Human Research - Full Board IRB Review

Required Forms for Initial Submission

Institutional Research Application for non-clinical trials ¹

OR

Institutional Research Application for Clinical Trials ²

¹ Required for non-clinical trials only.
No CTO clearance necessary.

² Required for clinical trials only. 
Note: If this study is a clinical trial, start with the CTO Portal. CTO will review your application and instruct you when to submit required forms to the IRB. In the meantime, prepare the required forms so they will be ready to submit upon clearance from CTO.

*Required for all submissions (except for VA only studies)

*Required for all submissions

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. 

*Required for all submissions
Include the sponsorSponsorare the agencies, institutions, companies, organizations, foundations, or individual grantors responsible for the initiation, management, or financing of a research study.   's protocol with your submission
OR
Use the Form BC Protocol Template Form if you do not have a sponsor's protocol. Do not use for clinical trials.
OR
Use the Form CT Clinical Trial Protocol Template Form and Schedule of Events for investigator initiatedInvestigator InitiatedIndicates that the study plan was developed by a local investigator and not from an external entity.  clinical trials

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

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.

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.

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

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

ConsentConsentis a person's voluntary agreement to participate in research.  Forms - Submit as applicable

Submit this form if applicable to your research.
For non-VA studies only.
Combined research consent + HIPAA authorization.
For research studies contributing to another repositoryRepositorydata management centers (data centers) and human specimen repositories (sometimes called registries, banks, or libraries) are used to store data and/or specimens for future use. When the use is for research purposes, the data centers/repositories must be approved by the Institutional Review Board (IRB). Human Specimen Repositories collect, store, and distribute human tissue/specimen materials for research purposes. Repository activities involve three components: (i) the collectors of tissue samples; (ii) the repository storage and data management center; and (iii) the recipient investigators. Human repository repositories may be combined with data management centers.   , refer to the informed consent guidance for repositories.
For assistance with drafting the Concise Summary, see the available resources.

Submit this form if applicable to your research.
For VA studies and studies where VA is a site.
Note: If study the includes optional components or sub-studies, submit separate Form D-1 for each component/sub-study
For research studies contributing to another repository, there must be a separate repository consent form.
For assistance with drafting the Concise Summary, see the available resources.

For studies collecting pregnancyPregnancyencompasses the time from confirmation of implantation (through any of the presumptive signs of pregnancy, such as missed menses, or by a medically acceptable pregnancy test), until expulsion or extraction of the fetus.  outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant.

Submit this form if applicable to your research.
For VA studies and studies where VA is a site.
For studies collecting pregnancy outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant.

Use this form for continued follow-up after withdrawal from interventions.

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.

Submit this form if applicable to your research.
This is a BLANK template for one of the following: (1) Alteration to Consent (not all required elements of consent will be presented) (2) Waiver of Informed Consent Process (When consent is not obtained) (3) Waiver of Documentation of Informed Consent Process (consent will be obtained but a signature will not).

Submit this form if applicable to your research.
This is PRE-POPULATED form which contains acceptable template wording when requesting a waiver of consent to complete a chart review study.

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

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

Submit this form if applicable to your research.
Authorization for Use & Release of Individually Identifiable Health InformationIndividually Identifiable Health Informationprivate information including demographic information collected from an individual, and (1) is created or received by a health care provider, health plan, employer, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and (a) that identifies the individual; or (b) with respect to which there is a reasonable basis to believe the information can be used to identify the individual.  .

Submit this form if applicable to your research.
Authorization for Use & Release of Individually Identifiable Health Information.

Submit this form if applicable to your research.
Complete Form I if a covered entityCovered Entityare Health plans, health care clearinghouses and health care providers who come into possession of protected health information in connection with a transaction that is subject to federal HIPAA requirements  will remove the identifiers. The de- 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.   data or specimens will be released to the PI from a covered entity.

Submit this form if applicable to your research.

Submit this form if applicable to your research.
Form J-1 - This document is used to notify the IRB that an investigator plans to use or disclosure PHI of decedents (deceased persons); to assure the IRB that it is being requested solely for the purpose of research on the PHI of decedents for the Research Project described; and to assure the IRB that it is necessary for conduct of this Research Project. The researcher agrees that upon request by UTHSCSA or affiliated institution’s Covered Component from whom the PHI is sought, he/she will provide documentation establishing that the Individual’s(s’) whose PHI is/are being requested is/are deceased.

Collaboration - Submit as applicable

Submit this form if applicable to your research.
This form is used 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.   .

Submit this form if applicable to your research.
Use this form when you are collaborating with researchers from an InstitutionInstitutionany public or private entity or agency (including federal, state or other agencies).  that is part of the Greater Plains Collaborative Reciprocity Agreement. This form will need to be filled out by the relying institutionRelying InstitutionIndicates the institution that is relying on another organization's IRB or IACUC (reviewing IRB or IACUC)   .

Advertisements & Data Collection Instruments - Submit as applicable

This is not an IRB template. Include the proposed advertisements (any type for recruiting) (if applicable) with your submission. 
See Guidelines for Advertising

Submit this form if applicable to your research.

Submit this form if applicable to your research.
Complete if you wish the study to be posted on the Find a Study website.

Form M - Proposed data collection instrument(s)

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

Submit this form if applicable to your research.

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

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

Use of Drugs and/or Devices - Submit as applicable

Submit this form if applicable to your research.

Submit this form if applicable to your research.

Submit this form if applicable to your research.
May be Exempt from IDEIDEInvestigational Device Exemption filed with the FDA   .

Submit this form if applicable to your research.

Submit this form if applicable to your research.

This is not an IRB form. Please review if applicable to your research. See the OCR Policy for Drug/Device Storage.

Form S - Copy of package insert or FDA approvedFDA Approvedor cleared refers to FDA having issued premarketing approval (PMA) or cleared the device for marketing via a Premarket Notification 510(k).  label (PDR reference)

This is not an IRB template. Include this document for drug or device studies with study directed use of FDA approved medication/device for approved medical indication.

Use of Radiation / Use of Gene Transfer - Submit as applicable

Submit this form if applicable to your research.

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

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

Submit this form if applicable to your research.

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

Vulnerable Populations - Submit as applicable

Submit this form if applicable to your research.

Form U - Research Involving Pregnant Women, Fetuses, &/or Neonates

Submit this form if applicable to your research.

Form U - Prefilled for Pregnant Partners

Submit this form if applicable to your research.

For studies collecting pregnancy outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant.

Form V - Research Involving Prisoners

Submit this form if applicable to your research.

Form W - Research Involving Children, Healthy Neonates, and/or Neonates (Viability not in question)

Submit this form if applicable to your research.

Texas Department of Family and Protective Services Request for Approval (Form Inst-J)

Submit this form if applicable to your research.
For research involving Child Protective Services

Other Materials - Submit as applicable

Form AA - Grant Application

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

Form CC - Investigator Brochure

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

Form HH - Mays Cancer Center Review Committee

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

Form R - Monitoring Participant Safety and Data Integrity

Submit this form if applicable to your research.
Complete this form for all studies considered more than minimal risk, where NIH or FDA require a plan, or IRB requested a plan.

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.