Human Subjects Research

*To avoid confusion and delays, only one new study per Principal Investigator (PI) is accepted in the queue at a time.*

***The IRB forms have been updated. ***Beginning October 1, 2016 old versions of the forms will NOT be accepted. Please be sure that your internet browser is set to always show the most current versions. This can be done automatically by changing your browser settings to, “keep …until I close” or “Delete browser history on exit”, etc. If you have trouble opening or saving a document, contact our office 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.

***NIH Definition Change***
The NIH has changed their definition of a clinical trial for NIH-funded studies. Please review the attached guidance to determine whether your study is now considered a clinical trial.
NIH Clinical Trial Definition

For new submissions the following forms are required:

• Initial Review Application (Form 200)
• Research Personnel Form (Form 201)
• Protocol (Form 504c)

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.

Required for New Submissions
	Initial Review Application (HRP-200) (DOCX)
	Research Personnel (HRP-201) (DOCX)
	Consent (HRP-500) (DOCX)
	Consent Not Requiring Signature (HRP-501) (DOCX)
	Protocol (HRP-504c) (DOCX)
	Research in a Foreign Country (HRP-502) (DOCX)
	Not Regulated Research Request Form (HRP-421NRR) (DOCX)
	Not Human Research Request Form (HRP-421NH) (DOCX)
	Investigational Drug Worksheet (HRP-425) (DOCX)
	Monitoring Participant Safety Data Integrity (HRP-429) (DOCX)
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)
Worksheet
	FERPA (HRP-300) (DOCX)
	Investigational Device Worksheet (HRP-426) (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)

	Responsibilities of Individuals Engaged in Research Involving Human Subjects at UTSA (DOC)
	UTSA Instructions for CITI training Part 1 (PDF)
	CITI Navigation Instructions (PDF)
	Training – Correct course screenshot (PDF)
	Short Guide for IRB submission (PDF)

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.

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:
BVB Room 4.356 from 2-4 pm on following days:
September 11th & 26th; October 9th & 24th; November 13th & 28th.

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
The Belmont Report
	Ethical Principles and Guidelines for the Protection of Human Subjects in Research
The Nuremberg Code
	Nuremberg Code
World Medical Association
	Declaration of Helsinki
Federal Regulations
Department of Health and Human Services (DHHS)
	DHHS Code of Federal Regulations 45 CFR 46
	Exempt Categories
	Expedited Categories
Family Educational Rights and Privacy Act (FERPA)
	FERPA Homepage Title34 CFR 99 (PDF)
Food and Drug Administration (FDA)
	Title 21 CFR 50Title 21 CFR 56
Guidance
Office of Human Protections (OHRP)
	OHRP Homepage
HIPAA
	DHHS Office of Civil Rights
	NIH HIPAA Privacy Rule: Information for Researchers
Other Links of Interest
	The Tuskegee Timeline

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 must be completed, and a completed initial review application (HRP-200), a research personnel form (HRP-201), and a protocol (HRP-504) must have been submitted.

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 an official letter; the period of approval is limited to no longer than one year from the date of approval. Regulations require that the study undergo continuing review by the IRB at least annually. A Continuing Review Report is available and should be submitted at least one month prior to expiration. (Regulations do not allow a grace period past expiration.)

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.