Waivers

Waivers are frequently requested but are amongst the least well understood topics. Investigators may request a complete waiver or an alteration for the requirements for consent, documentation of consent, assent or written authorization (HIPAA).

Requesting a Waiver

The IRB has assembled a series of webpages (below) devoted to the various types of waiver requests. Clearly defining what type or types of waiver are desired can help minimize confusion in the IRB application and speed up the approval process.

The IRB is required by the regulations to possess certain information to make a waiver determination. Multiple waiver requests are frequently necessary. For example, a request for a waiver of consent almost always requires a waiver of assent and Written Authorization (HIPAA). The regulatory requirements overlap but are not identical. As a result, the questions in the eIRB system have a certain amount of repetition in order to ensure that the IRB has all of the information needed to make a determination for each waiver.

It is the investigator's responsibility to explicitly supply the necessary information for each type of waiver request. Failure to address each of the elements for each type of waiver will delay the IRB's ability to act on the request.

Waiver Document

• Use the Combined Waiver Consent HIPAA Element when requesting any type of consent or HIPAA waiver (starting on page 2)
• Adapted from Childrens' Hospital of Philadelphia