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Fall 2018 

02-20-2019 15:00

Introduction

Since 2013, institutional animal research facilities have been required to have a contingency plan that covers care in the event of common emergencies such as electrical outages, fires, and natural disasters (Animal Plant Health Inspection Service, 2013; Donaho, 2014). In May, 2018, the Office of Human Research Protection (OHRP) and the Food and Drug Administration (FDA) finalized guidance (first issued in draft form in August, 2016) containing 55 recommendations for what should be included in written procedures for Institutional Review Boards (IRBs) that oversee human subjects research. The 51st recommendation is:

  • 51. Contingency plans for transferring oversight of one or more studies to another institution or IRB in the event that the IRB is unable to continue oversight of the study (e.g., the IRB closes, suffers loss due to fire, natural disaster). (OHRP & FDA, 2018, p. 13)

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