During the 18-month study period, 60 bracelets were requested by 50 individuals. Forty- six surveys were completed and analyzed (response rate 92%). No bracelets were requested after the first year of trial enrollment and all persons requesting to opt out of the trial were approached about participation in the survey. The majority of respondents were Caucasian, female, highly educated, religious and over 50 years of age ().
Demographic characteristics of persons opting out of an exception from informed consent cardiac arrest trial.
Responses to the Likert scale questions are depicted in . Respondents generally supported medical research in emergency medicine (70%), but objected to all research using EFIC, regardless of the study question, protocol or subject matter (87%). Most (82%) favored the rights of the individual over public health interests.
Likert scale survey responses assessing attitudes about medical and exception from informed consent research among persons opting out of an exception from informed consent cardiac arrest trial.
When asked to choose discreet reasons for opting out of the study (), 91% stated they would opt out of any study performed without prospective consent. Smaller proportions of respondents reported prior negative experience with medical research or preferred not to participate in any clinical research. A minority of persons objected to the institution (hospital) coordinating the research and any research with U.S. government sponsorship. Seventy-six percent reported unwillingness to participate in the ROC PRIMED study, in particular. When asked about the mechanism for learning about the study, 84% of respondents reported the newspaper, 11% listed TV and 16% stated “word of mouth.”
Survey responses assessing specific reasons for requesting to opt out of an exception from informed consent cardiac arrest trial.
In the qualitative analysis, five overlapping themes emerged: (1) questioning the ethics and processes of EFIC research; (2) concerns about how this particular study would impact end-of-life preferences; (3) emotionally charged protests to EFIC research; (4) negative references to other public health controversies; and (5) objections to the study protocol based on misinformation. These themes are detailed below, with illustrative quotes included in .
Themes and illustrative quotes from persons opting out of an exception from informed consent cardiac arrest trial regarding attitudes about medical and exception from informed consent research.
The first theme focused on concerns about the ethics of EFIC research. A majority of persons opting out of the trial expressed strong concerns about the EFIC regulations. Many respondents emphasized the rights of the individual over the needs of the community. Several persons stated that it would be more ethical if the community were able to opt in, rather than opt out. Subjects endorsed a lack of faith in the public disclosure system and expressed concerns that many in the community could have missed the announcements and be unaware of the on-going trial. Some suggested that information should be distributed to everyone in the community (e.g. by mass mailing).
The second theme was the potential adverse impact of the trial on end-of-life preferences. Respondents commonly confused enrollment in the study with involuntarily being put on life-support. Many identified poor experiences with family members “on life support” or expressed concerns about “the quality of life” after implementation of the trial intervention, worrying that this intervention may “save people at the expense of who they are.” Others confused participation in the study with choosing a life-prolonging measure versus no resuscitation. Two respondents, in addition to opting out of the survey, specifically asked where they could get information about a DNR order or advance directives.
The third theme involved emotionally charged responses to the study and EFIC research. The topic of medical research without informed consent elicited a strong emotional outpouring from many respondents, often including inflammatory, emotionally-charged language. Several respondents did not want to reveal the media source where they learned of the trial because they thought researchers would “stop” the sources from advertising the study, not understanding that study investigators had issued press releases in order to inform the public. There was a common belief that every patient should receive standard, approved treatment as the default and that research-based treatment should only be provided by individual request. Respondents indicated that being exposed to investigational treatment makes them feel like “lab rats” . The strength of individual emotions and tone used was noteworthy for strong elements of anger, fear, sarcasm, and distrust of institutions and government.
The fourth theme focused on negative references to previous public health controversies. Many respondents (particularly those responding through the web site) referenced previous public health controversies as support for their disagreement with the trial. Respondents cited water fluoridation, medical experiments in Nazi concentration camps, organ donation and previous EFIC studies conducted in this community.
The final theme involved objections to the study protocol based on misinformation about the trial. The misinformation involved both the PRIMED study and the process of medical research. Multiple persons requesting opt-out bracelets seemed to prefer no resuscitation in the event of cardiac arrest or were concerned that the study interventions would lead to inappropriate resuscitation. Other respondents cited personal medical conditions (e.g., a pacemaker/defibrillator) as reasons for not wanting to participate in the cardiac arrest trial. This theme had substantial overlap and interaction with theme two (adverse impact of the trial on end-of-life preferences).