The COGR virtual meeting held on February 27–March 1, 2024 focused on the Biden Administration’s Executive Order 14110 regarding artificial intelligence (AI), examining how federal agencies such as NIST and HHS are responding to its directives, and what challenges and opportunities lie ahead. The presentations outlined ongoing federal efforts to promote trustworthy, safe, and ethical AI development and deployment, notably through NIST’s initiatives such as the Trustworthy AI Resource Center, the USAI Safety Institute, and new frameworks for AI risk management and standards. HHS presented its recent progress in the health sector, including advances in algorithmic transparency, strategies to address racial and ethnic disparities in AI-driven healthcare, and robust engagement with legislative, regulatory, and industry stakeholders. The agency’s strategic objectives encompass issuing AI guidance, advancing safety and quality, leveraging funding mechanisms, public engagement, and responsible deployment of AI within health and human services.
A significant portion of the meeting was dedicated to implications for research ethics, oversight, and regulatory compliance, particularly in relation to the Common Rule and IRB responsibilities. The OHRP emphasized that many uses of AI in research fall outside the Common Rule’s purview, making shared responsibility and ethical vigilance among institutions, investigators, and developers crucial. Detailed considerations were provided for different AI research applications: using data to develop AI, AI as a study intervention, AI in non-investigational procedures, and AI as an administrative tool. Clear guidance was given regarding informed consent, privacy, oversight, equitable subject selection, and the distinction between research and clinical care. The presenters encouraged ongoing education, consultation of federal guidance, and active dialogue to ensure that AI’s integration into research and health services upholds rigorous standards for safety, ethics, and public trust.
