Under federal regulations, which statement describes exemption eligibility?

Under federal regulations, which statement describes exemption eligibility?

• A. The research falls into one of eight categories of research activity described in the regulations.
• B. The research involves drug trials.
• C. The research requires full board review.
• D. The research collects identifiable private information.

Answer: (A)

The idea being tested is that exemption eligibility is determined by whether the research fits into one of the federally listed exempt categories. If a project matches one of those eight categories described in the regulations, it may be exempt from the standard IRB review requirements. That makes this choice the best description of how exemption works. Drug trials and activities that require full board review are not automatically exempt; many involve more than minimal risk or complex oversight, so they typically do not qualify for exemption. Collecting identifiable private information isn’t itself enough to grant exemption—exemption depends on fitting one of the specific exempt categories, some of which require data to be de-identified or handled in particular ways.

The idea being tested is that exemption eligibility is determined by whether the research fits into one of the federally listed exempt categories. If a project matches one of those eight categories described in the regulations, it may be exempt from the standard IRB review requirements. That makes this choice the best description of how exemption works.

Drug trials and activities that require full board review are not automatically exempt; many involve more than minimal risk or complex oversight, so they typically do not qualify for exemption. Collecting identifiable private information isn’t itself enough to grant exemption—exemption depends on fitting one of the specific exempt categories, some of which require data to be de-identified or handled in particular ways.