Ethics and review boards: Guiding principles, permissible and non-permissible questions, IRB process

Ethics plays a crucial role in clinical research, ensuring the protection of human research subjects from exploitation and other potential harms. Traditionally, the principles of autonomy, beneficence, non-maleficence, and justice have guided medical ethics by the bedside. However, before the development of corresponding principles for research in the 1970s, serious ethical violations were committed against vulnerable patients in the name of science. Current ethical guidelines hold clinical research to seven ethical requirements to protect research subjects, including social and scientific value, scientific validity, fair subject selection, favorable risk–benefit ratio, independent review, informed consent, and respect for enrolled subjects. Furthermore, research in the United States must adhere to the Common Rule (45 CFR 46), which mandates review and monitoring of studies by Institutional Review Boards to ensure adherence to rigorous scientific and ethical standards.