University of Vermont

Human Subjects Research - Institutional Review Boards - IRBs

forms_safety

Waiver or Alteration of Consent and HIPAA Authorization

Waiver of Documentation of Consent/HIPAA:  In some research, verbal or implied consent of the subject is sufficient and a signed consent form is not necessary.  A typical example would be a mailed survey with a cover letter explaining the research.  The receipt of a completed survey implies that the subject wanted to participate.

Alteration of Consent/HIPAA:  In some research, an alteration of the individual’s informed consent or elements of the process may be waived.  An example of an alteration of consent would be when research requires deception.  In these cases, some of the elements of informed consent are met but not all.  Information typically held would be the basis for the research and subjects are debriefed after the research is complete. Studies that involve more than mild deception (e.g., fake interaction partners, false feedback, fabricated interpersonal acceptance or rejection) should include a post-experimental interview, an interactive debriefing, and a written debriefing.

Waiver of Consent/HIPAA:  In some research, written or verbal consent is not possible.   A typical example would be retrospective record or pathology reviews.  Consent is not possible because the subjects are not available to sign a consent form.

The request form has been combined to address the three different types of requests above.  One copy is required.
Waiver Materials Last Updated
Request for Waiver of Informed Consent/Authorization/Documentation6/27/11

  


Last modified May 22 2014 03:50 PM

Ethics and Compliance Reporting and Help Line
Contact UVM © 2014 The University of Vermont - Burlington, VT 05405 - (802) 656-3131