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).
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 CITI Program campus administrator, Dr. Margaret Hoey.
- Fitchburg State University RCR and IRB Training Guidelines (PDF)
- CITI Collaborative Institutional Training Initiative
The Application Process
First, download a copy of the Fitchburg State University Application for the Conduct of Research Involving Human Subjects.
- All members of the research team, including faculty advisors, must complete the online CITI training based on their status. This includes the Responsible Conduct in Research training.
- Applicants should review the IRB Policies and Procedures manual
- 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.
- Applicants should submit a completed application to the IRB Chair through firstname.lastname@example.org. Completed applications should include the following::
- A signed copy of the signature page
- Certificates of completion for the online NIH tutorial,
- Any relevant supporting documents (e.g., copies of surveys, informed consent forms)
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.
- Fitchburg State IRB Change in Protocol Form (MS Word)
- Fitchburg State IRB Annual Update Form (MS Word)
- Fitchburg State IRB End of Project Report (MS Word)
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.
- More information or suggestions on creating informed consent documents
- An example of what an informed consent document should look like from Gallaudet University's IRB (PDF)
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 Tuesdays.
- 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 April 15th.
Note: Based on recent proposal turnaround time data and comparative data from peer institutions, the IRB has now set a goal of the following:
- 10 business days turnaround for first-time submissions of completed proposals that are subject to expedited review
- 15 business days turnaround time for first-time submissions of completed proposals which require a full IRB review.
Proposals for student research projects are thus encouraged to be submitted with in the first five weeks of the semester in which the project is to be completed.
Contacting the Human Subjects Committee
We're here to help! Please don't hesitate to contact the Human Subjects Committee or Karen Keenan (Chair) with any questions at email@example.com.
Current Membership of the Human Subjects Committee
- Karen Keenan, Chair (Exercise & Sports Science)
- Jessica Alsup (Exercise & Sports Science)
- Katharine Covino-Poutasse (English Studies)
- David Heikkinen (Exercise & Sports Science)
- Robert Hynes (Counseling Services)
- Margaret Hoey (Academic Affairs, ex-officio)
- Sara Levine (Psychological Sciences)
- Yang Liu (Business Administration)
- Thomas Schilling (Psychological Sciences)
- Robin Streb (Community Member)
- David Svolba (Humanities)