FAQ: Waivers

  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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