Institutional Review Board (IRB) for Human Subjects Protection

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NOTICE: FINAL RULE changes for IRB requirements

Changes in the Common Rule took effect on January 21st, 2019; What does it mean?

  • Studies approved by the IRB prior to January 21st, 2019 (including requests for Modifications and Continuing Reviews) will continue to be processed under the old Common Rule and researchers are not required take additional actions to remain compliant. The recent changes will affect only NEW study applications approved on or after January 21, 2019.
  • Among the most important changes are: new requirements for consent forms, the addition of new Exempt Categories and the elimination of an Annual Continuation Review for studies falling under an Expedited Review  Category.  Remember, the changes will only apply to applications for new studies approved on or after January 21, 2019.  If you have an Expedited study approved by the IRB before January 21, 2019 you must continue to comply with the Annual Continuation Review requirement under the old Common Rule.  Your IRB approval letter indicates the applicable expiration date.  In case of doubts, revisit your IRB approval letter or contact one of our IRB coordinators.
  • Avoid delays by using the updated consent and assent form templates!  Our consent and assent form templates have been updated to comply with new regulatory requirements.  Make sure to visit our webpage www.utrgv.edu/irb to use an updated template. 
  • What if your new study application was submitted using an old consent form template and it is pending approval as of January 21, 2019? The changes in the regulations affect the consent form of new studies at UTRGV falling under an Expedited or Full Board Category.  If your application meet this description and it is pending approval as of January 21, 2019, the Office of Research Compliance will assist you with the conversion of the consent forms submitted into the new compliant consent form. 
  • 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.
  • Submit for IRB Approval on Tick@Lab

    If you are seeking IRB approval for your new project, an amendment or a continuation please submit your request on Tick@Lab. You must be a registered user in order to have access to the site. The site uses a single-sign on method with your UTRGV credentials. If you are unable to log in (i.e. access denied) please submit an access request.

    Access Request Instructions


    Link to Tick@Lab [https://lar.utrgv.edu/tickatlab/default.aspx]

    Tick@Lab Training Materials

    1. Tick@Lab Orientation – Read This First!
    2. Tick@Lab – Training for New Project Submission
    3. Tick@Lab – Training for Amendments (Modifications) and Continuations (Extensions) Submission
    4. Tick@Lab for Committee Members

    UTRGV IRB Templates Please click here to access our templates. This is a SharePoint which requires UTRGV log in. Here you will find templates for our consent forms, recruitment materials, and much more. Note, this area is accessible to anyone with a UTRGV log in, this is not where you should submit your IRB materials. Please do not modify any existing templates. When saving your document, please use ‘Save As’ to save a new copy.

  • Submission Deadlines and Meeting Dates

    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 3 weeks prior to each board meeting.

    IRB Panel 2 Meetings and Deadlines – Health Affairs IRB

    Thursday, February 21, 2019 from 9:30- 11:30am (Deadline to Submit: January 31, 2019)

    Thursday, March 21, 2019 from 9:30- 11:30am (Deadline to Submit: February 28, 2019)

    Thursday, April 18, 2019 from 9:30- 11:30am (Deadline to Submit: March 28, 2019)

    Thursday, May 16, 2019 from 9:30- 11:30am (Deadline to Submit: April 25, 2019)

    Thursday, June 20, 2019 from 9:30- 11:30am (Deadline to Submit: May 30, 2019)

    Thursday, July 18, 2019 from 9:30- 11:30am (Deadline to Submit: June 27, 2019)

    Thursday, August 15, 2019 from 9:30- 11:30am (Deadline to Submit: July 25, 2019)


    IRB Panel 3 Meetings and Deadlines – Social Behavioral IRB

    Thursday, February 21, 2019 from 2:00 – 4:00 pm (Deadline to Submit: January 31, 2019)

    Thursday, March 21, 2019 from 2:00 – 4:00 pm (Deadline to Submit: February 28, 2019)

    Thursday, April 18, 2019 from 2:00-4:00 pm (Deadline to Submit: March 28, 2019)

    Thursday, May 16, 2019 from 2:00-4:00 pm (Deadline to Submit: April 25, 2019)

    Thursday, June 20, 2019 from 2:00-4:00 pm (Deadline to Submit: May 30, 2019)

    Thursday, July 18, 2019 from 2:00-4:00 pm (Deadline to Submit: June 27, 2019)

    Thursday, August 15, 2019 from 2:00-4:00 pm (Deadline to Submit: July 25, 2019)

  • 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 in the section above titled “Submit for IRB Approval on Tick@Lab” under UTRGV IRB Templates. The form is titled “Outside Activity Disclosure (OAD) Form” and is located in the folder for Researchers. Please submit your OAD form on Tick@Lab with your submission. If you are submitting a new project, you may attach the completed form on the Personnel tab. If you are being added to a project either through an amendment or a continuation, please include the completed form on either the Amendment tab, Continuation tab, or the Personnel tab.

    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.

  • Levels of Review – Decision Charts

  • 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

    To view a list of our board members, please click here.

  • Policy and Guidelines

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Feedback to the IRB
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