Protecting Human Research Subjects

On October 1, 2000, the NIH implemented the requirement for education on the protection of human research volunteers for all investigators submitting NIH applications for grants or proposals for contracts, or receiving new or non-competing awards for research involving human subjects. Before funds are awarded for competing applications or contract proposals involving human subjects, investigators must provide a description of such education completed by study personnel involved in the design and conduct of research. Similarly, after October 1, 2000, investigators submitting non-competing renewal applications for grants or annual reports for research and development contracts that involve human subjects must include a description of such education for research study personnel in their annual progress reports. For study personnel added to a project after the budget period begins or after the principal investigator has submitted a progress report, training must be completed before they undertake human subject research and documentation must be provided to NIH at the time of the next progress report.

Effective November 15, 2006, UTHSC will update its required educational training program for faculty investigators/ mentors, IRB members, administrators and all other individuals who participate in the conduct of human subject research, including those using human-derived materials. Investigators are responsible for documenting training for personnel that perform research procedures, handle investigational materials, or participate in the conduct of the research. All researchers and staff should have training completed by June 30, 2006. Documentation of completion of training will be a requirement of IRB protocol submissions after the June 30, 2006 deadline.

The newly adopted training program is the Collaborative IRB Training Initiative (CITI). This program, completed in March of 2000, is the result of a collaborative effort between the University of Miami and the Fred Hutchison Cancer Research Center to create a web based human subject protections training program. It is currently being used by many institutions in the U.S. and has become the standard for academic research centers.

The CITI training program can be accessed by linking to www.citiprogram.org. You will be asked to register using your UT NetID as your username. If you do not have a UT NetID, use your first initial and last name. If you are an employee of the university, you will also need to enter your UT employee personnel number (EPN). This will allow your training to be entered into the human resources mandatory training database. Contact your business manager if you do not know your EPN. If you are not paid by the University and do not have an EPN, please enter NOEPN in the appropriate field.

Once you have registered, you can access the Institutional Information page for instructions. In general, each module takes 10-15 minutes to complete. All training modules do not have to be completed at one sitting. Successful completion of the program will be automatically registered by the program and you will receive a printable certificate.

There will be an additional requirement that individuals be re-certified at three year intervals. You will receive an e-mail notification from CITI when refresher training is due.

The UTHSC Office of Human Subject Protections (OHSP) will administer this program. For questions or concerns regarding the CITI training program, you may contact:

For University of Tennessee faculty and staff employees, certification of training must be secured through successful completion of the CITI training program. Completion of alternative training in other settings will not be accepted.

Got Questions? Check out the "CITI Register Guide" where detailed registration information is available on-line at http://www.uthsc.edu/research/research_compliance/OHSP/register.php