It’s no question that research institutions shoulder an increasingly heavy federal compliance load. A new multi-institutional study published October 2015 by Vanderbilt University found that regulatory compliance represents three to 11 percent of higher education institutions’ total non-hospital operating expenses. The study, which involved 13 colleges and universities across the U.S., also found that research faculty and staff spend four to 15 percent of their time complying with federal regulations.
The White House Office of Management & Budget (OMB) has taken steps to reduce some of this burden. The Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards recently combined eight OMB circulars into a single uniform set of regulations. However, many research organizations are still struggling to understand all the new changes and more importantly, how to implement them.
And now, institutional compliance offices are facing the prospect of even more upheaval with the proposed changes to the Common Rule, issued in September by the Department of Health and Human Services (HHS), along with 15 other federal agencies. This is the first attempt in almost 25 years to update the federal regulations governing the ethical conduct of research involving human subjects, and most would agree that it’s long overdue. The research landscape has changed dramatically since the original adoption of the Common Rule in 1991 and policy should too.
HHS has stated that their goal with the proposed changes to the Common Rule is “to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” To this end, here are some of the most significant recommendations:
- Strengthen informed consent to protect the interests of human subjects. Consent forms will be simplified (no more legalese or burying key information in a lengthy document) with nonessential information moved to a separate appendix. The use of biospecimens or identifiable data in secondary research will also require specific consent from the subject, even if privacy is safeguarded.
- Reduce or eliminate oversight burden for minimal-risk research. Continuing review will no longer be required for studies that undergo expedited review and for studies that have completed their interventions and are merely conducting data analysis or observational follow-up. In addition, grant and contract proposals will no longer require IRB review for certification.
- Streamline IRB operations for multisite studies. Multisite studies in the U.S. will require the use of a single IRB. All participating institutions will rely on a single IRB of record, thus reducing inefficiencies and redundancies.
These are all positive recommendations, but even welcome changes come with growing pains. When the Common Rule changes are finalized and implemented, institutional compliance offices will have to learn new ways of doing things and make sure they’re on top of all new requirements. Cayuse IRB can help compliance offices with these and future changes. Designed in collaboration with an accredited AAHRPP institution, Cayuse IRB leverages industry best practices to simplify compliance requirements. As a fully cloud-based application, Cayuse quickly updates the software as regulatory changes occur, so your research compliance solution will adapt to the changing needs of your institution.