Doing Human Subject Research? Changing NIH Policies Impacting You. Feb 23, 2018, 17:09 PM by Melodi Moore Doing Human Subjects Research? Changing NIH Policies May Impact You Does your study… Involve one or more human subjects? Have a health-related biomedical or behavioral outcome? Evaluate the effect of interventions on the human subjects? Have a health-related biomedical or behavioral outcome? If “yes” to ALL of these questions, your study is considered a clinical trial. Unsure how to answer the questions? We have a tool that can help! https://grants.nih.gov/ct-decision/index.htm Please contact one of the following persons for additional information or clarifications about… IRB – Vicki McNamara, vimcnama@UTMB.EDU Good Clinical Practice (GCP) Training – Christy Taylor-Bray, cjtaylor@utmb.edu ClinicalTrials.gov Registration & Reporting – Lori Simon, lasimon@utmb.edu