Institutional Review Boards (IRBs) are formally designated independent groups charged with the review and ethical oversight of research involving human subjects. The IRB is composed of knowledgeable experts in various fields to provide guidance to researchers to minimize risks and maximize benefits for research participants. Moreover, the IRB is in place to protect the rights and welfare of human subjects in research projects. IRBs inform their decisions based on the principles of the Belmont Report, and established regulations and policies from the Code of Federal Regulations and Food and Drug Administration (FDA) (if applicable).

IRB oversight has been required for human subject research dating back to 1974¹; however, the terms research and human subjects are often misunderstood and inconsistently applied today. Federal guidelines were altered in 2018 to define human subjects to include, “information about [not just physical interventions and interactions with] a living individual”. Artificial intelligence and machine learning (AI and ML) research involving human data challenges the federal human subjects guidelines stemming from the difficulty in defining “about whom” the data is being collected.

This White Paper is intended to be used as a basis for further discussion. We seek feedback on it to inform future iterations of the recommendations it contains. Our aim is to help IRBs build their capacity as regulatory bodies responsible for protecting human subjects in research. We provide recommendations on how AI HSR can be reviewed and adequately overseen within the current regulatory framework until a more thorough regulatory framework can be developed. We also include a decision tree for human subjects and exempt category four (4) (secondary use) determinations, based off the
Office of Human Research Protections (OHRP) current guidance².

For IRB professionals the questions arise in two realms: Is the activity “human subjects research” and, if yes, does it meet Exempt criteria?

Check out our new White Paper that discusses how to make AI HSR determinations.


  1. Protection of Human Subjects, 39 Fed. Reg. 105, 18914-18920 (1974) (to be codified at 45 C.F.R. [[section]] 46).
  2. United States Department of Health and Human Services (DHHS). “Human Subject Regulations Decision Charts”. Accessed 30 December 2021.

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