Institutional Review Board
The University's Institutional Review Board (IRB) is charged by the University President with the responsibility of reviewing research proposals for the purpose of protecting the rights of individuals who are subjects of any research, conducted by faculty, staff, or students of Simmons University. Federal Regulations place responsibility on the University and the Principal Investigator to insure that high ethical standards are maintained for all research involving human subjects. Simmons University provides education through a web based training program in human research subjects' protections—CITI Program (see below).
New Federal IRB Guidelines - effective January 21, 2019
New federal guidelines regarding human subjects in research took effect on January 21, 2019. All IRB applications approved on or after that date are subject to the new guidelines.
CITI IRB training modules have been updated in accordance with the Revised Common Rule. Please note, if you will be submitting a new protocol on January 21, 2019 or later, you will need to complete the new CITI IRB training, even if your certificate under the old training has not yet expired.
Key changes include revised definitions of human subjects and interventions, as well as an updated lists of activities deemed not to be research, revised categories of vulnerable populations, and changes related to informed consent.
Please email us with any questions you may have.
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, Room E-206, MCB or send them as an 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.
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.
NOTE: Nursing@Simmons students should first contact Professor Patricia Rissmiller with their questions regarding the submission of IRB protocols.
Beginning September 1, 2010, the Simmons University Institutional Review Board (IRB) will require all individuals conducting research involving human subjects through the University to complete the CITI (Collaborative Institutional Training Initiative) Program, a web-based human subjects research investigator education program and include their certificate of completion in their IRB packet.
The Simmons University IRB has defined the curriculum for this course, in accordance with your role in Human Subjects Research. While most Simmons researchers will take the Social Behavioral and Educational (SBE) courses, if you are conducting research involving collecting human biological samples or specimens, you will need to take the Biomedical course. Students who must take the biomedical course should select the Students with Projects Involving Biological Specimens learner group, unless otherwise advised.
For projects submitted after January 20, 2019: All investigators with new protocols being reviewed and approved on or after January 20, 2019, must complete the new CITI training modules. NOTE: You must complete the revised CITI training modules, even If you have a current CITI certificate that has not expired.
While most students will take the 'students conducting no more than minimal risk research' curriculum, research advisors may require more extensive training. Please check with your advisor about which course you are required take. Faculty supervisors will need to complete the Social and Behavioral Educational (SBE) IRB training for investigators, not the student version.
Instructions for investigators with a current CITI certificate that has not expired: If your certificate has not yet expired, please access the course that you completed and choose the 'Review' option for each module. Review the materials, which were updated on January 20, 2019, and re-take the quizzes.
Do not take the "New Common Rule" course. That course just summarizes all the changes, it doesn't 'teach' human subjects protection content.
NOTE TO FACULTY RESEARCH ADVISORS REGARDING CITI TRAINING: Faculty supervisors will need to complete the Social and Behavioral Educational (SBE) IRB training for investigators, not the student version. Completion certificates must be either filed with student protocols or placed on file at email@example.com.
Researchers will have to register with CITI Program and sign in to complete the modules and take the quiz at the end of each session. If you are currently affiliated with other institutions that use CITI, our program compares the modules you need for Simmons with the ones you've already completed elsewhere and will prevent duplication of efforts. It will direct you to only the remaining modules that need to be completed.
CITI Registration Instructions — please read completely and carefully.
For new users, below is the link for registering CITI system. Please affiliate yourself with Simmons.
You must select a course and a learner group. You want to select the Human Subjects Research Courses course and then choose the appropriate learner group level.
Student Researchers who are conducting minimal risk research should choose Students. Students must complete the required modules plus 1 elective module to generate a certificate of completion.
Other Researchers, such as faculty, and students involved in more than minimal risk research should select Social & Behavioral.
Do NOT select the Responsible Conduct of Research (RCR) course, unless you have been specifically asked to do so.
Click on the 'How do I register?' link under Help & Support for detailed instructions on how to register.
If you have already registered and thus have a user name and password access the CITI training.
New Federal guidelines regarding human subjects in research took effect on January 21, 2019. All IRB applications approved on or after that January 21, 2019 are subject to the new guidelines. All IRB applications approved on or before January 21, 2019 are subject to the pre-2018 guidelines. Please select the appropriate forms and guidance below.
Guidelines and Templates
- IRB Manual: Instructions to Investigators
- Levels of Review
- IRB Project Description Template
- IRB Checklist
Forms and specific guidance for protocols being submitted for the first time on or after January 21, 2019
- Research Project Cover Sheet
- Overview of Changes to Informed Consent under the Revised Common Rule
- What should an informed consent include? - under Revised Common Rule
- Continuing Review Cover Sheet - Required for active Full Review projects and may be requested by IRB on a case by case basis
Forms and specific guidance for projects approved by January 20, 2019
Note: All projects approved on or before January 20, 2019 that will continue beyond 1 year are subject to Continuing Review.
- What should an informed consent include? - under pre-2018 Common Rule
- Continuing Review Cover Sheet - for projects continuing beyond 1 year that are subject to pre-2018 Rule
- Transition Form to Revised Common Rule - Please submit the Transition form with your continuing review materials.