Bento Silvana Ferreira, Hardy Ellen, Osis Maria José Duarte
Centro de Assistência Integral à Saúde da Mulher, Universidade Estadual de Campinas - Unicamp, Campinas, Brazil.
Dev World Bioeth. 2008 Dec;8(3):197-206. doi: 10.1111/j.1471-8847.2006.00183.x.
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.
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.
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.
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.
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.
在巴西，每项涉及人类的研究都必须制作一份知情同意书，且须由研究参与者签署：这在第196/96号决议中有规定。(1) 必须通过特定的结构化流程获得同意。
了解女性对于在邀请其参与避孕方法研究时，应如何进行知情同意获取过程的看法。
开展了8个焦点小组讨论，共有51名居住在坎皮纳斯大都市区的女性参与。参与该研究的女性要么正在参与女性健康领域的一项临床试验，要么在过去12个月内参与过此类试验。使用主题指南进行焦点小组讨论；讨论内容进行了录音、转录并开展了主题分析。
总体而言，邀请女性参与研究的人员应为研究团队成员，但不应是首席研究员。与研究相关的信息应通过口头和书面形式，分别在个人和小组环境中提供。除其他事项外，还应告知研究志愿者有关风险、可能的副作用和不适，包括长期影响。有人建议使用视听辅助工具来提供信息。
获取知情同意的过程被视为在志愿者与研究者/研究团队之间建立关系的一种方式。研究参与者期望获得的信息与第196/96号决议规定的要求一致。使用视听辅助工具将提高对所提供信息的理解。
