Journal
RESUSCITATION
Volume 84, Issue 6, Pages 825-830Publisher
ELSEVIER IRELAND LTD
DOI: 10.1016/j.resuscitation.2013.01.030
Keywords
Exception from informed consent; Resuscitation research; Research ethics; Opt-out
Categories
Funding
- Oregon Clinical and Translational Research Institute [UL1 RR024140]
- Oregon Clinical and Translational Research Institute (National Center for Research Resources, a component of the NIH)
- Oregon Clinical and Translational Research Institute (NIH Roadmap for Medical Research)
- Resuscitation Outcomes Consortium (ROC) [U01/HL-04-001]
- Resuscitation Outcomes Consortium (ROC) (National Heart, Lung and Blood Institute)
- ROC
- National Heart, Lung and Blood Institute [5U01 HL077863, HL077881, HL077871 HL077872, HL077866, HL077908, HL077867, HL077885, HL077863]
- National Institute of Neurological Disorders and Stroke
- U.S. Army Medical Research & Material Command
- Canadian Institutes of Health Research (CIHR) - Institute of Circulatory and Respiratory Health
- Defense Research and Development Canada
- Heart and Stroke Foundation of Canada
- American Heart Association
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Background: We sought to characterize persons who requested to opt out of an exception from informed consent (EFIC) cardiac arrest trial and their reasons for opting out. Methods: At one site of a multi-site, out-of-hospital, cardiac arrest EFIC trial (September 2007 - June 2009), persons who did not want to participate in the study could request an opt-out NO STUDY bracelet to prevent trial enrollment. We surveyed all persons who requested a bracelet by phone interview, web or mail. Opt-out bracelets were advertised in all public communication about the study, including community consultation and public disclosure efforts. Survey questions included demographics, Likert scale items about attitudes toward the trial and research in general, plus open-ended questions. We used descriptive statistics for standardized questions and qualitative analysis to identify common themes from open-ended questions. Results: Sixty bracelets were requested by 50 individuals. Surveys were completed by 46 persons (92% response rate). Seventy percent of respondents agreed emergency research is important, but 87% objected to any research without consent. In the qualitative analysis, 5 overlapping themes emerged: questioning the ethics of EFIC research; concerns about how the study would impact end-of-life preferences; subjective emotions including sarcasm, anger, and allusions to past unethical research; negative reference to unrelated public health controversies; and objections to the study protocol based on misinformation. Conclusions: A primary reason for opting out from this EFIC trial was opposition to all research without informed consent, despite stated support for emergency research. Understanding the demographics and beliefs of persons opting out may aid researchers planning EFIC studies and help provide clarity in future EFIC-related community education efforts. (C) 2013 Elsevier Ireland Ltd. All rights reserved.
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