OVPR - Institutional Review Board (IRB)

General: Regsource Regulatory Page – Provides information for regulatory affairs, FDA information, Federal Register and clinical trials. The Presidents Council on Bioethics National Human Genome Research Institute PRIMR Public Responsibility in Medicine and Research Expedited Review Categories IRB Guidebook IRB Forum NIH Bioethics Resources on the web Research Compliance Resources (from the Association of American Medical Colleges) Medical Terminology in Lay Language (from Stanford University) Medical Terminology in Lay Language (from University of Michigan) International Conference on Harmonisation - guidance from regulatory authorities from Europe, Japan, and US regarding drug development
Medical Radation: Medical Radiation Subcommittee (MRC) Application: DOC PDF Medical Radiation Subcommittee (MRC) Description Radioactive Drug Research Committee (RDRC) Description
Clinical Trials: CenterWatch Clinical Trials (includes National Cancer Institute) ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. NIH Clinical Trials
Department of Health and Human Services (DHHS) OHRP - DHHS Common Rules Medline NIH Office of Human Subjects Research Office for Protection from Research Risks Public Health Service
Food and Drug Administration (FDA) MedWatch Information for Clinical Investigators - Guidance for clinical investigators involved in clinical trials of investigational drugs Good Clinical Practice: Consolidated Guidance - Guidance for investigators, sponsors, and IRBs Food and Drug Administration – Information Sheets FDA Center for Biologics Evaluation & Research FDA Center for Devices & Radiological Health FDA Center for Drug Evaluation
National Science Foundation (NSF) Human Subjects - basic policy information Behavioral and Social Science Research – NSF interpretation of applying IRB regulations to behavioral/social science research
Veterans Health Administration (VHA) ORCA (Office of Research Compliance and Assurance)