Andrea Seykora, Research Compliance Manager, Kaiser Permanente Center for Health Research Northwest. Melinda Allie, Research Compliance Program Manager, Kaiser Permanente Center for Health Research Northwest. Kaija Maggard, IRB Manager, Kaiser Permanente Center for Health Research Northwest.
June 10, 2019
The concept of a “partial” waiver of consent or authorization is common in IRB review, despite not appearing in the HHS, FDA, or HIPAA regulations
Examine the regulatory criteria for waiver and alteration of consent and authorization and learn how they may apply to different portions of a study
Explore strategies for collecting information from researchers to facilitate clear and compliant waiver determinations by the IRB
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