Human Subjects Protection (HSP) Certification

Duke Medicine currently uses the web-based modules available at the Collaborative Institutional Training Initiative (CITI) website (www.citiprogram.org) for certification in Human Subjects Protection (HSP) Training. The Duke Office of Clinical Research (DOCR) is responsible for tracking module completion.

All Duke Medicine clinical research personnel who participate in the conduct of research with human subjects (i.e. are responsible for the study design, data, or specimen collection or who contribute to the scientific development or execution of the study in a substantive, measurable way) need to fulfill this training requirement. In addition, all Duke Medicine staff involved in the review, approval, or oversight of research involving human subjects also needs to complete this training.

All Duke Medicine personnel meeting the above criteria will initially complete eight (8) CITI modules (see attached policy for the list of required modules). Satisfactory completion of the Duke Medicine Biomedical Basic Course requires an average score of 80%. In addition to the above-mentioned eight (8) CITI modules, any Duke Medicine personnel involved in the conduct, review, approval or oversight of research with children is required to complete the CITI module entitled "Vulnerable Subjects - Research with Children." Individuals will be required to update their CITI modules by completing a refresher course every two years, and e-mail reminders about the refresher course will be sent in advance of the expiration date.

The DOCR will not accept CITI training for Duke Personnel from other institutions. For personnel who conduct research at the Durham VA Medical Center, the DOCR 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.  Questions can be directed to DOCR.Help@dm.duke.edu or 681-6665. 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 DOCR will not be providing educational credits through a centralized portal within Duke Medicine.
 


Instructions for CITI module completion 

Instructions for Completing the Research with Children Module

CITI module requirements for the Department of the Navy
 

Duke Medicine Policy for HSP Training

Step-by-Step instructions to renew your CITI modules