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  1. Voluntary Participation and Comprehension of Informed Consent in a Genetic Epidemiological Study of Breast Cancer in Nigeria.Patricia A. Marshall, Clement A. Adebamowo, Adebowale A. Adeyemo, Temidayo O. Ogundiran, Teri Strenski, Jie Zhou & Charles N. Rotimi - 2014 - BMC Medical Ethics 15 (1):38.
    Studies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research. We investigated voluntary participation and comprehension of informed consent among women involved in a genetic epidemiological study on breast cancer in an urban setting of Nigeria comparing women in the case and control groups.
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  • Post-Trial Access to Study Medication: A Brazilian E-Survey with Major Stakeholders in Clinical Research.S. M. Dainesi & M. Goldbaum - 2012 - Journal of Medical Ethics 38 (12):757-762.
    Objectives To analyse the perspective of clinical research stakeholders concerning post-trial access to study medication. Methods Questionnaires and informed consents were sent through e-mail to 599 ethics committee (EC) members, 290 clinical investigators (HIV/AIDS and Diabetes) and 53 sponsors in Brazil. Investigators were also asked to submit the questionnaire to their research patients. Two reminders were sent to participants. Results The response rate was 21%, 20% and 45% in EC, investigators and sponsors’ groups, respectively. 54 patients answered the questionnaire through (...)
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  • Can Informed Consent to Research Be Adapted to Risk?Danielle Bromwich & Annette Rid - 2015 - Journal of Medical Ethics 41 (7):521-528.
    The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for (...)
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  • Informed Consent in Clinical Research in France: Assessment and Factors Associated with Therapeutic Misconception.I. S. Durand-Zaleski, C. Alberti, P. Durieux, X. Duval, S. Gottot, P. Ravaud, S. Gainotti, C. Vincent-Genod, D. Moreau & P. Amiel - 2008 - Journal of Medical Ethics 34 (9):e16-e16.
    Background: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials .Patients and methods: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient (...)
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