About Human Subject Research Training
Information regarding training requirements and compliance.
HRPP Training Information
The purpose of MCW's Human Subject Research Protections (HSRP) training is threefold:
- Responsible Conduct in Research - to assure a thorough and universal foundation in the ethical and legal principles guiding human participant research.
- Scientific Integrity - to enhance the awareness of, and sensitivity to research integrity issues such as conflict of interest.
- Public Duty - to demonstrate to our study volunteers, the community, and research sponsors that we have the training and expertise necessary to protect the rights and welfare of research participants.
The MCW Human Subject Research Protections training requirements include:
- Completion of CITI training - Individuals should complete the applicable learner groups within CITI & maintaining on-going CITI certification. Within the learner group modules, individuals will be asked to:
- Read the Belmont Report; and
- Review MCW/FH human subject research policies (corporate, IRB, and departmental) and key research documents
- Individuals are responsible to maintain their HSRP training records and keep them current during their tenure in conducting research. Completion information can be accessed via eBridge, under Researcher Profiles.
- Additional Human Subject Research Protection training is required each year for investigators and coordinators. This additional on-going training must be tracked, maintained by the investigator or coordinators and available for inspection.
- MCW investigators and coordinators must obtain three hours of human subject protection education annually.
- Non MCW members of the research team must obtain one hour of human subject protection education annually.
MCW Certification Program (CITI)
Banking training is required for those individuals involved in the design, conduct or management of a local MCW/FH/BCW bank.
A local MCW/FH/BCW bank is a bank/repository established for the purpose of future research.
IRB banking trained is required for individuals
- who have access to the local bank/repository database,
- obtain informed consent for banking of data or specimens in the local bank, or
- have record keeping or other administrative responsibility for the local bank.
Banking training can be completed either by attending the in-person presentation or online training.
- The in-person training is offered approximately every 3 months;
- The online module is available for those who cannot attend the in-person training.
Successful completion of this module includes completing the quiz with a passing score of 80% or greater. The training is valid for three years.
The Department of Defense (DOD) module must be successfully completed by all research staff (investigator and research staff) involved in the design, conduct, or analysis of human subject research supported by the DOD including its components (Army, Navy, Air Force, Marine Corps, or recruiting DOD personnel).
This includes human subject research that is
- funded by the DoD or a DoD component, and/or recruits from the DOD or a DOD component through a contract, grant, cooperative agreement or other arrangement,
- using property, facilities, or assets of a DoD component, or
- involving military or civilian personnel from a DoD component.
Successful completion of the module includes completing the quiz with a passing score of 80% or higher.