文章基本信息

标题：Informed Consent: An International Researchers’ Perspective
本地全文：下载
作者：Roberto Rivera ; David Borasky ; Robert Rice 等
期刊名称：American journal of public health
印刷版ISSN：0090-0036
出版年度：2007
卷号：97
期号：1
页码：25-30
DOI：10.2105/AJPH.2005.081604
语种：English
出版社：American Public Health Association
摘要：We reported 164 researchers’ recommendations for information that should be included in the informed consent process. These recommendations were obtained during training workshops conducted in Africa, Europe, and the United States. The 8 elements of informed consent of the US Code of Federal Regulations were used to identify 95 items of information (“points”), most related to benefits and research description. Limited consensus was found among the 3 workshops: of the 95 points, only 27 (28%) were identified as useful by all groups. These points serve as a springboard for identifying information applicable in different geographic areas and indicate the need for involving a variety of individuals and stakeholders, with different research and cultural perspectives, in the development of informed consent, particularly for research undertaken in international settings. INFORMED CONSENT IS AN important resource for protecting participants in research studies. All major national and international organizations require that “effective informed consent” 1 or “voluntary informed consent” 2 be obtained before a prospective participant is enrolled in a research study. The Council for International Organizations of Medical Sciences (CIOMS) defines informed consent as (1) receiving information necessary to make an informed choice about study participation, (2) understanding that information, and (3) making a voluntary decision on whether to participate. 2 Determining how much detail should be provided and balancing this with the potential participants’ need for information and capabilities to understand it is a major challenge for researchers and institutional review boards. To facilitate these efforts, the US Code of Federal Regulations (CFR) 1 requires that the following 8 basic elements be presented to participants to ensure informed consent: (1) research description, (2) risks, (3) benefits, (4) alternatives to study participation, (5) confidentiality, (6) compensation, (7) contacts, and (8) voluntary participation. The CFR also provides a brief elucidation of what type of information should be provided under each element. This limited clarification of the CFR creates the potential for different interpretations; more detailed specifications should be considered. Information deemed essential for CFR-required elements is presented here, gathered from experienced researchers who participated in international research ethics training workshops. The need to involve a variety of individuals with different field experiences when developing informed consent documents was evident from our analysis of these researchers’ opinions.