Ethical Principles for Medical Research Involving Human Subjects – The Helsinki Declaration
The Helsinki Declaration stands as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
Consistent with the mandate of the World Medical Association (WMA), the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles. The Declaration is comprised of 37 articles. It is structured as a preamble, followed by eleven chapters dealing with specific principles, namely: General Principles, Risks, Burdens and Benefits, Vulnerable Groups and Individuals, Scientific Requirements and Research Protocols, Research Ethics Committees, Privacy and Confidentiality, Informed Consent, Use of Placebo, Post-Trial Provisions, Research Registration and Publication and Dissemination of Results, and Unproven Interventions in Clinical Practice. Since 2016, the Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks has complemented the Declaration of Helsinki.
Reference of the resource
World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, Geneva, 2013.