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.

  • 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. Waiver of an element 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.

  1. In 2012 the IRB approved a waiver of consent for review of records for the period starting January 1, 2001 up until December 31, 2006. Once the study started there weren't enough cases. Can we extend the date range for records up to Dec 31, 2011?

    The IRB can extend the record review period because the additional records were all existing as of the date of the original submission to the IRB. This means that the original justification for both of the waivers (consent and HIPAA) do not need to be modified.

  2. On May 1, 2012 the IRB approved a waiver of consent for review of records for the period starting January 1, 2005 up until December 31, 2008. The protocol was submitted on April 15, 2012. There weren't enough cases identified to do the study. Can we extend the date range for records up to February 20, 2014?

    The IRB can approve the extension of records up to April 15, 2012. All of the records after April 15, 2012 represent prospective subjects since they were created after the date of the original submission. It was possible to obtain the consent and HIPAA authorization for these subjects. Either, the rationale justifying the waivers would need to be updated to explain why it wasn't practicable to obtain consent for the prospective subjects at the time they were seen or the consent and HIPAA authorization for the subjects seen after April 15, 2012 will be needed . For details, see Waiver of Consent and Waiver of HIPAA.

  3. Under what circumstances would the IRB grant the waiver?

    The IRB might grant the new waiver request, provided the waiver requests for the prospective subjects meet all of the requirements for waiver of consent and waiver of HIPAA. For example, the investigator is seeking to determine the proportion of CHOP's outpatients that receive influenza vaccination. Because there are hundreds of thousands of parents who would need to be consented, the justification for the waiver would be that it was impracticable to obtain consent and HIPAA authorization even for prospective subjects. The IRB could approve this request. If the study doesn't meet the requirements for waiver, the consent of all subjects seen after April 15, 2012 will be needed. For more information regarding extending the study period and converting a retrospective study into a retrospective and prospective study, see Waiver of Consent.

  4. Can an investigator get a waiver to review existing records and then telephone subjects to administer a questionnaire?

    This is a common request but it cannot be granted. If the subjects are available to answer a questionnaire, then it would be practicable to obtain their consent to review records. The IRB would grant the waiver request for all subjects that could not be contacted. For those subjects, it would clearly be impracticable to obtain consent.

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