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The Office of Research Support (ORS) does not administer or oversee HOP policy 5-2011* or training related to the policy. ORS administers HOP policy 7-1210, “Promoting Objectivity in Research by Managing, Reducing or Eliminating Financial Conflicts of Interest” so if you conduct research and have:

  1. Not submitted a Financial Interest Disclosure (FID), you will need to complete mandatory training and file a FID. Instructions for completing these requirements are located at http://www.utexas.edu/research/rsc/coi/training.html.
  2. Previously submitted a FID, you are not required to complete additional training nor re-disclose the same information to comply with the UTS 180/HOP 5-2011 policy requirements.   However, you may have other responsibilities under that policy.

*If you have questions concerning the other policy, HOP policy 5-2011, “Conflicts of Interest, Conflicts of Commitment, & Outside Activities,” you should contact the Provost’s Office evpp_coi@austin.utexas.edu.

IRB News

IRB Update Volume 4, Issue 6, June 2014

When Should I Submit an Amendment?

After a study has been approved by the IRB, an Investigator should submit an Amendment Application when planning to implement any changes. Regardless of how minor or benign the proposed change might seem any change in a protocol must be approved by the IRB BEFORE the Investigator implements it.

  • Common examples requiring an Amendment Application:
  • Changing or adding an instrument/measure to the protocol
  • Changing or adding recruitment methods or recruitment materials
  • Changing or adding informed  consent documents
  • Adding or removing a Co-Investigator or research personnel
  • Adding a research site
  • Increasing the sample size
  • Adding planned research activities not included in the previously approved proposal

An Investigator should not wait until it is time to submit a Continuing Review Application to submit an Amendment. An Amendment can be submitted at any time.

A direct, online submission link to the amendment application is available on the “Forms” section of the IRB website:

http://www.utexas.edu/research/rsc/humansubjects/forms.html 

Also available on this page is the Amendment Summary Form, which is now required for all amendment submissions.

If the initial application was determined to meet the criteria for exemption from the regulations, contact your Program Coordinator or ORS to verify if an Amendment Application is required.

A Friendly Reminder on Continuing Review Applications

For Expedited and Full Board studies, in order to renew approval for another year, PIs must complete the following steps:

  1. Submit a Continuing Review Application at least 30 days in advance of the expiration date (or 60 days in advance for a full board study).                
  2. Submit the currently approved version of ALL the required documents.

All research personnel must also have updated training (human subjects AND Conflict of Interest) and have a current Financial Interest Disclosure (FID) form on file. Contact your IRB Program Coordinator if you require assistance.

ORS Educational Sessions & Workshops 2014

The following course is available:

RC 201 – IRB Intro
July 9, 2014
10:00 - 11:30 AM
POB 3.408

Please check the ORS news page and TXClass for future offerings.

Upcoming Meeting Date(s)

The next IRB Full Board meeting is July 28, 2014.
The deadline to upload required documents is July 9, 2014.

Visit the IRB Meeting Deadlines and Dates page for the 2014 schedule.


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To read past issues of the IRB Update, visit the IRB Update Archive.