Castronovo F P
Brigham and Women's Hospital, Boston, Massachusetts 02115.
Invest Radiol. 1993 Jun;28(6):533-8. doi: 10.1097/00004424-199306000-00014.
The communication of a suitable radiation risk consent form statement to a potential research subject has always been difficult to formulate. Concomitant with this is the equally problematic task of ensuring that subjects understand the true risks of the study. In an effort to document how other Institutional Review Boards (IRBs) express radiation risk associated with participating in a research investigation, a questionnaire was developed and was sent to 23 large medical-research institutions.
Questions pertained to the manner of comparing risk, units for expressing radiation dose, patient population differentiation, and statements for given situations. In addition, each institution was asked to provide examples of radiation-related in-house consent form statements. Thereafter, the examples were forwarded to the responding institutions for grading.
Fourteen responses were received and summarized. The majority compared the study test to a similar radioactivity study, Nuclear Regulatory Commission (NRC) occupational limits and/or Radioactive Drug Radiation Committee (RDRC) limits. There was an equal distribution of radiation units used; absorbed dose, dose equivalent, and effective dose equivalent. The majority of respondents did not differentiate between normal individuals and patient volunteers. Included in the 14 responses were 46 in-house generated radiation-related consent form statements. The latter were assembled and forwarded to the 14 responding institutions with instructions to "approve" or "disapprove" each. Nine statements obtained an 80% or greater acceptance rating, with three > 90%. The remaining were overwhelmingly rejected as suitable radiation risk statements.
Based on the submitted material and statement grading results, recommendations were formulated toward producing a standard format for expressing radiation risk in the consent form. Effective dose equivalent in comparison to annual natural environmental radiation or occupational radiation dose limits were recommended based on these data. While an "optimum" radiation risk consent form statement may not be attainable, these results nevertheless provide recommendations based on a consensus of practitioners in the field.
向潜在研究对象传达合适的辐射风险同意书声明一直难以制定。与此同时，确保研究对象理解研究的真正风险这一任务同样存在问题。为了记录其他机构审查委员会（IRB）如何表达与参与研究调查相关的辐射风险，我们编制了一份问卷并发送给23家大型医学研究机构。
问题涉及风险比较方式、辐射剂量表达单位、患者群体区分以及特定情况下的声明。此外，要求每个机构提供与辐射相关的内部同意书声明示例。此后，将这些示例转发给回复机构进行评分。
共收到14份回复并进行了总结。大多数回复将研究测试与类似的放射性研究、核管理委员会（NRC）职业限值和/或放射性药物辐射委员会（RDRC）限值进行了比较。所使用的辐射单位分布均匀；包括吸收剂量、剂量当量和有效剂量当量。大多数受访者没有区分正常个体和患者志愿者。在这14份回复中包括46份内部生成的与辐射相关的同意书声明。后者被汇总并转发给14家回复机构，并要求对每份声明“批准”或“不批准”。9份声明获得了80%或更高的认可率，其中3份超过90%。其余声明绝大多数被拒绝作为合适的辐射风险声明。
基于提交的材料和声明评分结果，制定了关于在同意书中表达辐射风险的标准格式的建议。根据这些数据，建议将有效剂量当量与年度自然环境辐射或职业辐射剂量限值进行比较。虽然可能无法获得“最佳”的辐射风险同意书声明，但这些结果仍然基于该领域从业者的共识提供了建议。
