Sunday, 10th December 2023

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Declaration of Helsinki

The Declaration of Helsinki is considered the cornerstone of human research ethics. The set of ethical principles stated in the declaration were developed by the World Medical Association for the medical community. The initial texts were revised six times, the latest revision being made in 2008 when the final version of the Declaration of Helsinki was issued.

Basic principles stated in the first issue of the Declaration

1. Clinical research must be conducted in conformity with the moral and ethical scientific principles. The research must be based on scientifically established facts such as laboratory experiments or animal experiments.
2. Only scientifically qualified individuals should conduct clinical research. A qualified medical specialist should also supervise the clinical process.
3. The importance of the final objective must be proportional to the risk of the subject in order to conduct clinical research in a legitimate manner.
4. Risks must be assessed carefully before starting a clinical research. They must be compared with the benefits they will bring to the subject or the other individuals directly or indirectly involved in the process.
5. If the personality of the subject might be altered by the use of clinical drugs or other experimental procedures, the doctor who performs the clinical research must take special caution.
6. When a doctor treats sick patients, he or she may use a new therapeutic measure only if it is in the best interest of the patient and the doctor thinks it will save their life or alleviate suffering. The doctor must also obtain the freely given consent of the patient in order to be able to use an experimental treatment.

7. If the doctor finds that clinical research is justified, he or she may combine it with professional care.
8. If scientific clinical research is conducted on human beings, the doctors must protect the lives and the health of their subjects. They must explain to their subjects or patients all the aspects related to the research including the purpose, the nature and the risks.
9. No clinical research may be conducted on human beings without their free consent and after they were previously informed about the research. If the subject is not legally competent to exercise his power of choice, his legal guardian consent must be procured.
10. Consent for medical/scientific research must be obtained in writing. The responsibility of the research does not fall on the subject even after his/her consent was given. The specialists who are conducting the research take full responsibility on the outcome, good or bad.
11. The research worker must always respect the subject’s right to safeguard his personal integrity.
12. The subject or his/her legal guardian has the right to withdraw permission for the research at any time during the proceedings. The researchers must discontinue the investigations or the clinical trials if permission was withdrawn or in the case they think or suspect that if continued, the research might be harmful to the individual.

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