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 in order 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 of Documentation of Consent

    Frequently called Verbal Consent, the investigator must obtain consent following the same requirements as written consent but the subject does not sign a consent document.

  • Waiver of Consent

    Waiver of one or more elements of consent is permitted provided that the research is no more than minimal risk and meets specific criteria outlined in 45 CFR 46.116(f)(3).

  • Waiver or Alteration of HIPPA

    The IRB may approve a waiver or alteration of HIPAA provided that the research meets the criteria outlined in 45 CFR 164.512(i)(2)(ii).

  • Waiver of Assent

    The regulations for waiver of assent are contained in Subpart D which enumerates the special protections for children in research. There are three ways in which the IRB can waive assent for some or all of the subjects.

  • Waiver of Parental Permission

    Waiver of Parental permission is permitted under 45 CFR 46.408(c) when it is not a reasonable requirement to protect subjects.

Summary:

Frequently called Verbal Consent, the process is more correctly referred to as Consent with Waiver of Documentation. The investigator must obtain consent following the same requirements as written consent but the subject does not sign a consent document.

Summary:

Waiver of one or more elements of consent is permitted provided that the research is no more than minimal risk and meets specific criteria. Alteration of consent is appropriate if one or more of the 8 required elements is not relevant to the research activity. Complete waiver of consent is also permitted; this is most frequently granted for retrospective research but is also possible for some types of prospective research.

Summary:

The IRB may approve a waiver or alteration of HIPAA provided that the research meets the criteria outlined in 45 CFR 164.512(i)(2)(ii) (see below). The requirements overlap but are not the same as those for waiver of consent and waiver of documentation of consent. There are additional requirements for HIPAA that are more stringent than for waiver under the Common Rule (research regulations).

Summary:

The regulations for waiver of assent are contained in Subpart D which enumerates the special protections for children in research. There are three ways in which the IRB can waive assent for some or all of the subjects.

Summary:

Waiver of Parental permission is permitted under 45 CFR 46.408(c) when it is not a reasonable requirement to protect subjects. This waiver is usually limited to minimal risk research, such as surveys, interviews or focus groups. Research about sexuality, drug use, teen driving habits or other topics of importance to adolescents may not be possible without a waiver. The parents of these teens may not be accessible and therefore, may not be a reasonable requirement.

UNDER CONSTRUCTION

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