If you’re a human, there’s a very good chance you’ve been involved in human subjects research.

Maybe you’ve participated in a clinical trial, completed a survey about your health habits, or took part in a graduate student’s experiment for $20 when you were in college. Or maybe you’ve conducted research yourself as a student or professional.

Key takeaways

• AI is changing the way people conduct research on humans, but our regulatory frameworks to protect human subjects haven’t kept pace.
• AI has the potential to improve health care and make research more efficient, but only if it’s built responsibly with appropriate oversight.
• Our data is being used in ways we may not know about or consent to, and underrepresented populations bear the greatest burden of risk.

As the name suggests, human subjects research (HSR) is research on human subjects. Federal regulations define it as research involving a living person that requires interacting with them to obtain information or biological samples. It also encompasses research that “obtains, uses, studies, analyzes, or generates” private information or biospecimens that could be used to identify the subject. It falls into two major buckets: social-behavioral-educational and biomedical.

If you want to conduct human subjects research, you have to seek Institutional Review Board (IRB) approval. IRBs are research ethics committees designed to protect human subjects, and any institution conducting federally funded research must have them.

We didn’t always have protection for human subjects in research. The 20th century was rife with horrific research abuses. Public backlash to the declassification of the Tuskegee Syphilis Study in 1972, in part, led to the publication of the Belmont Report in 1979, which established a few ethical principles to govern HSR: respect for people’s autonomy, minimizing potential harms and maximizing benefits, and distributing the risks and rewards of the research fairly. This became the foundation for the federal policy for human subjects protection, known as the Common Rule, which regulates IRBs.

National Archives

National Archives

It’s not 1979 anymore. And now AI is changing the way people conduct research on humans, but our ethical and regulatory frameworks have not kept up.

Tamiko Eto, a certified IRB professional (CIP) and expert in the field of HSR protection and AI governance, is working to change that. Eto founded TechInHSR, a consultancy that supports IRBs reviewing research involving AI. I recently spoke with Eto about how AI has changed the game and the biggest benefits — and greatest risks — of using AI in HSR. Our conversation below has been lightly edited for length and clarity.

You have over two........

© Vox