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Human Subjects

Policies & Guidance

Waiver of Written Documentation of Authorization

On July 31, 2014, the Indiana University IRB began considering requests for alteration of certain elements of Authorization for the Release of Health Information (HIPAA Authorization). Specifically, researchers now have a mechanism to obtain authorization without obtaining a physical signature or date.

The following criteria must be met in order for a request for alteration to be approved. [Note: these are the same criteria required for a full waiver of authorization and are different from the criteria required for a waiver of written documentation of informed consent.]

  1. The use or disclosure of the PHI involves no more than minimal risk to the privacy of individuals based on, at least, the presence of the following elements:
    1. An adequate plan to protect health information identifiers from improper use and disclosure.
    2. An adequate plan to destroy identifiers at the earliest opportunity consistent with conduct of the research (absent a health or research justification for retaining them or a legal requirement to do so).
    3. Adequate written assurances that the PHI will not be reused or disclosed to (shared with) any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of the PHI would be permitted under the Privacy Rule.
  2. The research could not practicably be conducted without the waiver or alteration.
  3. The research could not practicably be conducted without access to and use of the PHI.

The IRB is the final arbiter of whether or not a certain study meets these criteria. If this alteration is approved, authorization will still need to be obtained, but a physical signature and date will not be required. We have provided a template for this process on our Forms & Templates page.

The most common instance of when this request for alteration would be appropriate would be for those studies that consent via the web—where agreement, but no physical signature, can be obtained. If researchers anticipate another situation in which this might be appropriate, they should feel free to contact the Human Subjects Office for assistance with the submission.

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