Important NIH Application Changes Effective January 25, 2018

Three important changes affect National Institutes of Health applications as of today, January 25, 2018:

1. For NIH applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.
   
   This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. The requirement does not apply to career development, research training or fellowship awards.
   
   Applicants will be expected to include a plan for the use of a sIRB in the grant applications and contract proposals they submit to the NIH (for due dates on or after January 25, 2018).
   
   For more information: Single IRB Policy for Multi-site Research


2. Also effective for NIH due dates on or after January 25, 2018, NIH will require all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed and designated for clinical trials.
   
   For more information: Reminder: Policy on Funding Opportunity Announcements (FOA) for Clinical Trials Takes Effect January 25, 2018 (NOT-OD-18-106)


3. NIH applicants must use FORMS-E application packages for due dates on or after January 25, 2018.
   
   For more information: Reminder: FORMS-E Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2018 (NOT-OD-18-009)