What is a Collaborating Investigator?

A Collaborating Investigator is an individual who is otherwise unaffiliated with Yale who is listed on a Yale research protocol and who is not covered by another institution’s Federalwide Assurance (FWA).  Typically, such an investigator does not have access to an IRB whereby his/her approval in the research can be approved.  Under certain circumstances, Yale will extend its own FWA to include the external investigator; thereby permitting the Yale IRB to approve the investigator’s participation in the research project provided the investigator demonstrates appropriate qualifications.  Collaborating Investigators may be affiliated with a non-Yale institution, or may not be affiliated with any institution (work as independent researchers). 

What are the requirements and the process to become a Yale Collaborating Investigator?

The University requires that investigators from institutions that are not covered by an FWA be held to the same standards as is required of all University research personnel.   In order to ensure that investigators are knowledgeable about the standards expected by Yale of persons conducting research, Yale requires that these non-Yale individuals be approved as a Collaborating Investigators by the University’s Signatory Official or his or her designee prior to engaging in any Yale human research project.

In accordance with Yale IRB policy and federal guidance, approval to participate as a Collaborating Investigator is required when an investigator or research team member is not affiliated with Yale University, is not covered under the FWA of another institution, and will assist in the conduct of Yale research under the direction and supervision of a Yale University Principal Investigator.  Potential Collaborating Investigators may not engage in the conduct of Yale research until a Collaborating Investigator Request has been approved and signed by the University’s Signatory Official or his or her designee, and the investigator. 

The following materials are required for preparing a request for approval of a collaborating investigator to take part in a Yale research project:

• a Request for Permission to Serve as a Collaborating Investigator
• a letter of support from the Principal Investigator of the research protocol, describing the research, the prospective Collaborating Investigator’s role in the research and the PI’s plan for supervision of the Collaborating Investigator
• documentation of human research protections training
• documentation of HIPAA for Researchers training, if applicable
• a copy of the prospective Collaborating Investigator’s Curriculum Vitae
• a copy of the prospective Collaborating Investigator’s medical license, if applicable
• a letter of support from the prospective Collaborating Investigator’s institution, if the Collaborating Investigator’s role in the research involves the resources of the Collaborating Investigator’s institution, and/or if the Collaborating Investigator will be engaged in the research as part of his/her employment at the Institution.

The request is available online at http://yale.edu/hrpp/forms-templates/biomedical.html, “Request for Permission to Serve as a Collaborating Investigator”.

Completed requests and required supporting materials should be submitted to the Yale IRB.  The IRB will review the request and make a recommendation regarding approval.  When a decision is made, the IRB will notify the Principal Investigator.  If approved, a copy of the approved request will be maintained in the IRB research study file.

Forms

• Collaborating Investigator Instructions
• Request to Serve as a Collaborating Investigator