IRB Policy 120 Protocol Transfer

Effective Date: August 12, 2022.

I. Policy Purpose

The purpose of this document is to describe available options and next steps for transferring the duties and responsibilities of the approved Principal Investigator (PI) to a new PI.

II. Definitions

Investigator: The HHS regulations at 45 CFR part 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB.

Principal Investigator (PI): One investigator is designated the “principal investigator” with overall responsibilities for the study.

III. Policy Statement

When a PI on a Southern Illinois University Carbondale approved IRB protocol relinquishes affiliation with the university the PI no longer has this institution’s approval to continue their study and must either identify a new PI who will accept responsibility for the study in its entirety, including those actions taken before assuming the role of the PI, or close the study.

When transferring PI responsibility to a new PI, the following is required:

• A written statement of transfer from the current PI and statement of acceptance from
  the new PI.
  • The new PI must meet eligibility requirements as defined under IRB policy #110
    (Who can serve as a PI).
  • The new PI must have access to all current and previous regulatory and
    participant documentation, as applicable.
• Revisions to the current student documents to update PI name and contact information.
• A modification submission to change the PI. 

The study may also be closed rather than transferred to a new PI. Please see the IRB website and file the Protocol Close-Out Form (a fillable pdf).

Additional considerations may apply for grant funded projects. Questions regarding how the transfer of an IRB protocol might impact a grant should be directed to the Office of Sponsored Projects.