Selecting your NIH Study Team

An investigator is "engaged" in HSR when they:

• Obtain information or biospecimens through intervention or interaction with subjects
• Obtain consent from subjects
• Obtain, use, study, analyze, or generate identifiable private information or identifiable biospecimens
• Analyze coded data/samples and can reidentify subjects based on their access to the code key or prior involvement in the protocol

In the PROTECT Smartform, you will need to identify each person working on your study team, specify their role on the team, and indicate if they are obtaining informed consent.

You also need to consider the following:

• Training: All NIH investigators must complete the required CITI training.

• Conflicts of Interest: If your study is a "covered" protocol, all NIH study team members must complete financial disclosures and be cleared to participate by your IC Deputy Ethics Counselor.

NIH Principal Investigators (PIs) must ensure that investigators delegated to obtain informed consent are qualified to do so. This qualification is based on their familiarity with the protocol, research, clinical experience, and qualifications. Those designated to obtain informed consent must be identified in PROTECT before initiating the informed 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).

The NIH IRB provides automatic oversight to NIH study team members identified in PROTECT when they are:

• NIH Employees (intramural or extramural)
• Special Volunteers (note there are 4 different types of volunteers in NED)
• Intergovernmental Personnel Act (IPA) appointees (distinct from IPA detailees)
• Visiting Fellows (VF)
• Intramural Research Training Awardees (IRTA)
• Cancer Research Training Awardees (CRTA)
• NIH Contractors if:
  • The contractor is working at an NIH site with an NIH employee; or
  • The OHSRP Director/designee has determined that the NIH's Federalwide Assurance (FWA) covers the contractor's activities.

The NIH IRB does not automatically oversee all other investigators engaged in HSR. A separate written agreement may be needed before the NIH IRB can oversee other study team members. To get NIH IRB oversight, they will need either:

1. The NIH FWA extended to them via an Individual Investigator Agreement (IIA) or FWA Coverage Agreement, or
2. A Reliance Agreement between NIH and their home institution to work on the study.

Review the Decision Tree listed below to establish what agreement may be needed 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.