REGISTRATION OF OFF-SITE RESEARCH

Submission Instructions

1. Submission of Studies for Registration Only

a. Prior to the initiation of any research activity, including research development, Principal Investigators, students or trainees must submit the following to the UTSW IRB:

i. a cover memo requesting IRB registration only, documenting that the above criteria for registration is met, and signed by the PI or student. If the student is acting as the PI on the study, the memo must also be signed by the Faculty Sponsor;
ii. a copy of the approved study protocol or project summary;
iii. a copy of the approved informed consent form, if applicable; and
iv. a copy of the IRB approval letter from the approving institution.

b. IRB personnel will review the submission to determine if the study qualifies for registration only.
c. If the IRB personnel determines the study is not eligible for registration only, they will communicate to the PI or student by e-mail that formal submission, review and approval by the UT Southwestern IRB is required.
d. If the IRB Chair determines the study is eligible for registration only, the designated IRB personnel will send a Registration of Off-Site Research Acceptance letter via e-mail to the PI, Student and/or Faculty Sponsor as appropriate.

2. Continuing Review
a. If the research continues beyond expiration date, the Principal Investigator is responsible for providing the UT Southwestern IRB with evidence of the continuing review approval from the approving institution.

3. It is the Principal Investigators responsibility to notify the UT Southwestern IRB if serious safety concerns or other problems should result in suspension or termination of approval of this study at the approving institution.