University of Vermont

Human Subjects Research - Institutional Review Boards - IRBs

training_faqs

Required Human Subjects 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. Alternatively, collaborating researchers may add or change their affiliation to UVM through CITI to register their completion. 
  • 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?   

Link to CITI’s page: https://www.citiprogram.org
To begin the training process, click the link above and then click “Log In” which is located at the top right of the CITI page. Then, click "Log In Through My Institution", click “University of Vermont” and use your UVM Net ID and password to sign in.

For additional training instructions, CLICK HERE.

 

What Information Do I Need to Complete the Program? 

A UVM NetID and password is required to register your training 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 training.

 

Which CITI Course(s) Do I Need to Take?

You may currently complete either the "Biomedical Research" or the "Social Behavioral Education Sciences" course. Both courses meet the required training for human subjects research, so you may decide what you want the focus of your content to be.

 

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.

 

How do I Document that I have Completed the Training? 

A certificate of completion can be obtained from your CITI main menu at any time. Additionally, you may go to our training completion page to view the list of people who have completed our required training.

 

Why Is My Name Not Showing in the Completion List?

There are a few different possibilites why this may be the case:

    • If you didn't sign into CITI via SSO (i.e. with your UVM NetID and password), your name will not appear on the list. If you do not have a UVM NetID, please see "What Information Do I Need to Complete the Program?"
    • Make sure you completed the appropriate course. See "Which CITI Course(s) Do I Need to Take?" for details.
    • The completion list updates every morning, so if you just completed the course today, please wait a day to find your name in the dropdown.

 

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.

 

What is the passing grade for the required training?

You must achieve an average score of at least 85% across all required modules of the course you're taking.


Good Clinical Practice Training FAQs

            

What is Good Clinical Practice (GCP)?
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.  Compliance with GCP provides assurance that the study data are credible and accurate and that the rights, safety, confidentiality and well-being of research participants are protected.

Is GCP training the same as Human Subject Training?
No. GCP training is a separate training and is not basic human subjects protection training.  GCP principles are specific to clinical trials.

Who is Required to Complete Good Clinical Practice Training?
GCP training is required for all investigators and staff who are involved in the conduct, oversight or management of clinical trials involving Human Subjects irrespective of funding source supporting the research activity.  

Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For more information, see the NIH definition of clinical trial here.

Do my lab technicians need to complete GCP training?
Lab technicians who are listed as key personnel are required to complete GCP training.  It is essential that the entire study team be in the mind-set to protect subjects’ rights and assure data integrity from the bench to the bedside.  Lab technicians are equally responsible as other members of a research team for ensuring data integrity.  If a lab technician does not follow good practices and that results in data that cannot be used, then the subject’s participation is for not. 

What are the GCP requirements for collaborators who are listed on my protocol, but are not affiliated with either UVM/UVMMC?
Collaborators are required to complete GCP training through CITI.  If the collaborator has completed CITI at their respective institution, they need to associate that training with the University of Vermont.  CITI instructions to associate with another institution are below.

Add/Change Affiliated Institution

I am a social behavioral researcher, do I need to take GCP?
Yes, GCP training is required for all UVM/UVMMC investigators and clinical trial staff involved in a clinical trial, regardless of funding source.

Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For more information, see the NIH definition of clinical trial here.

When should the GCP training be completed?
GCP training must be completed for all key personnel listed on new protocols prior to submission.  New protocol approvals will not be released until all individuals on the protocol have met this requirement.

How Often Do I Need to Retake GCPs?
Every three years, all key personnel still listed on an active clinical trial are required to complete GCPs refresher training.

Which CITI Courses Meet the Requirement?
Take one of the following
-If engaged in international research then the ICH focus course would be more applicable to you.

U.S. FDA Focus

GCP for Clinical Trials with Investigational Drugs and Medical Devices
GCP FDA Refresher (The refresher should be taken every 3 years subsequent to the completion of the course above)

OR

ICH Focus

GCP for Clinical Trials with Investigational Drugs and Biologics
GCP ICH Refresher (The refresher should be taken every 3 years subsequent to the completion of the course above)

Last modified June 21 2017 11:42 AM

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