Stroke Patients' Preferences and Values About Emergency Research

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.