New England Research Institutes, Inc. — Department of Health and Human Services SBIR Phase II: NHLBI

Description

DESCRIPTION provided by applicant andquot The PHS Syphilis Study Guatemala Willowbrook radiation experiments andquot 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 To meet with clinical experts and identify families from related trials for the complete film Aim Develop the minute broadcast film Aim Conduct an evaluation of the film in preparation for national broadcast Aim Conduct national broadcast and outreach operations in collaboration with WebMD 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