McKechnie L, Gill A B
C Floor, Clarendon Wing, Leeds General Infirmary, Belmont Grove, Leeds LS2 9NS, UK.
Arch Dis Child Fetal Neonatal Ed. 2006 Sep;91(5):F374-6. doi: 10.1136/adc.2005.075036.
Inherent to all medical research is respect for the rights of the individual. Neonatal research is made more complex by the issue of proxy consent. Obtaining valid informed consent for entry of an infant into a research project needs to deal with this complexity. New evidence on the role and responsibilities of parents in giving consent has implications for all clinical staff that are considering embarking on and/or recruiting infants in research projects. This review explores the issues around informed consent for neonatal research and provides a framework by which consent could be improved. It is to be hoped that such improvements to the process will increase recruitment of infants to research studies while enhancing the validity of the consent process.
所有医学研究都必须尊重个人权利。代理同意问题使新生儿研究变得更加复杂。为婴儿参与研究项目获得有效的知情同意需要应对这种复杂性。关于父母在给予同意方面的作用和责任的新证据对所有考虑开展和/或招募婴儿参与研究项目的临床工作人员都有影响。本综述探讨了新生儿研究知情同意方面的问题，并提供了一个可以改进同意程序的框架。希望对这一过程的此类改进将增加参与研究的婴儿数量，同时提高同意程序的有效性。
