Options for Fulfilling ORD Training Requirements
NOTE: Training in ethical principles on which human subjects research is to be conducted is required every 3 years for VA Investigators conducting human subjects research and their research staff.
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. 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.
VA now also requires training every 3 years for all voting R&D Committee members (including the Chair), which consists of the two required Ethics Modules included in each stage of the training for Human Subjects Protection. This is set up for each VA facility as a separate course, and it is recommended that each member of the R&D Committee be encouraged 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
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.
To change your station's options 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.) Whether your VA facility wants to have the renewal interval for the Human Subjects Protection course changed. The default is annual renewal, and it may be set to any number of years up to 3 years. If this is done, all currently valid completion certificates will also be updated accordingly.
2.) If your VA Facility wishes to have ORD approval of the affiliate's CITI modules or training required by another federal agency as meeting ORD training requirements, please submit a list of those CITI modules to both email@example.com and VHACOORDRegulatory@va.gov.
3.) GCP training in CITI that is certified by TransCelerate BioPharma as satisfying the requirements for mutual recognition has now been set up for VA Facilities. If there are investigators at your VA Facility who are required by their research sponsors to complete GCP training, it is recommended that these courses be turned on for your VA Facility. These courses can be turned on for your VA Facility by either the ACOS/R&D or AO/R&D submitting a request to Dr. Alice Huang (firstname.lastname@example.org) to request it.
Some Investigators and research staff have continued to use the GCP training modules that used to be part of the training that VA required for all research with human subjects. Please be aware that those modules are known to be out of date and will not be updated. Access to those modules will be turned off after October 1, 2020.
Some VA Facilities had custom GCP courses set up previously for your stations, based on the TransCelerate certified curricula. If those custom courses contain the same modules as are required for the new courses, learners who completed the VA Facility’s custom training will get credit for the new training when the learners enroll in it. Please note though that the courses that satisfy the requirements for mutual recognition were updated a few years ago, so if the VA Facility’s custom course was set up before that, the modules in it will not match those in the current course, and learners who completed the custom training will still have to take the new course to get credit. It will be worthwhile in any case to have everyone switch over to the new training, as that is the training that will be updated as needed for all VA stations.
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. George Lathrop (email@example.com) or Dr. Alice Huang (firstname.lastname@example.org).
ALTERNATIVE TO CITI: VA COURSE FOR VA RESEARCH PERSONNEL THAT MEETS ORD'S REQUIREMENTS FOR TRAINING IN ETHICAL PRINCIPLES DURING COVID-19 PANDEMIC
Name and Description of Course
Human Subjects Protections Training: For VA Research Personnel Conducting Human Subjects Research During COVID-19 Pandemic - ORD has developed a set of training slides to meet ORD’s training requirement in ethical principles for research personnel who are conducting VA human subjects research activities during the COVID-19 pandemic. This abbreviated training serves as an alternative to CITI training during the pandemic. 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 is required to be filed with your local research office as proof of your human subjects protections training.
The training course may be used to satisfy initial training and/or renewal of training requirements. Each VAMC can decide whether to adopt the use of this alternative training option during the COVID-19 pandemic and how it will be used at the respective facility. For example, facilities may opt to restrict its use to certain research personnel or to only those personnel who are renewing their human subjects protection training. Facilities choosing to use this option must update all impacted research program SOPs to include use of this training option as an alternative to CITI and the parameters of its use at the facility. SOPs should also reflect the time period by which the individual will need to complete CITI course requirements once ORD has indicated the phasing out of this alternative training option. For example, the following statement could be included in relevant SOPs: Research personnel who have used ORD’s alternative Human Subjects Protections Training for VA Research Personnel Conducting Human Subjects Research During the COVID-19 Pandemic to satisfy human subjects protection training requirements must complete CITI human subjects protections training requirements within one year of the date that ORD ends use of the alternative course.
ALTERNATIVE TO CITI: VA COURSE FOR VA PERSONNEL THAT MEETS ORD'S REQUIREMENTS FOR TRAINING IN ETHICAL PRINCIPLES FOR EXPANDED ACCESS PROGRAMS FOR TREATMENT OF MONKEYPOX
Name and Description of Course
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.
Name and Description of Course
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.