Elsevier

Social Science & Medicine

Volume 68, Issue 1, January 2009, Pages 183-191
Social Science & Medicine

Patients' perceptions of research in emergency settings: A study of survivors of sudden cardiac death

https://doi.org/10.1016/j.socscimed.2008.10.001Get rights and content

Abstract

Conditions such as stroke, sudden cardiac death, and major traumatic injury are major causes of morbidity and mortality, and there is a need for clinical research to improve treatment for these conditions. However, because informed consent is often impossible, research in these situations poses ethical concerns. Despite growing literature on the ethics of emergency research, little is known about the views of relevant patient populations regarding research in emergency settings conducted under an exception from informed consent (EFIC).

In this qualitative study, survivors of sudden cardiac death (SCD) – recruited from an outpatient cardiology clinic in late 2005 – were asked their views on scenarios representing different types of EFIC research. Patients were generally accepting of such research, more than previous studies would have predicted. Their concerns focused primarily on study risks and benefits and less on waiving consent or randomization.

EFIC research is of international importance and ethical controversy. This study represents the first attempt to assess views of SCD survivors on this type of research and one of the first to assess patients' views in-depth. Findings indicate broad acceptance of EFIC research among this population and re-focus discussion on what risks are reasonable for non-autonomous subjects. The study also demonstrates potential for valuable input from patients regarding complicated and ethically challenging issues using a method that allows them to develop opinions on unfamiliar issues.

Introduction

The need for clinical research on treatment of life-threatening and debilitating emergent conditions such as stroke, sudden cardiac death, and major traumatic injury is indisputable. These conditions represent important public health problems, and many current treatments are minimally effective and poorly studied (Cearnal, 2006, Halperin et al., 2007). Such research, however, poses ethical challenges. Patients are acutely ill and typically unable to make enrollment decisions, and consultation with surrogates is often impossible within an appropriate timeframe.

The U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) passed regulations in 1996 permitting an exception from informed consent (EFIC) for certain studies in emergency settings (U.S. Department of Health and Human Services, U.S. Food and Drug Administration, 2004), but few studies have been conducted under these regulations (Hiller et al., 2005, Nichol et al., 2004). Many investigators have noted difficulty and confusion in implementing the regulations, particularly requirements for community consultation and disclosure (Biros, 2007a, Flynn, 2008, Halperin et al., 2007, Kremers et al., 1999, Passamani and Weisfeldt, 2000, Schmidt, 2007). Residual ethical concerns also exist regarding enrolling patients with critical illness in studies without consent, as evidenced by recent controversy surrounding a randomized controlled trial (RCT) of a blood substitute (PolyHeme) in severe hemorrhagic shock (Burton, 2006, Kipnis et al., 2006, Stein, 2004). The U.S. FDA (2006) made attempts to clarify regulations and ongoing barriers to EFIC research, but controversy and confusion remain, as evidenced by testimony at a recent public hearing (Academic Emergency Medicine, 2007, Biros, 2007b). Challenges with emergency research are also prominent internationally. In Europe, many countries have developed policies allowing EFIC research after the European Directive on clinical research failed to include provisions to permit it, but such research remains controversial (Lecouturier et al., 2008).

Despite attention to the ethics of research in emergency settings (Adams and Wegener, 1999, Fost, 1997, McRae et al., 2005, Passamani and Weisfeldt, 2000), few data exist regarding how patients view this research (Lecouturier et al., 2008). Only one study has involved patients enrolled in a trial without consent (Abramson & Safar, 1990); it simply reported that interactions with individuals and families were generally positive when asking for continued participation in a trial of brain resuscitation. The study did not assess participants' views of the research; many did not even understand the study in which they had been enrolled.

