Informed consent for enrolling minors in genetic susceptibility research: A qualitative study of at-risk children's and parents' views about children's role in decision-making
Informed consent for enrolling minors in genetic susceptibility research: A qualitative study of at-risk children's and parents' views about children's role in decision-making
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DOI：
10.1016/s1054-139x(02)00459-7
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发表时间：
2003-04-01
影响因子：
7.6
通讯作者：
Wissow, LS
中科院分区：
文献类型：
--
作者：
Geller, G;Tambor, ES;Wissow, LS
为了更好地了解疾病风险增加的家庭决定让他们的孩子参加遗传易感性研究的过程，以便制定关于将来有风险的孩子参加这种研究的知情同意过程的建议。方法：家长和孩子（10-17岁）来自心脏病风险增加的家庭（n = 21对）或乳腺癌（n = 16对）参加了两个面对面的，录音，半结构化的采访：最初的采访是与父母和儿童分别进行，并进行了后续的家庭访谈1年后。采访成绩单进行编码的基础上共同themes.Results：家庭不同的阶段，在何种程度上，儿童将参与决策的研究参与。一般来说，孩子越大/越成熟，研究的风险越小，交流方式越开放，共同做出决定的可能性就越大。大多数孩子都希望父母能提供一些意见，但仍然认为最后的决定应该是他们自己的。大多数父母都想做出初步决定，考虑让他们的孩子参加拟议中的研究是否合理，但没有人反对孩子与研究人员单独相处。在我们的研究中，所有的父母和孩子都非常重视如果孩子不愿意，不要强迫他们参加非治疗性研究。关于招募儿童参加遗传易感性研究的决定应基于知情同意程序，该程序应：（a）使父母和儿童有充分的机会向研究人员提出问题并相互交流，以及（B）让儿童有机会在没有父母影响的情况下行使其拒绝参与的权利。这一过程应适合儿童的成熟程度和在家庭中的沟通方式。(C)青少年医学协会，2003年。
To better understand the process by which families at increased risk of disease would decide in order to enroll their children in genetic susceptibility research to develop recommendations regarding the informed consent process by which at-risk children are enrolled in such research in the future.Methods: Parents and children (ages 10-17 years) from families at increased risk for heart disease (n = 21 dyads) or breast cancer (n = 16 dyads) participated in two face-to-face, audio-taped, semi-structured interviews: Initial interviews were conducted with parents and children separately, and follow-up family interviews were conducted 1 year later. Interview transcripts were coded based on common themes.Results: Families vary in the stage at which, and degree to which, children would be involved in decision-making about research participation. In general, the older/ more mature the child, the less risky the research and the more open the communication style, the greater the likelihood that decisions would be made jointly. Most children wanted some parental input, but still thought the final decision should be theirs. Most parents would want to make the initial decision about whether it would be reasonable to consider enrolling their child in the research being proposed, but none opposed the child having some time alone with the researcher. All parents and children in our study placed extreme importance on not forcing children to participate in nontherapeutic research if they do not want to.Conclusions: Decision-making about enrolling children in genetic susceptibility research should be based on an informed consent process that (a) gives parents and children sufficient opportunity to ask questions of the researcher(s) and to communicate with one another, and (b) gives children the opportunity to exercise their right to refuse participation without parental influence. This process should be tailored to the child's maturity level and style of communication in the family. (C) Society for Adolescent Medicine, 2003.