Ready or Not, Here They Come: Proposed Changes to IRB Regulations - The Common Rule

Image of a stamp that says APPROVEDThe research world is abuzz with the proposed changes to the current regulations protecting human subjects participating in research studies. What does this mean for SHSU? Research at this institution must adhere to federal regulations (45 CFR 46) issued by the Department of Health and Human Services (DHHS). On September 8, 2015, DHHS issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects (Common Rule). The NPRM proposes the first revisions to the “Common Rule” since its publication in 1991.

At the 2015 Advancing Ethical Research [IRB] Conference, attended by IRB Administrator, Sharla Miles, and IRB Chair, Dr. Donna Desforges, the following information was confirmed: the comment period for the NPRM ends on January 6, 2016. Afterward, DHHS has 30 days to review all comment submissions before issuing its “Final Rule.” Ultimately, DHHS will give universities and other institutions up to one year (or up to 3 years for specific changes) to comply and implement all changes associated with the new regulations.

For your reference, the organization, Public Responsibility In Medicine & Research (PRIM&R) has created a chart comparing the current Common Rule with the proposed changes, section by section. Additionally, the Federal Register published a guide to the proposed changes. SHSU’s IRB committee is continuing to monitor the situation and will provide further information, training, and support for the changes as they become the new federal regulations.

For a list of general compliance tips and reminders, click here.

If you have any questions, please contact Sharla Miles (4-4875;