Persons Required to Complete Education
Education in human research protection is required for all faculty, staff, and students directly involved in the conduct of research with human subjects, including anyone who does any of the following:
- Collects data from or about human subjects
- Conducts study procedures or interventions with human subjects
- Uses or has access to private data that can be linked to identifiable persons
This policy applies to all research involving the use of human participants
regardless of whether it is funded and regardless of the source of sponsorship. It applies to both currently active and future research.
Researchers not employed by or affiliated with USF must either meet the requirements of their respective institutions or complete one of the USF foundation requirements.
Two Types of Requirements
- One-time completion of the foundation requirement
- Annual completion of IRB-approved continuing education courses
Foundation Requirement
The foundation requirement is a one-time requirement that must be completed before the individual first becomes directly involved in the conduct of human subject research at USF.
This requirement consists of 1) required readings and 2) one foundation course as listed at: http://www.research.usf.edu/cs/irb_courses_foundation.htm.
Completion of the foundation requirement meets the education requirement for the first year of human subject research at USF. The foundation course will meet USF IRB requirements one time only and cannot be repeated to meet the education requirement for other years.
Continuing Education (CE) Requirement
A USF IRB-approved CE course must be completed annually for each year that the individual is involved in human research. Before each IRB Continuing Review, IRB staff will verify that a USF IRB-approved CE course has been completed within the 12 months prior to the expiration of study approval. Please see below for an example of how the renewal period is applied.* Please see below for the education requirements for exempt research.
DO NOT REPEAT THESE COURSES - Each course will meet USF IRB requirements one time only and cannot be repeated to meet the education requirement for other years. This is consistent with our goal to provide new opportunities for learning each year. The single exception to this policy is the CITI Refresher Course, which may be repeated because new content is added to it annually.
The USF IRB-approved Continuing Education courses are listed at http://www.research.usf.edu/cs/irb_courses_ce.htm.
Requirement for Exempted Studies
Those persons who conduct exempt studies are required to complete the foundation requirement, if they are a first time Principal Investigator, prior to submission of the Exemption Certification Request. If the foundation course was completed more than twelve months prior to submission of the Exemption Certification Request, a CE course must be completed within the 12 months prior to the submission. There is no continuation review associated with research deemed to be exempt. However, the PI is expected to keep his/her education on protection of human subjects current while conducting research activities which have been certified as exempt.
Submission Procedures
The attendees will be provided certificates at the completion of the live, USF IRB-sponsored presentations, if the individual registered prior to attending the course. A copy of those certificates will be forwarded automatically to the USF IRB.
For all other courses, submission directions specific to the course are explained on the Foundation Requirement and Continuing Education Courses pages.
The Principal Investigator (PI) must keep his/her Certificates of Completion on file, as well as a copy of the certificates for all key personnel involved in the conduct of the study. It is the responsibility of the Principal Investigator to ensure that key personnel complete continuing education on human research protections, and provide to the PI copies documenting that they are in compliance with USF IRB requirements.
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: Please contact: Neil Pekovsky at (813) 974-8553 or npekovsky@research.usf.edu or John Arnaldi, Coordinator of Education, at (813) 974-7363 or jarnaldi@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.
