Declaration of Helsinki

 The Declaration of Helsinki is a foundational document in the field of medical research ethics, providing ethical guidelines and principles for the conduct of clinical trials and biomedical research involving human subjects. It was adopted by the World Medical Association (WMA) in 1964 and has since undergone multiple revisions, with the latest version as of my knowledge cutoff in January 2022 being the 2013 version.

Key principles outlined in the Declaration of Helsinki include:

Informed Consent:

Researchers must ensure that individuals participating in research provide informed, voluntary, and comprehensible consent. Participants should be adequately informed about the research purpose, methods, potential benefits, and risks.

Beneficence and Non-Maleficence:

The well-being of research participants should be the paramount consideration. Researchers must strive to maximize potential benefits and minimize risks to participants. Ethical research should do no harm and prioritize the welfare of individuals.

Research Ethics Committee (REC) Approval:

The Declaration emphasizes the role of independent ethical review through Research Ethics Committees. All research involving human subjects should be reviewed and approved by an appropriately constituted REC.

Scientific and Social Value:

Research should be scientifically and socially valuable. It should contribute to generalizable knowledge and be designed to address important questions that can potentially benefit society.

Respect for Vulnerable Populations:

Special protection is required for individuals and groups that may have limited capacity to protect their own interests. This includes but is not limited to, those who are unable to provide informed consent, such as minors or individuals with cognitive impairments.

Privacy and Confidentiality:

Participants have the right to privacy, and researchers must ensure confidentiality of individual data. Researchers should avoid the collection of unnecessary personally identifiable information and take measures to protect participants' privacy.

Justice:

The benefits and burdens of research should be distributed equitably among different population groups. Access to the benefits of research should not be unfairly denied.

Placebo Use and Post-Trial Access:

The Declaration addresses the use of placebos and emphasizes the importance of providing participants with post-trial access to interventions that have proven effective.

The Declaration of Helsinki serves as a global standard for ethical conduct in medical research, guiding researchers, sponsors, and ethics committees in their efforts to ensure the rights, safety, and well-being of research participants. It reflects the evolving ethical considerations in the conduct of biomedical research and underscores the importance of upholding ethical standards to maintain public trust in the scientific community.

P. Mavya

193/092023