The Helsinki Declaration is a key document in the field of medical ethics, developed by the World Medical Association (WMA). It provides ethical principles for medical research involving human subjects, including research on identifiable human material and data. The 2013 Revised Version is the latest update, adopted at the 64th WMA General Assembly in Fortaleza, Brazil.
Key Highlights of the 2013 Revised Version:
Ethical Considerations in Research: Emphasizes the well-being of research participants over the interests of science and society. Reinforces the need for informed consent from all participants. Includes vulnerable groups, requiring additional protections for them. Risk and Benefit Assessment: Stresses that research should only be conducted if the potential benefits outweigh the risks. Researchers must ensure that risks are minimized. Scientific and Ethical Review: All research must undergo a rigorous review by an independent ethics committee. Research protocols should be publicly available. Post-Trial Provisions: Researchers are required to ensure access to interventions identified as beneficial during the study after its conclusion. Use of Placebos: Placebo use is restricted to cases where no proven intervention exists or when compelling methodological reasons justify it. Protection of Privacy: Emphasizes the confidentiality of personal data and the protection of participants' identities. Compensation for Harm: Provides that participants harmed as a result of research should be compensated. Dissemination of Results: Researchers have an ethical obligation to make research results publicly available, regardless of whether the results are positive or negative. Importance of the 2013 Revision:
This version responded to evolving ethical challenges in research, such as globalization, advances in technology, and the increasing complexity of clinical trials. It aims to ensure that human rights and dignity remain at the forefront of medical research worldwide.
