Children's Hospital received $150,000 under the Human Subjects Research Enhancements program, RFA-OD-02-003. These funds are being used to develop recommendations to strengthen the informed consent process for clinical research at Children's Hospital. An informed consent specialist was hired to conduct a literature review, document the current practices at Children's by conducting interviews and focus groups with families, IRB members, and researchers and to prepare a set of recommendations for improving the informed consent process. Due to an unanticipated delay in hiring an informed consent specialist, a one-year no-cost extension was applied for and granted. The work on the first grant is currently underway. Funding from the second Human Subjects Enhancement Program RFA_OD-03-007 will be used for a different but related focus. Data in the literature suggest that improved educational tools on the complexities and methods for obtaining and granting informed consent in pediatric research would be useful to the research and participant communities. Funds for this grant will be used for developing one or more sustainable educational initiatives designed to enhance and strengthen the process of obtaining informed consent in pediatric research.
