The meaning of opt-out.

In the June issue of Resuscitation, Nelson and colleagues1 deterine attitudes and opinions of persons who, a priori, chose to opt ut of an exception from informed consent (EFIC) cardiac arrest esearch trial. In order to opt out, a “no study” bracelet could be equested that expressed the wearer’s desire to not be included in he trial. A description of the mechanism to opt-out of the study was ncluded within the public notification material developed to fulfil he EFIC requirements and was also described in pre-study commuity consultation activities. Medics had to ascertain the absence of n opt-out bracelet prior to enrolling a patient into the trial. Indiiduals who obtained opt-out bracelets were later interviewed to etermine factors associated with their opt-out decision. The invesigators hoped to characterize persons who opt out of EFIC studies nd their concerns, so that future trials could specifically address hese issues. The investigators did a remarkable job fulfilling the requireents for EFIC studies. Community consultation included almost 00 individuals in 13 community presentations. Public notificaion was extensive, and potentially reached thousands of citizens; ress releases were sent to several media outlets with widespread issemination of study information into the local area by newspaers and radio reports. The IRB mandated that an opt-out option be ncluded in material related to the study. At the end of 18 months, ixty opt out bracelets were requested by 50 individuals, representng a very small number of community members from potentially housands who had the opportunity to opt-out. While most respondents valued emergency research, the majorty of those who opted out (91%) did not approve of research nrollment without prospective informed consent. These indiiduals were concerned about the ethics of EFIC research, and heir responses seemed to imply that they prioritized the rights f the individual over the needs of society. Smaller numbers of espondents related previous negative experiences with research, preference not to be involved in research of any kind, and distrust f government or institutional sponsorship of, or involvement in, esearch. These same concerns have been found when other comunity attitudes about research have been gauged.2,3 A majority f respondents (71%) objected specifically to this cardiac arrest tudy, often due to misconceptions about the study or confusion hat this EFIC trial would interfere with end-of-life preferences. A arge number of responses were emotionally charged, inflammaory, or angry, suggesting significant distrust in the medical and cientific enterprise. It appears that all persons requesting to opt out heard about the tudy through a media source used in public notification attempts, r by word of mouth. It is not stated whether any opt-out requests