Human Subjects Research – IRB
Institutional Review Board-IRB
The UTSA Institutional Review Board (IRB) is the university committee that reviews and approves human subject research to protect the rights and welfare of those subjects. The Board is charged with the responsibility to formulate and implement procedures to assure UTSA’s compliance with federal, state, and institutional regulations for the safeguarding of the welfare and well-being (physical, mental, social, legal, etc.) of human subjects involved in research projects in which UTSA is engaged or for which UTSA otherwise exercises oversight.
The UTSA IRB operates under the Federalwide Assurance number (FWA), 00003861, with the Office for Human Research Protections (OHRP) under the Department of Health and Human Services. The IRB advises and educates researchers, staff, and students on research with human subjects and promotes best practices for the ethical conduct of research with these individuals.
Online Human Subjects Protocol Management System
All active IRB studies (submitted before 9/15/2020): use existing forms on the IRB Website.
Beginning 10/1/2020: All new submissions must be submitted using Cayuse IRB. All previous submissions will continue to be managed using the old forms outside of the electronic system.
IMPORTANT: If this is your first time using this system please email irb@utsa.edu to set up a user profile. We will need the following to complete a new user account:
- Name
- UTSA ID (abc123)
- UTSA email address
- Department
- College
For more information about the electronic system, sign up for the Cayuse Support Center and visit the “Human Ethics” section.
The IRB Office offers a monthly training course on submitting a study through Cayuse. Register for the course here.
Students, Please contact us at irb@utsa.edu if you cannot sign up for the course via the training website.
24-25 Full Board Meeting Schedule (PDF)
Information
Electronic Protocol Submissions. Submit your new protocols through Cayuse IRB All previously approved submissions will be maintained using existing forms located below. If you have questions, contact Tammy Lopez or Shannon Marquess at IRB@utsa.edu.
Coming soon:The IRB office will implement a Post Approval Monitoring (PAM) program in which we randomly select 1-2 approved studies a month for not-for-cause audits. The PAM program will ensure UTSA researchers and the IRB are in compliance with federal guidelines for human participant safety procedures. This program is not meant to be punitive but will help ensure participant safety is monitored appropriately and required documentation is on file. Please contact us if you have any questions about this program.
Announcement of IRB Thursday Schedule
The IRB Office has designated Thursday afternoons, between the hours of 1:00 p.m. to 5:00 p.m., as a “set aside” period of time where no phone calls will be received, emails will not be addressed, no help labs will be scheduled, nor appointments made. Thank you for your consideration in helping us to more quickly process your requests.
Is your study a clinical trial?
The NIH has a broad definition of clinical trial that applies to NIH-funded studies. Please review the guidance linked here to determine whether your study is considered a clinical trial.
If you are interacting with your participants, include one of the following:
- Consent Not Requiring Signature (Form 501). Use if you will not collect signatures.
- Consent – SocBeh (Form 500). Use if you will collect signatures.
Note for personnel updates:
If you need only to add new research personnel, email your “Research Personnel Form (HRP-201)” revised with track changes to IRB@utsa.edu. In the subject line of your email state “personnel update” and include your IRB#. No other forms are required.
Be Aware: For document version control and to improve review times, all MS-Word documents coming from the IRB have “Track Changes” on. If you make changes or revisions, you must use these documents.
| Required for New Submissions |
|---|
| Consent (HRP-500) (DOCX) |
| Consent Not Requiring Signature (HRP-501) (DOCX) |
| Research in a Foreign Country (HRP-502) (DOCX) |
| Investigational Drug Worksheet (HRP-425) (DOCX) |
| Monitoring Participant Safety Data Integrity (HRP-429) (DOCX) |
| Individual Investigator Agreement Form (DOCX) |
| Letter of Support Template (PDF) |
| Checklists |
|---|
| Children Checklist (HRP-310) (DOCX) |
| Research Involving Impaired Adults (HRP-414) (DOCX) |
| Research Involving Prisoners Checklist (HRP-308) (DOCX) |
| Research Involving Impaired Adults (HRP-414) (DOCX) |
| Required Forms for On-going Research |
|---|
|
Continuing Review Application (HRP-202 CR) (DOCX) |
| Closure Request (HRP-202 CL) (DOCX) |
| Modification Application (HRP-203) (DOCX) |
| Promptly Reportable Information (HRP-204) (DOCX) |
| Worksheet |
|---|
| FERPA (HRP-300) (DOCX) |
| Investigational Device Worksheet (HRP-426) (DOCX) |
| Faculty PI / Student Worksheet (HRP-1000) (DOCX) |
| Policies |
|---|
| Definitions (HRP-001) (DOCX) |
| Abbreviations (HRP-002) (DOCX) |
| Designations (HRP-003) (DOCX) |
| Human Research Protection Program (HRP-010) (DOCX) |
| IRB Member Review Expectations (HRP-020) (DOCX) |
| Legally Authorized Representatives Children and Guardians.utsa (HRP-021) (DOCX) |
| End Approval Dates (HRP-022) (DOCX) |
| IRB Records (HRP-023) (DOCX) |
| IRB Roster (HRP-024) (DOCX) |
| States and Transitions (HRP-050) (DOCX) |
| UTSA 2021-2022 IRB Roster (DOCX) |
Human Subjects Protection Training Requirement for All Investigators
All Researchers are required to complete the following training PRIOR to submission of new studies.
