13. Groups that are under-represented in medical research should have adequate access to research participation. Particular care must be taken when carrying out research which may have an impact on the environment and the welfare of animals used for research purposes. These principles need to be further developed into additional protocols on specific biomedical topics. To date, four additional protocols have been adopted on the prohibition of human cloning, transplantation of organs and tissues of human origin, biomedical research and genetic testing for health purposes. In addition to these binding instruments, the Bioethics Committee has also adopted a number of recommendations and published several reports and white papers. If a subject considered legally incompetent, such as a minor child, is able to consent to decisions regarding participation in the research, the investigator must obtain this consent in addition to the consent of the legally authorized representative. The physician may combine medical research with professional care, with the aim of acquiring new medical knowledge, only to the extent that the medical research is justified by its potential diagnostic or therapeutic value for the patient. 24.
Every precaution must be taken to protect the privacy of research participants and the confidentiality of their personal data. The British Medical Journal announced the emergence of the DoH in its July 18, 1964 issue with the following words: “A draft code of ethics for human experimentation was published in the British Medical Journal on October 27, 1962. A revised version was adopted as a final draft at the world medical association meeting in Helsinki in June 1964. . This is called the Declaration of Helsinki” [6] (emphasis added). This discreet announcement was attached to just over 700 words of the original DoH text. There seemed to be little evidence at the time of the importance of this document in the context of research ethics. Paragraph 1 first sets out the purpose of the DoH. Although this statement has not changed from previous versions, it has been moved to the DoH opening instruction. However, the second sentence explicitly states for the first time that the provisions of the DoH apply to identifiable human tissues and identifiable data. The Scope of the Council`s action has been gradually expanded to include other forms of international cooperation in the field of medical sciences, in addition to the coordination of congresses.
As a result, in 1952, the name of the Council was changed to the Council of International Organizations of Medical Sciences (CIOMS) and its statutes were revised. Overall, there was little comment on this paragraph, although Riis expressed two concerns [40]. First, he believes that anonymized research should also be covered by the statement because of the potential harms associated with “group stigma.” .