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

 描述（由申请人提供）：获得潜在研究参与者的充分知情同意是生物库依赖性研究的重大挑战。为了保持公众的信任和支持，重要的是要建立一个明智的决策过程中收集和使用的生物标本收集在临床环境中。对于大多数在美国出生的婴儿，在新生儿筛查完成后生成残留的干燥血液生物标本。一些程序选择存储这些标本以用于多种用途，包括生物医学研究。例如，密歇根生物信托基金会保留和编目新生儿筛查残留生物标本，用于医学和公共卫生研究。确定如何提高对未来生物库依赖性研究的广泛同意的理解是国家的优先事项。具体目标1：确定必要的关键信息项，以便就残留生物标本的保留和未来研究使用的广泛同意做出知情决定。方法包括焦点小组与新的父母，以确定关键的信息要素有关的同意使用残留的生物标本内的密歇根生物信托。还将与参与医院、卫生部门和大学的IRB人员举行额外会议，以确定他们对知情同意过程的期望和要求。具体目标二：根据目标1中收集的数据，创建最先进的电子知情同意信息（EICI）工具，用于临床环境中保留和使用残留生物标本。获奖的遗传科学学习中心将开发西班牙语和英语的专业EICI。EICI的验证将利用密歇根生物信托基金的社区和科学咨询委员会的反馈来完成。具体目标3：通过将EICI知情同意方法与以下两种方法进行比较，对EICI知情同意方法进行评价：a）在电子平板电脑上提供的传统知情同意;和B）当前基于纸张的知情同意方法。将招募密歇根州讲西班牙语和英语的父母（n = 630），在产后临床护理期间进行生物库研究需要知情同意，并随机分配至三组之一。具体目标4：在干预前后，通过焦点小组和与分娩医院和社区卫生部工作人员的访谈，评估EICI的可行性。

 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.