Question

A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?
A. If a proposed study qualifies for exemption, federal regulations do require review at the foreign site where it will be conducted.
B. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted but still require review at the U.S. site by the institution’s IRB.
C. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.
D. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted, but still require review by the institutional official at the local site

Answer 1

Answer:

B. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.

Explanation:

Researches that are exempt from review consist of studies with human subjects that do not implicate more than the minimal risk and match one or many exempt categories. OPHS staff evaluates exempt research applications, and this process is shorter and faster than the one for non-exempt research.