Notice Number: NOT-TR-17-018
Key Dates
Release Date: June 16, 2017
PA-16-287
Issued by
NIH Office of the Director
Purpose
The purpose of this notice is to encourage applications to PA-16-287 only from CTSA awardees for up to one year of supplemental support to develop resources needed to facilitate single Institutional Review Board (sIRB) review for multi-site research. In addition to being within the scope of the awards, administrative supplement requests are intended to support:
- Development of activities that can be maintained after the period of supplemental support;
- The sharing of any information, methods, resources, or products developed using these funds widely and without charge to other institutions, via publications, presentations, and workshops.
Applications that entail collaboration with institutions outside their networks, for example, with non-CTSA institutions, with other programs within their institution or with other CTSA institutions, are strongly encouraged.
Submissions Requested
NIH is encouraging requests for administrative supplements from CTSA institutions for projects not to exceed one year of supplemental support for the development of costing models, business processes, system changes, and efficient procedures and tools needed to facilitate sIRB review for multi-site research.
All applications must include a detailed description of the proposed activities. The following are examples of activities that could be proposed to assist institutions in implementing sIRB review:
- Development and/or testing of infrastructure/technologies for computer tracking of human subjects protocols, secure records retention, electronic protocol submission, adverse events across multiple research sites for sIRB use.
- Development of methods for confidential and secure data storage and sharing systems for all stages of research across multiple research sites for sIRB review and use.
- Strategies to coordinate sIRB approval of consent forms and other activities used at relying sites in multi-site clinical research.
- Optimization of systems for coordinating across research sites conducting multi-site clinical research for sIRB review.
- Development of tools for strengthening continuing sIRB reviews for multi-site research.
For the purpose of this announcement, a CTSA institution is defined as the prime recipient of an active CTSA hub award (UL1) made under the following funding opportunities: Clinical and Translational Science Award (U54) (PAR-15-304); Clinical and Translational Science Award (U54) (RFA-TR-14-009); or Institutional Clinical and Translational Science Award (U54) (RFA-TR-12-006).
The project and budget period of the supplement must be within the currently approved project period for the existing parent award.
Recipients of supplemental funds under this announcement will be expected to attend a meeting of awardees to be convened by the NIH Office of Science Policy in the Washington D.C. area. At this meeting, recipients of supplemental funds will share successful strategies, modalities, and processes for sIRB review. After the meeting, participants will develop a final report to be posted on the NIH website, which will describe promising and widely applicable approaches for modifying and enhancing institutional IRB infrastructure to allow for efficient and effective sIRB review of multi-site studies.
Budget and Available Funds
Budgets are limited to $300,000 in direct costs and should reflect the actual needs of the proposed projects and be reasonable with respect to the activities proposed. All program-related expenses must be justified as specifically required by the proposed activities and must not duplicate items generally available from other sources at the applicant or collaborating institutions.
Funds should be budgeted for travel to a meeting of grantees by the PI(s) and/or other relevant individual(s) with significant day-to-day involvement in the activities performed under the administrative supplement request.
NIH intends to commit approximately $3 million total costs in FY2017 funds to support 8-10 administrative supplements to develop the framework at CTSA institutions necessary to follow the "NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (NOT-OD-16-094 and NOT-OD-17-027). Highest priority for funding consideration will be given to applications that entail collaboration with institutions outside their networks, for example, with non-CTSA institutions, with other programs within their institution or with other CTSA institutions.
Submitting an Application
Prospective applicants should follow the instructions in Section IV in PA-16-287: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (https://grants.nih.gov/grants/guide/pa-files/PA-16-287.html ). The Research Strategy section is limited to 6 pages.
Applications are due by 5:00 PM local time on July 17, 2017 and should be submitted to Irene Haas (below). Please include this notice number (NOT-TR-17-018) in the title.
Application Review
Applications will be reviewed as described in Section V in PA-16-287: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (https://grants.nih.gov/grants/guide/pa-files/PA-16-287.html ).
Inquiries
Please direct all inquiries to:
Valery Gordon, Ph.D., M.P.H.
Office of Science Policy
Telephone: 301-496-9838
Email: gordonv@od.nih.gov
P.J. Brooks, Ph.D.
Division of Clinical innovation
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-443-0513
Email: pj.brooks@mail.nih.gov
Irene Haas
Office of Grants Management and Scientific Review
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0836
Email: irene.haas@nih.gov
and Human Services (HHS)
