4th and long or 1st and 10

by Kelly M. Willenberg, DBA, RN, CCRP, CHRC, CHC

Kelly M. Willenberg (Kelly@kellywillenberg.com) is President and CEO of Kelly Willenberg, LLC in Chesnee, SC.

It’s been a year since my life was turned upside down. In that time, my research compliance life has been the only part of my life that is somewhat normal. Every day has presented me with new challenges and some chaotic times. Your life as a research compliance professional is probably very similar. You need to be on both the offensive and defensive sides to manage the research playbook.

One forward pass that is not yet certain is the revised Common Rule, which has been postponed yet again. According to Laura Odwazny, a Senior Attorney with the U.S. Department of Health and Human Services, who spoke at the Research Compliance Conference in Austin last June, the goal of the update was to provide three burden-reducing provisions. These include: (1) a revised definition of “research”; (2) eliminating Institutional Review Board (IRB) review of certain funding proposals and grant applications; and (3) no continuing review for certain low-risk research, unless an IRB requires it.

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