Regulatory Fatigue Syndrome: A Novel Approach to a Weary Condition

Monday, September 22, 2014 — Poster Session I
12:00 p.m. – 2:00 p.m.	FAES Academic Center	NIAID	RSCHSUPP-1

* FARE Award Winner

Authors

• SM Albert
• SL Kopka
• TJ Miller
• DG Chaitt
• JF Pierson

Abstract

The numerous regulatory policies, submission and review procedures, and stakeholder sign-offs necessary for protocol development and approval often overwhelm and exhaust NIAID intramural investigators, resulting in a condition recently coined “Regulatory Fatigue Syndrome” (RFS). The NIAID protocol navigation/protocol development program (PN/PDP) supports investigators struggling with RFS by providing writing and logistical assistance throughout protocol development. The PN/PDP team identifies applicable regulatory policies, review procedures, and stakeholders early in the protocol development process and then outlines and coordinates the logistics and multiple review and submission procedures to decrease waiting periods and repetition. This poster details one clinical research protocol which involved reviews by numerous regulatory entities, each with unique submission processes and requirements, including a Scientific Review Committee, Institutional Review Board, the Food and Drug Administration, Data and Safety Monitoring Board, Recombinant DNA Advisory Committee, and Radiation Safety Committee, among others. Multiple stakeholders were involved, including a biotech company, contracting office, and regulatory and monitoring groups. Meeting dates and submission requirements were identified and drafted in close collaboration with the investigator. Through detailed planning and a thorough understanding of protocol requirements, reviews, and approval procedures, the PN/PDP kept the stakeholders and investigators engaged and on track, lessening the effects of RFS.

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