The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research

电子知情同意信息（EICI）对残留新生儿标本研究的影响

• 批准号: 9495603
• 负责人: JEFFREY R. BOTKIN
• 金额: $ 41.75万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9495603
• 关键词: Acute; Address; Adult; Attitude; Authorization documentation; Award; Biomedical Research; Birth; Blood; Catalogs; Categories; Child; Clinical; Collection; Communication; Communities; Community Health; Comprehension; Conflict (Psychology); Consent; Data; Decision Making; Development; Elements; Ethics; Evaluation; Feedback; Focus Groups; Foundations; Future; Group Interviews; Health; Hospital Departments; Hospitals; Human Resources; Infant; Informed Consent; Institutional Review Boards; Intervention; Interviewer; Knowledge; Learning; Legal; Medical; Methods; Michigan; Multimedia; Neonatal Screening; Newborn Infant; Outcome Measure; Pamphlets; Paper; Parents; Participant; Perception; Postpartum Period; Process; Randomized; Regulation; Research; Residual state; Resources; Sampling; Science of genetics; Specimen; Tablets; Universities; Validation; base; biobank; blind; clinical care; expectation; improved; interactive multimedia; meetings; novel; programs; public health relevance; public health research; public trust; recruit; repository; research study; screening program; theories; tool

 DESCRIPTION (provided by applicant): Obtaining adequate informed consent from potential research participants is a significant challenge for biobank-dependent research. To maintain public trust and support, it is important to establish an informed decision-making process for the collection and use of biospecimens collected within clinical settings. For the majority of all infants born in the US, residual dried blood biospecimens are generated after newborn screening is completed. Some programs have chosen to store these specimens for several uses including biomedical research. For example, the Michigan BioTrust retains and catalogs newborn screening residual biospecimens for use in medical and public health research studies. Identifying ways to improve comprehension about broad consent for future biobank-dependent research is a national priority. Specific Aim 1: Identify the key information items necessary to make an informed decision about broad consent for the retention and future research use of residual biospecimens. Methods include focus groups with new parents to determine key information elements relevant to consent for use of residual biospecimens within the Michigan BioTrust. Additional meetings with IRB personnel within the participating hospitals, health departments and universities will also be conducted to ascertain their expectations and requirements for the consent process. Specific Aim 2: Based on the data collected in Aim 1, create a state-of-the-art electronic informed consent information (EICI) tool for use in the clinicl setting about the retention and use of residual biospecimens. The award-winning Genetic Science Learning Center will develop the professional EICI in Spanish and English. Validation of the EICI will be completed using feedback from both community and scientific advisory boards for the Michigan BioTrust. Specific Aim 3: Evaluate the EICI consent approach by comparing it to: a) traditional consent delivered on an electronic tablet; and b) the current paper-based consent approach. Both Spanish and English speaking parents (n = 630) in the state of Michigan, where informed consent is required for biobank research during postpartum clinical care, will be recruited and randomized to one of three groups. Specific Aim 4: Assess feasibility of the EICI through focus groups and interviews with birthing hospitals and Department of Community Health staff before and after the intervention.

 描述（由适用提供）：从潜在的研究参与者那里获得足够的知情同意是对生物银行依赖研究的重大挑战。为了维持公众的信任和支持，建立一个知情的决策过程很重要，以收集和使用临床环境中收集的生物测量。对于在美国出生的所有婴儿中，大多数婴儿都会在完成新生儿筛查后产生残留的血液生物测量。一些程序选择将这些物种存储用于多种用途，包括生物医学研究。例如，密歇根州生物群落保留和目录新生儿筛查残留的生物种类用于医学和公共卫生研究。确定提高对未来生物银行依赖性研究的广泛同意的理解的方法是国家的优先事项。具体目的1：确定有关保留和未来研究使用剩余生物测量的广泛同意决定所必需的关键信息项。方法包括与新父母的焦点小组，以确定与密歇根州生物群体中使用残留生物测量有关的同意相关的关键信息要素。还将与参与医院，卫生部门和大学内的IRB人员进行额外的会议，以确定他们对同意过程的期望和要求。具体目标2：基于AIM 1中收集的数据，创建一个最先进的电子知情同意信息（EICI）工具，以在临床环境中使用，以保留和使用残留的生物测量。屡获殊荣的遗传科学学习中心将以西班牙语和英语开发专业的EICI。 EICI的验证将使用密歇根州生物群岛的社区和科学咨询委员会的反馈完成。特定目的3：通过将EICI同意方法进行比较与以下方式评估EICI同意方法：a）在电子片剂上交付的传统同意； b）当前基于纸张的同意方法。密歇根州的西班牙语和英语父母（n = 630）都将在产后临床护理期间进行生物库研究的知情同意，并将被招募并随机分为三组之一。具体目标4：干预前后，通过焦​​点小组和对生日医院和社区卫生人员的访谈评估EICI的可行性。