Key steps for initiating human subjects research
1. Verify the proposal involves ‘human subjects research’
To be considered ‘human subjects research’, the proposal must meet the definition of ‘research’ and ‘human subject’.
All proposals involving ‘research’ and ‘human subjects’ require Institutional Review Board Approval (IRB).
Proposals that do not meet the definition of ‘human subjects research’ do not require review by an IRB.
If you are unsure, or documentation is required to confirm that the proposal does not meet the definition of 'human subjects research, submit proposals through PROTECT for formal review and determination of ‘not human subject’ research.
2. Establish Principal Investigator (PI) eligibility, training, and conflicts of interest
Investigators who plan to serve as NIH PIs must get approval from their Institute and Center (IC) leadership, who will determine if they are qualified for the role based on their education, training, and experience. Typically, only NIH Federal Employees can be PIs but, in limited cases, a Non-NIH Federal Employee can serve in the role if they receive concurrence from IC Leadership and approval from the NIH Institutional Official (IO).
All NIH Investigators must complete the initial human subjects protections course: either the CITI Biomedical Basic course and/or CITI Social-Behavioral-Educational Basic course based on the type of research they conduct. If conducting non-exempt human subjects research, PI’s must also complete CITI Good Clinical Practice (US FDA Focus).
PROTECT is the NIH IRB’s electronic system. PIs always need an account as they are responsible for the conduct of the study and need access to view, edit, or perform actions on their study submissions. Study team members who need to view, edit, or perform actions on submissions also need to have an account. To request a new account (or edit an existing account) go to the NIH PROTECT Help Desk.
PIs determine if their protocol meets the definition of Covered Research Protocol. If it does, PIs must ensure that the assessment of actual and apparent conflicts of interest (COI), financial and non-financial, is completed for all investigators and individuals who will be engaged in activities. The assessment must take place at specific timepoints in the lifespan of the protocol, these include at the time of initial and each continuing review as well as when adding new investigators to the study. If an investigator is identified as an inventor on intellectual property that is being evaluated in the research, the NIH PI must disclose this to the Reviewing IRB and ensure that the research complies with any management plan established by the Reviewing IRB.
3. Prepare and submit your IRB application
All human subjects research must be submitted to the Institutional Review Board (IRB). This includes multi-site research where the NIH IRB will act as the IRB designated to review and approve the research, as well as studies where the NIH's research activities will be reviewed by an External IRB.
Do you need help drafting your protocol or submitting your protocol to the IRB and other ancillary review committees?
The Office of Research Support & Compliance (ORSC) has Protocol Navigators that can help you. To request assistance with your IRB submission please use the following link: Office of Research Support & Compliance (ORSC) Service Inquiry Form for PN Section
ORSC Protocol Navigators provide support to clinical investigators from the initial phase of protocol development until the protocol is completed and closed by the IRB. Support includes providing protocol templates, drafting parts of the protocol in accordance with NIH IRB approved template and boilerplate language, routing of the protocol through the PRIA process, the scientific review process and submission to the IRB. In addition, protocol navigators identify whether protocols need additional review or regulatory support and direct PIs to those sections in the office. For more information about ORSC Protocol Navigation support please visit: Protocol Navigators | NIH Clinical Center - America's Research Hospital
4. After Initial Approval
Research cannot begin until it is reviewed and approved by the Reviewing IRB.
- The PI is fully responsible for conducting the approved research and must maintain IRB approval throughout the implementation of the research.
- All research must follow the IRB-approved protocol and supporting documents.
- The PI must submit any revisions to the research to the Reviewing IRB for review and approval before implementing them.
- If a study has an expiration date, the PI must submit and obtain approval for a continuing review (progress report) to continue the research.
- If IRB approval lapses, the PI must stop all research activities until re-approval is obtained.
- For multi-site studies, the PI must ensure that the participating site receives IRB review and approval before it begins any study implementation.
- Participating sites are submitted for approval after the IRB approves the overall study.
- The PI must report any non-compliance with the research protocol to the IRB.