Declaration of Helsinki

The Declaration sets out ethical principles for medical research involving human subjects, including research on identifiable human material and data. It is addressed primarily to physicians, but everyone involved in medical research is encouraged to follow it.

A physician's first duty is to protect the health and rights of the patient. Medical research ultimately requires human subjects, but its aims can never take precedence over the rights and interests of an individual subject. Responsibility for protecting subjects always rests with the physician or researcher, and only appropriately qualified people may conduct the research.

Research may proceed only where the importance of its objective outweighs the risks and burdens to subjects. Risks must be carefully assessed in advance and then continuously monitored, managed and documented. If the risks are found to outweigh the benefits, the study must be modified or stopped immediately.

Vulnerable groups and individuals must receive specific protection. Research involving them is justified only when it responds to that group's health needs and priorities, and the group stands to benefit from the results.

Research must rest on accepted scientific principles, a thorough review of the literature and, where appropriate, animal experimentation. A protocol stating the objectives, methods, funding, conflicts of interest and provisions for compensation must be prepared before the study begins.

The protocol must be reviewed and approved by an independent research ethics committee (IRB) before the study starts. The committee has the right to monitor studies in progress and to receive reports of serious adverse events.

Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

Participation must be voluntary. Consent is taken in writing after the purpose, methods, benefits, risks and the right to withdraw have been fully explained. Where a subject cannot give consent, it is sought from a legally authorised representative, but the subject's own dissent must be respected. Refusing or withdrawing must never affect the patient–physician relationship.

A new intervention must in principle be tested against the best proven intervention. Placebo is strictly limited to cases where there are compelling, scientifically sound reasons for it and where subjects face no risk of serious or irreversible harm.

Where an intervention is found to be beneficial, arrangements for post-trial access must be made in advance for participants who still need it, and disclosed to them during the consent process.

Every study involving human subjects must be registered in a publicly accessible database before the first subject is recruited. Negative and inconclusive results must be published alongside positive ones, together with sources of funding, institutional affiliations and conflicts of interest.

Where no proven intervention exists or the known ones have been ineffective, an unproven intervention may be used after expert advice and informed consent. It should then become the subject of research designed to evaluate its safety and efficacy.