- Human Research Ethics Training: All UTSA Faculty, staff, employees, or/and students engaged in human research (this includes people or their private, identifiable information) are required to complete either the CITI “Social/Behavioral Research Course” or the “Biomedical Research Course” before submitting a new study OR being added as research staff. A refresher course is required every 3 years. The training requirement can be obtained in the Introduction to the CITI Course.
- All UTSA employees and students have a MyUTSA ID (abc123) and should use Single Sign-On (SSO) to ensure that the course record is linked to your UTSA Training Log. Log in via SSO
- If you have used CITI before UTSA implemented SSO, please proceed to login to CITI and select UTSA for SSO login instructions. Please check your CITI account profile and verify that the UTSA network account ID is your MyUTSA ID.
- Important: The course called “Responsible Conduct of Research (RCR)” does NOT fulfill the UTSA Human Subjects Research Ethics Education requirement. This is an optional module.
- Click here for Online Training Access
- Conflict of Interest Disclosure and Conflict of Interest Training: All UTSA Faculty, staff, employees, and/or students engaged in research are required to disclose and report. Disclosures must be updated annually between January 1st and March 1st. The Office of Institutional Compliance and Risk Services has created a web page with additional resources including training materials and the Policy. Please visit the Conflict of Interest in Research & Intellectual Property Website for more information.
- For questions regarding the policy and the disclosure/approval process, contact the Office of Institutional Compliance & Risk Services by email at compliance@utsa.edu or by phone at (210) 458-2667.
- For individual investigators (individuals who are not affiliated with an institution), we accept the OHRP Human Research Protection Foundational Training. Once the individual has completed the training, you can add their training certificates to the Miscellaneous Attachments page in Cayuse. OHRP Training
We offer a monthly “Intro to Cayuse” class to teach users how to submit an IRB application. If you are faculty or staff, you can find the course under My Training. If you are a student, please contact irb@utsa.edu for course dates and times.
We offer a self-paced course on the history of the IRB with a focus on participant safety and protections for anyone with Canvas access to complete. Please log into Canvas and search for “Human Subjects Research” (NPC-REDKE-IRB) to enroll in this course. The course is 3 modules long and you will be provided with a completion badge to add to your profile.
| Cayuse Job Aids |
|---|
| Cayuse New Submission (PDF) |
| Cayuse NHSR Submission (PDF) |
| Cayuse Modification Steps (PDF) |
| Cayuse Certification Steps (PDF) |
| Cayuse Incident Steps (PDF) |
| Cayuse Annual Check-in Steps (PDF) |
| How to Find Attachments Steps (PDF) |
| How to Close a Study in Cayuse (PDF) |
| Less Frequently Used Forms and Guidance Information |
|---|
| DOD Obligations (HRP-810) (DOCX) |
| DOE Obligations (HRP-811) (DOCX) |
| DOJ Obligations (HRP-812) (DOCX) |
| ED Obligations (HRP-813) (DOCX) |
| EPA Obligations (HRP-814) (DOCX) |
| FDA Obligations (HRP-815) (DOCX) |
| ICH-GCP Obligations (HRP-816) (DOCX) |
| Guidance Information for New Forms |
|---|
| Investigator Obligations (HRP-800) (DOCX) |
| Prompt Reporting Requirements (HRP-801) (DOCX) |
| Informed Consent (HRP-802) (DOCX) |
| Documentation of Informed Consent (HRP-803) (DOCX) |
| Investigator Manual (UTSA) (HRP-910) (DOCX) |
The following links provide information concerning the ethical principles, codes and federal regulations that govern the protection of human subjects in research. Please notify the Office of the IRB at irb@utsa.edu of any links that are not functioning.
| Ethical Principles & Codes |
|---|
| The Belmont Report |
| Nuremberg Code |
| Declaration of Helsinki |
| SOPs |
|---|
| Regulatory Review (HRP-101 SOP) (DOCX) |
| Designated Reviewers (HRP-102 SOP) (DOCX) |
| Non-Committee Review Preparation (HRP-103 SOP) (DOCX) |
| Non-Committee Review Conduct (HRP-104 SOP) (DOCX) |
| Committee Review Preparation (HRP-105 SOP) (DOCX) |
| Committee Review Conduct (HRP-106 SOP) (DOCX) |
| Committee Review Monitoring (HRP-107 SOP) (DOCX) |
| Minutes (HRP-108 SOP) (DOCX) |
| Not Otherwise Approvable Research (HRP-109 SOP) (DOCX) |
| Consultation (HRP-110 SOP) (DOCX) |
| Post Review UTSA (HRP-111 SOP) (DOCX) |
| New Information (HRP-112 SOP) (DOCX) |
| Unexpected Incarceration (HRP-113 SOP) (DOCX) |
| Suspension and Termination by the Organization (HRP-114 SOP) (DOCX) |
FAQs
The UTSA IRB is the standing committee that reviews and approves human subjects research for the purpose of protecting the rights and welfare of participants. The IRB operates under the oversight of the Office of Human Research Protections (OHRP) under the Department of Health and Human Services (DHHS).