Training: Research Involving Human Subjects

Federal regulations require that all personnel involved in any NIH sponsored research take and pass a training course on human subjects research before embarking on such research. MIT policy extends this requirement to all MIT personnel involved in any human subjects research.

This requirement extends to all personnel who play a role in research involving human subjects including principal investigators, associate investigators, student investigators, study coordinators, visiting scientists, consultants, laboratory technicians and assistants.

The requirements encompass all types of interactions with human subjects including, direct contact, indirect involvement, analysis of data and analysis of blood/tissue samples.

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.

All personnel involved in studies utilizing humans as research subjects must undergo recertification in human subjects research training every three years from the date of original approval.

If you engage in Biomedical or Social and Behavioral research then you must complete a specially designed web-based training course by following the link to the University of Miami CITI program. This course is hosted by the CITI program at the University of Miami and is accepted by institutions nationwide. When registering for the course, select the modules appropriate to your research activities (biomedical or social and behavioral investigators) and complete only the basic course. Do not complete the Responsible Conduct of Research (RCR) course.

For MIT Faculty, staff, or students: Please log into the CITI site via the MIT portal . You will need a valid MIT certificate for authentication, available via IS&T.

For non MIT personnel: Please log into the University of Miami CITI site. When registering for the course, select 'Massachusetts Institute of Technology Affiliates' as your institution.

COUHES may accept proof of human subject training from some other institutions.

If you are conducting clinical research sponsored by NIH you are required to complete additional training.

The Principal Investigator and Faculty Sponsor must manage the status of all personnel involved in their exempt research in COUHES Connect, 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 subject 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.

Investigators can view their own human subject training and the training of others by following these instructions.