No More Hand Me Downs: A National Broadcast Film on Clinical Research with Childr

不再有旧事：一部关于儿童临床研究的全国广播电影

• 批准号: 8521681
• 负责人: Lisa D Marceau
• 金额: $ 15万
• 依托单位: NEW ENGLAND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8521681
• 关键词: Address; Adult; Awareness; Belmont Report; Caregivers; Categories; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Clip; Collaborations; Complex; Confidentiality; Development; Devices; Ensure; Ethics; Evaluation; Federal Government; Film; Focus Groups; Fright; Genetic Transcription; Goals; Grant; Guatemala; Hand; Health; Health Personnel; Helsinki Declaration; Hour; Human; Image; Individual; Informed Consent; Internet; Interview; Knowledge; Location; Medical; Medical Research; Methods; Mind; Minority; Misinformation; Multimedia; Names; National Heart, Lung, and Blood Institute; Parents; Participant; Pediatric Nursing; Pediatric Research; Perception; Pharmaceutical Preparations; Phase; Policies; Population; Production; Program Reviews; Public Health; Quality of life; Radiation; Recording of previous events; Recruitment Activity; Reliance; Reporting; Research; Research Subjects; Risk; Role; Safety; Small Business Innovation Research Grant; Source; Syphilis; Testing; Time; Underserved Population; United States National Institutes of Health; Work; falls; human subject; improved; maltreatment; pediatrician; programs; prototype; research study; response; social

DESCRIPTION (provided by applicant): There are two components to this study where human subjects are involved: development of content, and assessment of content. For the Development and Reel Review three focus groups will be held: 1) general audience; 2) minority, 3) parents specifically. We will conduct groups in these three categories to ensure we produce a film that is generally appealing, but also addresses the important concerns discussed in this proposal regarding minority and pediatric populations in particular. Development focus groups (n=30): Subjects will be recruited with the assistance of Amy Tonkonogy of WGBH, to gather groups representing national broadcast appeal. Reel Clip focus groups: The Reel Clip focus groups will be held with the same individuals who participated in the Development focus groups. 6.1.2. Sources of Material Participation will consist of (for development) discussing the content needs and delivery approach of the program. The feasibility assessment (clip reel review) will involve reviewing the script and clip reel to determine if we addressed the concerns of the participants. 6.1.3. Potential Risks There are no anticipated risks to participation in the review f content or feasibility discussions. 6.2. ADEQUACY OF PROTECTION AGAINST RISKS 6.2.1. Recruitment and Informed Consent Participants will be recruited with assistance from Amy Tonkonogy, building from expertise on testing programs for national broadcast. Access to participants will be through established methods of recruitment used by WGBH. Once identified, NERI will conduct informed consent prior to conducting the interviews, which will occur at NERI (WGBH is conveniently located within several miles of NERI, and NERI will provide an independent location for holding the groups). 6.2.2. Protection against Risk The major risk to the participants is a breach in confidentiality. Any identifying information captured during discussions or review of the program will be recorded electronically and be stored on a locked project drive accessible to the project staff (PI and PM). All names and identifying information captured during recording will be removed during transcription. 6.3. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS There is no expected benefits to participation. The benefits of participation in the prototype evaluation may include acquired knowledge about clinical trials. 6.4. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED If this program is an effective it could improve knowledge of clinical trials and reduce the reliance on misinformation and misperceptions about trial participation. 6.5. CLINICAL TRIALS.GOV Not Applicable

描述（由申请方提供）：本研究包括两个部分，其中涉及人类受试者：内容开发和内容评估。对于发展和卷审查将举行三个焦点小组：1）一般观众; 2）少数民族，3）父母具体。我们将在这三个类别中进行分组，以确保我们制作的电影具有普遍吸引力，但也解决了本提案中讨论的关于少数民族和儿童群体的重要问题。发展焦点小组（n = 30）：将在WGBH的Amy Tonkonogy的协助下招募受试者，以聚集代表国家广播呼吁的团体。卷轴夹焦点小组：卷轴夹焦点小组将与参加开发焦点小组的相同人员举行。6.1.2.材料参与的来源将包括（为发展）讨论的内容需求和交付方式的计划。可行性评估（剪辑卷审查）将包括审查脚本和剪辑卷，以确定我们是否解决了参与者的问题。6.1.3.潜在风险参与内容审查或可行性讨论没有预期风险。6.2.风险防护的充分性6.2.1.招募和知情同意参与者将在Amy Tonkonogy的帮助下招募，并根据国家广播测试计划的专业知识进行招募。将通过WGBH使用的既定招聘方法接触参与者。一旦确定，NERI将在进行面谈之前进行知情同意，面谈将在NERI进行（WGBH位于NERI几英里范围内，NERI将提供一个独立的地点举行团体）。6.2.2.风险防范参与者面临的主要风险是违反保密规定。在项目讨论或审查期间捕获的任何识别信息将以电子方式记录，并存储在项目工作人员（PI和PM）可访问的锁定项目驱动器上。在记录过程中捕获的所有姓名和识别信息将在转录过程中删除。6.3.拟议研究对受试者和其他人的潜在受益参与研究无预期受益。参与原型评估的受益可能包括获得有关临床试验的知识。6.4.知识的重要性获得如果这个程序是一个有效的，它可以提高临床试验的知识，减少对错误信息的依赖和对试验参与的误解。6.5.临床试验. GOV不适用