Department Review for Clinical Research

Humans subjects regulations require the IRB to ensure that risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk and that Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. The department review process provides the IRB with information to help determine if the proposed research meets all the regulatory criteria for approval.

The department review should assess scientific validity of the proposed research. The department review should also include a feasibility assessment with particular attention to the feasibility of meeting enrollment targets. (example - Feasibility Questionnaire) In addition to conducting a review of proposed research, a robust departmental oversight mechanism should also be able to assess whether the research is progressing well and help the research team resolve any problems during the course of the research.

Suggested goals of the department oversight mechanism:

Facilitate research that meets the department research goals.
Advise on the scientific validity of proposed protocols.
Assess the feasibility of proposed protocol:
- Whether investigators are qualified by experience, education and training to conduct the research,
- Whether the investigator has access to adequate resources including facilities and research staff,
- Whether the recruitment plan will be able to meet target accrual.
Establish prioritization for recruitment when there are multiple open protocols with similar eligibility criteria.
Assist researchers to conduct research according to the good clinical practice guidelines.
Oversee the progress of various projects in the department’s research program.

Department Representative Signature within iRIS Routing:

All new protocols must have department approval before they are reviewed by the IRB. Protocols from School of Dentistry, Cizik School of Nursing, School of Public Health, School of Biomedical Informatics and Graduate School for Biomedical Sciences and others (not from McGovern Medical School) may be routed within iRIS for departmental representative signature. Instructions for routing to departmental representative can be found on the iRIS Navigation page.

Department Review for Clinical Research Form (McGovern Medical School):

Protocols from McGovern Medical School which qualify for full board review undergo department review and a completed Department Review Form must be submitted with initial application in iRIS under 'Other Study Documents'. CPHS does not require department review in the following situations:

Protocols that meet exemption criteria (see policy Exemptions)
Protocols that qualify for review by expedited procedure (see policy Expedited Review)
Federally funded protocols (grants that have already been awarded by NIH or other federal agencies)

Department review is required for industry sponsored clinical trials being submitted to the UTHealth IRB for review and approval. It is highly recommended that protocols being reviewed by commercial IRBs undergo department review, but this is not required by the IRB.

Department Review Process: Submit protocol and other study documents to the person coordinating departmental review in your department. We strongly recommend that the form be completed by the department reviewers and not be pre-filled by the study team. You should receive a signed Departmental Review for Clinical Research 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 before submitting to the IRB for review. Submit the signed form in 'other study documents' section with the initial application in iRIS. If you do not agree with any comments and suggestions provided by the department review, include a cover letter with justification along with your iRIS application. You do NOT have to route for department signature when you submit the initial application within iRIS.

Frequently Asked Questions:

Which protocols require departmental research review? All initial submissions from Medical School that require a full board review (i.e. not eligible for exemption or review by the expedited procedure) must undergo departmental research review. CPHS does not require department review for protocols reviewed by commercial IRBs or federal agencies such as NIH. However, your department might require all projects to be submitted for review.

How can I determine whether my protocol is exempt or expedited? In general, clinical trials are reviewed at a full board meeting. Clinical trials are research studies participants are prospectively assigned to one or more interventions to evaluate the effects of these interventions on health related biomedical or behavioral outcomes. These protocols should undergo department review and a signed department review form must be submitted with the initial application in iRIS. Most studies involving no contact with participants (e.g. chart reviews, analysis of de-identified data or samples, etc) meet criteria for exemption. Protocols that are no greater than minimal risk may meet criteria for review by expedited procedure. You may contact the CPHS office at 713-500-7943 or [email protected] for clarification.

What outside peer review will be accepted in lieu of departmental review? Protocols for grant applications that have already been reviewed and funded by NIH will not require departmental review. Do attach evidence of funding in lieu of the completed departmental research review form.

Do protocols submitted to external IRBs require departmental review? The IRB does not require department review for industry sponsored protocols being reviewed at an external IRB, including commercial IRBs. However, your department might require review. Department reviewers should be mindful that it might not be possible for investigators to request for changes to industry protocols. Department review might focus on the feasibility of conducting the trial at UTHealth including feasibility of meeting enrollment target, qualifications of the research team and competing trials at UTHealth etc.

How do I submit the signed department review form in iRIS? The Departmental Review for Clinical Research Form should be uploaded in the Study Document section in iRIS, under the Departmental Research Review category. The attachment process is the same as for any other study document. For instructions visit Basic iRIS.

Who is responsible for the department review in my department? Each department has established its own procedure. Please consult within your department to determine the appropriate process. Refer to this list of Department Reviewers to find the person to contact within your department.

What if I disagree with the department peer review? We encourage you to work with your department reviewer and make changes to your protocol based on the department review and resolve any differences before submitting to CPHS for review. If there are issues that you are unable to resolve with the department reviewer, you may submit to CPHS with a cover letter explaining the differences and providing your justification.

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