What document outlines the ethical treatment of human research subjects?

The document that outlines the ethical treatment of human research subjects is the Institutional Review Board (IRB) guidelines. These guidelines are established to ensure that research involving human participants is conducted in a manner that respects and protects their rights and welfare. The IRB plays a critical role in the oversight of research studies, reviewing research proposals to assess the risk versus benefits, ensuring informed consent, and making sure that the privacy and confidentiality of subjects are preserved.

These guidelines help ensure compliance with regulatory requirements, such as the Common Rule, and they reflect ethical principles rooted in respect for persons, beneficence, and justice. The IRB's evaluation process is crucial for maintaining high ethical standards within research environments, which ultimately safeguards participants and maintains public trust in research initiatives.

While hospital bylaws, ethics committee protocols, and patient safety manuals may have roles in institutional governance and safety, they do not specifically address the comprehensive ethical treatment of human research subjects in the detailed manner that IRB guidelines do.