communications Coordinator.