Abstract

Review of research protocols involving positron emission tomography studies on healthy volunteers focused attention on the radiation exposure disclosure statements contained in the informed consent form. Of particular concern was the observation that breast doses from positron emission tomography studies are greater than breast doses from other research uses of radioisotopes, as well as routine nuclear medicine and radiographic procedures. Disclosure of individual organ doses is not normally provided on informed consent forms. A worksheet was developed to aid research investigators in the determination of effective dose equivalents and organ dose equivalents from all sources of radiation to which a volunteer is exposed. Three standardized risk statements are discussed. The final selection and use of these statements are determined by worksheet calculations of effective dose equivalents and organ dose equivalents.

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