Human Subjects Protection (HSP) Certification
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Effective January 1, 2009, Duke Medicine adopted the web-based modules available at the Collaborative Institutional Training Initiative (CITI) website ( www.citiprogram.org ) for certification in Human Subjects Protection (HSP) Training. Duke Medicine transitioned from the IRB online ethics training modules to CITI modules. The Clinical Research Support Office (CRSO) is responsible for tracking module completion.
All Duke Medicine clinical research personnel who interact with study participants or who have access to study participant information shall initially complete six (6) CITI modules (see attached policy for the list of required modules). Satisfactory completion of a module requires a passing score of 80%. Completion of these modules is by all Duke Medicine personnel meeting these criteria on their next annual IRB renewal date within the 2009 calendar year. In addition to the above six (6) CITI modules, any study personnel involved in research with prisoners is required to complete the CITI module entitled "Vulnerable Subjects - Research with Prisoners." Any study personnel involved in research with children is required to complete the CITI module entitled "Vulnerable Subjects - Research with Children."
The CRSO will not accept training for Duke Personnel from other institutions unless the individual can provide documentation of CITI training as required by Duke Medicine. For personnel who conduct research at the Durham VA Medical Center, the CRSO has access to the current CITI training required by the Durham VA Research Office and accepts this as certification in lieu of Duke Medicine CITI module completion. This completion data will be uploaded into Duke Systems on a regular basis.
Please note: CME/CE and AMA credits are available through CITI. The individual must complete a minimum of 12 modules from the Human Subjects Research program (Basic or Refresher) to be eligible for credits. The individual has to apply personally for the credits for a cost ranging from $40 to $80 depending on the type of credits they are applying for and the module program completed. The CRSO will not be providing educational credits through a centralized portal within Duke Medicine.
For instructions for CITI module completion, click here. 
For more information on this new policy, please click here.
For Frequently Asked Questions about CITI, click here.
For information on how to look-up certification status of other researchers click here. 
