Exception from informed consent in pediatrics

儿科知情同意的例外情况

• 批准号: 6816266
• 负责人: MARILYN C MORRIS
• 金额: $ 10.24万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-15 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6816266
• 关键词: behavioral /social science research tag; cardiopulmonary resuscitation; clinical research; clinical trials; community; confidentiality; ethics; focus groups; handbook; health care personnel; health care policy; health care quality; heart arrest; informed consent; parents; patient care management; patient oriented research; pediatrics

DESCRIPTION (provided by applicant): Appropriately designed clinical trials to improve outcome from pediatric cardiac arrest are currently not being conducted because of the difficulty of obtaining informed consent for research participation from a parent during or soon after a child's cardiac arrest. The applicability of exception from informed consent to pediatric resuscitation research must be clarified to allow progress in caring for children who suffer a cardiac arrest. This is a proposal for a career development grant to provide the experience and formal education necessary for a young investigator to become a successful and productive clinical researcher in the field of pediatric cardiac arrest. The young investigator will earn a Masters in Public Health focused the practical kills necessary to propedy conduct clinical trials and on the policy and ethical issues at the interface between resuscitation research and bioethics. She will augment these skills by conducting a research plan under the experienced mentorship of a team of outstanding physicians and scientists. The goal of the research plan is to determine in what cases and through what mechanisms exception from informed consent should be applied to pediatric in-hospital resuscitation research. She will determine what categories of in hospital pediatric resuscitation research may appropriately be conducted with an exception from informed consent and what type of community consultation and public disclosure process is appropriate for trials of different levels of risk. She will make this determination through extensive consultation both with health care providers and with the lay community invested in the health of children. She will then develop a document categorizing types of pediatric in-hospital resuscitation research and delineating appropriate components of a community consultation and public disclosure process for each of these broad types of research.

描述（由申请人提供）：针对改善儿童心脏骤停结果的适当设计的临床试验目前没有进行改善，因为在儿童心脏骤停期间或不久之后，很难获得父母的知情同意书的知情同意。必须澄清知情同意书对小儿复苏研究的适用性，以允许照顾遭受心脏骤停的儿童。 这是一项职业发展赠款的建议，以提供年轻研究者成为儿科心脏骤停领域的成功且富有成效的临床研究人员所必需的经验和正规教育。这位年轻的研究者将赢得公共卫生硕士学位，将预先进行临床试验进行必要的实际杀戮以及复苏研究与生物伦理学之间的界面上的政策和道德问题。她将通过在杰出医师和科学家团队的经验丰富的指导下制定研究计划来增强这些技能。研究计划的目的是确定在哪些情况下以及通过知情同意的哪些机制例外，应应用于小儿院内复苏研究。她将在知情同意书的例外以及哪种类型的社区咨询和公共披露过程适用于不同风险试验的情况下，可以适当地进行医院儿科复苏研究中哪些类别。她将通过与医疗保健提供者以及对儿童健康投资的外行社区进行广泛咨询来做出这一决定。然后，她将开发一份文件，以分类小儿院内复苏研究类型，并为每种广泛类型的研究中的各种社区咨询和公开披露过程中描述适当的组成部分。