The purpose of this application is to strengthen the informed consent process for clinical research conducted at Children's Hospital. A full time individual with appropriate expertise in working in a clinical setting, experience with literature reviews, conducting sessions with open ended interviews, familiarity of the issues related to informed consent in a pediatric setting and pertinent regulations federal regulations and writing skills will be hired to conduct a literature review to compare and contrast practices for implementing the informed consent/assent process. In addition this individual will conduct interviews and focus groups with research subjects, families, IRB members and research staff to understand the current practice and culture for obtaining informed consent. Based on the literature review and interviews, a written set of recommendations for improving the informed consent process at the Children's Hospital will be provided. Included in the recommendations will be suggestions to evaluate whether the recommendations have a measurable effect on the consent process, once implemented. Funds are requested for a full time individual, a part time research assistant, a computer workstation and funding for supplies and limited travel to attend national meetings where current practices in improving the informed consent process will take place.
