New Online Human Subjects Protocol Management System
We are pleased to announce that the Office of Research Integrity has adopted an online protocol management system for your new IRB submissions and future protocol management. The new system will allow you to complete your protocol online, monitor the progress of the review, upload all associated documents, and access all approved documents through the portal. Here is a timeline of our transition to this new system:
All active IRB studies (submitted prior to 9/15/2020): continue to use existing forms located on the IRB Website
Beginning 9/15/2020: You have the option to submit new protocols using Cayuse IRB (login required)
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 vprhelp@utsa.edu to setup a user profile. We will need the following in order to complete a new user account:
- Name
- UTSA ID (abc123)
- UTSA email address
For more information about the electronic system, sign up for the Cayuse Support Center and visit the “Human Ethics” section.
Additional guidance documentation is forthcoming on the IRB Website.
Important Notice Regarding COVID-19 Impact to Human Subject Research
- Face-to-face research with human subjects is reviewed on a case-by-case basis for restarting or beginning. See the Checklist for Face to Face Human Subjects Research (8/14/2020) for guidance on what information to provide for review. Send to IRB@utsa.edu
- Changes to approved IRB protocols that eliminate apparent immediate hazards to the subject do not require prior IRB approval. Investigators may make the change and notify IRB@utsa.edu. Examples include moving from face-to-face visits to phone or virtual visits.
Institutional Review Board (IRB)
The UTSA Institutional Review Board (IRB) is the university committee that reviews and approves human subject research for the purpose of protecting 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 a Federalwide Assurance (FWA) 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.
IRB IMPORTANT DATES & DEADLINES:
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IRB Meeting and Deadlines (PDF) |
Important Announcements
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 458-6473 or IRB@utsa.edu.
***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..
NIH Clinical Trial Definition
Forms
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.
OR
- 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.
Policies
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Definitions (HRP-001) (DOCX) |
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Abbreviations (HRP-002) (DOCX) |
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Designations (HRP-003) (DOCX) |
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Human Research Protection Program (HRP-010) (DOCX) |
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IRB Member Review Expectations (HRP-020) (DOCX) |
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Legally Authorized Representatives Children and Guardians.utsa (HRP-021) (DOCX) |
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End Approval Dates (HRP-022) (DOCX) |
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IRB Records (HRP-023) (DOCX) |
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IRB Roster (HRP-024) (DOCX) |
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States and Transitions (HRP-050) (DOCX) |
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UTSA 2015-2016 IRB Roster (DOCX) |
IRB Training & Development
Human Subjects Protections Training Requirement for All Investigators
All Researchers are required to complete the following trainings 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 one of the three basic CITI courses prior to submitting a new study OR being added as research staff. A refresher course is required every 3 years. Information about the training requirement can be obtained at Introduction to the CITI Course.
Click here for Online Training Access
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 prior to UTSA having 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.
- Conflict of Interest, Conflict of Commitment, and Outside Activities: All UTSA Faculty, staff, employees, or/and 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. For more information please visit the Conflict of Interest in Research & Intellectual Property Website.
For questions regarding the policy and the disclosure/approval process, you may contact the Office of Institutional Compliance & Risk Services by email at compliance@utsa.edu or by phone at (210) 458-2667.
IRB Help Lab
Get the answers to all your IRB questions. The Institutional Review Board (IRB) Staff offers help sessions. Make an appointment, or drop by. You may bring in an electronic copy of any materials with which you need assistance or call (210) 458-6473 for a telephone consultation.Click here for more information (PDF). Times and locations listed below:
Main Campus:
GSR Bldg. Room 2.104N/P
Every Tuesday & Wednesday from 9:00 A.M. to 11:00 A.M. and 1:30 to 3:30 P.M.
