Three NIH (National Institutes of Health) Notices of Interest
Reminder of Guidance on Requirement for NIH Single Institutional Review Board (IRB) Plan
NIH applicants proposing multi-site studies involving non-exempt human subjects research are expected to use a single IRB (sIRB) to serve as the IRB of record for all study sites. However, the sIRB plan is no longer required at application stage.
Instead, the applicant must provide a statement naming the sIRB of record in the Just-in-Time submission prior to award. If, in delayed-onset research, an sIRB has not yet been identified, the recipient will provide the name of the sIRB to the funding NIH Institute/Center (IC) prior to initiating the multi-site research study/project. Providing the name of the sIRB of record satisfies the NIH sIRB policy requirement for an sIRB plan for NIH grant applicants.
Applicants should follow the instructions corresponding to their grant application package in the application guide when completing PHS Human Subjects and Clinical Trials Information Form questions regarding use of an sIRB.
Resources - NIH Single IRB for Multi-site or Cooperative Research (Policy implementation website)
Extending the Special Exception to the NIH, AHRQ, & NIOSH Post-Submission Material Policy During the COVID-19 Pandemic
For applications submitted for the May 2022 Council (beginning with applications submitted for the September 25, 2021 due date for Spring 2022 review meetings), the NIH, AHRQ, and NIOSH will accept a one-page update with preliminary data as post-submission materials for applications submitted under all activity codes, ONLY if the Funding Opportunity Announcement (FOA) used for submission allowed preliminary data in the application. One page of preliminary data will be accepted for single component applications or for each component of a multi-component application.
The deadline for submitting all post-submission materials, including preliminary data, will be 30 days before the study section meeting. Because applications for emergency competitive revisions and urgent competitive revisions undergo expedited review, post-submission materials will not be accepted for those applications.
Clarification and Guidance for Applicants Preparing Applications for the Fall 2021 Due Dates During the COVID-19 Pandemic
Reviewers will continue to receive instructions to assume that constraints arising from the COVID-19 pandemic (e.g., lab occupancy restrictions, declines in patient accrual, etc.) will be resolved during the project period and thus should not affect their scores.
Therefore, NIH grant applications should NOT include contingency or recovery plans for problems resulting from the COVID-19 pandemic. However, applicants may address effects due to the pandemic on productivity or other scoreable issues in their Personal Statement in the NIH Biosketch. Reviewers will be instructed to take these pandemic-related circumstances into account when assessing applicants' productivity and other score-driving factors.
