We interrupt your research compliance program!

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.

Interruptions — life’s temporary pauses that cause us to stop or take a break from our activity. Research compliance seems to have many of these types of breaks. In 2018, we have to face numerous interruptions for new areas of change. Consider the 2018 Common Rule implementation and what you did to prepare for it. Remember the action items and the list to get your team ready? You had new standard operating procedures, new elements of the informed consent, and the upcoming single Institutional Review Board (IRB) to consider. I remember when asking the question, “Did you check the box?” was an easy answer. With another interruption, we are challenged with keeping up.

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