Exempt Human Subjects Research

Exempt Human Subjects Research does not include any of the following:

  • Evaluation the safety or effectiveness of a drug (approved or non-FDA approved) or medical device.
  • Prisoners (incarcerated)
  • Research interaction with Children

Human Exempt Research must be one or more of the following:

  • Conducted in established or commonly accepted educational settings, involving normal education practices
  • Only including interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior
  • Involving benign behavioral interventions and collection of information from adults with their agreement
  • Secondary research use of identifiable private information or identifiable bio-specimens
  • Studying, evaluating or examining public benefit or service programs
  • Taste and food quality evaluation of consumer acceptance studies
  • Storage or maintenance of identifiable private information or biospecimens for secondary research use

NOTE:  Institutional Review is conducted concurrently by UT Health San Antonio through the Office of Clinical Research.   An institutional activation letter from UTHSA is required prior to beginning your research.  Does not apply if UT Health San Antonio is not engaged in research activities.

The exempt application forms are listed below. Submit the application to IRBMail@UTHSCSA.EDU

Required Forms for Initial Submission

Institutional Application for non-clinical trials*Required for all submissions
Inst M - Personnel Form*Required for all submissions (except for VA only studies)
Form B-3 - Exempt Request - General Information Sheet*Required for all submissions
Form M - Proposed data collection instrument(s)

*Required If Applicable

This is not an IRB template. Include the proposed data collection instrument(s) [used to record data (i.e., CRF, Excel spreadsheet, survey, questionnaire)] with your submission.

Form A - Signature Assurance Sheet

*Required for all submissions

Please note: Assure that both the PI and the PI’s chair sign this form or we will not be able to accept the submission.  The PI cannot be the same as the chair due to the that presents.

How to digitally sign Adobe forms.

Billing / Payment Forms - Submit as applicable

Billing GridThis is not an IRB template. Submit if any are being used to provide conventional patient care or procedures.
Participant Payment Plan FormSubmit if you plan to pay subjects.
Study BudgetThis is not an IRB template. Include (if applicable) with your submission.
AgreementThis is not an IRB template. Include (if applicable) with your submission.

Related Forms - Submit as applicable

Form D-IS (Information Sheet)Submit this form if applicable to your . 
Template to use when developing information sheet. Differs from in that it does not contain a signature section.
Telephone ScriptThis is not an IRB template. Include (if applicable) with your submission.

HIPAA (Health Insurance Portability and Accountability) - Submit as applicable

Form J - HIPAA Waiver of Submit this form if applicable to your .

Collaboration - Submit as applicable

Form K-2 - Intent to Rely FormSubmit this form if applicable to your . 
This form should be to document centralized IRB review under a Broad or Reciprocal agreement. This form helps to ensure any outstanding concerns or requirements by the Deferring Site are addressed before the study is approved by the .

Advertisements Technology Instruments - Submit as applicable

Form L - Proposed advertisement(s)This is not an IRB template. Include the proposed advertisements (any type for recruiting) (if applicable) with your submission.  
See Guidelines for Advertising
Form L-1 - Find a Study WebsiteSubmit this form if applicable to your . 
Complete if you wish the study to be posted on the Find a Study website.
Form NN - Use of Technology in Submit this form if applicable to your .
Form NN - Use of Technology in (Redcap)Submit this form if applicable to your . 
This is a PRE-POPULATED form for eConsent using UTHSA Redcap.
Schedule of EventsThis is not an IRB template. Include (if applicable) with your submission.

Other Materials - Submit as applicable

Form AA - Grant ApplicationThis is not an IRB template. Include (if applicable) with your submission.
Form BB - 's Not often used in Exempt submissions. This is not an IRB template. Include the (if applicable) with your submission.
Form BC - Template FormNot often used in Exempt submissions. Submit this form if applicable to your .
Form HH - Mays Cancer Center Review CommitteeThis is not an IRB template. Include (if applicable) with your submission.
Form X - Related (COI) ReportSubmit this form if applicable to your . 
See HOP Conflicts of Interest in Scholarly, Research, and Clinical ActivityHOP Conflict of Commitment, and HOP Institutional Conflict of Interest Policy as applicable.
Letters of Support or Memorandum of Understanding for Off-site This is not an IRB template. Include (if applicable) with your submission.