Informed consent: an international researchers' perspective.
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.
Rivera
Roberto
R
Office of International Research Ethics, Family Health International, Research Triangle Park, NC 27713, USA. rrivera@fhi.org
Borasky
David
D
Rice
Robert
R
Carayon
Florence
F
Wong
Emelita
E
D000349:Africa; D032921:Consensus; D018864:Cultural Diversity; D003479:Curriculum; D028744:Ethics Committees, Research; D032984:Ethics, Research / Q000193:education*; D005060:Europe; D005843:Geography; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D038622:Internationality; D009939:Organizations, Nonprofit; D018579:Patient Selection / Q000941:ethics*; D011634:Public Health / Q000941:ethics*; D012108:Research Personnel / Q000193:education*; D012941:Social Responsibility; D014481:United States