Declaration of Helsinki
Overview
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.
History
The Declaration of Helsinki was adopted by the 18th WMA General Assembly in Helsinki, Finland in June 1964. It has been amended seven times since, with the most recent amendment occurring at the 64th WMA General Assembly in Fortaleza, Brazil in October 2013.
Principles
The Declaration of Helsinki consists of a preamble and 37 principles. The principles can be categorized into three main sections: general principles, principles applicable to medical research combined with professional care (clinical research), and principles applicable to non-therapeutic medical research.
General Principles
The general principles emphasize the importance of respecting the rights, safety, and well-being of research participants. They also stress the need for a well-formulated protocol, a favorable risk-benefit assessment, and the informed consent of the participant.
Clinical Research Principles
The principles applicable to clinical research highlight the need for medical research to be conducted by scientifically qualified individuals and under the supervision of a competent and ethically approved health care professional. They also emphasize the importance of post-trial provisions.
Non-Therapeutic Research Principles
The principles applicable to non-therapeutic research underscore the necessity of minimizing the risk of harm to research participants. They also stress the importance of ensuring that the benefits of the research outweigh the risks.
Impact
The Declaration of Helsinki has had a significant impact on the ethical conduct of medical research worldwide. It has influenced numerous national and international regulations and guidelines related to human research ethics.
Controversies
Despite its widespread acceptance, the Declaration of Helsinki has been the subject of several controversies. These controversies primarily revolve around the interpretation and application of certain principles.
Future
The future of the Declaration of Helsinki continues to be a topic of debate within the medical and research communities. As medical research continues to evolve, so too will the ethical challenges it presents.
