The Clinical Trials Support Office would like to provide guidance and reminders regarding training requirements for faculty and staff facilitating human subject research. The only research study team staff exempt from the Good Clinical Practice and Human Research During COVID Module requirements are administrative staff who are not required to accept their roles in eResearch and have no other research-related role. For more information on any of the following training, please consult the UMOR Research Compliance website.
Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS)
All human research at UM requires Human Subject Protections (HSP) training through the Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS). Recently updated, the Responsible Conduct of Research and Scholarship (RCRS) course, which is part of PEERRS and is designed to meet federal and institutional requirements, must be completed by June 30, 2021. This requirement applies to all U-M employees and students engaged in any facet of research and scholarship, regardless of internal or external support. More information is available here.
The Responsible Conduct of Research and Scholarship (RCRS) course and Research Administration course are required for all individuals listed on a Proposal Approval Form (PAF) or Award (AWD) for sponsored funding in any investigator role.
Good Clinical Practice (GCP)
Currently, only trials that follow the International Council for Harmonization Good Clinical Practice (ICH-GCP) require the CITI GCP training. This does not include all trials, but enough for all trialists to be certified.
Points to note:
- All NIH trials follow ICH-GCP.
- Obtaining CITI GCP training can avoid some sponsored-required training since many accept CITI.
- The Social and Behavioral Research Best Practices training fulfills the NIH requirement for GCP training for social and behavioral clinical trials only.
Human Research During COVID-19 Training Module
The Human Research During COVID-19 Training Module is required for faculty & staff prior to resuming human research activities on UMOR approved reactivation studies.
Study team members must complete the training module if any of the following are true:
- They will interact with human participants.
- They will be returning to work on a U-M campus.
- They will be returning to work and spending time in proximity to other U-M study team members.