Why persons choose to opt out of an exception from informed consent cardiac arrest trial

Maria J. Nelson, Nicole Deiorio, Terri Schmidt, Dana Zive, Denise Griffiths, Craig Newgard

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)825-830
Number of pages6
JournalResuscitation
Volume84
Issue number6
DOIs
StatePublished - Jun 2013

Fingerprint

Heart Arrest
Informed Consent
Research
Emergencies
Communication
Demography
Out-of-Hospital Cardiac Arrest
Disclosure
Anger
Postal Service
Ethics
Emotions
Referral and Consultation
Public Health
Research Personnel
Interviews
Education
Surveys and Questionnaires

Keywords

  • Exception from informed consent
  • Opt-out
  • Research ethics
  • Resuscitation research

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Emergency
  • Emergency Medicine

Cite this

Why persons choose to opt out of an exception from informed consent cardiac arrest trial. / Nelson, Maria J.; Deiorio, Nicole; Schmidt, Terri; Zive, Dana; Griffiths, Denise; Newgard, Craig.

In: Resuscitation, Vol. 84, No. 6, 06.2013, p. 825-830.

Research output: Contribution to journalArticle

Nelson, Maria J. ; Deiorio, Nicole ; Schmidt, Terri ; Zive, Dana ; Griffiths, Denise ; Newgard, Craig. / Why persons choose to opt out of an exception from informed consent cardiac arrest trial. In: Resuscitation. 2013 ; Vol. 84, No. 6. pp. 825-830.
@article{9aefa071e64142b887af540be65f10a2,
title = "Why persons choose to opt out of an exception from informed consent cardiac arrest trial",
abstract = "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.",
keywords = "Exception from informed consent, Opt-out, Research ethics, Resuscitation research",
author = "Nelson, {Maria J.} and Nicole Deiorio and Terri Schmidt and Dana Zive and Denise Griffiths and Craig Newgard",
year = "2013",
month = "6",
doi = "10.1016/j.resuscitation.2013.01.030",
language = "English (US)",
volume = "84",
pages = "825--830",
journal = "Resuscitation",
issn = "0300-9572",
publisher = "Elsevier Ireland Ltd",
number = "6",

}

TY - JOUR

T1 - Why persons choose to opt out of an exception from informed consent cardiac arrest trial

AU - Nelson, Maria J.

AU - Deiorio, Nicole

AU - Schmidt, Terri

AU - Zive, Dana

AU - Griffiths, Denise

AU - Newgard, Craig

PY - 2013/6

Y1 - 2013/6

N2 - 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.

AB - 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.

KW - Exception from informed consent

KW - Opt-out

KW - Research ethics

KW - Resuscitation research

UR - http://www.scopus.com/inward/record.url?scp=84879880785&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84879880785&partnerID=8YFLogxK

U2 - 10.1016/j.resuscitation.2013.01.030

DO - 10.1016/j.resuscitation.2013.01.030

M3 - Article

VL - 84

SP - 825

EP - 830

JO - Resuscitation

JF - Resuscitation

SN - 0300-9572

IS - 6

ER -