Training Requirements for Human Subjects Protection
The Veterans Health Administration (VHA) Office of Research and Development (ORD) requires two trainings for Human Subjects Protection;
- The Ethical Principles of Human Subjects Protection
- Good Clinical Practice.
NOTE: All other applicable VA and VHA training requirements at the local and national level must be met (e.g., privacy 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 Lucindia.Shouse@va.gov or Erica Doruska at Erica.Doruska@va.gov.
The following people are required to take both Ethical Principles of Human Subjects Protection and Good Clinical Practice training:
- 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;
- All members of the research office whose responsibilities include involvement with human research (e.g., the ACOS for R&D and the AO for R&D);
- All VA IRB staff, all VA IRB voting members, and all ex officio, nonvoting members of VA IRBs;
- VA representatives to external IRBs (e.g., affiliated academic institutions);
- All voting, and ex officio, nonvoting members of R&D Committees; and
- Members of other research committees or subcommittees that review research involving human subjects.
- 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.
- Nonscientist members (e.g., clergy, lawyers, community representatives, subject advocates) may require individualized training to ensure comprehension of their responsibilities as an IRB member. If a local facility provides such training, it needs to be included in its SOPs.
These two trainings must be completed before commencing participation in human subjects research, and training is to be updated every 2 years thereafter.
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 and Good Clinical Practice
CITI published revised refresher modules on March 31, 2013. ORD took this opportunity to make the VA CITI human subject research training requirements more
flexible and compatible with affiliate CITI requirements. The revised VA curriculum has been loaded in CITI for all VA research programs and is now
available for your use. All VA-specific coursework, except the Good Clinical Practices (GCP) modules, has been removed. Learners can choose the modules
most applicable to their roles and interests in human subjects research.
The new requirements are:
You must complete the 5 required GCP modules, plus your choice of 8 elective modules from a list of 18.
You must complete the 6 required GCP refresher modules, plus your choice of 8 elective modules from a list of 32. The
refresher training is required every two years after the initial training.
If you have any technical problems, comments, or suggestions about the CITI site and navigation through it, contact Mike Fallon (firstname.lastname@example.org) or Alice Huang (email@example.com).
If you have any questions about VA human subject research and GCP training requirements, contact Lucindia Shouse (firstname.lastname@example.org) or Erica Doruska (email@example.com).