The Human Study Lifecycle

Clinical trials must be reviewed and cleared by the Clinical Trials Office (CTO) before the research application can be submitted to the designated Institutional Review Board (IRB).

To start the approval process, complete the Clinical Trial Portal on-line submission form.

Be prepared to upload the following files to the portal:

• If externally sponsored trial, the sponsor's protocol
• If investigator initiated trial, the Clinical Trial Protocol Template (Form CT) 
• If not provided in the protocol, include a list of all study procedures, frequency and timing using the Schedule of Events Template

Studies relying on the UT Health SA IRB - Submit to IRBMail@UTHSCSA.EDU

• -Download the "Full Board Review" application.
• -Download the "Expedited Review" application.
• -Download the "Repository" application.

Studies relying on an  external IRBExternal IRBAn IRB operated by an organization other than UTHealthSA   - Submit to OCRMail@UTHSCSA.EDU

• -Download the "External IRB" application.

If there are plans to utilize UTHSA IRB for the review of multiple sites for the first time, contact the IRB staff prior to submitting - 210-567-8250 or IRB@uthscsa.edu.

Several institutions have signed the SMART IRB Agreement that may allow the UTHSA IRB to review and approve a researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   study for all sites participating in the study. See the list of SMART IRB participating sites.

• -Download the UTHSA Institutional Profile to be used with potential relying sites.

Learn more about Pre-Submission IRB Consultation 

Learn more about SMART IRB agreement in this video 

Learn more about using the SMART IRB reliance platform

Learn more about the UTHSA IRB submission process for multiple sites

In order to qualify for exemption, the researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   must be minimal riskMinimal RiskThe probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For VA studies the determination includes tangible or intangible risk. For DOD research the determination does not include the inherent occupational risks that certain subjects face in their everyday life.   and all the research activities must fit within one or more of the Exempt categories. 

• -Download the "Exempt" application.  

Submit the application to IRBMail@UTHSCSA.EDU

IRB approval is required for the following special situations that do not meet the regulatory definition of human subjects researchHuman Subjects Researchresearch involving living individuals whenever the investigator obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens or interacts/intervenes for research purposes.   :

• -Download the "Expanded Access /Treatment Use of an Unapproved Drug/Device" application.
• -Download the "Emergency Use of an Unapproved Drug/Device" application.
• -Download the "Treatment Use of a Humanitarian Use Device (HUD)" application.

Non-Human ResearchNon-Human Researchresearch that does not involve "human subjects" as defined by the regulations.   does not require IRB approval. However, we strongly encourage you to submit a brief description using our short form so that we can make an official determination.  You may find this useful if you plan on submitting your research to a journal or professional meeting. 

• - Download the "Non-Human Research" application.

Submit the application to IRBMail@UTHSCSA.EDU

Learn more about Non-Human Research determinations.

Non-Regulated ResearchNon-Regulated Researchactivity that does not meet the regulatory definition of research.   projects do not require IRB approval. However, we strongly encourage you to submit a brief description using our short form so that we can make an official determination.  You may find this useful if you plan on submitting your research to a journal or professional meeting.

• - Download the "Non-Regulated Research" application.

Submit the application to IRBmail@uthscsa.edu.

Learn more about Non-Regulated Research determinations.

Non- clinical trialClinical Trialone type of Clinical Research that follows a pre-defined plan or protocol. Subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.   researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   identifiedIdentifiedindividual is identified as a prospective subject during recruitment: 1) by obtaining the results of procedures performed as part of the practice of medicine, 2) by responding to recruitment activities, or 3) referred by a provider.   as having a billing riskBilling RiskThe risk of making clinical billing errors.   are forwarded to the CTO for completion.  The CTO will contact you as needed. 

The Participant Payment Form that is submitted to the OCR ( External IRBExternal IRBAn IRB operated by an organization other than UTHealthSA   ) or OIRBOIRBabbreviation for the UT Health San Antonio Office of the IRB.  (Internal IRB) is forwarded to the CTO for completion.  The CTO will contact you as needed.

In addition, the CTO will assist you with setting up the financial recordsFinancial Recordsfinancial information maintained to support accurate billing of clinical services associated with a research study.  required by HOP 7.7.2.  

For more information review the Participant Payment Guide​

Institutional activation is provided by the Office of Clinical Research and includes the following:

• -Verification of research team members credentialing and training
• -Clinical Trial Office clearance
• -Office of Sponsored Programs clearance
• -Verification of IRB approval
• -Verification of other Institutional Committee approvals
• -Documentation of ClinicalTrials.gov requirements (if applicable)
• -Drug/Device storage ​​​​(if applicable)

Learn more about research team members credentialing and scope of practice

Learn more about training requirements 

Learn more about other committee approvals