Helsinki ethical principles for medical research involving human subjects

Declaration binds the physician with the words: “The health of my patient will be my first consideration” and the International code of Medical Ethics declares that physicians shall act in the patient’s best interest when providing medical care”.

It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfillment of this duty.

Medical progress is based on research that ultimately must include studies involving human subjects.

The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.

While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.

It is the duty of physicians who are involved in medical research to protect the life, health, dignity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

Medical research should be conducted in a manner that minimizes possible harm to the environment.

Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a company appropriately qualified physician or other healthcare professional.

Groups that are underrepresented in medical research should be provided appropriate access to participation in research.

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