CITI Human Subjects Protection Training
MIT requires all personnel who are directly involved in human subjects research to complete Human Subjects Protection Training. This includes:
- Principal Investigator, co-investigators, study coordinators, and any other study personnel who are engaged in human subjects research (see example scenarios). In general, an individual is considered engaged in human subjects research when he/she, for the purposes of the research project, obtains:
- data about the subjects of the research through intervention or interaction with them
- identifiable private information about the subjects of the research
- the informed consent of human subjects for the research
- Faculty Sponsors who provide direct oversight to study personnel serving as Principal Investigators, Co-Investigators, or other study roles on the COUHES application.
- Investigators and all key personnel who will be involved in the design or conduct of NIH-funded human subjects research.
The requirement to complete Human Subjects Protection Training applies to all types of human subjects research, including: Exempt, Expedited and Full Board studies.
CITI Human Subjects Protection Training is mandatory for those who are directly involved in conducting human subjects research. However, we recommend that anyone else indirectly involved with human subjects complete CITI training or similar human subjects protection training.
CITI Refresher Training Requirement
All personnel who are directly involved in human subjects research must undergo recertification in human subjects research training every three years from the date of original approval.
How to Register and Complete CITI Training
For more information on how to register and complete CITI human subjects protection training, see Training: Research Involving Human Subjects.
Additional Training Requirements
Study sponsors might have their own training requirements. It is the responsibility of the Principal Investigator to identify and comply with all applicable training requirements.
NIH-Funded Clinical Trials
All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP). The GCP training is an additional requirement; it does not replace the Human Subjects Protection training.
Responsibilities of Principal Investigators and Faculty Sponsors
Principal Investigators are responsible for confirming that all study personnel have taken and passed the training course on human subjects research, and are "certified" to participate in studies involving human subjects. In addition, Principal Investigators are also responsible for identifying and complying with any additional training requirements that apply to the study.
The Principal Investigator and Faculty Sponsor must manage the status of all personnel involved in their research in COUHES Connect (this includes both exempt and non-exempt research), such as adding and removing personnel. Principal Investigator and Faculty Sponsor are responsible for ensuring that all study personnel are trained, and that any person whose training has lapsed no longer participates in the research and is removed as study personnel.
Investigators involved in human subjects research must maintain their training throughout their engagement in the research. Principal investigators and faculty sponsors have a responsibility to ensure that all study personnel maintain their training until the research is complete.
To learn how to complete training and view study personnel compliance, see Training: Research Involving Human Subjects.