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

Public Health Relevance

Despite decades of work to improve the safety of research subjects, fear about mistreatment of potential research participants remains a concern for many. Mistrust as a result of early, well-publicized abuses continues to outweigh the many rules and requirements now in place to ensure high ethical standards. These fears are particularly entrenched with minority and underserved populations such as children. Excellence in research is essential to our health and quality of life, yet while many potential participants recognize the need for clinical studies, they avoid participating.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-RPHB-C (10))
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Rosenberg, Ellen
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New England Research Institute
United States
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