Institutional Review Board - Human Subjects Committee

We Want to Protect Your Rights

In compliance with Federal laws and regulations, Fitchburg State University (FSU) has established an Institutional Review Board (IRB) for reviewing research with humans, known as the Human Subjects Committee (HSC). The primary goal of the Institutional Review Board (IRB) is to protect the rights and welfare of those individuals who agree to participate in research.

All research involving the use of human subjects conducted by Fitchburg State University faculty, staff, or students, or sponsored, in part or in whole, by Fitchburg State must be reviewed and approved prior to the start of the project and then conducted in full compliance with IRB policies and procedures.

Prior to Submitting an IRB Application

Prior to completing an application, please review the Fitchburg State University Institutional Review Board Policies and Procedures (PDF)

Prior to submitting an IRB proposal, the Human Subjects Committee requires that each member of a research team (including faculty advisors) complete the National Institutes of Health's (NIH) Human Participant Protections Education for Research Teams

This free, web-based course presents information about the rights and welfare of human participants in research. You will need to register to take the tutorial however there is no charge for it. The two-hour tutorial is designed for those involved in conducting research involving human participants. It satisfies the NIH human subjects training requirement for obtaining federal funds. You will have the option of printing a certificate of completion from your computer after completing the course. Certificates of completion are good for 3 years from the date of completion.

Beginning in January 2018, all proposers and investigators submitting new or renewal applications to the IRB will be required to demonstrate completion of the CITI collaborative training modules. These modules will replace NIH training that was previously accepted and include Responsible Conduct in Research and IRB specific modules. For more information on the CITI program, and applicable training modules that may be required, please see the information below or contact the IRB chair or the Faculty Scholarship Coordinator, Dr. Meg Hoey.

The Application Process

First, download a copy of the Fitchburg State University Application for the Conduct of Research Involving Human Subjects (PDF). Please open this file in Adobe Acrobat or similar PDF viewer instead of your default web browser.

Steps:

  1. All members of the research team (including faculty advisors) should complete the online National Institutes of Health's (NIH) Human Participant Protections Education for Research Teams tutorial
  2. Applicants should review the IRB Policies and Procedures manual
  3. Applicants should complete the Fitchburg State University Application for the Conduct of Research Involving Human Subjects. Your responses to each question/item should be explained in language simple enough for a layperson to understand. In addition, the application should be filled out completely. Applications will not be reviewed until complete.
  4. Applicants should submit a completed application, including a signed copy of the signature page and certificates of completion for the online NIH tutorial, along with any relevant supporting documents (e.g., copies of surveys, informed consent forms) via email to: humansubjects@fitchburgstate.edu

Please Note: The Signature Page of the application must be signed in order for applications to be reviewed. Signed applications may be scanned (into PDF format; photos of signature pages will not be accepted) and emailed to the committee.

Other Forms:

Informed Consent

Most research studies will require obtaining informed consent from participants before data collection can begin. We are happy to consult with you on drafting an appropriate consent form for your study, so please don't hesitate to contact us.

IRB Meetings

The IRB meets regularly throughout the academic year. We urge proposers to carefully review guidelines and consult with the IRB chair or an IRB member if they are unsure about what constitutes a complete application.

  • Meetings are scheduled typically on Wednesdays.
  • In order for committee members to have adequate time to review your materials prior to the meetings, complete applications (and supporting materials) must be received six business days prior to a scheduled meeting for applications designated for expedited review. Applications designated for full IRB review will take longer.
  • Meeting minutes are available upon request. All meetings are open and applicants may elect to attend meetings if they so choose (although this is not required).
  • The Human Subjects Committee only reviews time-sensitive applications during summer months (e.g., those needing approval to ensure grant funding). Applications deemed not to be time-sensitive will be reviewed in the next Fall semester. Those who wish to focus on summer research are encouraged to submit their complete applications to the IRB no later than 15-April.

Meeting Dates for Fall 2017:

Note: The IRB has set a goal to provide a 5-business day turnaround for first-time submission of complete proposals that may be subject to expedited review and a 10-business day turnaround for first-time submission of complete proposals which require a full IRB review:

  • November 15th
  • November 29th
  • December 13th

Contacting the Human Subjects Committee

We're here to help! Please don't hesitate to contact the Human Subjects Committee with any questions at humansubjects@fitchburgstate.edu

Current Membership of the Human Subjects Committee

  • Thomas Schilling (Chair, Psychological Sciences)
  • Wayne Whitfield (Industrial Technology)
  • Lena Ficco (Psychological Sciences)
  • Denise LaFrance (Education)
  • Monica Maldari (Exercise and Sports Science)
  • Katharine Covino-Poutasse (English Studies)
  • Robert Hynes (Counseling Services)
  • Heather Layton (Community Member)
  • John Schaumloffel (Academic Affairs, ex-officio)