The University of Texas Rio Grande Valley

The Division of Research, Innovation, and Economic Development

Institutional Review Board (IRB) for Human Subjects Protection

Institutional Review Board (IRB) for Human Subjects Protection
The UTRGV's Institutional Review Board (IRB) reviews all research that meets the definition of human subjects research. The board is made up of UTRGV faculty, staff, and members of the community. The board evaluates research proposals to make sure the planned research follows the ethical principles of human subjects protection and that it adheres to university policies and federal regulations.


Obtain IRB Approval on IRBNet

In order to submit your request you must first register on IRBNet using a valid e-mail address. Using your UTRGV assigned email address is recommended, but please do not use your UTRGV credentials (Username/Password) when registering. During the registration process, you will be sent a confirmation email to the e-mail address that you have provided to IRBNet to finalize your registration. In the IRBNet library you will find a list of forms and templates available for your use.
Link to IRBNet Website [http://www.irbnet.org]
IRBNet Instructional Documents

  1. Read This First 
  2. Application Requirements 
  3. Modification Request Requirements - Submission
  4. Continuing Review Request Requirements - Submission

IRBNet Training Documents (with pictures of the website)

  1. IRBNet Energizer - New User Registration
  2. IRBNet Energizer - New Project Submission
  3. IRBNet Energizer - Post-Submission Advanced Topics
  4. IRBNet Energizer - Messages and Alerts
  5. IRBNet Energizer - Multisite Projects
  6. IRBNet Energizer - Submitting a Revised Project Package (Modification)
  7. IRBNet Energizer - Training and Credentials 

 Submission Deadlines

Human subjects research proposals are reviewed via one of three processes: “exempt”, “expedited”, or “full”. “Exempt” and “Expedited” review is possible with certain categories of research (as specified in the federal regulations) and may be reviewed outside of the full IRB committee by one or more experienced IRB members. Expedited and Exempt protocols are reviewed in the order received; there are no deadlines for these protocols. Please note that "expedited" refers to the fact that it is not subject to review by the full committee, but does not guarantee a fast approval process. Please submit your IRB applications as early as possible before the anticipated start date.
Protocols that do not qualify for exempt or expedited review must be reviewed by the full IRB committee at a convened meeting.

  • For full review, the deadline for protocol submission is the first Tuesday of each month. The IRB will only review complete protocols (no missing items) submitted by the deadline. In most cases, protocols are not complete and are sent a list a missing items. It is best to submit the protocol well before the deadline to ensure you have enough time to submit all missing items by the deadline. IRB committee meetings are scheduled approximately 2 weeks following the monthly submission dates. The exact meeting dates are based on committee member schedules and therefore vary by semester.

Levels of Review – Decision Charts


Human Subjects Protection Training (CITI)

Note: Effective 6 / 29 / 2017 all persons conducting research are required to complete the Responsible Conduct of Research (RCR) training on the CITI Program Website, in addition to any other training required by the committee in which approval is being sought.

An active CITI Human Subjects Protection Training and Responsible Conduct of Research Training is required for all members of the research team. The Human Subjects Protection Courses are good for 2 years, while the Responsible Conduct of Research Courses are good for 4 years.

Human Subjects Protection Courses

  • Group 1: Social Behavioral Research Course
  • Group 2: Biomedical Research Course

Responsible Conduct of Research Courses

  • Biomedical Responsible Conduct of Research Course
  • Social Behavioral Responsible Conduct of Research Course

The course you should complete depends on the type of research you are going to conduct. All CITI completion reports must be provided upon submission of an IRB request such as a new project or modification to add someone to a project. If you are submitting a continuation request for extension of approval, be sure to check whether your CITI course is still valid. It should be at least 3 months from expiration. If you have registered on IRBNet, you may include a copy of your CITI completion report on your IRBNet User Profile under the Training & Credentials section. If you have someone on your team or are adding someone to your team that is not registered on IRBNet, you may include a copy of his or her CITI completion report within the IRBNet package prior to submission. The CITI completion report is a 2-page document that lists details such as user information, course name, date of completion and expiration, and a list of modules with scores.

You may have a CITI account already. If you are registered under another institution (UTB, UTPA, or any other institution) and are now part of UTRGV, you may change your account by affiliating with another institution. Please do not create a new account. To set up your affiliation with The University of Texas Rio Grande Valley, please follow these steps:

  1. Log In
  2. Select blue tab below your Course that reads "Click here to affiliate with another institution"
  3. Type in "Rio Grande Valley” in the search box, our institution should pop up directly below the search box
  4. Select "University of Texas - Rio Grande Valley"
  5. Enter the required information for your profile

To Add the Human Subjects Protection, Basic Course

  1. Select "Basic Course, Human Subjects Protection"
  2. Select "Group 1: Social Behavioral Research Course" or “Group 2: Biomedical Research Course”

To Add the Responsible Conduct of Research Course
       6.    Select “Responsible Conduct of Research”
       7.    Select “Biomedical Responsible Conduct of Research Course” or “Social and Behavioral Responsible Conduct of Research Course”

The CITI course will be added to your main menu.

New Users: Please use the CITI Website Walkthrough document below for registration guidance.


