Biomedical research ethics updating international guidelines

Ethical guidelines did not truly appear until after World War II.

Prior to this point, efforts to regulate human experimentation—such as the codes of Thomas Percival in England (1794)—were few and exceptional [].

Many other international guidelines were subsequently proposed by different organizations, including the International Ethical Guidelines for Biomedical Research Involving Human Subjects (1982; revised, 2002) [], prepared by the Council for International Organizations of Medical Sciences (CIOMS) and the World Health Organization WHO, and the Guidelines for Good Clinical Practice (GCP, 1995; revised, 2004), prepared by the ICH [].

However, there is a question about the appropriateness of the application of such international guidelines to different regions across the globe, including the Middle East.

While these guidelines cover general biomedical research involving children, the definition of ‘child’ has been variable according to various legal and social contexts.

As per the National Commission for Protection of Child Rights, a child is defined as a person from 0 to 18 years of age.

They include research proposals should be scientifically sound; the equation between the potential benefit and the risk or potential harm should be at least as favourable for the proposed research procedure as for the alternatives available to the children; there should be benefit to children in general and, in most cases, to the individual child subject; the need for the study should be justified by a thorough review of literature; and the research should be conducted by a team of investigators who have the requisite expertise.We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP).Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others.Recently, a lot of efforts have been made in many countries in the Middle East.However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies.

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