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  1. Can the written information to research subjects be improved?--an empirical study.E. Bjorn, P. Rossel & S. Holm - 1999 - Journal of Medical Ethics 25 (3):263-267.
    OBJECTIVES: To study whether linguistic analysis and changes in information leaflets can improve readability and understanding. DESIGN: Randomised, controlled study. Two information leaflets concerned with trials of drugs for conditions/diseases which are commonly known were modified, and the original was tested against the revised version. SETTING: Denmark. PARTICIPANTS: 235 persons in the relevant age groups. MAIN MEASURES: Readability and understanding of contents. RESULTS: Both readability and understanding of contents was improved: readability with regard to both information leaflets and understanding with (...)
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  • Informed Consent Procedures: Responsibilities of Researchers in Developing Countries.Soledad Sánchez, Gloria Salazar, Marcia Tijero & Soledad Díaz - 2001 - Bioethics 15 (5-6):398-412.
    We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision‐making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss it with (...)
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  • Informed consent and participant perceptions of influenza vaccine trials in South Africa.K. Moodley - 2005 - Journal of Medical Ethics 31 (12):727-732.
    Background and objectives: There are few insights from sub-Saharan Africa on research participants’ experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa.Method: Four to 12 months after completion of the trials, participants were contacted to (...)
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