UNLABELLED: 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.
UNLABELLED: 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.
Authors: Dianne Quigley; Alana Levine; David A Sonnenfeld; Phil Brown; Qing Tian; Xiaofan Wei Journal: Sci Eng Ethics Date: 2018-01-03 Impact factor: 3.525