Interim funding under the """"""""Human Subjects Research Enhancements Program"""""""" will provide opportunity for Temple University to undertake new initiatives to strengthen its human research subjects protection program. In particular, the interim funds will be used to: (a) upgrade our technology and database monitoring/tracking system for IRB activities, and (b) implement new initiatives in education and training for investigators, administrators and IRB members in human subjects protection and the ethical conduct of research.
Specific aims and objectives for the technology/database upgrade include: tracking and incidence reporting of adverse events; electronic submission of IRB protocols; web-based submission of informed consent; electronic checklist for protocol reviews; and monitoring and tracking of continuing reviews.
Specific aims and objectives for the education initiative include: develop a stuctured program of workshops/seminars/briefings for the research community in the ethical conduct of human subjects research; develop an IRB News Digest for the research community, administrators and IRB members highlighting policy, procedures and regulations governing human subjects research; update SOPs and procedures manual for IRB staff, investigators and IRB members; and initiate the process for self-assessment and accreditation.
