Training Requirements for Human Subjects Protection

The Veterans Health Administration (VHA) Office of Research and Development (ORD) requires all individuals involved in conducting VA human subjects research to complete training in the ethical principles on which human subjects research is to be conducted no less frequently than every 3 years.

NOTE: All other applicable VA and VHA training requirements at the local and national level must be met (e.g., privacy and VA information security training).

The following VA Investigators and research staff are required by ORD to take training in ethical principles on which human subjects research is to be conducted:

• All individuals involved in the conduct of VA human subjects research regardless of pay status, appointment type (title 38, title 5, IPA, or WOC), and length of time at the VA facility, including, but not limited to:
• Investigators;
• Study coordinators;
• Research assistants;
• Other members of the research team;
• Trainees, such as house officers and students.
• This training requirement also applies to investigators and research team members conducting studies involving human subjects that are exempt from IRB review, as well as those conducting human research for which the IRB has granted a waiver of informed consent or a waiver of documentation of informed consent.

Research and Development (R&D) Committee voting members and the Chair are also required to complete two modules on ethical principles of human research protection every three years. This training consists of the two required Ethics Modules included in each stage of the training for Human Subjects Protection. This has been set up for each VA facility as a separate course, and it is recommended that each member of the R&D Committee be encourage to enroll in that course. After enrollment, those who also complete Human Subjects Protection training will automatically be credited with completing the R&D Committee member training, so this will not increase their training burden. Only those R&D Committee members who do not otherwise complete the Human Subjects Protection training required by VA will have to complete additional modules for this course.

• Initial Training. Learners must complete two (2) required Ethics Modules selected by ORD, plus 6 additional modules from a selected list of 28 elective modules.
• Refresher Training. Learners must complete two (2) required Ethics Modules selected by ORD, plus 6 additional modules from a selected list of 42 elective modules.

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 (alice.huang@va.gov). Please refer to the directions described in the Options for Fulfilling ORD Training Requirements for detailed instructions on how your ACOS/R&D, AO/R&D, or R&D Coordinator can request changes in the VA Facility's CITI curriculums. Instructions for how to obtain ORD approval of the affiliate's CITI modules as meeting ORD training requirements are also described.

If you have any technical problems, comments, or suggestions about the CITI site and navigation through it, contact George Lathrop (george.lathrop@va.gov) or Alice Huang (alice.huang@va.gov).

If you have any questions about VA human subject research training requirements, please send your questions to VHACOORDRegulatory@va.gov.

To view other Department of Veterans Affairs (VA) and Veterans Health Administration (VHA) mandated trainings, please go to the EES intranet site by copying and pasting this link into your browser: http://vaww.ees.lrn.va.gov/Training/. To sign in to LMS, go to https://www.tms.va.gov/SecureAuth35/.