New AI Consent Guide Helps Researchers Strengthen IRB Submissions and Protect Participants
Rutgers Office for Research (OfR) continues to remain at the forefront of technology while staying true to its mission and values with the release of AI in Human Subjects Research: Rutgers Consent Guide.
The guide was developed by the OfR’s Human Research Protection Program (HRPP) and Institutional Review Board (IRB) teams to support and advise researchers who would like to incorporate AI into human research studies. According to assistant vice president for Research Regulatory Affairs Hila Berger, MPH, CHC, CIP, the guide will be strongly recommended for researchers to help them be transparent about how AI will be used in the study by providing “clear, ethical, and participant-centered language that explains in the consent forms how AI is used, what data it accesses, and the associated risks, safeguards, and limitations.”
In addition to offering ethical guidance, the tool helps researchers meet IRB expectations up front, reducing the likelihood of time‑consuming revisions and streamlining the approval process, thus allowing them to focus more on the research itself. The guide’s central focus is transparency, participant comprehension, and strong safeguards related to privacy, bias, data use, and model limitations, while still allowing enough flexibility to address the needs of individual studies.
“AI continues to grow and expand as a resource and tool across a variety of fields, and higher ed research is no different,” said Michael E. Zwick, PhD, senior vice president for research at Rutgers and head of the OfR. “We want to ensure that our researchers are able to access and use all of the tools they need to further their work while at the same time maintaining our high standard for safe, ethical, and focused human research.”
“I am immensely proud of the HRPP and IRB teams, who recognized early that AI will be a factor in human research and worked hard to put together a guide that will support everyone involved, from the researchers to the participants,” said José M. Román, JD, DMin, vice president of Research Administration within the OfR. “Transparency and participant understanding in human research is important, and this guide will prove to be a valuable resource for researchers in both areas.”
The tool also includes plain-language examples aligned with Rutgers IRB consent templates areas across sections including key information, purpose, procedures, risks, benefits, privacy, commercial use, data retention, and potential bias. The guide will serve as a living document that will be updated as new AI technologies, practices, and considerations arise in human subjects research.
The guide is available to all researchers via the OfR’s website.