Three surveys asked patients in emergency departments their views on EFIC research, all reporting limited support. In two studies, only half of patients were accepting of research involving more than minimal risk (McClure et al., 2003, Smithline and Gerstle, 1998). Interestingly, in the study by McClure et al. (2003), despite lukewarm support for EFIC research in general, most patients were personally willing to be enrolled without consent when presented with a scenario in which a study involves more than minimal risk and they have a serious condition and existing treatments are poor. The scenario as presented contained few details, and the reason for this discrepancy is unclear. However, it was likely driven by an expectation for significant benefit in the scenario. The third study, examining general attitudes rather than particular scenarios, found less than half of participants accepting of EFIC research (Triner et al., 2007). A fourth survey, of Scottish outpatients, found increased acceptance and willingness to be enrolled, particularly if risks are minimal, raising questions about whether EFIC acceptance may vary by geography or culture (Booth, Lind, Read, & Kinsella, 2005). These surveys were all limited by using closed-ended questions about topics that most people have never considered and not exploring participants' reasons for their views or level of understanding of research generally or in emergencies. The latter two in particular contained little to no description of research and how it differs from clinical care. It is difficult to know whether these findings represent informed or considered attitudes.

Two qualitative studies attempted to deepen understanding. Blixen and Agich (2005) conducted in-depth interviews with recent stroke patients. Most supported stroke research and said they would base enrollment decisions primarily on risks and benefits to them. About half had significant concerns with waiving consent, but the nature of those concerns was not examined in-depth, nor were particular scenarios. Richardson et al. (2005) asked focus group participants to consider several scenarios with varying levels of risk and benefit. They reported general acceptance of low-risk scenarios and wide variation in concerns about EFIC research in general, particularly when involving greater risks. Their data suggest broader acceptance than other studies, and this study is the only one to ask participants to consider scenarios in an open-ended format. Importantly, responses differed from responses to more abstract questions and from survey research. Neither study, however, discussed RCTs.

Finally, some data on public views of EFIC research come from reports of community consultation and disclosure efforts from particular trials and the FDA docket of EFIC research (Mosesso et al., 2004, Santora et al., 1998, Shah and Sugarman, 2003). Most comments received during two-way public disclosure and community consultation have been supportive. Community consultation efforts, however, have rarely been reported, and public disclosure is not often designed to solicit comments.

Because EFIC research may involve significant risks and represents an important departure from common clinical research practice, exploring the nature and range of potential participants' views and understanding is critical. This study deepens knowledge of how a significant and previously unstudied population – survivors of sudden cardiac death (SCD) – view research in emergency settings without informed consent. By using in-depth interviews and asking participants to evaluate particular examples, this study fills an important gap in existing literature and contributes to discussion of appropriate research methodology when conducting empirical research in bioethics.

Section snippets

Methods

This qualitative study enrolled adult survivors of SCD who have an implantable cardioverter-defibrillator (ICD) for prevention of recurrent fatal arrhythmia, an important population for several reasons. First, with the exception of Blixen and Agich (2005), prior studies have not focused on individuals likely to be enrolled in EFIC research. Patients in this study experienced a condition that could have made them eligible for enrollment and may put them at increased risk of having an event

Results

Results are provided describing the study population, participants' experience with and attitudes toward research and medicine, and attitudes toward emergency research.

Discussion

The clearest message from this study is that participants believed EFIC research can be acceptable in emergency settings. Nobody found such research inherently unacceptable, and the level of acceptance of particular scenarios was higher than previously reported. Thirteen of 15 participants accepted the RCT of a new blood substitute, and 10 of 11 accepted the public access defibrillation study. In contrast, McClure et al. (2003), reported that only 48.5% and 61.5% would be willing to be enrolled

Limitations

This study population was small, and participants were generally older, white, and well-educated. In addition, the population was recruited from one U.S. urban academic cardiology clinic and may differ from the populations of community-based clinics or clinics in other countries. It is certainly possible that views on this type of research differ in countries with a less individualistic focus on health care (Booth et al., 2005). No important differences in response were obvious based on

Conclusion

This exploratory, qualitative study deepens understanding of how survivors of SCD view research in emergency settings without informed consent. It revealed greater support than previously demonstrated and illustrated that most concerns center around reasonable risks and benefits. Given the need to conduct RCTs comparing existing treatments, participants' responses suggest a need for regulatory clarity regarding these studies. The suggestion that increases over minimal risk without prospect of

References (56)

  • V.L. Shavers et al.

