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Training provided by another affiliate will be accepted by the Corporate Director of the HRPP as long as it meets the training requirement. Corporate Director of HRPP will review other training upon request to determine whether or not it meets the requirements of this Manual. If other training is accepted by the HRPP, the individual will be required to complete CITI training at the time of the next renewal.
Special Circumstances
If the IRB of an affiliated academic institution or other external organization serves as the IRB of record for some of the offices of this Health System, the external IRB members are to be encouraged to complete HRPP required human subjects protection training or its equivalent. McLaren’s HRPP is not required to track such training.
Individuals outside of MHC (e.g., phlebotomists, x-ray, and laboratory technicians) who are not MHC’s or subsidiary hospitals’ employees and whose work occurs exclusively outside this Health System must meet their own institutions’ requirements for training.
Required Conflict of Interest Training for Investigators
All research primary investigators, sub or co-investigators and academic advisors are required to complete COI training through CITI prior to the start of any study activities. COI training certificate is good for four years.
Optional eProtocol Training
Initial research application submission and all subsequent IRB submissions must be done through the eProtocol system. Once a user ID and password is obtained from the HRPP office, navigation and completion instructions are built into the eProtocol system. However, if one-on-one or group training is preferred, the EQuIP office can accommodate this request.
IRB Education
o Initial Education
IRB staff will also train IRB members on the SOPs, checklists, and worksheets applicable to IRB members including regulatory and guidance requirements.
o Continuing Education
To ensure that oversight of human research is ethically grounded and the decisions made by the IRB are consistent with current regulatory and policy requirements, training is continuous for IRB
Human Research Protections Program Manual McLaren Health Care
Revised 12/1/16
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