HRPP Training Requirements
To achieve its aims, components of the University’s Human Research Protection Program (HRPP) have set forth training requirements related to the conduct of human subject research. The information below provides a summary of potential institutional training requirements, as they relate to the nature of the research being conducted, the sponsor/funding agency, and/or an individual’s role.
Note: This list is not inclusive of all Sponsor and/or Department-Specific training requirements.
Training requirements based on research nature
All personnel engaged in the research are required to complete and maintain Human Subject Protection (HSP) training via the Collaborative Institutional Training Initiative (CITI). Refresher training is required every 3 years.
Research personnel may be required to complete and maintain Good Clinical Practice (GCP) training by the sponsor/funding agency (e.g., see NIH Policy on GCP Training). Refresher training is typically required every 3 years.
Study staff must complete Health Insurance Portability & Accountability Act (HIPAA) training. HIPAA training is routinely included in the University of Rochester’s Office of Human Resources’ New Employee Orientation for URMC and Affiliates workforce members (via MyPath), though it is the responsibility of a trainee’s supervisor to ensure the training is completed (see HIPAA Policy 0P6 Privacy Training for Workforce). Training is available for study team members that do not have access to MyPath via the Privacy Office website.
All research personnel responsible for tracking patient visits and reviewing patient charges are required to complete eRecord (Epic) Research Coordinator and OnCore Clinical Trial Management System (CTMS) training.
For eRecord (Epic) Research Coordinator course availability, search the class schedule for the course on the eRecord training page.
OnCore CTMS training is role-based. Training requirements are assigned to trainees once the OnCore CMTS User Access Request Form has been completed.
All research personnel subject to potential safety hazards must complete Environmental Health and Safety’s (EH&S) Hazard Assessment Tool & Training Indicator. This assessment tool will identify required EH&S training, based on the individual’s responses/role. The ‘Hazard Assessment Tool’ is available in MyPath for University of Rochester faculty/staff. New staff are encouraged to complete the tool with the assistance of their supervisor, as the supervisor will have a greater understanding of what hazards the trainee may be exposed.
The Principal Investigator (PI) is required to complete IND training / IDE training (as applicable), prior to FDA submission. Training is optional, but strongly recommended, for research personnel who will be involved in FDA-related aspects of the study.
All research personnel involved in image acquisition and subject handling that requires access to the scanner or scanner console are required to complete UR CABIN MRI Safety Training.
Training requirements based on funding
The administrator with functional responsibility for the sponsored project is required to complete Continuous Learning for Administrators of Sponsored Programs (CLASP) training. ‘Functional responsibility’ is characterized as having an ability to originate, authorize, or approve transactions associated with sponsored programs; involvement with proposal preparation; or active review and monitoring of the financial activities of sponsored project accounts. CLASP training is facilitated by the Office for Research and Project Administration (ORPA), with both instructor-led and online sessions. Maintenance, via continuing education hours, is required annually.
Individuals involved in creating grant proposals in the Integrated Online Research Administration (IORA) system are required to complete IORA Overview training. The ‘Integrated Online Research Administration Overview’ training course is available in MyPath.
The Principal Investigator, named key persons, and anyone who will be delegated Purchasing Authority for the project is required to complete 2 CFR 200 Procurement Principles training. The course is completed once; maintenance training is not required.
The ‘2 CFR 200 Procurement Principles’ course is available in MyPath for University of Rochester faculty/staff.
The trainee/fellow/participant/scholar is required to complete and maintain Responsible Conduct of Research (RCR) training. Refresher training is required every 4 years. For additional information, see NIH RCR Requirements.
All individuals participating in the NSF-funded research are required to complete Responsible Conduct of Research (RCR) training. For additional information, see NSF RCR Requirements.
All personnel meeting the PHS definition of ‘investigator’ are required to complete Conflict of Interest training prior to receipt of a PHS award. ‘Investigator’ refers to any individual who is responsible for the administration, design, conduct, or reporting of sponsored research, internally funded research that involves human subjects, or proposals for such funding. Refresher training is required every 4 years.
The ‘University of Rochester Conflict of Interest Policy Course’ and ‘Conflict of Interest Refresher Course’ are available in MyPath for University of Rochester faculty/staff. For additional information, see the Faculty Conflict of Commitment and Interest Policy and corresponding FAQs.