Institutional Training and Educational Requirements
4.0 Institutional Training and Educational Requirements
Our Institution operates in compliance with the Office for Human Research Protections (OHRP) under an approved Federalwide Assurance (FWA). The Institution is responsible for ensuring that all investigators involved in conducting or supporting human subjects research understand and act in accordance with the requirements set by HHS regulation. As stated in the Terms of the FWA, OHRP strongly recommends that institutions and their designated IRBs establish training and oversight mechanisms (appropriate to the nature and volume of their research) to ensure that investigators receive continuing education of and comply with the following:
Relevant Ethical Principals
Relevant Federal Regulations
Written IRB Procedures
OHRP Guidance
Environmental Health and Radiation Safety
Other applicable guidance as required
State and local laws
Institutional Policies for the protection of human subjects
Required Training
Temple University has established training requirements for Investigators and Research Personnel. Successful completion of these requirements by Investigators and Research Personnel is required prior to approval of a research project involving Human Subjects. Please note that periodic renewal of certain certificates and approvals may be required.
Institutional Review Board - Human Subject Protections Training - This computer based, on-line training system is required of all study team members that are listed on protocols and all others who will be performing any aspect of the protocol. The On-line training system is self-paced and takes approximately 4 hours. Pre-registration with the IRB is required.
Health Insurance Portability and Accountability Act (HIPAA) Training - The University provides HIPAA training at New Employee Orientientation as well as periodic continuing education.
Additional Training
Health System Medical Record Training
Fall Research Seminar Program
Certificate and Graduate Courses in the Quality Assurance and Regulatory Affairs Program