Downtown Campus:
Spring 2020: DB Room 3.110 from 2-4 on the following days:
January 29, February 11 & 26, April 7 &22, and May 5
Guidance
| Guidance Information for New Forms | |
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Investigator Obligations (HRP-800) (DOCX) |
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Prompt Reporting Requirements (HRP-801) (DOCX) |
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Informed Consent (HRP-802) (DOCX) |
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Documentation of Informed Consent (HRP-803) (DOCX) |
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Investigator Manual (UTSA) (HRP-910) (DOCX) |
| Less Frequently Used Forms and Guidance Information | |
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DOD Obligations (HRP-810) (DOCX) |
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DOE Obligations (HRP-811) (DOCX) |
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DOJ Obligations (HRP-812) (DOCX) |
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ED Obligations (HRP-813) (DOCX) |
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EPA Obligations (HRP-814) (DOCX) |
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FDA Obligations (HRP-815) (DOCX) |
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ICH-GCP Obligations (HRP-816) (DOCX) |
Ethics, Regulations & Guidelines
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 and Codes | |
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| The Belmont Report | |
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Ethical Principles and Guidelines for the Protection of Human Subjects in Research |
| The Nuremberg Code | |
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Nuremberg Code |
| World Medical Association | |
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Declaration of Helsinki |
| Federal Regulations | |
| Department of Health and Human Services (DHHS) | |
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DHHS Code of Federal Regulations 45 CFR 46 |
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Exempt Categories |
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Expedited Categories |
| Family Educational Rights and Privacy Act (FERPA) | |
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FERPA Homepage Title34 CFR 99 (PDF) |
| Food and Drug Administration (FDA) | |
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Title 21 CFR 50Title 21 CFR 56 |
| Guidance | |
| Office of Human Protections (OHRP) | |
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OHRP Homepage |
| HIPAA | |
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DHHS Office of Civil Rights |
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NIH HIPAA Privacy Rule: Information for Researchers |
| Other Links of Interest | |
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The Tuskegee Timeline |
SOPs
FAQs
What is the Institutional Review Board (IRB)? 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).
Who should submit research to the IRB?
- UTSA faculty, students, or staff conducting human subject research as a part of their position at UTSA
- Investigators who wish to recruit UTSA students, faculty, or staff using non-publicly available information or who wish access to those individuals
- Investigators conducting human subjects research using UTSA facilities (when UTSA is engaged in research – consult the IRB Office for further information regarding engagement in research)
What is meant by “research”? Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (Code of Federal Regulations: Title 45, Part 46.102).
An exercise conducted for educational purposes only and not for the purposes of developing generalizable knowledge may not constitute research. Moreover, using a survey to collect data specifically for the purpose of internal program evaluation and quality improvement may not constitute research.
What is meant by “human subject”? Human Subject refers to a living individual participating in an investigation where the following will be collected:
(1) data through intervention or interaction with the individual, or
(2) identifiable information, specimens, cells, tissue, etc.
- An example of public (non-private) information is the telephone book.
- An example of private information would be a student’s UTSA transcript.
How do I apply for IRB approval? Application forms and instructions are available on this page. Submit your application, research protocol and any additional documents (consent forms, etc.) to the IRB office at IRB@utsa.edu.
When should I submit my study to the IRB for approval? Studies, or research, that involves more than minimal risk must be reviewed by the IRB at a convened meeting. A convened meeting is held once each month and applications should be submitted at least 6 weeks prior to an IRB meeting. View Convened IRB deadlines.
All other human subjects research (e.g., exempt or expedited) that involve minimal risk procedures may qualify for review by the IRB Chair or the Chair’s designee. There are no deadlines for submission for these studies. They are reviewed in order of in-processing date.
For a study to be in-processed, all requisite trainings and current year COI disclosure must be completed, and the following forms must be submitted via e-mail to irb@utsa.edu. The documents which must be completed include:
Initial Review Application (HRP-200)
Research Personnel Form (HRP-201)
Protocol (HRP-504)
Consent Form (HRP-500) OR Consent Not Requiring Signature (HRP-501)
Documents must be submitted as separate attachments in Word format. Do not submit zip files or through Dropbox, etc. Be sure to attach data collection instruments, recruitment materials, etc.
What is minimal risk? Minimal risk typically refers to procedures or activities that an average person would expect to occur during their daily life.
Is there a time period for IRB approval of a research study? The IRB will inform you of the approval period in your official letter. Regulations require that some studies require annual review. Researchers will receive a check-in e-mail from the IRB Office close to the approval anniversary date. If you plan to continue the research, you must respond to the e-mail. Otherwise, your study will be closed and you may not continue conducting the research.
How do I obtain approval for a change to my research? Submit a request for a modification to the protocol (Modification Application) for IRB approval prior to implementation of any change to the research.
Contact Staff
Shannon Marquess
Senior Research Compliance Coordinator
(210) 458-6179
Location: GSR 2.104P
Shannon.Marquess@utsa.edu
Tammy Lopez, J.D., CIP
Senior Research Compliance Coordinator
(210) 458-6473
Location: GSR 2.104N
Tammy.Lopez@utsa.edu
