This page has been updated to reflect the New Rule effective January 21, 2019.
Federal regulations require that all personnel involved in any NIH sponsored research take and pass a training course on human subjects before embarking on such research.
MIT extends this requirement to:
- All MIT personnel involved in any human subjects research
- 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 encompasses all types of interactions with human subjects including, direct contact, indirect involvement, analysis of data and analysis of blood/tissue samples.
To enable study personnel to meet this requirement, MIT has developed a web-based training course. It can be accessed via the Human Subjects Training link on the main menu. COUHES may accept proof of human subjects training from some other institutions.
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.
To obtain the certification status of prospective study personnel, investigators should view the opening page of the online training course, click on "View all Human Subjects Trainees" and then "View the List". Access to the list requires an MIT Web Certificate.
Additional training for NIH funded clinical trials
All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be training in Good Clinical Practice (GCP). A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluation the effects of those interventions on health-related biomedical or behavioral outcomes. This link has more information regarding the GCP training policy and the definition of clinical trial. The GCP training is an additional requirement; it does NOT replace the Protections of Human Participants training.
For more information about NIH Funded Clinical Trials, check out their website at https://grants.nih.gov/policy/clinical-trials/definition.htm.