Question

Research conducted in prisons is not exempt under 46.104 if the subject population only includes prisoners. For research governed by the Common Rule, the exemptions at 46.104 (Protection of Human Subjects 2018) "do not apply to research subject to Subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners." This means that the research does not include only prisoner subjects or aim to recruit prisoners as subjects. The research questions being answered also do not involve prisoners. It does allow that the research may happen to include a prisoner subject (or a subject who becomes a prisoner) and the prisoner subject's data may still be used without IRB approval for Subpart C.

Although expedited review of prisoner research is permitted, OHRP strongly discourages the use of expedited review procedures as an acknowledgement of the vulnerability of prisoners as a class.

The other answers are incorrect because they assume that an IRB can use an exempt status for prisoner research. The study could qualify for expedited review, but OHRP strongly discourages the use of expedited review procedures as an acknowledgement of the vulnerability of prisoners as a class.

Answer 1

In research, particularly involving prisoners, informed consent is crucial and must clearly communicate the study's risks and intentions. Violations like inducements without full disclosure or inadequate information about the study's design contravene ethical standards and require an Institutional Review Board (IRB)'s oversight to ensure participant protection.

Step-by-step explanation:

Research involving human subjects, particularly those who are vulnerable such as prisoners, is strictly regulated to ensure ethical standards are met. This entails clear communication of risks and obtaining informed consent from participants. For instance, if inmates in a correctional facility are induced to participate in a study for good behavior credit without full disclosure of the research's implications, it constitutes a violation.

Similarly, not informing participants adequately about the distribution of placebos in a clinical trial violates the tenet of informed consent. It's imperative that such studies receive approval from an Institutional Review Board (IRB), a committee that oversees adherence to ethical guidelines established for protecting human subjects in research. Compliance with these guidelines is non-negotiable, irrespective of the subject's nature, from medical to sociocultural research.