Selecting Investigators for your NIH Study

All researchers conducting HSR on your protocol must be listed as investigators in PROTECT.

An investigator is engaged in HSR when they:

• Interact or intervene with participants for research purposes
• Obtain informed consent from participants
• Access or use identifiable private information or identifiable biospecimens
• Analyze coded data or biospecimens when they can readily identify participants

In the PROTECT SmartForm, list each investigator, select their study team role, and indicate whether they will obtain informed consent.

The NIH IRB provides automatic oversight to NIH study team members, covered by the NIH FWA and listed in PROTECT when they are one of the following:

• NIH Employees (intramural or extramural)
• Special Volunteers (Other volunteer classifications exist but only Special Volunteers are automatically overseen by the NIH IRB)
• Intergovernmental Personnel Act (IPA) appointees (distinct from IPA detailees)
• Visiting Fellows (VFs)
• Intramural Research Training Awardees (IRTAs)
• Cancer Research Training Awardees (CRTAs)
• NIH Contractors if:
• they work at an NIH site with an NIH employee; or
• the OHSRP Director/designee determines that the NIH FWA covers their activities.

Note: Investigators engaged in HSR who do not fall under these categories are not automatically overseen by the NIH IRB. A separate written agreement may be necessary before the NIH IRB can oversee their activities. Policy 109 describes which investigators are automatically covered under the NIH FWA.

If an investigator is NOT automatically covered under the NIH FWA (i.e., their NED designation is NOT listed above or they have no NED designation), an additional written agreement may be required before the individual can be part of the NIH study team and participate in your study.

Depending on their situation, they will need either a:

1. Reliance Agreement between the NIH and the investigator's home institution, or
2. The NIH FWA can be extended to them via an Individual Investigator Agreement (IIA) or FWA Coverage Agreement, if they are not affiliated with an institution that holds an FWA.

Use the Decision Tree listed below to determine which agreement is necessary or contact the NIH Reliance and Single IRB Team for guidance. If the Decision Tree indicates you need an FWA Coverage Agreement for an investigator, please complete and submit the form below.

If your study is a covered protocol, NIH study team members must complete the required financial disclosures and receive approval from their IC Deputy Ethics Counselor before participating.

All investigators must complete applicable human subjects research training.

Training requirements depend on the investigator's relationship with NIH, specifically their designation in the NED and their planned research activities. NIH employees, Special Volunteers, and other investigators covered under the NIH’s FWA complete NIH-required training through the NIH CITI Portal . Investigators not covered by the NIH’s FWA, need to follow the training requirements of their home institution unless told otherwise by OHSRP.

The Principal Investigator is responsible for ensuring that investigators delegated to obtain informed consent are qualified to do so. These qualifications should be based on their familiarity with the protocol, relevant research and clinical experience, and professional responsibilities.

Investigators who will obtain informed consent must be identified in PROTECT before they begin the consent process. Only certain NIH trainees/fellows may obtain consent:

VFs, IRTAs, and CRTAs Serving as Associate Investigators (AIs): These trainees may observe or participate in the informed consent process only under direct and constant supervision by a qualified NIH federal employee investigator. They may not sign the informed consent document.

Post-doctoral IRTAs/CRTAs and Post-doctoral VFs Serving as AIs: These individuals may obtain informed consent from a prospective subject without the presence of a qualified NIH federal employee investigator after sufficient training by the PI about the protocol. They must be knowledgeable, able to explain the protocol and informed consent document, and capable of addressing all subject questions. To be eligible to obtain consent, they must also have completed the "Elements of a Successful Informed Consent" course and the validated Objective Structured Clinical Examination (OSCE) for the Informed Consent Process offered by the NIMH Human Subjects Protection Unit (HSPU).

Being listed as a Volunteer in NED does not necessarily mean the individual is a Special Volunteer – this is the only type automatically overseen by the NIH IRB. Before adding a volunteer as an Associate Investigator (AI), carefully review the classification and IPD fields in their NED designation to confirm they are indeed a Special Volunteer and not one of the other 5 types of volunteer designation.

NED ENTRY: Not a Special Volunteer

NED ENTRY: Special Volunteer

Example: An investigator from another institution who is classified as a Volunteer Clinical Collaborator will generally need a reliance agreement between NIH and the investigator's home institution before being added as an Associate Investigator.

• Detetermine whether the investigator will be conducting human subjects research.
• Confirm whether the investigator is covered under the NIH’s Federalwide Assurance.
• Determine whether an additional agreement is needed before the NIH IRB oversees their research activities and the investigator can begin study activities.
• Verify that required human subjects research training has been completed.
• Complete Conflict of Interest requirements, if applicable
• Determine who should obtain Informed Consent
• Add all engaged investigators to PROTECT.

If you have questions about selecting your study team, investigator eligibility, IRB oversight, or volunteer requirements, contact OHSRP.

OHRP: Assurance Process Frequently Asked Questions