Federally Funded Research

In addition to the Code of Federal Regulations (45 CFR 46 – opens in a new window) governing research with human subjects, any research funded by or research that uses DoD resources, is subject to additional regulations. These include 32 CFR 219 (PDF file) and the subsequent DoD Instruction 3216.02. These requirements are synthesized together in NC State University’s IRB’s unit standard “Research with the Department of Defense”

Additional obligations for researchers completing research activities funded or supported by the DoD include a Scientific Merit Review, HRPO review, and providing additional Information in the Informed Consent form and IRB Protocol.

• A Scientific Merit Review: This occurs as part of the initial IRB review and approval process (DoDI.3.5.a.5). This should be carried out by someone unaffiliated with the study and it should include an assessment of the study’s scientific merit and the feasibility of study completion. Documentation of this review can be a letter from an expert or a completed NC State University “Scientific Merit Form”. To see how and when this applies to a research protocol associated with the Department of Defence, please review the NC State IRB SOP for research with the Department of Defence. 
• A Secondary Review called “HRPO Review”: After NC State University IRB review and approval has occurred, all DoD-affiliated research projects must undergo HRPO review regardless of the level of review assigned by the NC State University IRB. This type of review is carried out by the DoD’s Human Research Protection Office (HRPO). This type of review is required for all research subject to the DoD regulations. This review is not carried out by the NC State IRB office, though you will need to submit your NC State IRB-approved materials to HRPO after NC State IRB approves the study. 
• Additional Requirements: Research funded or supported by the DoD have additional requirements for the Informed Consent form, necessary information in the IRB application, and for “more than minimal risk” research, additional personnel and guardrails are required. Please review the NC State University’s IRB’s unit standard “Research with the Department of Defense”

In addition to the Code of Federal Regulations (45 CFR 46) governing research with human subjects, any research funded by the NIH is subject to additional rules from NIH. For detailed guidance about the NIH and human subjects research, please review the NC State University’s IRB’s guidance NIH Grants and the IRB (Word document)

Additional obligations for researchers completing research activities funded by the NIH on or after January 25, 2023 include:

Data Management and Sharing Plan

Effective January 25, 2023, the NIH issued the final NIH Policy for Data Management and Sharing (DMS Policy) to promote the management and sharing of scientific data generated from NIH-funded or conducted research. This policy established the requirements for submitting “Data Management and Sharing Plans.” NIH’s Data Management and Sharing Policy (DMSP) emphasizes the importance of quality data management practices and establishes the expectation for maximizing the appropriate sharing of scientific data generated from NIH-funded or conducted research, with justified limitations or exceptions. For details, please refer to the NIH Grants and the IRB Guidance, pages 5-12. To ensure compliance with this rule, the NC State IRB has required the following actions to occur:

• The completed DMSP must be uploaded to the IRB application for review and consideration during IRB approval. 
• If the data accessed or generated as a part of the NIH sponsored study is considered highly sensitive (red) or ultra sensitive (purple), an NC state IRB “Data Access and Security Plan” must be submitted to the IRB for review. This plan is completed with NC State’s Security and Compliance office and should be consistent with the DMSP required by the NIH. This access and security plan is NC State specific and it should operationalize your stated Data Management and Sharing Plan that you submit to the NIH. To request an NC State Data Access and Security plan, please complete the request via the Service Now Portal.
• Annual Renewal Approval or Check In with the NC State IRB Office: Due to the yearly reporting requirements from the NIH, the NC State IRB assigns an “approval expiration date” to all studies, including exemptions. This means that if there is an approval expiration date, the researcher must apply to the IRB for approval renewal BEFORE the expiration date of the protocol. Please submit the “Renewal Request NIH Supplement Form” for your annual approval renewal via the electronic IRB system. If your study was reviewed by the Full Board, the NIH Supplement Form should be uploaded in addition to completing the annual renewal request form on eIRB. 

Just In Time (JIT)

The NIH utilizes the “just-in-time” process for certain programs and award mechanisms. JIT refers to the application timeframe in which applicants are required to submit updated time-sensitive information to the NIH only if an award is likely. The JIT notice usually includes a request for content that was not included in the initial application, such as IRB approval. 

• If your grant application receives a just-in-time notice, you still need to submit a completed IRB protocol and related documents, including the NIH’s Data Management and Sharing Plan (DMSP), for review to the NC State IRB.
• To apply for a JIT review, please refer to the NIH Grants and the IRB Guidance, page 1 for an overview of the process and submit the initial JIT request to the IRB office via the NC State IRB Website. 

Use of the Single IRB (sIRB)

The NIH policy on the use of a single institutional review board of record for multi-site research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a single Institutional Review Board (sIRB). 

• The NIH sIRB policy only applies to the domestic sites of NIH-funded multi-site studies. 
• Multi-site studies under this policy means each site will conduct the same protocol. Protocols that address the same research question(s), involve the same methodologies, and evaluate the same outcomes are considered to be the “same research protocol”. 
• The multi-site studies affected by this policy involve non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. 
• For guidance on selecting a lead site (whose IRB will be the IRB of record that will review the project) please refer to the NIH Grants and the IRB Guidance, page 3.
• For details regarding cooperative research and formal agreements between and among IRBs, please review the NC State University’s IRB’s website for “Cooperative Research.” 

Institutional Certification

This certification assures NIH that submission of large-scale human genomic data to an NIH-designated data repository is consistent with the NIH Genomic Data Sharing Policy, the NIH Data Management and Sharing Policy, the informed consent of the original study participants, and/or the preferences of the original study population. The certification also states whether, after IRB review, research use limitation is deemed necessary. 

• The Institutional Certification will be requested as part of the JIT process and is required for award. The Institutional Certification is provided by the submitting investigator and the NC State Institutional Official (IO).
• The Institutional Certification, or in some cases, a provisional Institutional Certification, must be submitted and accepted before the award can be issued. Please refer to the NIH Grants and the IRB Guidance, page 8 for details. 

In addition to the Code of Federal Regulations (45 CFR 46 – opens in a new window) governing research with human subjects, any research funded by the NSF is subject to additional rules from NSF.

.118 Determinations  

For projects lacking definite plans for the use of human subjects, their data, or their specimens, NSF can accept a determination notice that establishes that the PI may conduct preliminary or conceptual work that does not involve human subjects. 

NSF’s Additional Guidance 

NSF provides additional guidance on their site regarding “Proposals Involving Human Subjects”, “Timing of IRB Review”  (opens in a new window), “Frequently Asked Questions,” and NSF’s expectations for “Preparing Your Data Management and Sharing Plan.”

In addition to the Code of Federal Regulations (45 CFR 46 – opens in a new window) governing research with human subjects, any research funded by USDA-NIFA is subject to additional rules from USDA-NIFA.

• Be prepared to provide USDA-NIFA information about IRB approval before the award is granted.
• IRB Information to communicate in the USDA-NIFA application system can be found on their site in the section called “What does NIFA look for when reviewing IRB or IACUC Assurances?”