We Want to Protect Your Rights
In compliance with Federal laws and regulations, Fitchburg State University 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. Jennifer Hanselman, firstname.lastname@example.org.
- Fitchburg State University RCR and IRB Training Guidelines (PDF)
- CITI Collaborative Institutional Training Initiative
The Application Process
The Fitchburg State Application for the Conduct of Research Involving Human Participants is now a dynamic form. Please review the IRB Policies and Procedures Manual prior to initiating the application. Each member of the research team must complete online CITI training based on their status prior to submission. At a minimum faculty, staff, and administrators must complete: Conflicts of Interest as well as Faculty/Researchers/Staff/Administrators Responsible Conduct of Research. Note: Additional training may be required based on the type of research being conducted and the researcher's role in the project. Training requirements for students also will depend on the type of research being conducted and the students' roles in the project. Please contact the IRB Chair with any questions at email@example.com.
- The research team should select one member of the research team to initiate and complete the initial draft of the application. This designee can be a member of the Fitchburg State faculty, staff, or administration, or can be a student. (Note: Students are required to have a faculty research advisor to complete an application and conduct research with human participants.)
- All supporting documents and materials (e.g., Informed Consent/Assent, Recruitment materials, Surveys, etc.) should be uploaded as PDFs as instructed in the application
- Certificates of completion for all required CITI training for each researcher should be uploaded as PDFs as instructed in the application
- Once the designated individual has completed and submitted the initial draft of the application, an email will be automatically sent to each researcher listed on the application so that they can review the application. Each member of the research team should either electronically sign and approve the application, or send the application back for revisions.
- Once the application has been approved and electronically signed by all researchers listed, it will automatically be submitted to the IRB Chair.
- 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.
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 15.
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 firstname.lastname@example.org.
Current Membership of the Human Subjects Committee
- Katharine Covino-Poutasse, email@example.com (English Studies)
- Melissa Dunn, firstname.lastname@example.org (Nursing)
- David Heikkinen, email@example.com (Exercise and Sports Science)
- Robert Hynes, firstname.lastname@example.org (Director, Counseling Services)
- Jennifer Hanselman, email@example.com (Academic Affairs, ex-officio)
- Karen Keenan, firstname.lastname@example.org (Exercise and Sports Science)
- Yang Liu, email@example.com (Business Administration)
- Robert Shapiro, firstname.lastname@example.org (Education)