Singhal Nalini, Oberle Kathleen, Darwish Amy, Burgess Ellen
Regional Clinical Division, Neonatology, Calgary Health Region, Calgary, Alberta T2N 2T9, Canada.
J Perinatol. 2004 Dec;24(12):775-82. doi: 10.1038/sj.jp.7211171.
By providing information and possibly shaping parents' preferences, health-care providers are thought to play a critical role in parental decisions to enroll their infants in research. Yet, little is known about health-care providers' beliefs about research with newborns. Previous studies suggest that parents and health-care providers are often at odds regarding attitudes towards research.
To examine the attitudes of health-care providers concerning the acceptability of research with newborn babies and the degree of research-related risk to which they would be willing to expose their own infant. These findings were compared with a previous study of parental attitudes.
DESIGN, SETTING AND PARTICIPANTS: A survey (pretested questionnaire with 20 scaled items and five case scenarios) of 50 doctors and 64 nurses conducted in a large tertiary care center in western Canada.
Study limitations were a response rate of 64.5% among nurses but only 22% among physicians. Both doctors and nurses were strongly supportive of research with newborns, but nurses were more averse to exposing infants to risk. Only 76.0% of nurses, compared to 92.2% of physicians, agreed that informed consent should be sought for all forms of research. When results were compared with parental perceptions, health-care providers were more likely to believe that research should be conducted for the good of all babies. Parents were generally less aware of the existence of an approval process for research in general. In responding to hypothetical scenarios with risk and direct benefit, parents were less willing to enroll their infants than were health-care providers. Approximately 30% of both groups would be willing to enroll their infants in a study involving moderate risk and no direct benefit.
Views of nurses, physicians, and parents regarding research with newborns are different. Overall, there is support for research; however, nurses are more likely to never enroll their own baby and enroll babies into minor studies without consent.
通过提供信息并可能影响父母的偏好,医疗保健提供者被认为在父母决定让其婴儿参与研究的过程中起着关键作用。然而,对于医疗保健提供者对新生儿研究的看法却知之甚少。先前的研究表明,父母和医疗保健提供者在对研究的态度上往往存在分歧。
考察医疗保健提供者对新生儿研究可接受性的态度,以及他们愿意让自己的婴儿面临的与研究相关的风险程度。将这些结果与之前一项关于父母态度的研究进行比较。
设计、地点和参与者:在加拿大西部一家大型三级医疗中心对50名医生和64名护士进行了一项调查(一份有20个量表项目和5个案例场景的预测试问卷)。
研究的局限性在于护士的回复率为64.5%,而医生的回复率仅为22%。医生和护士都强烈支持对新生儿进行研究,但护士更反对让婴儿面临风险。只有76.0%的护士(相比之下医生为92.2%)同意对所有形式的研究都应寻求知情同意。当将结果与父母的看法进行比较时,医疗保健提供者更有可能认为研究应该为了所有婴儿的利益而进行。父母总体上对一般研究审批程序的存在了解较少。在回应有风险和直接益处的假设场景时,父母比医疗保健提供者更不愿意让他们的婴儿参与研究。两组中约30%的人愿意让他们的婴儿参与一项涉及中度风险且无直接益处的研究。
护士、医生和父母对新生儿研究的看法不同。总体而言,对研究是有支持的;然而,护士更有可能永远不让自己的婴儿参与研究,并且在未经同意的情况下让婴儿参与小型研究。