Frequently Asked Questions

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.

 

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

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 Emory patients 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.

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

If you will only call a subset of patients to ask questions (e.g. ones whose medical charts are missing some key information, or only those who have certain diagnoses), then you may be able to justify how it is impracticable to contact all patients for their consent and authorization for the chart review, yet practicable to contact that small subset. Whichever patients you call, in this scenario, must provide their consent and authorization at that time, for the whole study. NOTE: you must avoid the appearance of "cold calling" patients in this scenario. More guidance is here: Adv and Recruiting Guides and Info

If you plan to contact all patients, then you would not be granted a full waiver, since clearly it is not "impracticable" to obtain consent and HIPAA authorization. The IRB may grant a waiver of signature (aka waiver of documentation) however, for a phone or online survey. 

Chart: What waiver do I require?

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