Effective January 1, 2010, education in the protection of human subjects is valid for two (2) years!
The USF IRB has changed our policy effective January 1, 2010 from annual renewal of human subjects training to every two years. The change in policy requires researchers and their staff to participate in more comprehensive training which can be found at http://www.research.usf.edu/cs/irb_education.htm Individuals who participated in human subjects education in 2009 will be required to renew their certification in 2010; however, the new certification will be valid until 2012.
Education in human research protection is required for all faculty, staff and students directly involved in the conduct of clinical research. This includes:
- Individuals who collect or enter data
- Individuals who conduct study procedures (including informed consent) or interventions with human subjects
- Individuals who use or have access to private information that can be linked to research subjects
This policy applies to all research involving the use of human participants regardless of funding or sponsorship. The policy also applies to both currently active and future research submitted to the USF IRB. All study team members must have current training in order to receive full approval from the USF IRB.
Failure to Comply
Failure to complete the education requirements by the end of the renewal period will result in this information being reported to the USF IRB for their review and determination of action. The IRB has the authority to suspend or withhold approval from any project that involves study personnel who fail to meet these education requirements.
For More Information
Please contact: (813) 974-7363 or research@research.usf.edu.
*Example of how the CE Renewal Period is applied:
A new PI, Dr. Researcher (and all of his research personnel) completes the CITI Foundation Course, and then submits an Application for Initial Review to the IRB for consideration. The IRB approves the study on June 16, 2006 with an approval period of 6/16/06 to 6/15/07. Dr. Researcher, and all key personnel involved in this study, must complete continuing education in human research protections before the Application for Continuation Review is submitted to the IRB, which will be due no later than May 1, 2007. Dr. Researcher will receive a reminder 90 days, 75 days, and 60 days prior to the end of his current IRB approval reminding him that his Continuation Review is coming due, including education for himself and all of his key personnel in human research protections. Dr. Researcher can submit his Application for Continuation Review anytime before May 1, 2007, once he and his research personnel have met the education requirement.
