Institutional Review Board (IRB) for Human Subjects Protection

×

October 1st, 2018 – The IRB is rolling out its new electronic submission system called Tick@Lab for IRB Submissions.

January 19th, 2019 – On June 18th 2018 the DHHS and several other Federal Agencies announced the Final Rule delays the general compliance data of the 2018 Requirements for an additional 6-month period ntil January 21, 2019. As of result of this delay to the general compliance date, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Common Rule until January 21, 2019. UTRGV will not implement any changes to its current processes until January 21, 2019.  We’ll keep you posted on the changes. 

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.


Human Subjects Protection Training (CITI)

CITI training is not required for exempt review studies. For Expedited and Full Review studies, all research team members must complete or have a current training course for Human Subjects Protection and Responsible Conduct of Research. Both of these courses are good for 4 years.

Human Subjects Protection training course – two groups to choose from depending on the type of research being conducted:

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

Responsible Conduct of Research training course – four groups to choose from depending on the type of research being conducted:

  • Biomedical Responsible Conduct of Research Course
  • Social Behavioral Responsible Conduct of Research Course
  • Humanities Responsible Conduct of Research
  • Physical Science Responsible Conduct of Research

If you will be conducting a clinical trial or clinical research, please complete the applicable course(s) below for Good Clinical Practice in addition to the above-mentioned courses:

  • Good Clinical Practice Social and Behavioral Research Best Practices for Clinical Research
  • Good Clinical Practice for Clinical Investigations of Devices
  • Good Clinical Practice for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
  • Good Clinical Practice for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)

Please note, Tick@Lab has a CITI Integration function which allows staff to verify completed training courses without the need for researchers to submit reports.


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.


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:

    Thursday, October 18, 2018 from 2:00 – 4:00 pm (Deadline to Submit: September 27, 2018)
    Thursday, November 29, 2018 from 2:00 – 4:00 pm (Deadline to Submit: October 31, 2018)
    Thursday, December 20, 2018 from 2:00-4:00pm (Deadline to Submit: November 29, 2018)

    *Our Spring meeting schedule and deadlines will be posted in December.


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


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 Glorimar Colon at (956) 665-3008 or Nadia Garza de Ramirez at (956) 882-7743.

true
Feedback to the IRB
true
true
true
true