The Declaration of Helsinki is a statement outlining the ethical principles for medical research. It provides a foundation for scientific efforts worldwide, protecting those who participate in medical research for their own benefit as well as the benefit of other people with similar medical conditions.
The ethical principles and protections outlined in the Declaration of Helsinki ensure that medical research is done in a way that results in the best possible outcomes for all.
Learn about the origins and revisions of the Declaration of Helsinki, the principles outlined, and how human research is informed by it.
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Why the Declaration of Helsinki Is Important
The Declaration of Helsinki provides guidance for ethical medical research in human beings. It was initially adopted by the 18th Assembly of the World Medical Association in Helsinki, Finland in June 1964.1
The Declaration of Helsinki was developed from 10 principles first stated in 1947 in the Nuremberg Code. It further incorporated elements from the Declaration of Geneva (made in 1948), a statement of the ethical duties of physicians.
Between 1975 and 2013, the Declaration of Helsinki was subsequently amended by nine general assemblies of the association. Though addressed primarily to physicians, its principles provide an ethical foundation for anyone participating in medical research involving human subjects.
Guiding Principles of the Declaration of Helsinki
There are several general guiding principles that lay the foundation for the ethical standards further detailed in the statement. These guiding principles include:
Protecting Patient Health
In line with the Hippocratic Oath “First, do no harm” (Primum, non nocere), and the Declaration of Geneva that emphasizes “the health of my patient will be my first consideration,” the first priority of medical research should be to promote the health and well-being of patients involved.
Knowledge Cannot Trample Rights
The purpose of medical research is to better understand the causes, development, and effects of diseases and to improve both diagnosis and treatment. According to the Declaration of Helsinki, “This goal can never take precedence over the rights and interests of individual research subjects.”
Physicians involved in medical research must protect:
- Life
- Health
- Dignity
- Integrity
- Right to self-determination (autonomy)
- Privacy
- Confidentiality of personal information1
Additional Considerations
Medical research involving humans should only be conducted by people with appropriate scientific and ethical education, training, and qualifications. In most cases, the research should be supervised by a qualified physician or healthcare professional.
When the research is conducted, it must also minimize potential harm to the environment. Underrepresented groups should be provided access to research opportunities. If harm occurs, subjects need to be appropriately compensated and treated.
Following Local Regulatory Norms
Physician-scientists must also take into account their local ethical, legal, and regulatory standards for research involving human subjects. These requirements should not reduce Declaration of Helsinki protections but may provide additional protections.
Special Protections Offered by the Declaration of Helsinki
There are 10 specific topic areas addressed within the Declaration of Helsinki.
Consideration of Risks, Burdens, and Benefits
Medical research must only be conducted if the importance of the findings outweighs the risks and burdens to the research subjects.
This means researchers not only need to consider the potential benefits to research subjects and other people affected by the same medical condition, but they also need to consider potential harms.
Risks must be monitored and mitigated, and if they start to outweigh the potential benefits, the study must be immediately modified or stopped.
Protection of Vulnerable Groups and Individuals
Special protections must be implemented to protect vulnerable individuals and groups. This includes people who have a higher likelihood of being wronged or suffering additional harm due to their status. These groups may include:
- Children
- People who are incarcerated
- People with intellectual or physical disabilities
- Racial or ethnic minorities who may face systemic injustice
Focus on Ethics
The basis for medical research must rest in sound scientific inquiry. This means researchers need to have a thorough understanding of the existing scientific literature, other relevant sources of information, and techniques of experimentation.
The study design must be clearly described and justified in the research protocol. Studies must also be conducted with transparency, which means researchers need to disclose:
- Funding sources
- Sponsors
- Institutional affiliations
- Potential conflicts of interest
- Incentives for subjects
- Compensation for harm1
Prior to the start of the study, the research protocol must be submitted for review by an independent research ethics committee. This committee is often an assigned institutional review board. The committee usually consists of qualified experts who transparently provide comments, guidance, and approval of the research.
Monitoring information may be provided in an ongoing fashion to the committee, especially reporting of serious adverse events.
The protocol may not be amended without the committee’s knowledge and approval. At the study’s conclusion, the researchers submit a final report to the committee that includes a summary of the findings and conclusions.
Protection of Privacy and Confidentiality
Personal information must be kept confidential and the privacy of participating research subjects must be protected.
Allowance of Informed Consent
Participation in medical research must be voluntary and informed consent should be obtained in writing from those who are able to provide it. As part of the consent process, information must be provided about the following:
- Study aims
- Methods
- Funding sources
- Conflicts of interest
- Institutional affiliations
- Anticipated benefits
- Potential risks
- Study outcomes
- Post-study provisions
A potential research subject may initially refuse to participate and has the right to withdraw consent at any time without reprisal. Further considerations exist for those who are incapable of giving informed consent due to mental or physical incapacity, such as obtaining consent from a legally authorized representative.
Use of Placebo
As a general rule, new interventions must be tested against the existing gold standard, or the best proven treatment that presently exists.
In rare cases, the new intervention may be compared to a placebo (no intervention). This usually only happens when no proven intervention exists or if there is a compelling reason to determine the efficacy or safety of the intervention and it’s determined that there is no additional risk to not receiving treatment.
Post-Trial Provisions
If an intervention is identified as beneficial within a trial, provision for post-trial access for all participants should be offered.
Dissemination of Research
All studies involving human subjects should be registered in a publicly accessible database. Upon completion of the trial, the researchers have an ethical obligation to share the results.
These reports must be complete and accurate. Negative or inconclusive results, as well as positive findings, must be disclosed.
Guidelines for Unproven Interventions
When a proven intervention does not exist, a physician may use an unproven intervention after appropriate considerations. These considerations incorporate professional judgment, expert advice and committee oversight, and informed consent. The research must be designed to evaluate its safety and efficacy with findings made publicly available.
Summary
The Declaration of Helsinki provides guidance for safe and ethical medical research involving human subjects. It is designed to prioritize the safety of and benefits to research subjects over all other goals, including the goal of obtaining new medical understanding.
Under the Declaration of Helsinki, researchers are required to have scientific or medical training and conduct their research under the guidance of a licensed healthcare provider.
They can only conduct research if the importance of the findings outweighs the risks to human subjects. Additionally, the research should be conducted with full transparency and vulnerable groups must be protected from potential harms.
If a tested medical intervention such as a new medication proves beneficial, everyone participating in the research should be given post-trial access.