Ethics Approval and IRB

The history of research ethics is shaped by abuses: the Nuremberg trials revealed Nazi experimentation, leading to the Nuremberg Code (1947). The Declaration of Helsinki (1964, regularly updated) established physician-researcher obligations. The Belmont Report (1979) defined three core principles: Respect for persons (autonomy and protection of vulnerable individuals — operationalized through informed consent), Beneficence (maximizing benefits and minimizing risks), and Justice (fair distribution of research burdens and benefits). IRBs/RECs independently review research protocols before data collection begins. They assess: the risk-benefit ratio, informed consent procedures and documents, participant selection fairness, data confidentiality protections, and vulnerable population safeguards. Informed consent must include: study purpose, procedures, risks, benefits, alternatives, right to withdraw at any time, and confidentiality protections — presented in language the participant can understand. Some research qualifies for exempt or expedited review (e.g., minimal risk surveys, use of de-identified data). Clinical trials must also be registered (e.g., on ClinicalTrials.gov) before enrollment begins.