Lobato Lucas, Bethony Jeffrey Michael, Pereira Fernanda Bicalho, Grahek Shannon Lee, Diemert David, Gazzinelli Maria Flávia
School of Nursing, Federal University of Minas Gerais, 190 Av, Alfredo Balena, Room 508, Belo Horizonte, MG 30130-100, Brazil.
BMC Public Health. 2014 Nov 6;14:1156. doi: 10.1186/1471-2458-14-1156.
In order for Informed Consent to be ethical and valid each clinical trial participant must be able to make a voluntary decision to participate, free from pressure or coercion. Nonetheless, many factors may influence the decision reached, and such influences may be different for male and female volunteers. Being aware of these differences may help researches develop better processes for obtaining consent that safeguard the right of autonomy for all participants. The goal of this study was to evaluate potential gender-based differences in the factors influencing clinical trial participation.
This cross-sectional study was conducted in the Northeast region of Minas Gerais, Brazil, in October 2011. A structured questionnaire was administered to 143 volunteers (48 male, 95 female) screened for participation in a clinical study of an investigational functional food with potential anthelminthic properties. Answers regarding their decision to participate in the study were compared, by gender, using chi-square and Mann Whitney tests. Odds ratios (OR) was used to measure association.
A majority of subjects (58% of males, 59% of females) listed the desire to collaborate with the development of a product against parasitic worms as their main reason for participation. Females were significantly more likely to report a decision influenced by friends, family, or researchers (OR 3.14, 3.45, and 3.46 respectively, p < 0.005). Females were also significantly more likely to report a decision influenced by general altruistic considerations (OR 8.45, p < 0.005). There was no difference, by gender, in the report of decisions influenced by informational meetings, understanding of the disease, or the availability of medical treatments or exams. There was also no difference in knowledge of the rights of research participants.
Study results indicate that there is a strong difference between male and female participants regarding social influences on the decision to participate in clinical research. Further research into the impact this may have on autonomy is warranted.
为使知情同意具有伦理道德性和有效性，每位临床试验参与者必须能够做出自愿参与的决定，不受压力或胁迫。然而，许多因素可能会影响所做出的决定，并且这些影响对于男性和女性志愿者可能有所不同。了解这些差异可能有助于研究人员制定更好的获取同意的流程，以保障所有参与者的自主权利。本研究的目的是评估影响临床试验参与的因素中潜在的性别差异。
这项横断面研究于2011年10月在巴西米纳斯吉拉斯州的东北部地区进行。对143名志愿者（48名男性，95名女性）进行了结构化问卷调查，这些志愿者经过筛选参与一项关于具有潜在驱虫特性的功能性食品的临床研究。使用卡方检验和曼-惠特尼检验按性别比较他们参与研究的决定的相关答案。比值比（OR）用于衡量关联性。
大多数受试者（58%的男性，59%的女性）将希望参与抗寄生虫产品的研发列为参与的主要原因。女性更有可能报告其决定受到朋友、家人或研究人员的影响（OR分别为3.14、3.45和3.46，p<0.005）。女性也更有可能报告其决定受到一般利他主义考虑因素的影响（OR为8.45，p<0.005）。在受信息会议、对疾病的理解或医疗治疗或检查的可用性影响的决定报告方面，按性别没有差异。在研究参与者权利的知晓方面也没有差异。
研究结果表明，男性和女性参与者在参与临床研究决定的社会影响方面存在很大差异。有必要进一步研究这可能对自主性产生的影响。
