Human Subjects Institutional Review Board

The Castleton University Human Subjects Institutional Review Board (HSIRB) is an ethics committee designed to review research at Castleton 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?

You should ask.  All you need to do is contact the Human Subjects Institutional Review Board Administrator, Amanda Richardson, 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 Castleton 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 Administrator to see if your project needs review.

How do I submit my project for review?

You can complete the Request For Review Form and email it along with the additional requested documentation to the HSIRB Administrator, Amanda Richardson, for review.

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 Adminstrator 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 will receive feedback on your submitted protocol within a week of submission.  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. 

Should you know that you have a small window for research or a deadline, please contact the HSIRB Administrator 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 Administrator to see what is necessary.  Should the work only be part of an assignment shown only to the instructor and not presented publicly or published in any way, it may not need review.  However, class projects/assignments are often an excellent opportunity to educate students about research ethics.

Do I need any training before I can submit an HSIRB project?

Yes, as of January 2018 all researchers (students and faculty), must provide their certificate of completion to the NIH Office of Extramural Research's Protecting Human Research Participants online training.  As of September 2018, the online NIH Training is no longer available. If you are a new Investigator and need to complete a training, please contact the HSIRB for assistance. The HSIRB is currently looking into finding a replacement training. If you have previously completed the required training, please submit your certificate with your HSIRB request for review materials.

Who should I contact with questions?

The Human Subjects Institutional Review Board Administrator, Amanda Richardson.

Human Subjects Institutional Review Board Forms, Templates, & Trainings

Request for Review Form

Informed Consent Template

NIH Office of Extramural Research's Protecting Human Research Participants Online Training

IRB Policy Procedures

Human Subjects Institutional Review Board

Amanda Richardson, Administrator
Megan Blossom
Amy Bremel
Leigh-Ann Brown
Rich Clark
Peter Kimmel, Chair
Korrine Rodrigue