Human Subjects Research - Institutional Review Boards - IRBs
Required Training FAQs
Who Needs to Complete the Human Subjects in Research Training?
- All individuals involved in the conduct of non-exempt research with human subjects, regardless of funding source, must complete the training. This includes anyone, including consultants and off-site personnel, who have direct contact with subjects or access to the research data. Consultants and collaborators from other institutions covered by Federal Assurance with the Office of Human Research Protections at the Department of Health and Human Services may provide certification of training from their own institution if their participation is not on site at UVM or UVM Medical Center.
- Personnel who are designated as the primary contact person for a specific protocol are required to complete the training regardless of whether they have subject contact or access to subject data so that they understand their regulatory responsibilities.
- Faculty who are listed as sponsors on student projects, course instructors for class projects, and students who are conducting non-exempt research are also required to take the tutorial.
Note: PIs and Faculty Sponsors (if applicable) who are listed on protocols that are deemed to be Exempt or Not Human Subjects are required to take the training, but other listed key personnel are not required to take the training.
When should the Training be Done?
We require that the training be complete for all key personnel listed on new protocols prior to submission. New approvals will not be released until all individuals involved with human subjects on the project have completed the training.
How Do I Access the Program?
The on-line training program (“Tutorial: Protection of Human Subjects in Research”) is accessible on the Committees on Human Research web site at http://www.uvm.edu/irb/tutorial/index.html.
What Information Do I Need to Complete the Program?
A UVM NetID and password is required to register your tutorial completion with our office. If you do not have a UVM Net ID, complete and submit the Request for UVM Net ID for Required Training form prior to beginning the tutorial.
Will Other Training Programs Meet this Requirement?
Completion of other training programs for local protocols will not meet the Committee’s requirement for training because a significant portion of the program addresses local policies & procedures. Consultants and collaborators from other institutions covered by Federal Assurance with the Office of Human Research Protections at the Department of Health and Human Services may provide certification of training from their own institution if their participation is not on site at UVM or UVM Medical Center.
What are the Requirements for NIH and Other Sponsors?
Our training generally meets these sponsors’ requirements.
How do I Document that I have Completed the Training?
You will receive a certificate after the registration via email. Also you may go to our website to print a certificate at any time.
How Often Do I Need to Be Retrained?
Every three years, all key personnel still listed on an active protocol are required to complete the entire tutorial again. The IRB will send a reminder as the anniversary nears. If training expires, that individual will be administratively removed from all active protocols. If the individual continues to work with human subjects after removal, it will be considered noncompliance.
Are There Other Types of Training?
The IRB has established a listserve of all active key personnel. Inclusion in this listserve is mandatory as long as you are working with human subjects. This listserve is used to disseminate new regulatory information and process changes.
In addition, the Committee has developed a consent module which would be appropriate for all consent designees to review.
Last modified January 28 2016 09:36 AM