Research Development

Human Subjects Institutional Review Board

 

The School of Graduate Studies and Research and Office of Research Development ensure University compliance with federal, state, local, and University regulations with regard to human subjects research. For information on regulatory compliance, policy and procedure, or the UIW HSIRB, please contact the Office of Research Development at (210) 805-3036.

 

Please note that the Application for IRB Approval has changed.
Please bear with us while we work to streamline the IRB submission and approval process.
Our goal is to reduce the time and frustration of both our researchers
and reviewers while maintaining protection of our research participants.

 

Before You Apply

Before submitting a research protocol for IRB approval, read through the IRB Manual and familiarize yourself with the approval process, regulations for the conduct of human subjects research, and responsibilities of the principal investigator (PI). Be sure all investigators – including co-investigators and faculty supervisor (if applicable) – take the required CITI training before applying. Failure to do so will result in a delay when processing of your application.

Remember: The IRB cannot review protocols for projects in-progress or already completed. Per federal regulations, research for presentation or publication cannot be reviewed for IRB approval following the conduct of the research. As soon as you identify a project's potential for publication or presentation stop conducting the research and apply for IRB approval. Data collected prior to the approval date cannot be included in the study.

 

Completing the Application

After familiarizing yourself with the manual and completing CITI training, the PI should complete the Application for IRB Approval. Read each section of the form carefully and provide all required information. Incomplete applications will be returned without review. If the PI is a student, the application must be approved and supervised by a faculty supervisor.

Additional guidance for completing the application can be found in the IRB Manual, FAQs, through your IRB Representative, or the Office of Research Development.

 

Submitting the Application

After completing the application, CITI training, and obtaining signatures from all co-investigators and faculty supervisor (if applicable), submit the application and all supporting materials (letters of support, consent documents, recruitment fliers, instruments, etc.) electronically to the Office of Research Development. The application will be checked for completion, logged into our system, and forwarded to the appropriate IRB representative(s).

 

Notification of Approval

Applicants will be notified electronically of IRB decisions including: requests for revision or clarification, conditional approval, and approval. Notification will include a letter of approval; a stamped copy of the signed protocol; and stamped copies of any consent documents, recruitment materials, or other materials.

Unless you receive a letter of approval and a stamped copy of your approved protocol, you may not initiate any research activity involving human subjects.

 

Closure or Continuation

IRB approval is good for one year. Before a protocol's expiry, investigators must submit a request for continuing review or closure of the protocol. Submission is mandatory. Failure to inform the IRB of continued work or closure of a protocol will result in administrative closure and notification of Federal and University policy violation.

Courtesy notification of protocol expiry is given 60, 30, and 14 days prior to expiration.

 


Assistance with Protocols, Review, or Consent Documents

For assistance, to schedule a workshop or demonstration for a class, or if any questions arise regarding training expiration dates or additional requirements, please contact the Office of Research Development for assistance at (210) 805-3036.

 


 

 


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