The Declaration of Helsinki is a statement outlining the ethical principles for medical research.
The Declaration of Helsinki was developed from 10 principles first stated in 1947 in the Nuremberg Code.
Between 1975 and 2013, the Declaration of Helsinki was subsequently amended by nine general assemblies of the association.
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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.
These requirements should not reduce Declaration of Helsinki protections but may provide additional protections.
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.
The study design must be clearly described and justified in the research protocol.
The protocol may not be amended without the committees knowledge and approval.
In rare cases, the new intervention may be compared to aplacebo(no intervention).
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.
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.
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.
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.
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