Table of ContentsView AllTable of ContentsImportanceGuiding PrinciplesGuiding Principles
Table of ContentsView All
View All
Table of Contents
Importance
Guiding Principles
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.
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Why the Declaration of Helsinki Is Important
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 ofphysicians.
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:
Additional Considerations
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.
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.
There are 10 specific topic areas addressed within the Declaration of Helsinki.
Consideration of Risks, Burdens, and Benefits
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:
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:
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 andinformed consentshould 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:
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 aplacebo(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.
1 SourceVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.World Medical Association.Declaration of Helsinki: Medical research involving human subjects.Additional ReadingDeclaration of Helsinki.British Medical Journal.1996;313(7070):1448-1449.Carlson RV,et al.The revision of the Declaration of Helsinki: past, present and future. Br J Clin Pharmacol. 2004;57(6):695-713. doi:10.1111/j.1365-2125.2004.02103.x
1 Source
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.World Medical Association.Declaration of Helsinki: Medical research involving human subjects.Additional ReadingDeclaration of Helsinki.British Medical Journal.1996;313(7070):1448-1449.Carlson RV,et al.The revision of the Declaration of Helsinki: past, present and future. Br J Clin Pharmacol. 2004;57(6):695-713. doi:10.1111/j.1365-2125.2004.02103.x
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
World Medical Association.Declaration of Helsinki: Medical research involving human subjects.
Declaration of Helsinki.British Medical Journal.1996;313(7070):1448-1449.Carlson RV,et al.The revision of the Declaration of Helsinki: past, present and future. Br J Clin Pharmacol. 2004;57(6):695-713. doi:10.1111/j.1365-2125.2004.02103.x
Declaration of Helsinki.British Medical Journal.1996;313(7070):1448-1449.
Carlson RV,et al.The revision of the Declaration of Helsinki: past, present and future. Br J Clin Pharmacol. 2004;57(6):695-713. doi:10.1111/j.1365-2125.2004.02103.x
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