Note: It is the responsibility of the Principal Investigator (PI) to oversee the conduct of all research activities, including the training and education of all study staff. HSP training is only meant to act as a baseline training requirement. Additional role and protocol-specific training are routinely required to ensure data integrity and compliance.
HSP Training for External Research Personnel
Human Subject Protection (HSP) training is required for individuals engaged in the conduct of human subject research. This includes individuals that are internal to the institution (e.g., University of Rochester faculty/staff/students), as well as those who are external to the institution but are collaborating with University of Rochester researchers.
- Internal research personnel are required to complete their human subject protection training through the University’s affiliation with the Collaborative Institutional Training Initiative.
- External research personnel may complete human subject protection training as described on this page.
Individuals affiliated with another academic, healthcare, and/or research organization
When external research personnel collaborate with the University on human subject research and are affiliated with another academic, healthcare, or research institution/organization (e.g., another academic medical center or another university), OHSP recommends that the individual complete HSP training in accordance with their affiliated institution’s training requirements. Most of these types of institutions already have HSP training requirements in place.
External research personnel do not need to duplicate training efforts and complete both the University’s and their affiliated institution’s HSP training.
In the rare event that an individual is affiliated with another academic, healthcare or research organization, and their affiliated institution does not have HSP training requirements in place, OHSP recommends that the individual complete the training through the University’s CITI subscription. Review instructions for registering and completing training.
Community research partners
External research personnel who collaborate with the University on human subject research and are not affiliated with an institution/organization that has existing HSP training requirements such as individuals who are members of the community or are affiliated with a community-based organization or agency can complete HSP training through either:
- The University’s CITI subscription (review instructions for registering for and completing training); or
- The University of Illinois Chicago’s CIRTification training platform (instructions are outlined below)
CIRTificatIon training platform
The training offered through the CIRTification platform was developed specifically for Community Research Partners. The content reviewed within the training is similar, but not identical, to the content provided via CITI.
Based on the differences in content described in CIRTification’s content comparisons summary, OHSP recommends that Community Research Partners complete HSP training via CIRTification when their role is limited to:
- Recruitment, enrollment, consent, and/or data collection activities in minimal risk research;
- Recruitment and/or minimal risk data collection activities in greater than minimal risk research; or
- Advisement activities related to study design and/or the development of consent and recruitment materials, subject education/instructional materials, or subject-completed measures (regardless of risk level).
- Access the CIRTification training website
- Select the ‘Register’ option in the upper right corner and then select the ‘I am not from UIC’ option.
- Complete the registration form. When asked to identify your site, select University of Rochester from the dropdown menu. Click ‘Register’ when complete.
- Click the ‘Course Catalog’ option in the green box.
- Select ‘Learn More’ in CIRTification description box and then select ‘Enroll’.
- Complete the enrollment and demographic information and click ‘Submit’.
- Following enrollment confirmation, select the ‘My Courses’ option in the upper right corner.
- Select your language preference to initiate the course. The training platform will walk you through completing the training modules You may log in an out of the course as many times as you need to in order to complete the training.
- Once the training has been completed, and you have passed the quiz at the end, the system will generate a certificate with a date of completion on it. Save a copy of this certificate as a PDF; a copy must be provided to your Principal Investigator. You can also log back in to the system at a later time with your email and password to obtain a copy of the completion certificate.
Alternatively, OHSP recommends that Community Research Partners complete HSP training via CITI when their role involves:
- Enrollment, eligibility verification, consent, and/or greater than minimal risk data collection activities in greater than minimal risk research;
- Research oversight responsibilities typically designated to a Principal Investigator or Co-Investigator;
- Research oversight responsibilities related to the identification and management of study-related risks and/or data and safety monitoring; or
- Research regulated by the Food & Drug Administration.
Alternative HSP training for external research personnel
In lieu of the training options described above, OHSP policy permits external research personnel to complete other formats of HSP training in order meet the training requirement, though this option should be used under very limited circumstances. In the event an alternative training option is used (i.e., options other than what is described above), the training should be reviewed by the OHSP Director of Research Education and Training prior to use to ensure the appropriateness of the content.
Still have questions?
Get additional support
If you have questions about the training requirements outlined on this page, you can contact Kelly Unsworth at kelly_unsworth@urmc.rochester.edu. Visit our Contact page for more ways to get in touch with our office.