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Informed Consent in Human Research: What to Say and How to Say It

Reiman, Robert E.*

doi: 10.1097/HP.0b013e318271b4c9

To ensure that the possibility of harm to human research subjects is minimized, clinical trials and other research protocols are subject to oversight by Institutional Review Boards (IRBs). IRBs require that subjects be fully informed about the real or potential risks of participation in a research study. The use of radiological examinations in research protocols subjects the participants to exposure to ionizing radiation, which in theory carries a risk of stochastic effects such as radiation-induced cancer, and in practice may lead to deterministic effects such as skin injury. Because IRB members and clinical study coordinators may have little knowledge of radiation effects or how best to communicate the risk to the research subjects, they will consult with institutional Radiation Safety Committees and radiation protection professionals regarding how to integrate radiation risk information into the informed consent process. Elements of radiation informed consent include: (1) comparison of the radiation dose to some benchmark that enables the study subjects to make a value judgment regarding the acceptability of the risk; (2) a quantitative expression of the absolute risk of stochastic effects; (3) an expression of uncertainty in the risk; and (4) understandability. Standardized risk statement templates may be created for specific radiological examinations. These standardized risk statements may be deployed as paper forms or electronically in the form of internet-based applications. The technical nature of creating useful radiation risk statements represents an opportunity for radiation protection professionals to participate productively in the clinical research process.

This paper discusses the issues of communicating radiation risk from diagnostic radiological examinations to clinical research subjects and describes methods to assist clinical investigators in including risk statements into informed consent documents.

*Radiation Safety Division, Duke University Medical Center, Box 3155, Durham, NC 27710.

The author declares no conflicts of interest.

(Manuscript accepted 29 August 2012)

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