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Exempt Human Subjects Research

Exempt Human Subjects ResearchExempt Human Subjects Researchresearch that meets the regulatory definition of human subjects research and qualifies for exemption.  does not include any of the following:

  • Evaluation the safety or effectiveness of a drugDrug1) a substance recognized by an official pharmacopoeia or formulary; AND 2) a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; AND 3) a substance (other than food) intended to affect the structure or any function of the body; AND 4) a substance intended for use as a component of a medicine but not a Device or a component, part or accessory of a device. Note: biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process).  (approved or non- FDA approvedFDA Approvedor cleared refers to FDA having issued premarketing approval (PMA) or cleared the device for marketing via a Premarket Notification 510(k).  ) or medical deviceMedical Devicean instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1) recognized in the USPÐNF, 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.  .
  • Prisoners (incarcerated)
  • Research interactionInteractionany communication or interpersonal contact between investigator and subject.   with ChildrenChildrena person who has not attained the legal age of majority under the applicable law of the jurisdiction in which the research will be conducted (18 years in the state of Texas), and therefore as a general rule cannot consent to treatment or procedures involved in research.  

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 informationIdentifiable Private Informationprivate information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the 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 researchEngaged in Researchin general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; (3) the informed consent of human subjects for the research; 4) whenever the institution receives a direct HHS award to support such research, even if all of the human subjects activities will be performed by agents or employees of another institution.  activities.

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

Required Forms for Initial Submission

Institutional Research 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 Research 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 conflict of interestConflict of Interestrefers to situations where the individual has the opportunity to influence the Health Science Center's business, administrative, academic, research, clinical, or other decisions in ways that could lead to personal financial gain or advantage or could appear to cause bias in the design, conduct, or reporting of research or educational activities.   that presents.

How to digitally sign Adobe forms.

Billing / Payment Forms - Submit as applicable
Billing Grid

This is not an IRB template. Submit if any clinical servicesClinical Servicesinclude clinical care, clinical tests or clinical procedures that are delivered as part of healthcare (i.e. delivered by professional and technical staff in a clinic, hospital, laboratory, research center, etc.).   are being used to provide conventional patient care or research procedures.
Participant Payment Plan Form

Submit if you plan to pay enrolledEnrolledscreened participants are enrolled if eligibility is verified (meet all inclusion criteria and none of the exclusion) and they consent to continue in the study.  subjects.
Study Budget

This is not an IRB template. Include (if applicable) with your submission.
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.   Agreement

This is not an IRB template. Include (if applicable) with your submission.

ConsentConsentis a person's voluntary agreement to participate in research.  Related Forms - Submit as applicable
Form D-IS (Information Sheet)

Submit this form if applicable to your research.
Template to use when developing information sheet. Differs from consent in that it does not contain a signature section.
Telephone Script

This 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 Authorization

Submit this form if applicable to your research.

Collaboration - Submit as applicable
Form K-2 - Intent to Rely Form

Submit this form if applicable to your research.
This form should be completedCompletedindicates that all study procedures, research related interactions, and acquiring the subject's Private Identifiable Information were completed as planned. The subject is no longer participating in the research   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 Reviewing IRBReviewing IRBor "designated IRB" indicates the IRB reviewing on behalf of relying institutions.   .

Advertisements & RecruitmentRecruitmenta pre-enrollment activity used to find potential subjects.   /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 Recruitment Website

Submit this form if applicable to your research.
Complete if you wish the study to be posted on the Find a Study website.
Form NN - Use of Technology in Research

Submit this form if applicable to your research.
Form NN - Use of Technology in Research (Redcap)

Submit this form if applicable to your research.
This is a PRE-POPULATED form for eConsent using UTHSA Redcap.
Schedule of Events

This is not an IRB template. Include (if applicable) with your submission.

Other Materials - Submit as applicable

Form AA - Grant Application

This is not an IRB template. Include (if applicable) with your submission.
Form BB - Sponsor 's ProtocolProtocolstep-by-step details of how a study will be conducted including objectives, design, procedures, measurements, management and analysis, as well as a discussion of relevant research ethics issues. 

Not often used in Exempt submissions. This is not an IRB template. Include the protocol (if applicable) with your submission.

Form BC - Protocol Template Form

Not often used in Exempt submissions. Submit this form if applicable to your research.

Form HH - Mays Cancer Center Review Committee

This is not an IRB template. Include (if applicable) with your submission.

Form X - Protocol Related Conflict of Interest (COI) Report

Submit this form if applicable to your research.
See HOP Conflicts of Interest in Scholarly, Research, and Clinical Activity, HOP Conflict of Commitment, and HOP Institutional Conflict of Interest Policy as applicable.

Letters of Support or Memorandum of Understanding for Off-site Research

This is not an IRB template. Include (if applicable) with your submission.

 

 

Need Help?

Contact the OIRB

210-567-8250

IRB@uthscsa.edu