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.
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).
There are a variety of VA courses and non-VA courses that have been approved by the Office of Research and Development. Clicking on this link will lead you to a list of approved courses. Also, your local affiliate course may be ORD approved by contacting Lucindia Shouse at email@example.com or Erica Doruska at firstname.lastname@example.org.
The following people are required 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:
- 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.
Training must be completed before commencing participation in human subjects research, and training is to be updated every 3 years thereafter unless local Standard Operating Procedures require more frequent training.
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/plateau/user/login.jsp.
NEW! CITI and VA Human Subject Protection
With the publication of the new VHA Handbook 1200.05 on November 12, 2014, all individuals involved in conducting VA human subjects research are required to complete training in ethical principles on which human subjects research is to be conducted. There is no longer a requirement for training in Good Clinical Practices. The revised VA curriculum has been loaded in CITI for all research programs and is now available for your use. You may choose the modules most applicable to your roles and interests in human subjects research.
The new requirements are:
- Initial Training. You must complete 8 modules, choosing them from a list a list of 18.
- Refresher Training. You must complete 8 modules, choosing them from a list of 32. The refresher training is required every 3 years after the initial training or more frequently if required by local SOPs.
If you have any technical problems, comments, or suggestions about the CITI site and navigation through it, contact Mike Fallon (email@example.com) or Alice Huang (firstname.lastname@example.org).
If you have any questions about VA human subject research and GCP training requirements, contact Lucindia Shouse (email@example.com) or Erica Doruska (firstname.lastname@example.org).