The VTSU Human Subjects Institutional Review Board (HSIRB) is an ethics committee designed to review research at VTSU to ensure human subjects are protected.
Institutional Review Boards are commonplace and are often required at educational institutions and other organizations that receive Federal funds.
How do I know if my project needs HSIRB review?
If you aren’t sure, you should ask. You can contact HSIRB@vermontstate.edu and explain a bit about your project.
The definition of “human subjects research” in this context is a systematic investigation that collects data from humans through intervention, interaction, or uses identifiable private information for the purposes of contributing to generalizable knowledge. Many forms of surveys, interviews, observations, and experiments led by faculty, staff, and students at VTSU meet this definition.
Whether or not a project needs HSIRB review can be complex and difficult to determine. To ensure compliance, you should contact HSIRB@VermontState.edu to see if your project needs review.
Do I need any training before I can submit an HSIRB project?
All investigators (including students and faculty advisers) need to complete the CITI Human Subjects Researcher, Social & Behavioral Research Basic Course. HSIRB will not review protocols until documentation of training completion is received. Instructions for completing this training as well as a way to submit evidence of completion are provided on the HSIRB canvas page. Please email HSIRB@VermontState.edu to request access to canvas and view instructions for completing the CITI training.
How do I submit my project for review?
The HSIRB manages a canvas page where all instructions, forms, policies, and other materials are provided. Please email HSIRB@VermontState.edu to request that you are added to the canvas page. You can request access to the canvas page at any time, even if you are not ready to submit your project.
To prepare for review, you will need to have all instruments (e.g., survey questions), participant/subject recruitment materials, a clear description of all study-related procedures, and consent documentation ready.
What does the HSIRB look for when it reviews protocols?
The HSIRB’s main concern is for the rights and welfare of research participants. It is guided by the ethical principles of the Belmont Report and the criteria established in Title 45, Part 46 of the Code of Federal Regulations (i.e., the Common Rule). Review includes weighing risk versus benefit, whether or not participation is truly voluntary, whether or not there are adequate protections for privacy and confidentiality of data, ensuring the informed consent process is adequate, to name a few.
Do all projects that get reviewed by the HSIRB go to the full committee (i.e., Full Board)?
No. Projects are first reviewed by the HSIRB administrator and/or chair to determine the level of review required. Levels of review include Exempt, Expedited, and Full Board. The level of review depends on several factors including the purpose of the project, the population under study, and the level of risk for subjects. Only projects that require Full Board review are sent to the full committee.
How long does HSIRB review take?
You should expect HSIRB approval to be finalized about one month from your submission date. If the project requires full board review, it may take longer than one month, depending on when it is submitted. You can expect initial feedback on your submitted protocol within two weeks of submission (although response time may be faster or slower, depending on how many proposals we receive). This may include a request for more information in order to complete the review and process your application. Most initial submissions need revisions prior to approval, so researchers should plan accordingly as projects cannot start until approval is received.
Protocols determined to need full board review will need more time for review to occur, as the board will need to discuss it at a monthly meeting. Meeting dates are posted on the HSIRB canvas page. Proposals that require full board review must be submitted at least two weeks before a scheduled meeting in order to be included on the agenda.
If you know that you have a small window for research or a deadline, please contact the HSIRB as early as possible to see if a more rapid review can be arranged. Please note: HSIRB approval cannot be granted after the project has already taken place. It must be done before any data is collected.
Do class or student projects need HSIRB review?
Maybe. Please contact the HSIRB to see what is necessary. If the work is only part of an assignment shown only to the instructor and not presented publicly or published in any way, it may not need review. However, we do request that faculty members overseeing these types of teaching activities register their class project via a separate process on the HSIRB canvas page. If you are a faculty member overseeing student projects that may need HSIRB oversight as part of a class you are teaching, please contact the HSIRB and request access to our canvas site so that you can review all relevant information and policies.
Who should I contact with questions?
You can reach the HSIRB at HSIRB@VermontState.edu. The current chair and/or administrator will respond at that email address.