 Financial Conflicts of Interest in Research (FCOIR)

As per University policy, all individuals involved in research must complete financial conflicts of interest in research reporting on a yearly basis.
Students who are not employed by UTRGV must complete the paper form found on IRBNet under Forms and Templates titled “Outside Affiliations Disclosure (OAD) Form.” This form is project specific, but only needs to be submitted once per calendar year. Please submit your OAD form in your IRBNet User Profile under Training & Credentials or in your project package on IRBNet.
All UTRGV employees must log into the UT System Outside Activity Portal http://outsideactivity.utsystem.edu

  • Acknowledge the policies and answer the status questions in the Portal.
  • Report any outside activity disclosures by clicking on ‘Make New Disclosure’ in the Portal.
  • If you have nothing to report, please click on ‘Report No Activity’ in the Portal.

Note: If a new financial interest is acquired that requires disclosure (relates to a project you are working on) you must submit a new form or report it online within 30 days.
For more information, please contact the Office of Research Compliance at (956) 665-2093.


Creating an Online Survey on Qualtrics

All online surveys are required to be conducted using Qualtrics survey software. Access to this software is provided by UTRGV and managed by UTRGV's IT department. This service can be used to create, manage, distribute and analyze surveys.

  • For Faculty: You have access to Qualtrics on your MyUTRGV account by clicking the survey icon.
  • For Students and Staff (Full Time/Part Time) you must request access by using the ServiceNow icon on your MyUTRGV account. Please submit a service request for access.

For questions regarding requesting access or using Qualtrics, please contact webhelp@utrgv.edu.
YOU MUST OBTAIN IRB APPROVAL PRIOR TO DISTRIBUTING YOUR SURVEY. DISTRIBUTING ANY SURVEYS WITHOUT IRB APPROVAL IS AGAINST UTRGV POLICY.
Below is the online survey consent page template. Please use this template for your online survey, because it includes all required elements of consent:
Online Survey Consent Page
Online Survey Requirements:

  1. The first page of the online survey should always be the consent page. See template above.
  2. The consent page should end with an "I consent to participate in this survey" and "I do not wish to participate" button, so that respondents can consent to participation. Please make sure that when respondents select the "I do not wish to participate" button, they are exited out of the survey. The buttons should be setup to require an answer before allowing the respondent to proceed with the survey on the next page.
  3. Please make sure that respondents are able to skip questions (aside from the consent question), if they choose to. Please note, this is a setting that you must change in Qualtrics. This will be verified during the review process.

Please note, Qualtrics has a default setting to record specific identifiers (Name, ID, IP Address and geographic location) from respondents. If you are conducting an anonymous online survey, you must change this setting and provide proof to the IRB. Please see the instructions below on how to change the settings in Qualtrics.
Anonymizing Responses in Qualtrics
Training videos about Qualtrics


 Board Members

  • Dr. Laura Seligman, IRB Chair- Scientist (Professor, Psychological Science)
  • Dr. Sandra Laston, IRB Vice Chair- Scientist (Associate Professor of Research, SOM South Texas Diabetes & Obesity Institute)
  • Dr. Rector Arya, IRB Member-Scientist (Assistant Professor of Research, SOM South Texas Diabetes& Obesity Institute)
  • Dr. Maria de Jesus Munoz, IRB Member- Scientist (Clinical Associate Professor, SOM Family &Preventive Medicine)
  • Dr. Lyuba Levine, IRB Member- Scientist (Professor, SOM Obstetrics & Gynecology)
  • Dr. Eugenia Curet, IRB Member- Non-Scientist (Assistant Dean,  SOM Office of Student Support, Counseling & Wellness)
  • Dr. Janani Krishnaswami, IRB Member- Scientist (Clinical Associate Professor, SOM Family &Preventive Medicine)
  • Dr. Bianca Cruz, IRB Member-Scientist (Clinical Assistant, Cooperative Pharmacy Program)
  • Dr. William Donner, IRB Member- Non-Scientist (Associate Professor, Sociology &Anthropology)
  • Jennifer Saxton, IRB Member-Non-Scientist (Assistant Professor, Theatre)
  • Dr. Karin Lewis, IRB Member-Non-Scientist (Assistant Professor, Human Development &School Services)
  • Dr. Hilda Silva, IRB Member-Non-Scientist (Associate Professor, Organizational & School Leadership)
  • Rebecca Stocker, IRB Community Member- Non-Scientist (Executive Director, HOPE Family Health Clinic)
  • Kimberly Fernandez, Ex-Officio Voting IRB Member (Sr. Research Compliance Specialist, Office of Research Compliance)
  • Diane Sheppard, Ex-Officio Non-Voting IRB Member (Chief Compliance Officer, Institutional Compliance)
  • Dr. Andrew Tsin, Ex-Officio Non-Voting IRB Member (Professor, SOM Chair of Biomedical Sciences Department/Associate Dean of Research)

 Policy and Guidelines


Questions

Please feel free to contact UTRGV Institutional Review Board (IRB) through E-mail: irb@utrgv.edu or Phone: (956) 665-2093.

You may also contact Lynne Depeault at (956) 882-7731 or by email to lynne.depeault@utrgv.edu