Document Detail


Informed consent in human research: what to say and how to say it.
MedLine Citation:
PMID:  23287515     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
ABSTRACT: 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.
Authors:
Robert E Reiman
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Health physics     Volume:  104     ISSN:  1538-5159     ISO Abbreviation:  Health Phys     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-04     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  2985093R     Medline TA:  Health Phys     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S17-22     Citation Subset:  IM    
Affiliation:
*Radiation Safety Division, Duke University Medical Center, Box 3155, Durham, NC 27710.
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