The Common Rule, the set of regulations which have governed human subjects research in the U.S. since 1991, is being replaced with the Final Rule on January 21, 2019. For more information, please read below.Notice Update: Delay of the Revisions to the Final Common Rule Revisions Effective July 19, 2018
Starting Fall 2008, researchers doing non-exempt research will be required to complete a course in conducting research using Human Subjects before their research protocols can be approved by the IRB. The IRB also strongly encourages researchers doing exempt research using human subjects to also complete a course. This requirement was approved by the Academic Senate in 2007-2008. After submission of a research protocol, the IRB will make the determination as to the exempt status of the protocol and notify the researcher.
The training requirement must be fulfilled by taking the CITI (Collaborative Integrative Training Initiative) research training course in human subjects research ethics. A certificate, valid for 3 years, will be issued on completion of the CITI courses. (An up-to-date NIH course completion certificate is also acceptable as proof of human subjects research training.) The ORSP will maintain a database of the researchers who have completed the training.
Researchers working with human subjects must take either the social/behavioral/educational module, or in appropriate cases, the biomedical module of the CITI course. Each module contains 9-10 required sections needed to complete the course, along with optional sections for special interests. Elective sections include HIPAA, international research, and research with prisoners, among others. Instructors may demo the course from the home page.
To register for the courses go to CITI Program. Go directly to “New Users Register Here.” You will choose the human subjects courses in the process of registration.