The Declaration of Helsinki is a set of ethical principles for medical research involving human subjects, including research on identifiable human material and data. It was developed by the World Medical Association (WMA) and has been revised multiple times since its adoption in 1964. The 2008 revision is one of these updates, emphasizing the protection of human participants and their rights.
Key Points from the 2008 Declaration of Helsinki:
Ethical Principles: Research must prioritize the well-being, rights, and safety of participants above the interests of science and society. Vulnerable populations require special protection. Informed Consent: Participants must be fully informed about the nature, purpose, risks, and benefits of the research. Consent must be voluntary and documented. Scientific Standards: Research must be scientifically justified and conducted by qualified individuals. Protocols must undergo independent ethical review before initiation. Risk and Benefit: Risks to participants must be minimized and outweighed by the potential benefits. The research must aim to improve health, understanding, or care. Post-Trial Access: Participants should have access to interventions identified as beneficial in the study. Placebo Use: Placebo-controlled trials are only ethically permissible when no proven intervention exists, or under specific circumstances where withholding treatment poses minimal risk. Publication and Dissemination: Researchers have a duty to publish results, including negative and inconclusive findings, to ensure transparency and accountability. Compensation for Harm: Participants harmed during the research must be adequately compensated. The 2008 revision occurred during the WMA's General Assembly in Seoul, South Korea, reflecting advancements in medical ethics and research practices. It remains a cornerstone document for guiding ethical research worldwide.
