Results of the Inquiry and Citation Review

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Bioethics issues in human studies

The role of Ethics Committees

Ethics Committees in multi-centre studies

When the collection, processing, use and storage of human genetic or proteomic data or biological samples are carried out in two or more States, the Ethics Committees in the States concerned should be consulted and the review of the project should be based on the principles of the International Declaration on Human Genomic Data and the ethical and legal standards adopted by the States [14]. However, to ensure that the study is conducted methodically in a proper way, local ethical or scientific review can't come up with modifications of the study protocol (e.g. dosages, inclusion or exclusion criteria). If the study would be of concern, the Ethics Committee is empowered to prevent a study that they believe is unethical. Any change would have to be made in every centre of a multi-centre study to guarantee the inter-centre comparability. For some multi-centre studies, scientific and ethical review may be facilitated by agreement among centres to accept the conclusions of a single review committee; its members could include a representative of the ethical review committee at each of the centres at which the research is to be conducted. In other circumstances, a centralized review may be complemented by the local review [11].

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