Frequently Asked Questions
What is the Simmons University Policy on the protection of human subjects?
In accordance with federal regulations, all research involving human subjects conducted at Simmons University or conducted by Simmons University faculty, staff, or students must be reviewed and approved by the University's Institutional Review Board (IRB).
Why is this policy important?
Federal regulations mandate that all research involving human subjects be formally approved by the IRB. If this policy is not complied with the University is at risk for losing its federal funding including funding of student programs (e.g., federal financial aid to students).
Review of research by the IRB maintains ethical standards for the conduct of research by protecting subjects, investigators and the University. This policy has been endorsed by the President's Council.
How does this policy affect me?
This policy applies to all Simmons University faculty, students, and staff who are conducting research as defined above. Specifically, all research conducted as part of class requirement is subject to this policy, as is any research conducted by faculty or staff, with or without outside collaborators.
What is the role of the Simmons University IRB?
The IRB is fulfilling a federally mandated function:
- The IRB reviews projects for their risk/benefit ratio to human subjects. While our role is not one of scientific merit review, this is taken into consideration when assessing risk/benefit.
- The IRB will work with researchers to develop proposals.
- The IRB provides education to the Simmons community about human research subjects' protections.
Simmons University is providing education through a web based training program in human research subjects' protections—CITI Program.
What constitutes human subjects research?
You are conducting research any time you systematically and purposefully obtain information by asking questions of and/or observing people in order to gather data for the purpose of generating knowledge. This definition applies to a classroom assignment, paper, presentation, pilot study, research project, thesis, or dissertation.
What is a human subject?
A human subject is defined as any living person. Research involving laboratory animals is approved and monitored by the University's Animal Care and Use Committee.
How does the IRB evaluate studies conducted for a class assignment?
A study is considered a "student class project," if it is a systematic investigation that students conduct as assignments designed to teach human research methods, where the results and data are not being disseminated outside of the classroom. This excludes all faculty research and any graduate research relating to thesis or dissertation.
Class projects cannot involve the following participants: institutionalized persons, persons unable to consent, children or members of a subject pool. Data collected for class projects is the student's data and should not be utilized by faculty or instructors without the student's express written permission. Faculty and instructors are not permitted to use class projects as a means of collecting data for their use.
Training Requirements: Supervising faculty or instructors must complete the CITI human subjects protection educational training. The IRB requires that students also complete this training. Supervising faculty / instructors are responsible for the ethical conduct of class project research.
Where should I submit my IRB protocol?
Please submit your protocol to the Office of Sponsored Programs via [email protected] as email attachment. If you are a student in the online Nursing program, your protocol must be signed off on by your instructor and sent to Professor Patricia Rissmiller who will forward it to the IRB. Hardcopy submissions will not be accepted. Please allow up to five business days for initial feedback, and ten business days for approval.
If you have questions about the types of projects requiring review by the IRB, what forms to use, and CITI training please direct them to the Human Protections Administrator via email or 617-521-2415.