for Medical School Human Subjects Research Protocols
Effective January 1, 2013 all initial applications for CPHS approval from the Medical School that are eligible for review at a full board meeting must be accompanied by a completed Department Review Form.
Exempt studies as well as applications that pose no greater than minimal risk to participants (such as retrospective records review, surveys, collection of biological samples, etc.- expedited) DO NOT have to have prior departmental review, but departments may choose to conduct review for all research.
Mechanisms for Departmental Review:
1. Department review committee
2. Review by designated individual
Some departments have a combination of the two mechanisms - they use a committee review for complex protocols and designated individual review for simpler protocols and protocols that have been peer reviewed.
STEP 1 - Determine whether your research protocol meets criteria for exemption. If yes, CPHS does not require a formal department review - proceed to submit an iRIS initial application as usual. (please note - your department may require this).
If the research does not meet exemption criteria:
STEP 2 - Determine whether your research protocol poses no greater than minimal risk to participants and includes procedures that can be found on this list. If yes, CPHS does not require a formal department review - proceed to submit an iRIS initial application as usual. (please note - your department may require this).
If the research does not meet expedited review criteria:
STEP 3 - Submit protocol and other study documents to the person coordinating departmental review in your department. You should receive a completed Departmental Research Review Form after the review has been completed. If there are comments and suggestions on the form, you are highly encouraged to incorporate the comments and suggestions into the study protocol. Submit this completed form along with all the usual documents via an iRIS initial application. If you do not agree with the comments and suggestions provided by the department review, include some justification along with your iRIS application.
STEP 4 - Since you will attach the completed department review form, you do NOT have to route for department signature when you submit the initial application within iRIS.
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
IRIS Support 713.500.7960