    Racial differences in factors that influence the willingness to participate in medical research studies

    Annals of Epidemiology

    (2002)
  • H.A. Smithline et al.

    Waiver of informed consent: a survey of emergency medicine patients

    Academic Emergency Medicine

    (1998)
  • Academic Emergency Medicine

    (2007)
  • J. Adams et al.

    Acting without asking: an ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research

    Annals of Emergency Medicine

    (1999)
  • M.H. Biros

    Food and Drug Administration public hearing on the conduct of emergency clinical research: testimony of the Society for Academic Emergency Medicine

    Academic Emergency Medicine

    (2007)
  • M.H. Biros

    Struggling with the rule: the exception from informed consent in resuscitation research

    Academic Emergency Medicine

    (2007)
  • C. Blixen et al.

    Stroke patients' preferences and values about emergency research

    Journal of Medical Ethics

    (2005)
  • M.G. Booth et al.

    Public perception of emergency research: a questionnaire

    European Journal of Anaesthesiology

    (2005)
  • B.A. Brody

    Ethical issues in drug testing, approval, and pricing: The clot-dissolving drugs

    (1995)
  • T.M. Burton

    Red flags: amid alarm bells, a blood substitute keeps pumping

    The Wall Street Journal

    (2006)
  • R.L. Comis et al.

    Public attitudes toward participation in cancer clinical trials

    Journal of Clinical Oncology

    (2003)
  • G. Corbie-Smith et al.

    Distrust, race, and research

    Archives of Internal Medicine

    (2002)
  • G. Corbie-Smith et al.

    Attitudes and beliefs of African Americans toward participation in medical research

    Journal of General Internal Medicine

    (1999)
  • N.W. Dickert et al.

    Getting the ethics right regarding research in the emergency setting: lessons from PolyHeme

    Kennedy Institute of Ethics Journal

    (2007)
  • S.J. Edwards et al.

    The ethics of randomised controlled trials from the perspective of patients, the public, and healthcare professionals

    British Medical Journal

    (1998)
  • N. Fost

    Waived consent for emergency research

    American Journal of Law and Medicine

    (1997)
  • H. Halperin et al.

    Recommendations for implementation of community consultation and public disclosure under the Food and Drug Administration's ‘exception from informed consent requirements for emergency research’

    Circulation

    (2007)
  • K.M. Hiller et al.

    Impact of the final rule on the rate of clinical cardiac arrest research in the United States

    Academic Emergency Medicine

    (2005)
  • Cited by (32)

    • Enrollment in research under exception from informed consent: The Patients' Experiences in Emergency Research (PEER) study

      2013, Resuscitation
      Citation Excerpt :

      This study employed a structured interview guide containing open and closed-ended questions with three principal goals: (1) to obtain quantitatively meaningful data with reliable estimates of prevalence of particular views; (2) to allow subjects to ask content-related questions to maximize understanding of and develop views on content being discussed; and (3) to qualitatively assess reasons for responses and subjects’ level of understanding. This interview method, derived from prior work, suits the complex nature of the content and the study's descriptive aims.12 The interview guide was cognitively pre-tested with RAMPART enrollees to ensure that questions were understandable.

    View all citing articles on Scopus

    We would like to acknowledge Holly Taylor in particular for her assistance in developing the instrument and methodology used in this study, as well as Hilary Bok, Ruth Faden, Katherine Smith, and Jeremy Sugarman for their valuable comments on the manuscript. We also thank Misti Capps and Kathy DeVaughn for their assistance in identifying and recruiting participants.

    View full text