Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need...

Area of Science:

• Bioethics
• Research Ethics
• Regulatory Science

Background:

• Research, particularly data-centric studies using AI and genomic technologies, poses significant risks to groups and third parties.
• Existing US federal regulations may not adequately address these group-specific harms.

Purpose of the Study:

• To explore the adaptation of US federal regulations to better align with current ethical thinking and protect group interests in research.
• To identify specific aspects of the Common Rule that require reconsideration regarding group interests.

Main Methods:

• Analysis of the Common Rule's provisions concerning institutional review board (IRB) risk/benefit assessment.
• Examination of disclosure requirements within the informed consent process for group harm.
• Review of criteria for waivers of informed consent in relation to group interests.

Main Results:

• The Common Rule's framework requires attention regarding IRB assessment, informed consent disclosures, and waiver criteria to better safeguard group interests.
• Systematic consideration of potential group harm by investigators and IRBs is crucial.

Conclusions:

• Investigators and IRBs must proactively consider group harm in research design and review.
• Informed consent processes should include information on potential group harm.
• Further public discussion, empirical research, and normative analysis are needed to refine regulations and policies for protecting group interests in research.