The following online courses or conferences satisfy the ORD 3-year requirement for training in ethical principles of human research protection by VA Investigators and their research staff.
1. ORD and Collaborative Institutional Training Initiative (CITI) have developed a training curriculum that satisfies ORD training requirements. With the publication of the revised VHA Handbook 1200.05, "Requirements for the Protection of Human Subjects in Research," on November 12, 2014, all individuals involved in conducting VA human subjects research are required to complete training on ethical principles on which human subjects research is to be conducted. There is no longer an ORD requirement for training in Good Clinical Practices.
ORD has now designated as "required" two of the modules that were previously in the list of electives for each stage of training. This does not affect any completion certificates that have already been earned, and the total number of modules required will not change. The minimum CITI training required to meet ORD requirements will now be as follows:
The revised training requirements are:
- Initial Training (Basic Course). Learners must complete two (2) required Ethics Modules selected by ORD, plus 6 additional modules from a selected list of 16 elective modules.
- Refresher Training (Refresher Course). Learners must complete two (2) required Ethics
- Modules selected by ORD, plus 6 additional modules from a selected list of 30 elective modules.
Each station's CITI account will be updated automatically to reflect this change after March 12, 2015. Please encourage learners affiliated with your station to complete any Human Subjects Protection training that is in progress before then. No records of completed modules will be lost, but it is possible that a learner might have to complete more than 8 modules, if the previously completed modules did not include the Ethics modules that will become required.
To change your station's requirements in CITI, please send a request from the AO/R&D, ACOS/R&D, or R&D Coordinator to Dr. Alice Huang (firstname.lastname@example.org), including the following information:
1) Choose one of the following options for what you would like done with the GCP modules (Please note that the VA Cooperative Studies Program still requires training in Good Clinical Practice for VA Investigators and research staff conducting CSP studies, but this does not have to be done in CITI. If you have questions concerning CSP requirements for training, please send those to Dr. Karen Jeans at email@example.com.):
a. Leave the GCP modules in place as required modules.
b. Remove the GCP modules from the Human Subjects Protection course altogether.
c. Make the GCP modules "optional" in the Human Subjects Protection course. This makes the
modules available to each learner who is enrolled in the Human Subjects Protection course, but
their completion is completely voluntary and will have no effect on earning a completion certificate.
Completion will be recorded in CITI, but will not be tracked for renewal.
d. Set up a separate GCP course, containing the previously required GCP modules. Completion of
the modules by those who enroll in this GCP course will be tracked by CITI, which will issue
completion certificates, and send reminder emails when the certificates are about to expire. This may
be useful if there are local or other requirements for GCP training. If your station wants the GCP
modules set up as a separate course, please specify the text to be used in the enrollment question
(e.g., "Have you been instructed to enroll in the GCP course by your VA Facility or a sponsor?").
2) Whether your station wants to have the renewal interval for the Human Subjects Protection course to be updated to 3 years. If this is done, all currently valid completion certificates will also be updated to expire 3 years from when the modules were originally completed.
3) If your VA Facility wishes to have ORD approval of the affiliate's CITI modules as meeting ORD training requirements, please submit a list of those CITI modules to both firstname.lastname@example.org and Dr. Marisue Cody at email@example.com.
If you have any questions about VA human subject research training requirements, please send your questions to VHACOORDRegulatory@va.gov.
If you have any technical problems, comments, or suggestions about the CITI site and navigation through it, please contact Dr. Mike Fallon (firstname.lastname@example.org) or Dr. Alice Huang (email@example.com).