Printer Friendly, PDF & Email

Community Representation, Better Study Design, Subject Payments Can Foster Justice in Research

“Injustice has no place in human subjects research and undermines public trust in science.”

So begin the recommendations issued by the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP), more than a year in the making, to help address both flagging respect for research and acknowledge gaping health disparities laid bare by COVID-19.[1]

“Researchers and many others recognize human subjects research as a primary human activity dedicated to objectivity and empiricism; however, it continues to be marred by unjust policies, practices, beliefs, and systems of power,” according to SACHRP. “It is time to reconsider and reestablish justice as a core principle in biomedical and social-behavioral research, reflecting the reality that the science of people must be accountable to people to be legitimate.”

The recommendations reflect “a balance between articulating large and important problems and providing recommendations that were practical as well as aspirational,” said former SACHRP Chair Stephen Rosenfeld, who also told RRC he is “very happy” with the final document.

The initial recommendations, “largely a theoretic and technical parsing” of the foundational Belmont Report, “evolved into something that I believe is responsive to real and urgent needs,” he said. Rosenfeld initiated the writing of the recommendations[2] and shepherded them to approval in July as a member of SACHRP’s Subcommittee on Harmonization after his leadership term ended in January.

Rosenfeld, head of the institutional review board (IRB) consulting firm Freeport Research Systems LLC, also praised the work of the committee, which included a new chair and a number of members who joined after drafting had begun. “We brought together a number of disparate and sometimes conflicting perspectives, and learned from one another through discussion and debate to come up with a recommendation that everyone could endorse,” he said.

RRC asked Rosenfeld how he hopes IRBs and institutional officials and staff will use the recommendations.

“First, I hope that IRB members feel they are able to access and use the committee’s guidance,” he said, without it being referred to them by administrators first. “I would hope this document would be read by all members of the ethical oversight community. It is, despite our best efforts, the product of a relatively small group of people, and solutions to the problems we raise will come from others. Addressing the problems we discuss is something that we’ll all do together.”

This document is only available to subscribers. Please log in or purchase access.