Clinical Trials, Human Subject Research, and the Development of New Technology

摘要

Academic intuitions have been placed in an increasingly complex internal and external regulatory environment which impacts the conduct of all research. In order to insure compliance with internal policies a number of separate units have been created in academic institutions where formerly a department Chair or Faculty Dean would have been sufficient to guide the conduct of both clinical and research faculty. Diversity, ethics, conflict of interest, contractual obligations, human resources, animal protection, vivarium, Institutional Review Boards, research administration , patient HIPPA and subject privacy, NIH policy and procedure, FDA drug and device regulations are each associated with a laundry list of items which must be read, understood and are subject to current compliance and retrospective reviews and audit.