Human Subjects
The University has established policies on the use of human subjects in all Simmons-initiated research and training projects. The Institutional Review Board (IRB) is charged with reviewing, approving, and overseeing all research involving human subjects at Simmons University. Federal Regulations place responsibility on the University and the Principal Investigator to ensure that high ethical standards are maintained for all research involving human subjects. Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A human subject is a living individual about whom an investigator (whether faculty/staff or student) conducting research: 1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or 2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. Students undertaking research projects that propose to use human subjects must do the following prior to beginning their projects: 1) complete the Collaborative Institutional Training Initiative (CITI) Program, a web-based human subjects research investigator education program and 2) prepare and submit an application to the IRB for review and prior approval. Students are expected to follow the IRB Process for Student Researchers (included with CITI training) and work closely with their faculty advisor to ensure the submission is consistent and includes all required elements, and that the submission and review timeline is aligned with the course completion expectations. Incomplete or inaccurate submissions will delay the review process. A copy of the Simmons University human subjects research policy, IRB forms, and link to the CITI training program may be found on the Institutional Review Board (IRB) site. The contact for the IRB is the Center for Faculty Excellence (irbprotocols@simmons.edu). It is expected that all members of the Simmons community will fulfill their legal and ethical responsibilities to ensure that the rights and safety of human subjects are protected.