title: Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants: a qualitative pilot study.
abstract: Few studies have explored the informed consent process among research participants in developing countries. This study aimed to evaluate the informed consent process, therapeutic misconception and motivation for participation among Egyptians participating in clinical trials. In a cross-sectional qualitative pilot study 103 participants in 10 clinical trials responded to a questionnaire. Over 90% agreed they had time to ask questions and received adequate information about the risks prior to consenting. All participants thought the research and the drug would improve their condition; only 46.1% were aware of receiving a non-approved experimental drug and 21.3% of being randomized. Reasons for participation included: better treatment (100%), to benefit society & advance science (85.4%), to receive free drugs (42.6%) and medical care (43.6%), to get hospitalized (15.8%) and to receive money or gifts (4.9%). Investigators need to emphasize the distinction between research and clinical care to address the high rate of therapeutic misconception.
authors.affiliation: Egyptian Society for Healthcare Development, Cairo, Egypt.
authors.forename: H
authors.initials: H
authors.lastname: Mansour
authors.affiliation: Faculty of Medicine, University of Alexandria, Alexandria, Egypt.
authors.forename: N
authors.initials: N
authors.lastname: Zaki
authors.affiliation: Faculty of Medicine, University of Cairo, Cairo, Egypt.
authors.forename: R
authors.initials: R
authors.lastname: Abdelhai
authors.affiliation: Faculty of Medicine, University of Alexandria, Alexandria, Egypt.
authors.forename: N
authors.initials: N
authors.lastname: Sabry
authors.affiliation: Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.
authors.forename: H
authors.initials: H
authors.lastname: Silverman
authors.affiliation: Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, United States of America. selkamar@epi.umaryland.edu.
authors.forename: S S
authors.initials: SS
authors.lastname: El-Kamary
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic; D003906:Developing Countries; D004311:Double-Blind Method; D004534:Egypt; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010865:Pilot Projects; D036301:Qualitative Research; D035842:Research Subjects / Q000523:psychology*; D011795:Surveys and Questionnaires; D055990:Therapeutic Misconception