Human Subjects Institutional Review Board
COVID-19 Research FAQ
The 2019 novel coronavirus is impacting both our personal and academic lives, and the Castleton University HSIRB places the health of all individuals as a priority. Effective March 25, 2020, all researchers are required to stop all in-person research activities and person-to-person recruitment immediately.
What research activities must be stopped?
All in-person interviews, in-person surveys, in-person research procedures, and in-person recruitment methods must be stopped at this time, regardless of any promises to maintain physical distance between individuals.
What types of research are permissible?
Online research and digital data collection that do not require person-to-person contact may continue as planned. This includes online surveys and interviews conducted via Zoom or other secure video software.
What should I do if I want to submit a modification to move my research to online formats?
Submit any proposed changes to your proposal in an e-mail message to the HSIRB (HSIRB@castleton.edu). Revised consent forms should be submitted as links or attachments. The HSIRB will review your proposed changes as quickly as possible.
Is the HSIRB operating as usual?
Yes, the HSIRB is operating as usual, albeit in an online environment only. The board will meet remotely if projects requiring full review are submitted.
When can I begin meeting with research participants in person again?
The HSIRB will evaluate communication from the university, the state of Vermont, and our regional and national colleagues to determine when researchers may continue in-person research and recruitment procedures. The HSIRB office will communicate this information by email and keep the HSIRB web site current.
This page will be updated periodically. For answers to other questions, please e-mail the HSIRB at HSIRB@castleton.edu.
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 Chair, Francesca Catalano, 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 the HSIRB 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 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 Administrator 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 one month 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.
Should 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. 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?
Beginning in January 2020, 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. A PDF or completion link should be emailed to the HSIRB. 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 Chair, Francesca Catalano.
Human Subjects Institutional Review Board Forms, Templates, & Training
Request for Review Form
Informed Consent Template
IRB Policy Procedures
Human Subjects Institutional Review Board Members
- Justin Carlstrom
- Megan Blossom
- Leigh-Ann Brown
- Carol "Gert" Mayes (community member)
- Margaret Miles
- Samantha Sarno
- Gerry Volpe