A guidance has been created to help ease the questions of when a study needs to be submitted for review by the Subcommittee on Human Use of Radiation.  The committee understands that other situations may arise; these are the most common situations that have been submitted to the committee.  If you have any questions, please contact the Human Use Liaison.

Types of Studies

1.      Retrospective (Chart review only)

a.       A study is opened and only a chart review will be performed to create a database.  Only the old radiological studies will be reviewed, no participants will have any radiological exams.  This study does not need SHUR review.

2.      Retrospective with study enrollment

a.       Participants are enrolled in a study based on the results of a radiological exam and no other radiological exams are performed the entire time of participation.  This study does not need SHUR review.

3.      Prospective with only standard of care radiological exams

a.       Any study that the participants receive only standard of care radiological exams must have SHUR approval.

4.      Prospective with standard of care and/or research based radiological exams

a.       Any study that the participants receive any type of radiological exam, standard of care of research based, must have SHUR approval.  All radiation must be reported.

5.      Prospective with no required radiological exams listed on the protocol

Participants are enrolled in a study that the protocol does not require any radiological exams BUT the PI states they would like to review the results of any standard of care radiological exam while the participant is part of the study.  This study does not need SHUR review only with the following clarified

New Studies

Determine if the study needs to be submitted on a RSF-021, RSF-022, or both.

            RSF-021 – Use for scans using radioactive materials

            RSF-022 – Use for studies using external radiation

Submit the required copies as listed on the RSF-021 and RSF-022 forms to the Human Use liaison

Continuing Review and Closed to Enrollment Studies

Submit a completed RSF-023 with the required documentation listed at the top of the form.

Note in comments box if study is closed to enrollment.

** If the study is closed to enrollment and all participants have received all radiographic studies, you can request that the study is closed to SHUR review.