Updates to Long-Standing Human Research Guidelines

The Department of Health and Human Services has released a final rule revising the federal regulations for the ethical conduct of research with human subjects, commonly called the Common Rule. The updates, which will take effect in January of 2018, reduce the regulatory burden on researchers while continuing to protect research subjects – especially those participating in high-risk studies.

These updates, which follow several years of planning and public discussions, mark the first significant changes to the Common Rule since it was issued in 1991.

Among the new provisions, the updated rule aims to improve informed consent – moving the most pertinent information to the front of the informed consent document and making them clearer and more concise. Researchers will be required to begin informed consent documents with a brief, focused summary of the most important information about participating in the study, such as the greatest risks to the subject. This provision aims to provide information up front that will help prospective subjects decide whether or not to participate in a study.

The new rule will focus administrative resources for the oversight of clinical trials to the studies that pose the greatest risk to subjects. This provision will expand the type of studies that are deemed low risk to be exempt from the regulations and only require administrative review, rather than full board review.  It will also eliminate the requirement for continuing review for many such expedited studies.

Finally, the revised regulations will require multi-site research studies to use a single Institutional Review Board (IRB) for review and approval, which will reduce redundancy of IRB review and potentially save time. However, exceptions may be made if federal agencies determine that using multiple IRBs is better for a specific clinical trial or context.  The implantation for the single IRB requirement is three years or January of 2020.

Overall, these changes are meant to foster creativity and innovation of our nation’s clinical researchers as well as engender trust in the research establishment from the general public.

Read a summary of the Common Rule updates, here.

To learn more, contact Kelley O’Donoghue in the University’s Office for Human Subject Protection.

Michael Hazard | 4/4/2017