Important News (added 12/6/2016):
Please note that after 1/1/17, all IRB submissions must include completed Humans Subjects Protections training through https://www.citiprogram.org/ for ALL team members listed on the IRB application. If a team member has not completed the appropriate CITI training at time of submission, the IRB application will be returned to you as incomplete and will NOT be processed by the IRB. You will then have the option to remove the team member and resubmit, or resubmit once all team members have taken the training.
This new policy is being implemented to encourage the completion of training before the writing of the IRB application so that all researchers have a basic understanding of ethical conduct of research and research regulations when designing and writing the study. In addition, this will reduce IRB turnaround times as the IRB will not need to hold an application approval until CITI training is completed, and those studies whose team members have completed training will receive priority for IRB review. Thank you for your cooperation and understanding.
The CITI Training Program
The Carilion Clinic IRB requires the completion of an education and training course provided through the Collaborative Institutional Training Initiative (CITI). CITI was formed as a collaboration between major research institutions to develop a web-based training program in human research protections. The program is used by more than 800 institutions.
A link to the CITI program site can be found here. Follow the instructions below to determine which curriculum you should take. Each CITI curriculum consists of a series of required modules and each module has a short quiz. You must pass each quiz with a minimum score of 80%. A running tally is compiled in the Grade Book. If you want to improve a score, you may repeat any quiz in which you did not score 100% correct by selecting the tab 'view this module again.'
CITI for Investigators and Study Staff
For investigators and staff involved in FDA-regulated/drug/device research:
- Good Clinical Practice (GCP)
FDA-regulated research requires completion of the Good Clinical Practice module. This training must be repeated every three years for investigators and staff who continue to participate in new FDA-regulated studies.
For investigators and staff involved in non-FDA regulated biomedical research:
- BASIC Biomedical
- Refresher 101 Biomedical
- Refresher 201 Biomedical
For investigators and staff involved in social/behavioral research:
- BASIC Social/Behavioral
- Refresher 101 Social/Behavioral
- Refresher 201 Social/Behavioral
Researchers and staff conducting research must first complete the Basic education module. After three years, investigators and staff must take the Refresher 101 module in order to participate in new studies. After six years, investigators and staff must take the Refresher 201 module in order to participate in new studies.
Investigators, study coordinators and other research staff are required to complete the appropriate CITI training before their research can be approved by the IRB. This requirement applies to all human subjects research.
The Conflict of Interest Mini-Course must be completed by researchers and staff who conduct research with external funding or support. The mini-course must be taken once every four years. Courses for IRB Members should not be taken by research personnel.
Upon completion of a required module, print or download a Course Completion Report as evidence that you have met the IRB training and education requirement. A report will automatically be sent to the IRB office from CITI. Call the IRB Administrator at 853-0728 if there are any questions.
CITI for IRB Members
IRB Members are required to read the Belmont Report and complete the appropriate education course of the CITI program. The Basic CITI course is required for all new IRB members. The Refresher 101 course is required for IRB members three years following the completion of the Basic requirement, and the Refresher 201 course is required for IRB members three years following the completion of the Refresher 101 course.
Each CITI course consists of a series of required modules and each one has a short quiz. You must pass each quiz with a minimum score of 80%. A running tally is compiled in the Grade Book. If you want to improve a score, you may repeat any quiz in which you did not score 100% correct by selecting the tab 'view this module again.'
Upon completion of required course, print or download a Course Completion Report as evidence that you have met your educational requirement. A copy will automatically be sent to the IRB office. Call the IRB Administrator at 853-0728 if there are any questions.
The Research & Development (R&D) department requires the completion of curriculum modules to ensure PIs and project personnel understand their roles and responsibilities. Call R&D (985-8510) or check the R&D intranet website for more information.