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J Med Ethics 2005;31:608-611 doi:10.1136/jme.2004.010488
  • Research ethics

Stroke patients’ preferences and values about emergency research

  1. C E Blixen1,
  2. G J Agich2
  1. 1Department of Biostatistics and Epidemiology, The Cleveland Clinic Foundation, Cleveland, OH, USA
  2. 2Department of Bioethics, The Cleveland Clinic Foundation
  1. Correspondence to:
 Carol E Blixen
 Department of Biostatistics and Epidemiology WB-4, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA; blixencccf.org
  • Received 2 September 2004
  • Accepted 11 January 2005
  • Revised 29 December 2004

Abstract

Background: In the USA, the Food and Drug Administration waiver of informed consent permits certain emergency research only if community consultation occurs. However, uncertainty exists regarding how to define the community(ies) or their representatives.

Objective: To collect data on the actual preferences and values of a group—those at risk for stroke—most directly affected by the waiver of informed consent for emergency research.

Design: Face to face focused interviews were conducted with 12 patients who were hospitalised with a stroke diagnosis in the previous year. The interviews were audiotaped and a transcript based method was used for their analysis.

Results: All 12 participants felt “that it was important that new treatments for stroke be developed”, but they were initially confused about the distinction between “research for stroke” and “emergency research for stroke”. However, after explanation, most (n  =  10; 83%) expressed willingness to participate in the latter. In the absence of a surrogate to give informed consent in a stroke emergency situation, the majority (n  =  11; 92%) said they would want the physician to “go ahead and enrol them in the trial”.

Conclusions: This study is the first to identify the values and concerns of individuals most directly affected by stroke emergency research. Further interviews and focus groups are needed to develop and test a validated questionnaire on the preferences and values surrounding emergency research for stroke.

Footnotes

  • This research was funded by the Research Programs Committee and the Division of Clinical Research at the Cleveland Clinic Foundation, Cleveland OH, USA. The researchers and their work were independent of the funders throughout the study.

  • Competing interests: none declared

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