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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.

HOP policy 5-2011 QUESTIONS? Contact the Provost’s Office evpp_coi@austin.utexas.edu or call Mike Kerker, Associate Vice Provost at (512) 471-2694.

IRB News

 

IRB Update Volume 4, Issue 9, September 2014

Obtaining a Waiver of Documentation of Informed Consent

Investigators  may apply for a waiver of documentation of informed consent if the research meets one of the two following conditions according to 45 CFR 46.117 & 21 CFR 56.109(c)(1):

Condition 1 (both must be true):

  • The research presents no more than minimal risk.
  • The research involves procedures that do not require written consent when performed outside of a research setting.

Condition 2 (all must be true):

  • The principal risks are those associated with a breach of confidentiality concerning the subject’s participation in the research.
  • The consent document is the only record linking the subject with the research.
  • Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.
  • The study is not FDA regulated.

If your study meets either of the above conditions, you can apply for a waiver of documentation of informed consent in the IRBaccess application form. Remember to also indicate in the proposal document that you are “requesting a waiver of documentation of informed consent” and to modify any consent documents accordingly (i.e., remove signature lines).

Contact your IRB Program Coordinator to determine if a waiver of documentation of informed consent is appropriate for your study.

When is a Subject Signature Not Required?

The following are typical examples in which an Investigator may obtain informed consent from subject(s) without requiring a written signature.

  • Research in contexts and cultures in which signing documents is considered inappropriate.
  • Research in populations with low literacy.
  • Research on sensitive topics or incriminating behavior.
  • Interviews that are not conducted face-to-face, e.g., Skype, email, etc.
  • Anonymous surveys.
  • Surveys distributed online where obtaining a physical signature is impractical.

Attention DRCs

ORS is hosting the following educational session for DRCs:

RC 501 – DRC Workshop
October 15
3:00 – 4:30 PM
FAC 328

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

Upcoming Meeting Date(s)

The next IRB Full Board meeting is: November 17, 2014.
The deadline to upload required documents is: October 29, 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.