Researcher Training

• See Human Subjects Research Training below
• See Animal Research Program for Animal Training
• See Biosafety Program for Laboratory Training

Human Subjects Reseach

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). To view other Department of Veterans Affairs (VA) and Veterans Health Administration (VHA) mandated trainings, please go to the EES intranet site at ILEAD (sharepoint.com). To sign in to TMS, go to https://www.tms.va.gov/SecureAuth35/.

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.

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.

CITI Courses

ORD and Collaborative Institutional Training Initiative (CITI) have developed a training curriculum that satisfies ORD training requirements. VHA Directive 1200.05, "Requirements for the Protection of Human Subjects in Research," requires that 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 is set up for each VA facility and is now as follows:

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

Options available at the discretion of each VA facility include (1) the renewal interval for the Human Subjects Protection training (up to three years), (2) requesting approval to accept training completed to meet the requirements of an affiliated institution, and (3) whether to offer GCP training.

Alternative to CITI for VA Personnel Participating in Expanded Access Programs for Treatment of Monkeypox

Human Subjects Protection Training For VA Personnel Conducting FDA-Regulated Expanded Access Program Activities for the Treatment of Patients with Monkeypox - ORD has developed a set of training slides to meet ORD's training requirement in ethical principles for personnel who are conducting any FDA-regulated expanded access program for monkeypox. This abbreviated training serves as an alternative to CITI training. No test is associated with the training slides. The individual can enter his or her name and the date the individual has reviewed the training course on the certificate at the end of the training. This certificate may be sent to your local research office as proof of completion of the training. This training is not required to be completed prior to patient treatment.

Non-VA Courses

• Public Responsibility in Medicine and Research (PRIM&R) Annual Conferences: Any PRIM&R Annual Advancing Ethical Research (AER)Conferences or Social, Behavioral, and Educational Research (SBER) Conference will meet ORD's requirements for training in ethical principles in human subjects protections.
• Certificate from Protecting Human Research Participants (previously offered by NIH)
• Dunn CM and Chadwick G. Protecting Study Volunteers in Research: A comprehensive manual designed to assist clinical research professionals in providing the highest standards of safety and ethical treatment for their study volunteers: Developed in accordance with ACCME standards, readers can apply for CME credits and Nursing Contact Hours. An exam is provided with each manual. Manuals can be ordered off Amazon.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 ORD CITI Training Administrators at CITI.Training@va.gov.

Questions about the R&D website? Email the Web Team

Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.