We’ve been noticing, as we review studies that qualify for exempt status review, that sometimes it seems like the consent process is the longest and most daunting-to-subjects part of participation. We realized that we didn’t have any consent material templates geared for exempt status research readily available.
At least that’s a problem we can solve — and we have solved it, at least temporarily. Two templates designed for exempt status research — one for survey-only studies, the other for non-survey studies — are now available on our website. We in the IRB office are developing a new appreciation for the notion that exempt status research is exempt from many regulatory requirements, and we want to try to make it easier for exempt status research to be carried out. Simplifying the consent process — by providing potential subjects they information they’d need to know to make a decision about participating, without bombarding them with details that really aren’t applicable to very low risk research — is one step in that direction.
As a reminder, we also have simplified our HIPAA authorization template. While we don’t have quite as much flexibility with HIPAA as we do with consent, we are thrilled to make this new, more-reader-friendly template, created by the UAMS Center for Health Literacy, available to the research community.