Thomas Jefferson University
Office of Human Research
The Office of Human Research (OHR) is one of 5 research support offices overseen by the Vice President for Research, TJU. The mission of these offices is to provide TJU faculty with the support and tools required to carry out successful basic and clinical research that is compliant with federal, state and local regulations.
The OHR is comprised of three divisions: the Division of Human Subjects Protection (DHSP) which includes the Institutional Review Boards (IRB), the Division of Clinical Trials Support, and the Division of Research Biosafety.
The Division of Human Subjects Protection (DHSP) provides administrative support for the three TJU Institutional Review Boards (IRBs). The DHSP receives for review all research protocols involving humans, ensures that requirements for training for personnel in human subjects research and HIPAA are met and up-to-date, monitors and assesses adverse events and unanticipated problems that may affect research subjects or others, notifies investigators when continuing review of protocols is imminent, and provides education for research coordinators, faculty and other personnel involved in human subjects research.
The Division of Clinical Trials Support has three main missions:1) supporting faculty members involved in clinical trials research by providing administrative infrastructure support services, 2) framing policy and operating issues surrounding clinical trials, and 3) providing education and training to the research community at TJU. The Clinical Trials Support Office hosts the Jefferson Clinical Research Forum (JCRF), a popular monthly meeting of research coordinators and research administrators where “hot” topics in clinical research are discussed. The Division also supports the Leadership Council of Clinical Coordinators (LCCC), a group of senior research coordinators who meet on a monthly basis with the Associate Director of the Division of Clinical Trials Support and the Director, OHR that provides a forum for discussion of programs that will improve the clinical research effort at TJU.
The Division of Research Biosafety inspects and certifies laboratories and investigators conducting research with biological agents and provides administrative support for the Institutional Biosafety Committee (IBC). All proposals for research involving biological agents, including recombinant DNA, are reviewed and approved by the IBC prior to the start of the research. In conjunction with the IRB, the IBC also reviews all protocols involving gene therapy or gene transfer in humans to ensure compliance with federal regulations and guidelines. The Division conducts biological safety training, reviews protocol submissions and is a resource for investigators.