Question

A researcher’s study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims, and the IRB chair agrees, that the study is exempt from IRB review. This decision: Is correct because the lack of direct interaction removes the concern of undue influence that might occur with contact with prisoners. Is wrong because the chair is the only person who can determine that a study is exempt from further review. It is not the researcher’s call. Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners. Is correct if the IRB chair is also the prisoner representative for the IRB.

Answer 1

Answer:

This decision: Is correct because the lack of direct interaction removes the concern of undue influence that might occur with contact with prisoners

Explanation:

According to the exempt criteria of the 45 CFR 46.104(d)(4) of the Office for Human Research Protections (HHS),  secondary research dealing with recorded data, without direct interaction with subjects of the study, is exempt of a IRB review, as there is little or no associated risk to study participants.

Answer 2

It is wrong because 46104 states that research conducted in prisons is not exempt if the subject population is only prisoners.