SACHRP Recommends OHRP Adopt Changes to Address Risks From AI

The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) recently approved recommendations on the ethical and regulatory considerations for the use of artificial intelligence (AI) in human subjects research after removing some language discussing the potential harms of AI.[1]

The advisory committee originally had okayed the document “IRB [institutional review board] Considerations on the Use of Artificial Intelligence in Human Subjects Research” at its meeting July 2. But the SACHRP Subcommittee on Harmonization, which crafted the document, continued work on it to address particular concerns expressed by the full SACHRP when the document was initially presented.

At the Oct. 19 SACHRP meeting, harmonization subcommittee member Stephen Rosenfeld, noted that the document, as originally approved, had a lengthy preamble with language that “was philosophic and talked about the harms” of AI in medical research. This is in addition to the “very concrete responses” to the questions that the HHS Office of Human Research Protections (OHRP) asked the panel to consider.

“After a long discussion [among subcommittee members], we just decided that there was enough in the preamble that was kind of speculative and reflected opinions from the subcommittee,” Rosenfeld told SACHRP members. “And the board, I think, while generally agreeing with our conclusions, wasn’t entirely comfortable.”

Therefore, Rosenfeld said, the subcommittee removed the preamble. Instead, he said, it inserted language stating, “Given the rapidly evolving nature of AI and machine learning (ML), and the imprecise definitions and varied understanding of those terms, the committee did not reach consensus on a concise background framing that it felt would be authoritative. On the other hand, given that same evolution and ubiquity of the use of these technologies, the committee felt it important to respond to the charge without undue delay.”

As part of its revisions, the subcommittee also provided “better examples” to explain the first two questions in the document, which touch upon data collection for AI and the definition of “human subjects” related to AI-powered research, Rosenfeld said.

In its original charge, SACHRP was asked to provide answers to 10 specific questions involving the use of AI and ML in human research, touching on when such research would be covered by or exempt from the Common Rule, changes needed in consent, and how IRBs should consider the potential for bias or flaws in research that includes AI.

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