Human Research Protection Program

HITECH Act

Yale Collaborating Investigators and Unaffiliated Investigators

 

What are Yale Collaborating Investigators and Unaffiliated Investigators?

A Collaborating Investigator is an individual who is listed on a Yale research protocol, is not affiliated with Yale, and is covered by another institution’s IRB.  Approval of the collaborating investigator’s IRB is required in order for them to participate in the Yale research.

An Unaffiliated Investigator is an individual who is not affiliated with Yale and who does not have access to an IRB whereby his/her approval in the research can be approved.  Under certain circumstances, Yale will permit the Yale IRB to approve the Unaffiliated Investigator’s participation in the research project, provided the investigator demonstrates appropriate qualifications.  Unaffiliated Investigators may be affiliated with a non-Yale institution, such as a community agency, or may not be affiliated with any institution (work as independent researchers). 

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

The University requires that investigators from institutions that are not covered by an IRB be held to the same standards 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 Unaffiliated 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 an Unaffiliated Investigator is required when an investigator or research team member is not affiliated with Yale University, is not covered under the IRB of another institution, and will assist in the conduct of Yale research under the direction and supervision of a Yale University Principal Investigator.  Potential Unaffiliated Investigators may not engage in the conduct of Yale research until an Unaffiliated 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 an Unaffiliated Collaborating Investigator

 The request also includes a statement of support from the Principal Investigator of the research protocol, describing the research, the prospective Unaffiliated Investigator’s role in the research, the reason the Unaffiliated Investigator is needed for the conduct of the research, and the PI’s plan for supervision of the Unaffiliated Investigator

  • documentation of human research protections training
  • documentation of HIPAA for Researchers training, if applicable
  • a copy of the prospective Unaffiliated Investigator’s Curriculum Vitae
  • a copy of the prospective Unaffiliated Investigator’s medical license, if applicable
  • a letter of support from the prospective Unaffiliated Investigator’s institution, if the Unaffiliated Investigator’s role in the research involves the resources of the Unaffiliated Investigator’s institution, and/or if the Unaffiliated Investigator will be engaged in the research as part of his/her employment at the Institution.

The request and instructions are available online on the HRPP social/behavioral forms website, and the HRPP biomedical forms website. “Request for Permission to Serve as an Unaffiliated 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

 

image of Yale campus