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

描述（由申请人提供）：本研究涉及人类受试者的两个组成部分：内容开发和内容评估。在“发展与影片回顾”中，将举行三个焦点小组讨论：1)普通观众；2)少数民族；3)特别是父母。我们将在这三个类别中进行分组，以确保我们制作的电影普遍具有吸引力，但也解决了本提案中讨论的关于少数民族和儿科人群的重要问题。发展焦点小组（n=30）：将在WGBH的Amy Tonkonogy的协助下招募研究对象，以聚集代表国家广播呼吁的小组。Reel Clip焦点小组：Reel Clip焦点小组将由参与开发焦点小组的同一个人举行。6.1.2. 材料参与的来源将包括（为了发展）讨论课程的内容需求和交付方法。可行性评估（剪辑剪辑审查）将包括审查脚本和剪辑剪辑，以确定我们是否解决了参与者的担忧。6.1.3. 参与内容审查或可行性讨论不存在预期风险。6.2. 对风险的充分保护6.2.1。招募和知情同意参与者将在Amy Tonkonogy的帮助下招募，她将利用全国广播测试项目的专业知识。参与者将通过WGBH使用的既定招聘方法获得。一旦确定，NERI将在进行访谈之前进行知情同意，访谈将在NERI进行（WGBH位于NERI几英里内的便利位置，NERI将提供一个独立的地点来容纳小组）。6.2.2. 参与者面临的主要风险是违反保密规定。在讨论或审查计划期间捕获的任何识别信息将以电子方式记录，并存储在项目人员（PI和PM）可访问的锁定项目驱动器中。在记录期间捕获的所有名称和识别信息将在转录期间删除。6.3. 拟议研究对受试者和其他人的潜在益处参与研究没有预期的益处。参与原型评估的好处可能包括获得有关临床试验的知识。6.4. 如果这个项目是有效的，它可以提高临床试验的知识，减少对参与试验的错误信息和误解的依赖。6.5. 临床试验。政府不适用

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