Coming Soon to Research Near You! Major Changes in Human Research Rules!

Change is in the air for research involving human subjects. In response to public sentiment, regulatory and advisory authorities are poised to change the rules for fundamental human research and ethics matters such as required disclosures, informed consent, safety measures, IRB review and data-sharing. These reforms are all designed to foster greater transparency, safety and efficiency, including faster time from research to cure.  

The Department of Health and Human Services (HHS) expects to issue a final new Common Rule (Federal Policy for the Protection of Human Subjects) soon, concluding a rule-making process that has generated more than 2,100 public comments. The 519-page document represents the first significant change in the Rule since its adoption 25 years ago. In September, the Blue Ribbon Panel on the Cancer Moonshot presented its “10 Transformative Research Recommendations” based on reports from the panel’s seven working groups. These recommendations will likely have impact that extends beyond cancer research. HHS has published the final rule clarifying and expanding requirements for submitting information about clinical trials and results to ClinicalTrials.gov. The 21st Century Cures initiative attempts to progress during a lame duck session in Congress.

This briefing will provide an overview of the changing regulatory and ethics landscape of human research, with emphasis on the practical impact on organizations sponsoring, conducting or involved in human research, including informed consent, disclosures, data-sharing and secondary research. Presenters will be Amy Judge-Prein, a partner in Faegre Baker Daniels’ FDA practice group, Catherine Clements, Counsel on the Regulatory Legal Team at Eli Lilly and Company, and Lisa Martin, Chief Compliance Officer at Indiana University Health.