Who is responsible for ensuring that a research study complies with ethical standards?

The principal investigator holds the primary responsibility for ensuring that a research study complies with ethical standards. This includes designing the study in a way that adheres to ethical guidelines, obtaining informed consent from participants, maintaining data confidentiality, and ensuring that any potential risks to participants are minimized and clearly communicated.

The principal investigator is typically the lead researcher who is accountable for the overall conduct of the study, and they must ensure that all personnel involved in the research follow ethical principles, as well, according to regulations such as the Belmont Report.

While institutional review boards (IRBs) play a crucial role in reviewing research proposals to ensure they meet ethical standards, their function is more of an oversight and evaluative nature rather than direct responsibility for compliance. Funding agencies may have their own ethical guidelines and requirements for compliance; however, their role is often supportive rather than regulatory. Research participants, on the other hand, are not responsible for ensuring compliance but rather have the right to expect that the research will be conducted ethically on their behalf.