December 21, 2023
- February 2, 2023 - IDeA Networks of Biomedical Research Excellence (INBRE) (P20 Clinical Trial Optional). See NOFO PAR-23-100.
National Institute of General Medical Sciences (NIGMS)
The purpose of this Notice is to alert potential applicants to PAR-23-100, " IDeA Networks of Biomedical Research Excellence (INBRE) (P20 Clinical Trial Optional)" of a clarification to the instructions for the Data Management and Sharing (DMS) Plan.
Part 2. Section IV. Application and Submission Information
Overall Component
Other Plan(s)
Currently Reads:
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
- All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
Update to Read (changes in Bold Italics):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
- All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing (DMS) Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a DMS Plan.
- Accordingly, since research will be supported through the Developmental Research Project Program, applications must include a DMS Plan. Since the research projects and associated data are not known at the time of application, a detailed plan is not required. Applications should include general plans for complying with the DMS policy, including any foreseeable issues. These issues may include, but are not limited to, the following examples:
- A description for anticipated projects involving American Indian/Alaska Native (AI/AN) participant data and/or engagement with AI/AN tribes, including any necessary Tribal approvals, Tribal sovereignty and privacy considerations, or Tribal community review.
- Restrictions related to research that is also supported by the private sector that may result in proprietary data.
- A commitment to identify appropriate methods/approaches and repositories for future scientific data resulting from the award that will make it findable and identifiable.
- The plan should also indicate a commitment to update the DMS Plan at the time of RPPR.
- As a reminder, NIH policy requires a single plan for the entire application, so plans are expected to be general and should not exceed 2 pages.
Part 2. Section IV. Application and Submission Information.
PHS 398 Research Plan (Developmental Research Project Program).
Currently Reads:
Research Strategy: INBRE applications should not include proposals for individual RPs or PPs in the application. Selected RPs and PPs will require prior approval from the NIGMS (see Section VI) post award. The plan for the DRPP should include:
- Goals and expectations for RPs and PPs if applicable.
- Budget, duration, and estimated number of awards to be issued in each project category.
- Eligibilities and pool of applicants for each project category.
- Plans to develop, issue, and disseminate funding opportunity announcements.
- Application and selection process.
- Plans for recruiting mentors for DRPP investigators and matching them with DRPP investigators.
- Expectations for mentors, and plans to train mentors, and track and evaluate mentoring performance.
- Plans to track and evaluate the performance of the DRPP.
- Plans to assure compliance with applicable federal policies and guidelines for research and research protections.
- If the DRPP intends to support projects involving short-term (1-2 years) clinical trials, plans for the lead of the DRPP to provide oversight that ensures:
- clinical trials have a strong scientific rationale and are ethical, safe, inclusive and effective;
- preliminary data and/or literature support for the clinical trial;
- the project leaders and key personnel will have the expertise, experience, and ability to design, organize, and implement the proposed clinical trial, as well as to manage data and statistics safely;
- the appropriate mentoring and oversight will be in place to assure safety of the clinical trial;
- potential ethical issues will be adequately addressed; and
- proposed trial sites will have appropriate research capacity to support the trials.
Update to Read (changes in Bold Italics):
Research Strategy: INBRE applications should not include proposals for individual RPs or PPs in the application. Selected RPs and PPs will require prior approval from the NIGMS (see Section VI) post award. The plan for the DRPP should include:
- Goals and expectations for RPs and PPs if applicable.
- Budget, duration, and estimated number of awards to be issued in each project category.
- Eligibilities and pool of applicants for each project category.
- Plans to develop, issue, and disseminate funding opportunity announcements.
- Application and selection process.
- Plans for recruiting mentors for DRPP investigators and matching them with DRPP investigators.
- Expectations for mentors, and plans to train mentors, and track and evaluate mentoring performance.
- Plans to track and evaluate the performance of the DRPP.
- Plans to assure compliance with applicable federal policies and guidelines for research, research protection, and data management and sharing.
- If the DRPP intends to support projects involving short-term (1-2 years) clinical trials, plans for the lead of the DRPP to provide oversight that ensures:
- clinical trials have a strong scientific rationale and are ethical, safe, inclusive and effective;
- preliminary data and/or literature support for the clinical trial;
- the project leaders and key personnel will have the expertise, experience, and ability to design, organize, and implement the proposed clinical trial, as well as to manage data and statistics safely;
- the appropriate mentoring and oversight will be in place to assure safety of the clinical trial;
- potential ethical issues will be adequately addressed; and
- proposed trial sites will have appropriate research capacity to support the trials.
Part 2. Section VI. Award Administration Information.
4. Reporting
Currently Reads:
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
In the RPPR, include progress towards the program accomplishments listed in the description of the overall research program to assist in evaluating the program. Progress reports should briefly describe status of DRPP Projects, including data and safety monitoring, and should notify NIH of serious adverse events, and unanticipated problems for human subjects and clinical trials projects. Criteria for evaluating the progress of DRPP investigators may include evidence of scholarly activities including publications, offering of new courses and programs, providing research experiences to students, attending and presenting research findings at scientific meetings and conferences, submission of external grant applications to NIH and other federal and non-federal agencies, and acquisition of awards such as Academic Research Enhancement Award (AREA, R15), Support for Research Excellence (SuRE, R16), and exploratory/pilot project grants (R03 and R21) that are appropriate to the mission of their institutions. Outcomes of students who participate in INBRE research and/or career enhancement activities should be tracked and reported in the RPPR (for example, the total number of students who had research experiences, have gone to graduate and professional schools, or have entered the biomedical workforce). In addition to submitting annual progress reports, INBRE awardees are also required to provide Supplemental Programmatic Data in the NIGMS Scientific Information Reporting System (SIRS). The SIRS system can be accessed at: https://sirs.nigms.nih.gov. Like the RPPR submission, SIRS submissions are due 60 days before the end of the active budget period. Approved DRPP Projects should be reported as separate components in the RPPR.
A summary of the issues discussed at each EAC meeting, recommendations made, and actions taken must be included in the yearly progress reports submitted to the NIGMS.
Update to Read (changes in Bold Italics):
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
In the RPPR, include progress towards the program accomplishments listed in the description of the overall research program to assist in evaluating the program. Progress reports should briefly describe status of DRPP projects, including data and safety monitoring, compliance with the approved Data Management and Sharing P lan (DMS Plan), and should notify NIH of serious adverse events, and unanticipated problems for human subjects and clinical trials projects. The criteria for evaluating the progress of DRPP investigators may include evidence of scholarly activities including publications, offering of new courses and programs, providing research experiences to students, attending and presenting research findings at scientific meetings and conferences, submission of external grant applications to NIH and other federal and non-federal agencies, and acquisition of awards such as Academic Research Enhancement Award (AREA, R15), Support for Research Excellence (SuRE, R16), and exploratory/pilot project grants (R03 and R21) that are appropriate to the mission of their institutions. Outcomes of students who participate in INBRE research and/or career enhancement activities should be tracked and reported in the RPPR (for example, the total number of students who had research experiences, have gone to graduate and professional schools, or have entered the biomedical workforce). The RPPR must also include a summary of the issues discussed at each EAC meeting, recommendations made, and actions taken.
In the event that new research supported by the DRPP projects is not covered by the current DMS Plan, an updated DMS Plan not exceeding 2 pages should be submitted as part of the RPPR.
All other aspects of this Notice of Funding Opportunity remain the same.
Krishan K. Arora, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: arorak@nigms.nih.gov
and Human Services (HHS)
