Frequently Asked Questions

• Submitting to the IRB

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).

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.

This policy applies to all Simmons University faculty, students, and staff who are conducting research. Specifically, all research conducted as part of a class requirement is subject to this policy, as is any research conducted by faculty or staff, with or without outside collaborators.

The Simmons IRB is fulfilling a federally mandated function:

• The IRB reviews projects submitted by faculty, staff, or students at Simmons 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 the risk/benefit to study participants
• The IRB will work with researchers to develop proposals the fulfill ethical requirements
• 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.

Student Researchers conducting not more than minimal risk research must complete 3 Social and Behavioral Research training modules and 1 elective.

Other researchers and students involved in more than minimal risk research must complete 8 Social and Behavioral Research training modules, plus 1 elective.

Please use your Simmons email address to set up your CITI Program account.

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. Please see the Office for Human Research Protections website for detailed information on what constitutes Human Subjects Research.

A human subject is defined as any living individual from whom you as a researcher collect data from.

You must wait to begin your research project and data collection until you’ve received written approval from the IRB. Human subjects research will not be granted approval retroactively.

We ask that investigators allow ten business days for feedback on their protocol and revisions to their protocol. The amount of time for full approval will depend on the complexity of the project and the risk involved.

A study is considered a "class project" if it is a systematic investigation that students conduct as assignments/projects 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 independent study, thesis, capstone project, 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 CITI training. The IRB requires that students also complete this training. Supervising faculty / instructors are responsible for the ethical conduct of class project research.

Yes, they need to submit their CITI training certificate or equivalent training certificate. You will need to attach the external investigator’s training certificate to your protocol in Cayuse.

If you are a student and the project is satisfying a degree requirement at Simmons University you will be required to submit to the Simmons University IRB, regardless of whether you have submitted to another institution's IRB.

If you are a Simmons faculty member and you are applying for IRB approval at another institution you should contact the Human Protections Administrator via [email protected] with the contact information of the external institution’s IRB and the submitted protocol. In most cases, an IAA (IRB Authorization Agreement) will be executed.

An evaluation project, otherwise known as a performance improvement project, is not human subjects research. A performance improvement project is defined as an investigation solely to evaluate whether putting research evidence into practice improves quality measures. You will be required to complete CITI training and submit a protocol to the IRB for official determination that it is a performance improvement project. If you publish the findings of the performance improvement project you must state that the project was determined to be a performance improvement project and not human subjects research by the Simmons University IRB.

Yes. You should be prepared to describe whether or not the data is publicly available and deidentified. You should also describe how the data is being stored and the measures in place to uphold confidentiality. The IRB will determine if approval is necessary.

These projects are dealt with on a case by case basis. We ask that you submit a description of your proposed research project to the Human Protections Administrator via [email protected]. The IRB will determine whether you should submit a protocol.

Studies that meet the definition of regulated research under the Common Rule may fit within one or more categories of "exempt" research. This does not mean that such studies do not need IRB review. In order for a research study to be deemed "exempt," investigators will need to submit a protocol to the IRB office via Cayuse, along with study related materials (e.g., consent forms, surveys, questionnaires, interview scripts/outlines, etc.). The determination of exemption must be made by an IRB reviewer. Please see the Office of Human Research Protections webpage on exempt research.

Modifications to exempt research should be submitted to the IRB for review and approval.

"Waiver of documentation of consent" means a participant may consent by oral or implied consent, versus a "waiver of informed consent," which could: (1) alter some or all of the required elements of informed consent, or (2) completely waive the requirement to obtain informed consent (with or without a signature). The IRB may approve a consent procedure which does not include or alters some or all of the required elements of informed consent provided all of the following are true:

• The research involves no more than minimal risk
• The waiver of informed consent will not adversely affect the rights and welfare of the subjects
• The signing of informed consent will expose participants to potential high risks that might affect the safety and well-being of the subjects
• It is not practicable to conduct the research without the waiver or alteration
• Whenever appropriate, participants will be provided with additional pertinent information after their participation.
• Examples of types of studies in which some or all elements of consent have been waived include retrospective chart reviews, studies of existing pathology specimens, ethnographic research, studies that require deception or passive (opt-out) consent.

The IRB will take into consideration the risks and potential harms involved in the research before granting a waiver of informed consent. Additionally, there are restrictions for when the IRB may waive the requirements for child assent and parental permission.

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 at [email protected] or by calling 617-521-2415.

NOTE: Nursing@Simmons students should first contact Professor Patricia Rissmiller at [email protected] with their questions regarding the submission of IRB protocols.