Helsinki Declaration

HELSINKI DECLARATION

Introduction

·       The Declaration of Helsinki is a set of ethical principles developed by the World Medical Association (WMA) for guiding physicians and researchers in conducting medical research involving human subjects.

·       It was first adopted in 1964 in Helsinki, Finland, and has since undergone multiple revisions to address emerging ethical issues in medical research.

Key Principles of the Helsinki Declaration

1. Protection of Human Subjects

• The health, well-being, and rights of research participants must take precedence over the interests of science and society.
• Research should be conducted only when the potential benefits outweigh the risks to participants.

2. Scientific and Ethical Considerations

• Research must be based on thorough scientific knowledge, preclinical research, and relevant literature.
• Ethical considerations must be integrated at every stage of research.

3. Informed Consent

• Participation in research should be voluntary, and individuals must provide informed consent after being given adequate information about:
• Purpose of the study
• Procedures involved
• Potential risks and benefits
• Right to withdraw at any time without penalty

4. Vulnerable Populations

• Extra precautions should be taken when involving vulnerable groups (e.g., children, prisoners, mentally ill individuals) to ensure they are not exploited.

5. Risk-Benefit Assessment

• Researchers must conduct a comprehensive risk-benefit analysis to ensure that the potential benefits justify any risks.

6. Institutional and Ethical Approval

• Every study must be reviewed and approved by an independent ethics committee (Institutional Review Board - IRB) before commencing.

7. Research on Placebo Use

• The use of placebos is permitted only when:
• No proven treatment exists.
• Withholding treatment does not cause serious harm to participants.

8. Privacy and Confidentiality

• Researchers must protect the privacy of participants and maintain confidentiality of personal data.

9. Publication and Transparency

• Negative and positive research results must be published to contribute to medical knowledge.
• Researchers must register clinical trials in a public database before starting the study.

10. Post-Trial Access

• Participants should have access to the best available treatments developed from the research after the trial ends.

Revisions and Updates

The Helsinki Declaration has been revised multiple times to address emerging ethical challenges, with significant amendments in:

• 1975 (Tokyo): Strengthened ethical review requirements.
• 2000 (Edinburgh): Introduced the concept of post-trial access to treatments.
• 2013 (Fortaleza, Brazil): Emphasized the obligation to publish all research results.

Significance in Medical Research

The Helsinki Declaration is considered the foundation of modern research ethics and has influenced:

• International Guidelines: Basis for the Good Clinical Practice (GCP) guidelines and various national regulations.
• Legal Frameworks: Adopted by many ethics committees and regulatory bodies worldwide.
• Protection of Human Rights: Ensures ethical conduct in research, preventing unethical experiments like the Tuskegee Syphilis Study.

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