Changes

Studies involving radiation exposure of patients adds another level of risk that must be evaluated by an institutional ethics review board with assistance of a radiation expert or radiation safety committee. In all investigations involving exposure of humans, a careful estimation of the radiation dose to the patients or volunteers should be made. The associated risks should then be weighted against the benefits for the patients or the society when volunteers are involved. A reasonable alternative is the ex-vivo exposure of tumor specimen, human blood or skin samples obtained from patients or healthy volunteers, to avoid the hazard of radiation exposure. Approval by an institutional ethics review board or human studies committee must be obtained prior to conducting human subject research. The researchers' role is to conduct their research ethically while maximizing benefits to the society and minimizing harm to the participants. ICRP has provided recommendations in the guidance [[ICRP Publication 105]] Radiological Protection in Medicine <ref name="Pub105"/> and a previous [[ICRP Publication 62]] Radiological Protection in Biomedical Research<ref name="Pub062">[[ICRP Publication 62]] Radiological Protection in Biomedical Research. Ann. ICRP 22(3), 1991.</ref>.