Consent Process

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Is it always necessary to give an informed consent document to study participants?

Federal regulations require investigators to obtain subject consent to research unless informed consent has been specifically waived by the IRB. ALL of the following requirements must be met to waive informed consent:

  1. The research presents no more than minimal risk to subjects
  2. The waiver will not adversely affect the rights and welfare of the subjects
  3. The research could not practicably carried out without the waiver; and
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after they have participated in the study.

The IRB may still require a summary or oral description of essential research information be disclosed to the subject.


How do I know when to submit a HIPAA waiver with my Exempt or Expedited IRB application?

A HIPAA waiver is necessary if your study will involve using, collecting or analyzing protected health information AND HIPAA authorization cannot be practicably obtained from the subject.  Some examples include, but not limited to, a retrospective chart review or a survey asking health information where a waiver of informed consent has been granted. For more information about HIPAA authorization waiver, visit “Informed Consent Guidelines” link or call OReC staff.


Do I always have to use an IRB-stamped Informed Consent?

According to federal guidance and UNTHSC IRB policy, investigators need to use the most current IRB-stamped informed consent during the consent process. This, not only indicates that the board has officially reviewed and approved the consent form, but provides documentation that an approved consent is being used. In addition, it may minimize the risk of study personnel using the wrong consent form if various versions exist.

Please contact OReC if you need further clarification or guidance regarding this issue.


This page was last modified on June 17, 2015