Artificial intelligence and medical research databases: ethical review by data access committees

Abstract

Background It has been argued that ethics review committees—e.g., Research Ethics Committees, Institutional Review Boards, etc.— have weaknesses in reviewing big data and artificial intelligence research. For instance, they may, due to the novelty of the area, lack the relevant expertise for judging collective risks and benefits of such research, or they may exempt it from review in instances involving de-identified data. Main body Focusing on the example of medical research databases we highlight here ethical issues around de-identified data sharing which motivate the need for review where oversight by ethics committees is weak. Though some argue for ethics committee reform to overcome these weaknesses, it is unclear whether or when that will happen. Hence, we argue that ethical review can be done by data access committees, since they have de facto purview of big data and artificial intelligence projects, relevant technical expertise and governance knowledge, and already take on some functions of ethical review. That said, like ethics committees, they may have functional weaknesses in their review capabilities. To strengthen that function, data access committees must think clearly about the kinds of ethical expertise, both professional and lay, that they draw upon to support their work. Conclusion Data access committees can undertake ethical review of medical research databases provided they enhance that review function through professional and lay ethical expertise.

Cross-border data sharing through the lens of research ethics committee members in sub-Saharan Africa

“…Rather than making data openly available without restrictions, a couple of interviewees advocated for a DAC to review and manage data access requests given the committee’s expected technical expertise and knowledge of data governance to better address challenges. Some interviewees reported that RECs were the ideal stakeholders for reviewing DTA’s given their members’ diverse skill sets, while others sided with legal entities [ 10 , 15 ]. These interviewees further expressed concern that RECs may not be adequately qualified to perform such a task and that managing data access requests may overburden RECs with added responsibility.…”

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