The purpose of this Notice is to announce updated instructions for demonstrating the eligibility of the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) in PAR-20-175, “Institutional Development Award (IDeA) Networks for Clinical and Translational Research (IDeA-CTR) (U54 Clinical Trial Optional)” by providing information on current and pending support.
The following section of the FOA is revised accordingly:
Part 2. Section IV. Application and Submission Information
2. Content and Form of Application Submission
Overall Component
Research & Related Other Project Information (Overall)
Current language:
Follow standard instructions.
Revised language in italics:
Follow standard instructions, with the following additional instructions.
Other Attachments: The application must contain the following attachments:
Current and Pending Support: To demonstrate the eligibility of the PD/PI, the application must include an attachment titled “Current and Pending Support” with the following information about all current and pending grants that support the PD/PI’s research program:
- Project Number
- Source of Funding and Title of the Project (or Subproject)
- Role on the Project and Level of Effort (in calendar-months)
- Dates of Approved/Proposed Project
- Annual Direct Costs
- Project Goal
Applications missing these attachments for each PD/PI will be considered incomplete and will be withdrawn without review.
Part 2. Section VI. Award Administration Information
1. Award Notices
Prior Approval of Pilot Projects
Current language:
Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.
The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan (//grants.nih.gov/grants/guide/url_redirect.htm?id=12000).
The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies (//grants.nih.gov/grants/guide/url_redirect.htm?id=21600).
Using PHS398 forms and instructions, the following sections need to be provided when submitting a Pilot project for approval:
- Face page (signed by institutional signing official)
- Project Summary (page 2)
- Research Strategy section
- Research proposal
- Rigor and transparency: As appropriate, a description of the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of project, and a description of the experimental design and methods proposed and how the investigator will achieve robust and unbiased results. If applicable, a brief description of the methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed project (see Notice NOT-OD-16-011 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-011.html) for details).
- External Advisory Committee approval – communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the pilot project.
- If proposed study involves human subjects, the following documents must be submitted to NIH:
- Current PHS Human Subjects and Clinical Trials Information Form https://grants.nih.gov/grants/howto-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm (https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjectsand-clinical-trials-information.htm)
- Institutional Review Board (IRB) approval
- Documentation of Investigational New Drug (IND)/Investigational Device Exemption (IDE) status for studies that are subject to FDA regulation
- Human Subjects Education Certification and Good Clinical Practice (GCP) Training Certification
- For all clinical trials, in addition to the information requested in Section 3.3 of the PHS Human Subjects and Clinical Trials Information form, the awardee institution will provide NIGMS with a statement detailing the risks to study participants, the frequency of monitoring of clinical trial data and participant safety, and the name(s) of the responsible party/parties for regulatory and legal compliance, adverse event reporting, and clinicaltrials.gov registration and results reporting.
- If the proposal involves Vertebrate Animals, the following documents must be submitted to NIH:
Revised language in italics:
Awardee-selected projects including those that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.
The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan.
The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies .
Using PHS398 forms and instructions, the following sections need to be provided when submitting a Pilot project for approval:
- Face page (signed by institutional signing official)
- Project Summary (page 2)
- Biographical Sketch
- Research Strategy section
- Research proposal
- Rigor and transparency: As appropriate, a description of the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of project, and a description of the experimental design and methods proposed and how the investigator will achieve robust and unbiased results. If applicable, a brief description of the methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed project (see Notice NOT-OD-16-011 for details).
- External Advisory Committee approval – communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the pilot project.
- If proposed study involves human subjects, the following documents must be submitted to NIH:
- Current PHS Human Subjects and Clinical Trials Information Form
- Institutional Review Board (IRB) approval
- Human Subjects Education Certification (required even when research is exempt)
- Submission of new enrollment report in the Human Subjects System (HSS)
- If the proposed project involves clinical trials, the following documents must be submitted to NIH:
- Current PHS Human Subjects and Clinical Trials Information Form
- Institutional Review Board (IRB) approval
- Documentation of Investigational New Drug (IND)/Investigational Device Exemption (IDE) status for studies that are subject to FDA regulation
- Human Subjects Education Certification and Good Clinical Practice (GCP) Training Certification
- For all clinical trials, in addition to the information requested in Section 3.3 of the PHS Human Subjects and Clinical Trials Information form, the awardee institution will provide NIGMS with a statement detailing the risks to study participants, the frequency of monitoring of clinical trial data and participant safety, and the name(s) of the responsible party/parties for regulatory and legal compliance, adverse event reporting, and clinicaltrials.gov registration and results reporting.
- If the proposal involves Vertebrate Animals, the following documents must be submitted to NIH:
- IACUC approval
- Vertebrate Animal Section
All other aspects of this FOA remain the same.
