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Spring 2008, Issue 8

Updated Education Requirements for Human Subjects Research

What are the updated SBER Institutional Review Board (IRB) education requirements?
They consist of online education modules provided by the Collaborative Institutional Training Initiative (CITI).

Who is required to complete the updated SBER IRB education requirements?
All SBER IRB members and investigators (faculty, research staff, students, faculty research advisers, and research assistants) involved in human subjects research are required to complete the CITI SBER Course.

Exceptions:

  1. Fletcher School investigators applying for exemption should complete required reading rather than the CITI SBER Course.

  2. If you completed the NCI IRB training course between 01/01/2003 and 07/24/2006 (when updated requirements were instituted) you do not need to take the CITI SBER Course at this time but you do need to take it before your five-year NCI training certification expires. For example, if you were certified by the NCI course on 01/01/2005, you will need to take the CITI SBER Course before 01/01/2010.

When do the updated SBER IRB education requirements have to be completed?
SBER IRB education requirements have to be completed prior to participation in any human subjects research activity.

Note: You may wish to complete the CITI SBER Course before you develop your protocol because the course features tips on the process.

How do I get started on the CITI SBER Course?

  1. Review the Tufts SBER IRB education requirements.
  2. Review the Tufts Institutional Instructions for the CITI SBER Course. These are especially important because they tell you which Learner Group you should choose and which modules you need to complete.
  3. Register at the CITI Program website. Everyone except IRB members should choose the “New SBER PI/New Research Team Members, including Students” Learner Group. Where “Address” is requested, please put in the address where you want your IRB protocol information sent.

How do I complete a CITI SBER Course module?
Click on the first required module, read the information, click on the quiz link at the bottom of the page, take the quiz, and click “Submit Exam” to receive a score and save it. If you exit the quiz without submitting it, you will have to take it again.

Tips:

  • You can log in and out of the CITI Program at your convenience, completing modules at your own rate. Remember to submit the exam before exiting each module.
  • You can go back to review a completed module at any time.
  • You can copy the content of the page to a Microsoft Word file for future reference.

What do I do when I’ve completed all modules required by the SBER IRB?
Please download and print your CITI Completion Report from the Learner Main Menu.

What do I do with my CITI Completion Report?
Retain your original CITI Completion Report and provide a copy to the principal investigator (PI) of your research project. PIs are required to retain copies of CITI Completion Reports for all research team members. Please note that these documents are subject to audit.

How long is the certification valid?
The SBER IRB CITI Program certification is valid for a maximum of five (5) years. If you are continuing in human subjects research, you need to renew your certification before it expires. The SBER IRB Administrator may require that you complete continuing or corrective education modules prior to expiration of your certification.

For more information, please go to http://www.tufts.edu/central/research/IRB/main.htm.

 

 

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