What ethical guidelines should be followed in research projects involving exposure of patients and healthy volunteers?
According to the Basic Safety Standards (BSS), the exposure of humans for medical research is deemed to be not justified unless it is: • in accordance with the provisions of the Helsinki Declaration and follows the guidelines for its application prepared by Council for International Organization of Medical Sciences (CIOMS); and • subject to the advice of an ethical review committee (or any other institutional body assigned similar functions by national authorities) and to applicable national and local regulations. The estimated risks of the irradiation should be explained to those individuals involved who knowingly incur doses while voluntarily helping (other than in their occupation) in the care, support or comfort of patients undergoing medical diagnosis or treatment (BSS II.26 and II.27).
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