FAQs for Training in the Protection of Human Subjects
The Collaborative IRB Training Initiative (CITI) is an educational program for the protection of human subjects in research. CITI was developed by experts in the IRB community and is focused on different aspects of bioethics and human subject research. There is a core course in biomedical research and one in social/behavioral research. Each module includes educational materials that can either be read on the screen or printed out. A brief quiz follows each module.
A person listed as study personnel in the IRB application is required to take the training. Any individual who is interacting and/or intervening with human subjects or handles the personally identifiable data of a human subject is considered study personnel. Study personnel who are involved in the informed consent process should also be included on the IRB study personnel list. Additional training requirements may be required by local review boards.
The University pays an annual fee for all UMASS Amherst users, individual users are not assessed a fee for the CITI training.
Researchers should select the track that corresponds to the type of research typically conducted. Generally, the Biomedical Research Module would be required for medical, physiological or pharmacological studies. This includes, but is not limited to, research with drugs, devices or other interventions. The Social and Behavioral Research Module related to studies on sociological, psychological, anthropological or educational phenomena including observational and survey research and work with population and/or epidemiological studies.
As of September 3, all human subjects researchers at UMass are required to complete a CITI Training refresher every 5 years. If researchers completed the basic course more than 5 years ago, a refresher course will be required in order to be considered in good standing.
The time required to complete each of the basic modules varies between 10 to 30 minutes. The total time is estimated to be 2-3 hours. The course does not have to be completed in one sitting and you can enter the course at any time. Units are designed to be taken sequentially.
The refresher course is comprised of various short modules which take about 5-10 minutes to complete. The refresher course in its entirety takes approximately 45 minutes to complete.
You do not need to complete the course in just one session. You are encouraged to use several "log-on" sessions, but you should take the quizzes immediately after completing each module.
If you log off the site and return at a later time, you will re-enter at the "Learner's Menu" page. Choose the Basic or Refresher Course and you will be taken to the Grade Book to begin at the next required module. The course software will keep track of your progress. When you finish the quiz for a module, the software will give you a link to your next module or the opportunity to view the Grade Book.
A passing score of 80% is required. If you are not satisfied with your score, you can retake the quiz to improve.
You are not required to submit your certification to the IRB. HRPO has access to the CITI course completion report and will review your training certification upon your submission to the IRB.
Certificates provided by researchers that have completed training on the previously required modules located on the Veteran's Administration web site, from the NIH modules or from another institution holding a Federal-wide Assurance will be accepted upon review.
As of September 3, 2013, all human subjects researchers at UMASS are required to complete a CITI Training refresher every 5 years. The refresher takes approximately 45 minutes to complete. If CITI training is expired (over 5 years) IRB submissions such as new studies, revisions, renewals will not be processed until the CITI refresher has been completed. (Note: Those who were grandfathered in with the NIH or VA training must now complete the CITI training.)
Human Research Protection Office (HRPO)
304 Research Administration Building
70 Butterfield Terrace
University Of Massachusetts
Amherst, MA 01003-9242
Phone: (413) 545-3428
FAX: (413) 577-1728