Final answer:
An institution is considered engaged in human subject research when its employees or agents interact with living individuals for research purposes or access private information for research. IRBs are responsible for reviewing research plans to ensure ethical treatment and informed consent of participants.
Step-by-step explanation:
The Common Rule stipulates when an institution is considered engaged in human subject research. This occurs when the institution's employees or agents intervene with living individuals for research purposes or have access to private information for research. Research involving human participants is governed by strict guidelines to ensure the safety and ethical treatment of the subjects. Institutional Review Boards (IRBs) have the responsibility to review and approve the research plans before any research begins. Their role is to ensure that:
- Risks to participants are minimized and reasonable compared to the benefits.
- Participants must provide informed consent, which requires a clear explanation of the risks and documented written consent.
Even with non-clinical studies such as interviews or observations, an IRB review is necessary to protect the participants' welfare and ensure ethical research practices.