Investigators leaving the NIH
Use these questions to identify the steps that the NIH study team and a departing NIH investigator must take when that investigator plans to continue research on an NIH protocol.
Use these questions to identify the steps that the NIH study team and a departing NIH investigator must take when that investigator plans to continue research on an NIH protocol.
Read through the questions to determine:
- If the planned on-going research activities will need IRB oversight; and
- If they do, whether any additional agreements (e.g., Reliance Agreement, Individual Investigator Agreement, or FWA Coverage Agreement) must be put in place to ensure appropriate IRB oversight.
Q1: Will the departing investigator conduct human subjects research (HSR) at the NIH?
An investigator conducts HSR when doing one or more of the following for the purposes of research:
- Interacts/intervenes with subjects;
- Obtains consent from subjects;
- Accesses identifiable private information;
- Works with identifiable data/samples;
- Works with coded data/samples and has access to the code key; or
- Works with coded/deidentified data/samples but can reidentify subjects based on their role or activities on the protocol e.g., departing investigator was the PI of a rare diseases protocol and consented all subjects.
A researcher who does not conduct HSR is considered not "engaged" and, at the NIH, is considered a “Collaborator” not an “Investigator”
STEPS FOR THE NIH STUDY TEAM
- If the protocol does not already allow for the planned research activities (e.g. sharing deidentified data/ samples, or coded data/samples without access to the code key), ensure there is a description of the activities in the protocol and that it has been reviewed and approved by the NIH IRB.
- Collaborators are not identified as study team members in the PROTECT Study Form.
- No further action needs to then be taken at the NIH
STEPS FOR THE INVESTIGATOR LEAVING THE NIH
- An approval from your new home institution may be needed to continue to be involved in the NIH protocol e.g., a determination that your planned activities are not HSR.
An investigator who conducts HSR on an NIH protocol is considered an “engaged” investigator and needs:
- To be covered by an institutions’ Federalwide Assurance (FWA) defined below;
AND
2. Regulatory review and oversight from an Institutional Review Board (IRB).
Go to Question 2
Q2: After leaving the NIH, does the departing investigator's on-going NIH research activities fall under the NIH Federalwide Assurance (FWA)?
All investigators conducting HSR on NIH protocols must be covered by an active FWA. A FWA is an institution’s written commitment to comply with the federal regulations that relate to the protection of human subjects under 45 CFR 46.
The NIH FWA automatically covers the following individuals:
- 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 FWA covers the contractor's activities.
Investigators conducting HSR who do not fall into any of the above categories are not automatically covered by the NIH's FWA. However, if eligible, the NIH FWA can be extended to them through a separate written agreement.
Select “No” if, after leaving the NIH, the departing investigator will not fall into any of the above designations.
NOTE: IRB approval for research activities is separate to being covered by an FWA and continues to be required when there is an “engaged” investigator i.e., if the answer to question 1 was “Yes”.
Before exploring whether the NIH's FWA can be extended to a departing investigator, inquiries will need to be made to establish if another institutions’ FWA covers them.
Go to Question 3
The Investigator’s activities will be covered by the NIH's FWA and they will be considered part of the NIH study team. The Reviewing IRB will continue to provide oversight.
STEPS FOR THE NIH STUDY TEAM WHEN NIH IS THE REVIEWING IRB
To continue to have IRB oversight, the investigator must be:
- Identified in part 1 of the Local Study Team members section of the PROTECT Study Form as they are in NED; and
- Compliant with the training requirements in NIH Policy 103, and the conflicts of interest requirements of NIH Policy 102 if involved in a ‘covered’ protocol.
STEPS FOR THE NIH STUDY TEAM WHEN THE REVIEWING IRB IS EXTERNAL
- Consult with the NIH Reliance and Single IRB Team and then the Reviewing IRB to establish what needs to be in place, if anything, to ensure continued IRB oversight for the departing investigator.
STEPS FOR THE INVESTIGATOR LEAVING THE NIH
- Ensure compliance with all applicable training requirements in NIH Policy 103
- Ensure compliance with NIH Policy 109, section E.4. “Responsibilities of non-NIH Investigators/Institutions”
Q3: Is the departing investigator moving to an institution with an FWA that will cover their HSR on an NIH protocol?
The departing investigator should contact the Human Research Protections Program (HRPP)/IRB office at their new institution to establish if its FWA will cover their on-going NIH HSR activities.
Being “covered” under an FWA means that investigators are acting on behalf of the FWA-holding institution, and that the institution is responsible for their actions when conducting HSR. Institutions typically limit FWA coverage to their employees as it provides a mechanism for accountability and oversight. However, institutions may choose to “extend” their FWA coverage to non-employees e.g., visiting academics, students etc.
To find out if the new institution has an active FWA, click on the FWA tab on the home page of this searchable database and search by the institution’s name.
This response confirms that the conduct of HSR on an NIH protocol by the departing investigator will not automatically be covered by any institutions FWA. The NIH study team needs to explore if the NIH will be willing to extend its FWA using a written agreement.
STEPS FOR THE NIH STUDY TEAM
- Contact the NIH Reliance and Single IRB Team to request that the NIH extend its FWA to the departing investigator via a written agreement.
- Only the NIH Institutional Official (IO) or designee has the authority to determine this. Investigators do not.
- If the NIH's FWA is extended, it means that the departing investigator is considered part of the NIH study team and their research activities on the NIH protocol will continue to be overseen by the Reviewing IRB as part of its review of the NIH protocol.
The NIH FWA is typically extended via an FWA Coverage Agreement or an Individual Investigator Agreement.
- This response confirms that the conduct of HSR on the NIH protocol by the departing investigator will be covered by their new institution’s FWA.
- The departing investigator is considered affiliated with the new institution and is no longer considered part of the NIH study team.
STEPS FOR THE NIH STUDY TEAM
- The next task is to ensure continued IRB oversight for the HSR. The options are outlined below and depend on the identity of the Reviewing IRB.
- If an external IRB is reviewing the NIH protocol, the investigator leaving the NIH needs to work with their new institution’s HRPP/IRB office to identify the best way to secure IRB oversight for their planned on-going HSR. For example, the new institution may need to enter into a reliance with the external IRB.
- The options if the NIH IRB is reviewing the NIH protocol depend on a few factors and include:
- Obtaining a Reliance Agreement between the NIH and the departing investigator’s new FWA-holding institution;
- Requesting that the NIH extends its FWA to the departing investigator via a FWA Coverage Agreement or an Individual Investigator Agreement; or
- In limited cases, having the departing investigator’s new institution conduct Local IRB review of the NIH protocol.
To identify the options for IRB oversight, click on the link below