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

描述(由申请人提供)：这项研究有两个组成部分，涉及人类受试者：内容开发和内容评估。对于发展和卷轴审查，将举行三个焦点小组：1)普通观众；2)少数群体；3)特别是父母。我们将在这三个类别中进行小组讨论，以确保我们制作的电影一般具有吸引力，但也解决了本提案中讨论的关于少数族裔和儿科人群的重要问题。发展重点小组(n=30)：将在WGBH的Amy Tonkonology的协助下招募受试者，以聚集代表国家广播呼吁的小组。卷轴剪辑焦点小组：卷轴剪辑焦点小组将与参加发展主题小组的人员一起举行。6.1.2.参与材料的来源将包括讨论计划的内容需求和交付方法(用于开发)。可行性评估(剪辑卷筒审查)将涉及审查剧本和剪辑卷筒，以确定我们是否解决了与会者的关切。6.1.3。潜在风险参与内容审查或可行性讨论不存在预期风险。6.2.防范风险的充分性6.2.1。招募和知情同意参与者将在Amy Tonkonology的协助下招募，以国家广播测试节目的专业知识为基础。WGBH将通过既定的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来关押小组)。6.2.2.防范风险参与者面临的主要风险是违反保密性。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，并存储在项目工作人员(PI和PM)可访问的锁定项目驱动器中。在录制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.拟议的研究对受试者和其他人的潜在好处参与没有预期的好处。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.获取知识的重要性如果该计划是有效的，它可以提高临床试验的知识，并减少对参与试验的错误信息和误解的依赖。6.5.临床TRIALS.GOV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