Guidance for Adding External Investigators

Purpose

The purpose of this guidance is to provide general considerations for adding external study staff to human subjects research reviewed and approved by the Charles River Campus IRB.

Defined Terms

Federalwide Assurance (FWA): Institutions that are engaged in non-exempt human subjects research must hold a FWA. Through the FWA, an institution commits to the U.S. Department of Health & Human Services (HHS) that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR part 46.

Reliance Agreement: A formal agreement that provides a mechanism for an institution engaged in research to delegate its IRB review to another IRB. Both the relying and the reviewing institutions must agree to the terms of the Reliance Agreement before research can begin. In the case where an external investigator is being added to a study, the Reliance Agreement must be approved before the external investigator can begin working on the research. Reliance Agreements may be executed through an IRB Authorization Agreement or SmartIRB. Please see the Single IRB Policy for more information.

Independent Investigator Agreement (IIA): A formal written agreement between an institution conducting research (e.g. the BU CRC) and an independent investigator who is engaged in the non-exempt human subjects research. An IIA extends an institution’s FWA to cover the non-exempt human research activities conducted by the independent investigator and commits the Investigator to federal regulations and the institution’s policies and procedures.

Guidance for Adding External Investigators

If you are adding external investigators to your CRC IRB human research project, please note:

Only investigators engaged in research need to be added to the study. Generally, personnel with human subjects’ responsibilities (e.g. obtaining informed consent, interactions/interventions with participants, access to identifiable information, etc.) are considered engaged in research. Please contact the IRB office if you have questions on whether or not an external investigator is engaged in research.

• Adding External Investigators:

• • If the external investigator is from BUMC, please contact Shayne Deal, Reliance Agreement Specialist, to discuss the most appropriate way to proceed with this addition. A Single IRB Form is needed to start the reliance agreement process.
  • If the external investigator’s home institution has a FWA* and a reliance agreement is already in place between the CRC IRB and the external investigator’s home institution for the study, please submit a Study Staff Amendment Form to request the external investigator(s) be added to the study.
  • If the external investigator’s home institution has a FWA* and a reliance agreement is not already in place, please contact Shayne Deal, Reliance Agreement Specialist, to determine if a reliance agreement is appropriate.
  • When adding external investigators, the PI should obtain current certification of  their home institution’s Human Subject Protection Training(s) and Conflict of Interest Disclosures. Please see the Single IRB Policy for more details.

• Adding Independent Investigators:

• • If adding external independent investigators (e.g. investigators who are not performing research activities in connection with an employer or institution and are not seeking academic credit for the research) please contact the IRB office to determine if an Individual Investigator Agreement (IIA) is appropriate.
  • A completed IIA Form must be submitted along with a Study Staff Amendment Form for external investigators that qualify for an Individual Investigator Agreement.

*To search the Office for Human Research Protections (OHRP) Database for Approved FWAs and Registered IORGs & IRBs, see here.