Lobato Lucas, Gazzinelli Maria Flávia, Gazzinelli Andréa, Soares Amanda Nathale
Escola de Enfermagem, Universidade Federal de Minas Gerais, Belo Horizonte, Brasil.
Cad Saude Publica. 2014 Jun;30(6):1305-14. doi: 10.1590/0102-311x00127813.
The aim of this study was to evaluate volunteers' knowledge of the information on the free informed consent form and their willingness to participate in a clinical trial. This was a quantitative, descriptive, cross-sectional study conducted in November 2011 with subjects from a clinical trial in Americaninhas, northeast Minas Gerais State, Brazil. A convenience sample included 143 adults of both sexes, 18 to 45 years of age. A structured questionnaire was applied one week after signing the free informed consent form. Most participants signed the free informed consent without sufficient knowledge of the research information and were influenced in their decision to participate in the trial. The authors conclude that signing the free informed consent form fails to express all participants' autonomy in clinical trials.
本研究的目的是评估志愿者对免费知情同意书上信息的了解程度以及他们参与临床试验的意愿。这是一项定量、描述性横断面研究,于2011年11月对巴西米纳斯吉拉斯州东北部阿梅里卡宁哈斯的一项临床试验中的受试者进行。便利样本包括143名18至45岁的成年男女。在签署免费知情同意书一周后应用结构化问卷。大多数参与者在对研究信息了解不足的情况下签署了免费知情同意书,并且他们参与试验的决定受到了影响。作者得出结论,签署免费知情同意书未能体现所有参与者在临床试验中的自主性。