Human Subjects forms - upload in the Compliance section as part of a compliance entry
Upload in the Attachments section, Proposal tab; see NIH application guide for details on applicability:
Cover Letter - RRSF424_Cover_Letter: include the application title and Funding Opportunity (PA or RFA) title of the NIH initiative. Follow the NIH application guide and FOA instructions. These are required for:
- LATE applications or for changed/corrected applications submitted after the due date — include specific information about the timing and nature of the cause of the delay
- Explanation of any subaward budget components that are not active for all periods of the proposed grant
- Required agency approvals, such as approval for applications of $500,000 or more, or approval for Conference Grant or Cooperative Agreement (R13 or U13). Include the official communication from an NIH official as part of your cover letter PDF
- Intent to submit a video as part of the application; the cover letter must include information about the intent to submit it. Updated guidance.
- Proposed studies that will generate large-scale human or non-human genomic data
- Proposed use of human fetal tissue from elective abortions
- DO NOT include assignment request information; all such requests MUST be transmitted using the Assignment Request Form (optional form)
Multiple PD/PI Leadership Plan — PHS_ResearchPlan_MultiplePILeadershipPlan – required for applications designating multiple PD/PIs. See NIH Application Guide for specific instructions.
Consortium/Contractual Arrangements — PHS_ResearchPlan_ConsortiumContractualArrangements — required for applications that include a subrecipient
Letters of Support — PHS_ResearchPlan_LettersOfSupport — required for consultants: include rate/charge for consulting services and level of effort/number of hours per year anticipated. Include other letters as appropriate, e.g., consortium participants, collaborators, or assurances of access to core facilities and resources.
Human Specimens and/or Data — PHS_HumanSubjectsAndCT_InvolveHumanSpecimensExp — required if there are NO human subjects, but you respond YES on the Questionnaire to the question: "Does the proposed research involve human specimens and/or data?" - review NIH guidance for the definition of human subjects research and about whether Human Subjects are involved.
Human Subjects, Other Requested Information — PHS_HumanSubjectsAndCT_OtherRequestedInfo — May be required if you answered YES to ALL four questions in section 1.4 of the Human Subject Study Record. Content is limited to what is described in your FOA or the NIH instructions. Do not use the "Other Requested Information" attachment to include any other information. If a specific file name is not given in the FOA, use a meaningful file name since it will become a bookmark in the assembled application image.
NOTE: To be clear, if you have a Compliance entry for Human Subjects, the only human subjects-related file uploaded on the Attachments tab would be the Other Requested Information attachment, and it is uploaded only if required by the FOA.
Vertebrate Animals — PHS_ResearchPlan_VertebrateAnimals — required if vertebrate animals are involved
Select Agent Research — PHS_ResearchPlan_SelectAgentResearch — required if applicable
Resource Sharing Plan(s) — PHS_ResearchPlan_ResourceSharingPlans — required if applicable
Authentication of Key Biological and/or Chemical Resources — PHS_ResPlan_Auth_Key_Bio-Chem_Resources — required if applicable
Foreign Justification — Other — enter Foreign Justification in the description field — required if you have responded "yes" to the following question in the Questionnaire: "Does this project involve activities outside of the United States or partnerships with international collaborators?"
Introduction to Application — PHS_ResearchPlan_IntroductionToApplication — required for RESUBMISSIONS only (an A1 application submitted within 37 months after the original submission)
Progress Report Publication List — PHS_ResearchPlan_ProgressReport_PubList — required for RENEWAL applications only