***Resources are Attached***
(1) Review the DHHS and FDA regulations in the attached material, and list the regulations you regard as material to determining whether an intervention is research or treatment.
(2) Review the definition of research in the revised Subpart A of 45 CFR Basic HHS Policy. Why are “scholarly and journalistic activities” deemed not to be research? Why are “public health surveillance activities” deemed not to be research?
(3) When clinicians or scholars decide that their activities are not research, and therefore do not consult with or submit anything to their IRB, it is difficult for an (Human Research Protection Program) HRPP's research oversight mechanisms to detect and correct potential errors. Are there ways for an HRPP to protect against this problem without being overly intrusive?
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