Required Training
Mandatory Training in the Protection of Human Subjects in Research Post-Revised Common Rule Implementation:
All faculty, students, and staff who are involved in the design and conduct of research with human subjects must complete mandatory training in the protection of human participants. Training must be completed before starting work on the project. Proof of completed training must be included as part of the IRB eForm review process.
McKendree uses the Collaborative Institutional Training Initiative (CITI) Program as the provider of human subjects research (HSR) training. The CITI program is recognized nationally as one of the HSR training standards. The Office for Human Research Protections (OHRP) training program titled Human Research Protection Program (HRPP) Resources is also nationally recognized and will satisfy the HSR training requirement. Both programs provide a certificate as proof of training completion.
While each research proposal will be evaluated on its own merits the more succinct HRPP program will generally satisfy the educational requirements for researchers conducting exempt and expedited studies. Depending on the proposed study population, research methodology, and other variables, researchers may be required to complete the more comprehensive CITI basic program, and relevant special topic modules, where appropriate.
Researchers beginning projects on or after January 1, 2022 must complete the relevant HSR training prior to submitting a study proposal eForm.
1. Researchers holding a pre-Revised Common Rule (2018 or earlier) CITI SBE or Biomed basic training certificate will be required to complete the CITI Legacy “refresher” module for either the SBE or Biomed certification OR chose to switch to the updated Revised Common Rule HRPP program.
From the CITI curriculum list, choose either the “Biomedical Research Investigators” (Biomed) or the “Social and Behavioral Research Investigators” (SBE) option—whichever is pertinent. Note: Where required by the nature of the population, study methodology, or the location involved, researchers must also complete appropriate supplemental module(s). Contact the IRB Chair for guidance.
2. If appropriate, researchers holding a pre-Revised Common Rule (2018 or earlier) HRPP certificate may complete the updated HRPP training covering the new Revised Common Rule or chose to switch to the appropriate CITI basic training. Access to the HRPP training content is located using the OHRP web site.
3. Researchers holding other human subjects research training certificates should contact the Chair of IRB to discuss options. Generally, institution-specific (“in-house”) training is not nationally recognized. Researchers completing institution-specific training will be required to complete one of nationally recognized training programs.
