Community meetings for emergency research community consultation.
نویسندگان
چکیده
OBJECTIVE To survey attendees at community meetings for an emergency research protocol and determine whether these meetings aid participants' understanding and decision to support the proposed emergency research. DESIGN Postmeeting questionnaire. SETTING Three community meetings for the PolyHeme study in San Antonio area. SUBJECTS One hundred fifty community meeting attendees. INTERVENTIONS PolyHeme research team representatives made a study presentation concerning exception to informed consent regulations. In addition, institutional review board (IRB) members attended these meetings and made a separate presentation about the IRB approval of research and the exception to informed consent in emergency research. The IRB members requested attendees to voluntarily complete an additional Community Consultation Survey assessing demographics, community meeting satisfaction, and impact of the community meeting on their attitudes toward emergency research studies. MEASUREMENTS AND MAIN RESULTS Feedback to the PolyHeme investigators with their validation questions indicated that 35% of the respondents objected to research without prior consent, but 82% gave approval for the study in the local community; 137 attendees completed the additional Community Consultation Survey. The average score on the adequacy of information provided about the PolyHeme study was 0.58 on a 5-point Likert scale (-2 to +2). Adequacy of IRB background information on human subjects research received an average score of 0.56, and the overall clarity of the information on community consultation was 0.91. Although 80% of respondents felt there was a potential benefit from PolyHeme, <67% would either want to participate or enroll their family members with or without prior consent. CONCLUSIONS The majority of community meeting attendees understand basic concepts and regulations of emergency research without prior consent. Despite an 82% concurrence with the study in their community, approximately 30% of persons would not willingly choose to participate in emergency research or provide consent for their family members despite knowledge about the process.
منابع مشابه
Social media and community engagement in trials using exception from informed consent.
T he field of emergency research has come a long way. Once stymied by the difficulties in obtaining informed consent from patients with catastrophic injury or illness, the Food and Drug Administration (FDA) and the Department of Health and Human Services published regulations 21 CFR 50.24 in 1996 to guide the ethical and legal conduct of emergency research using exception from informed consent....
متن کاملThe research on community consultation: an annotated bibliography.
Community consultation is a required element of research studies that use a waiver of or exception from informed consent. Its intent is to provide an additional patient safeguard in emergency research circumstances when prospective informed consent is not possible. Investigators have reported that community consultation may be the most difficult aspect in implementing research trials using a wa...
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Since 1996, specific federal regulations (21 CRF 50.24) have permitted the performance of emergency research when critically ill or injured patients and their surrogates are unable to provide meaningful prospective informed consent. The regulatory requirements for emergency research using exception from informed consent are aimed at providing additional safeguards for vulnerable patient-subject...
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متن کاملExperiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya
BACKGROUND The potential contribution of community engagement to addressing ethical challenges for international biomedical research is well described, but there is relatively little documented experience of community engagement to inform its development in practice. This paper draws on experiences around community engagement and informed consent during a genetic cohort study in Kenya to contri...
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ورودعنوان ژورنال:
- Critical care medicine
دوره 36 3 شماره
صفحات -
تاریخ انتشار 2008