DECLARATION OF HELSINKI

October 21, 2023

DECLARATION OF HELSINKI

Introduction

The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed originally in 1964 for medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.

The Declaration of Helsinki is a set of ethical principles and guidelines that govern the conduct of medical research involving human participants. It was adopted by medical the world medical association (WMA) in 1964 and has since undergone several revisions, with the latest version being in 2013.

Several versions of Declaration of Helsinki include:

Declaration of Helsinki - Version 1964
Declaration of Helsinki – Version 1975
Declaration of Helsinki – Version 1983
Declaration of Helsinki – Version 1996
Declaration of Helsinki – Version 2000
Declaration of Helsinki – Version 2004
Declaration of Helsinki – Version 2008
Declaration of Helsinki – Version 2013

Principles of the Declaration of Helsinki

The Declaration of Helsinki outlines the ethical principles that researchers and medical professionals should adhere to when conducting clinical trials and other forms of medical research. These principles are intended to protect the rights, safety, and well-being of human participants in research studies.

Informed Consent: Researchers must obtain informed and voluntary consent from participants before involving them in research. Participants should be fully informed about the purpose, procedures, potential risks, and benefits of the study.

Beneficence and Non-Maleficence: Researchers must prioritize the well-being of participants and ensure that potential risks are minimized while maximizing potential benefits.

Research Ethics Committees: Independent ethics review committees should assess and approve research protocols to ensure that they meet ethical standards and regulatory requirements.

Respect for Participants' Autonomy: Participants have the right to withdraw from the study at any time without facing negative consequences. Researchers should respect participants decisions and autonomy.

Privacy and Confidentiality: Participants' privacy and confidentiality should be protected, and their personal information should be kept confidential.

Equity and Fairness: Researchers should ensure that the selection of participants is fair and does not unfairly target vulnerable populations.

Placebo Use: The use of placebos in clinical trials is only acceptable when it does not deprive participants of an effective treatment.

Post-Trial Access: Participants who have participated in a clinical trial should have continued access to the study intervention if it is proven to be beneficial.

Why is this important?

The Declaration of Helsinki is especially important to protect the well-being of human subjects involved in biomedical research. It serves as a call of duty for physicians, that need to safeguard the welfare of the human subjects. Different European societies, such as the European Academy of Allergy and Clinical Immunology, the European Society of Cataract and Refractive Surgeons, the Biomedical Alliance in Europe, and the European Renal Association-European Dialysis and Transplant Association, have endorsed the declaration in their code of ethics and conduct.

The Declaration of Helsinki provides a foundational framework for ethical research practices and has been widely adopted by the global medical community. It helps ensure that research involving human participants is conducted in an ethical and responsible manner, with a focus on protecting the rights and well-being of those who contribute to scientific advancements.

Conclusion

The Declaration of Helsinki is a vital set of rules that make sure medical research is done ethically and responsibly. It's all about protecting the rights and well-being of people who take part in research studies. By following these rules, researchers can help advance science while treating participants with respect and care. This declaration reminds us that even in the pursuit of knowledge, people's safety and dignity come first.