SBIR-STTR Award

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 Statement:


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.

Project Terms:
Address; Adult; Awareness; Belmont Report; Caregivers; Categories; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Clip; Collaborations; Complex; Confidentiality; Development; Devices; Ensure; Ethics; Evaluation; falls; Federal Government; Film; Focus Groups; Fright; Genetic Transcription; Goals; Grant; Guatemala; Hand; Health; Health Personnel; Helsinki Declaration; Hour; Human; human subject; Image; improved; Individual; Informed Consent; Internet; Interview; Knowledge; Location; maltreatment; Medical; Medical Research; Methods; Mind; Minority; Misinformation; Multimedia; Names; National Heart, Lung, and Blood Institute; Parents; Participant; Pediatric Nursing; Pediatric Research; pediatrician; Perception; Pharmaceutical Preparations; Phase; Policies; Population; Production; Program Reviews; programs; prototype; public health medicine (field); Quality of life; Radiation; Recording of previous events; Recruitment Activity; Reliance; Reporting; Research; research study; Research Subjects; response; Risk; Role; Safety; Small Business Innovation Research Grant; social; Source; Syphilis; Testing; Time; Underserved Population; United States National Institutes of Health; Work

"The PHS Syphilis Study, Guatemala, Willowbrook, radiation experiments..." Despite decades of work to improve the safety of research subjects, these words bring to mind images of fear and the mistreatment of potential research participants, including 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. Recruitment for pediatric clinical trials presents unique challenges, including a lak of information for parents faced with a decision about whether to allow a child to participate. Despite best efforts of the National Institutes of Health to help improve, inform and standardize clinical trial recruitment these efforts are targeted to parents who are asked to involve their chid in a clinical trial. Misperceptions, fears and myths about the well-known (but not representative) mistakes, misconduct or abuse from the earliest days of clinical research persist regardless of these efforts. With demonstrated need for information about clinical research, the importance of clinical research to reduce social justice and disparities, and the vast gap between treatments used with children but never tested in children, no national broadcast program yet exists which has tackled the complex and important issue of clinical studies particularly in pediatric populations. The goal of this Phase Il SBIR application is to develop the one-hour, original narrative documentary-style film entitled, No More Hand Me Downs: Clinical Research and Children. To accomplish this goal, we will complete four major Aims: Aim 1: To meet with clinical experts and identify families from related trials for the complete film. Aim 2: Develop the 60 minute broadcast film. Aim 3: Conduct an evaluation of the film in preparation for national broadcast. Aim 4: Conduct national broadcast and outreach operations in collaboration with WebMD.

Public Health Relevance Statement:


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.

Project Terms:
Address; Adult; Award; Awareness; Belmont Report; Caregivers; Child; Childhood; Chronic; Clinical; Clinical Research; clinical research site; Clinical Trials; Clip; Collaborations; comparative effectiveness; Complex; Conduct Clinical Trials; Disease; Educational aspects; Ensure; Ethics; Evaluation; Failure (biologic function); falls; Family; Federal Government; Film; Fright; General Population; Goals; Grant; Guatemala; Hand; Health; health disparity; Healthcare; Hour; human subject; Image; impression; improved; Interest Group; Investments; Knowledge; maltreatment; Medical; meetings; Mind; Minority; Misinformation; operation; outreach; Parents; Participant; Patients; Pediatric Nursing; pediatrician; Perception; Pharmaceutical Preparations; Phase; Policies; Population; Preparation; Production; programs; public health medicine (field); public health relevance; Quality of life; Radiation; Recording of previous events; Recruitment Activity; Reporting; Research; Research Personnel; research study; Research Subjects; Resistance; response; Role; Safety; Small Business Innovation Research Grant; social; social disparities; Social Justice; success; Syphilis; Testing; tool; Underserved Population; United States National Institutes of Health; Work