Given the nature of our constantly changing human world, there is value in having flexibility with the interpretation and application of Expedited Category 7. However, with such a broad definition, it can be difficult for novice and expert reviewers alike to precisely know whether the application is appropriate to be reviewed at the expedited level, whether the research activities may be exempt from the HHS regulations, or in finding that full committee review is needed. Examination of the regulatory language in this session will provide a better understanding of what/who this category applies to and offer insight into navigating considerations for protecting the participants involved.
Learning Objectives:
Identify common research activities that present no more than minimal risk to human subjects and involve criteria listed within Expedited Category 7
Assess how the threshold for what is considered minimal risk can alter based on participant population(s), sensitivity of questions/procedures, informed consent considerations, and other elements necessary to ensure criteria for approval are met
Evaluate various case studies and explore strategies for ensuring consistency in reviews and appropriate protections for subjects are in place