dc.creator | Bento S.F. | |
dc.creator | Hardy E. | |
dc.creator | Osis M.J.D. | |
dc.date | 2008 | |
dc.date | 2015-06-30T19:13:19Z | |
dc.date | 2015-11-26T14:39:32Z | |
dc.date | 2015-06-30T19:13:19Z | |
dc.date | 2015-11-26T14:39:32Z | |
dc.date.accessioned | 2018-03-28T21:45:15Z | |
dc.date.available | 2018-03-28T21:45:15Z | |
dc.identifier | | |
dc.identifier | Developing World Bioethics. , v. 8, n. 3, p. 197 - 206, 2008. | |
dc.identifier | 14718731 | |
dc.identifier | 10.1111/j.1471-8847.2006.00183.x | |
dc.identifier | http://www.scopus.com/inward/record.url?eid=2-s2.0-57349160772&partnerID=40&md5=35bd4087060d7bb895675afcf10fbe73 | |
dc.identifier | http://www.repositorio.unicamp.br/handle/REPOSIP/105298 | |
dc.identifier | http://repositorio.unicamp.br/jspui/handle/REPOSIP/105298 | |
dc.identifier | 2-s2.0-57349160772 | |
dc.identifier.uri | http://repositorioslatinoamericanos.uchile.cl/handle/2250/1250032 | |
dc.description | In Brazil, every study involving human beings is required to produce an informed consent form that must be signed by study participants: this is stated in Resolution 196/96.1 Consent must be obtained through a specific structured process. Objective: To present the opinions of women regarding how the process of obtaining informed consent should be conducted when women are invited to participate in studies on contraceptive methods. Subjects and Methods: Eight focus groups were conducted, involving a total of 51 women living in the metropolitan region of Campinas. The women involved in the study were either participating in a clinical trial in the area of women's health or had participated in such a trial in the previous 12 months. A thematic guide was used to conduct the focus group discussions; the discussions were recorded, transcribed and a thematic analysis performed. Results: In general, the person who invites a woman to participate in a study should be a member of the research team but not the principal investigator. Information relating to the study should be given orally and in writing, both individually and in the group setting. Study volunteers should be informed about, among other things, the risks, possible side effects and discomforts, including long-term effects. The use of audiovisual aids to provide information was suggested. Conclusion: The process for obtaining informed consent was seen as a means of establishing a relationship between the volunteers and the investigator/research team. The information that the study participants expected to be given coincides with the requirements established under Resolution 196/96. The use of audiovisual aids would improve understanding of the information provided. © 2007 Blackwell Publishing Ltd. | |
dc.description | 8 | |
dc.description | 3 | |
dc.description | 197 | |
dc.description | 206 | |
dc.description | Resolução no. 196/96 sobre Pesquisa Envolvendo Seres Humanos. (1996) Bioética, 4 (SUPPL.), pp. 15-25. , Conselho Nacional de Saúde Brasil | |
dc.description | (2002) Section 3 - Responsible Conduct of Research: Summary - Informed Consent, , http://www.fhi.org/training/en/Retc/s3pg17.htm, Family Health International FHI, Research Triangle Park, NC: FHI. Available at:, Accessed 7 Sept 2006 | |
dc.description | International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) Geneva: CIOMS in collaboration with the World Health Organization, , http://www.cioms.ch/frame-guidelines-nov-2002.htm, Council of International Organizations of Medical Sciences CIOMS, Available at:, Accessed 28 July 2006 | |
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dc.description | Council for International Organizations of Medical Sciences, op. cit. note 4Macklin, R., Understanding Informed Consent (1999) Acta Oncologica, 38, pp. 83-87 | |
dc.description | Clotet, J., Goldim, J.R., Francisconi, C.F., (2000) Consentimento Informado e a sua Pratica na Assistência e Pesquisa no Brasil, p. 127. , Porto Alegre: EDIPUCRS | |
dc.description | Junges, J.R., Ética e Consentimento Informado. (2000) Cadernos de Ética em Pesquisa, 4, pp. 22-25 | |
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dc.description | Family Health International, op. cit. note 4Council for International Organizations of Medical Sciences, op. cit. note 4(2005) 5° Indicador Nacional de Alfabetismo Funcional - Um Diagnóstico para a Inclusão Social pela Educação, pp. 2-3. , Instituto Paulo Montenegro, Avaliação de Leitura e Escrita, São Paulo: Instituto Paulo Montenegro | |
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dc.description | Dawson, L., Kass, N.E., Views of US Researchers about Informed Consent in International Collaborative Research (2005) Soc Sci Med, 61, pp. 1211-1222 | |
dc.description | Sánchez, Informed Consent Procedures: Responsibilities of Researches in Developing Countries (2001) Bioethics, 15, pp. 398-412 | |
dc.description | Fitzgerald, D.W., Comprehension during Informed Consent in a Less-Developed Country (2002) Lancet, 360, pp. 1301-1302 | |
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dc.description | Agre et al., ibidFitzgerald et al, op cit. note 14Goldim, J.R., O Processo de Consentimento Livre e Esclarecido em Pesquisa: Uma Nova Abordagem. (2003) Rev Assoc Med Bras, 49, pp. 373-374 | |
dc.description | Hardy, E., Bento, S.F., Osis, M.J.D., Consentimento Livre e Esclarecido: Experiência de Pesquisadores Brasileiros na Área da Regulação da Fecundidade. (2004) Cad Sal Pública, 20, pp. 216-223 | |
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dc.description | Hossne, W.S., O poder e as Injustiças nas Pesquisas em Seres Humanos (2003) Interface, 7 (12), pp. 55-70 | |
dc.description | Dickens, B.M., Cook, R.J., Challenges of Ethical Research in Resource-Poor Settings (2003) Int J Gynaecol Obstet, 80, pp. 79-86 | |
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dc.description | Hardy et al, op. cit. note 21Barroso, C., Metas, D., Desenvolvimento do Milénio. Educação e Igualdade de Género. (2004) Cadernos e Pesquisa, 34, pp. 573-582 | |
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dc.description | Clotet et. al, op. cit. note 9Flory & Emanuel, op. cit. note 46Agre et al, op. cit. note 17Molyneux, C.S., Even if they ask you to stand by a tree all day, you will have to do it (laughter). . . !' Community Voices on the Notion and Practice of Informed Consent for Biomedical Research in Developing Countries (2005) Soc Sci Med, 61, pp. 443-454 | |
dc.description | Dawson & Kass, op. cit. note 15;Brown et al, op. cit. note 44Hossne, op. cit. note 36Diniz & Guilhem, op. cit. note 30(2002) The Ethics of Research Related to Healthcare in Developing Countries, , http://www.nuffieldbioethics.org/go/ourwork/developingcountries/publication-309.html, London: Nuffield Council on Bioethics. Available at:, Accessed. 14 Sept 2006 | |
dc.description | (2006) Voluntary Informed Consent, , http://www.georgetown.edu/research/nrcbl/nbac/clinical/Chap3.html, National Bioethics Advisory Commission NBAC, Bethesda, MD: NBAC. Available at:, Accessed 30 Aug 2006 | |
dc.description | E.L.C.P. Zoboli & L.A. Fracolli. A Vulnerabilidade do Sujeito de Pesquisa: Uma Abordagem Multidimensional. Boletim do Instituto de Saúde 2005 | |
dc.description | 35: April | |
dc.language | en | |
dc.publisher | | |
dc.relation | Developing World Bioethics | |
dc.rights | fechado | |
dc.source | Scopus | |
dc.title | Process For Obtaining Informed Consent: Women's Opinions | |
dc.type | Artículos de revistas | |