Applications for new research must be submitted to the IRB using the Kuali Protocols software. General instructions for creating a consent document and submitting a new protocol have been posted on the IRB Instructions and Forms webpage. Researchers should consult those documents prior to submitting any application.

Protocol Submission:

As of August 1, 2019, all NEW applications MUST be submitted through Kuali Protocols. If you would like to attend a training session on the navigation of the Kuali Protocols platform, please register for a session through the Office of Sponsored Programs and Research.

All submissions are reviewed in the order in which they have been received.  Please note that protocols should be submitted at least six weeks in advance of the anticipated project start date in order to allow IRB review and study investigator revisions to the protocol required by the IRB.

IRB Instructions and Forms Selection Page

Research found to include more than minimal risk (research that involves risks to participants that are greater than what is encountered in everyday life) must be reviewed at a full board IRB meeting.  The IRB meets on the third Friday of each month; for protocols that require full board review, they should be submitted in Kuali no later than the first day of the month in which the protocol is to be reviewed.  All other research will undergo initial review within two weeks of submission in Kuali. 

The Southern Connecticut State University (SCSU) Institutional Review Board (IRB) is responsible for safeguarding the rights and welfare of human participants in research. The IRB subscribes to the basic ethical principles for the protection of human participants in research that underlie The Belmont Report, and adheres to federal regulations published in The Federal Register, codified at Title 45 part 46, and to the terms of the U.S. Department of Health and Human Services' Office of Research Protections' Federalwide Assurance for the Protection of Human Subjects.

The IRB Purview:

The IRB's purview extends to: (1) all human research conducted by SCSU faculty, students, staff, administrators, or others who wish to conduct research under the auspices of SCSU; (2) all human research conducted on the SCSU campus or in cooperation with other research agencies and sites, regardless of whether the project is funded externally, internally or receives no funding support. 

The IRB, through human research protocol review, assures that: (1) anticipated risks to human research participants are balanced by benefits to the individual and society; (2) selection of participants is just and equitable; (3) research designs are appropriate to protect human research participants; (4) anonymity, privacy, and confidentiality of participants is not compromised; and, (5) when applicable, research participants have given knowledgeable, voluntary and autonomous consent to take part in the research.

The IRB reviews all new research project protocols, project continuances, and revisions in approved research, and renders decisions regarding: (1) exemption from IRB review and review level; (2) the need for protocol modification; (3) protocol approval; and, (4) protocol disapproval. 

Human Subjects Training: 

Investigators who wish to submit an Application for Human Research Review must have completed Human Subjects Training within the last three years. 

SCSU has joined the Collaborative Institutional Training Initiative (CITI), which makes a large range of training opportunities in ethical conduct of research available at no cost to the individual.  SCSU will accept documentation of the training from the previous NIH tutorial, or preferably, from the CITI Online training program now available at no cost to all SCSU faculty and students.  More information on the CITI program (how to register, the course catalog) can be found at SPAR website.

There are several courses available for researchers to complete.  The Social & Behavioral Research - Basic course is required for protocol submission.  Researchers are free to take as many training courses as they wish.  The IRB may recommend other courses depending upon the nature of the research once an application is submitted.  

The CITI Completion Record for all study personnel should be submitted along with the research protocol. 

Policies and Procedures for Responding to Allegations of Non-compliance with IRB Procedures

Course Instructor Notification: 

At SCSU, student human research participant activities which are completed in partial fulfillment of requirements for a course and are intended only to provide research training may only need to be submitted to the course instructor for notification prior to the collection of data, provided the instructor has an approved Course Instructor Notification Form on file with the SCSU IRB. This is not appropriate for undergraduate honors theses, MA theses or special projects.  Applications for course instructor certification may be obtained on line at the IRB Instructions and Forms Selection page.

External Investigators:

SCSU welcomes investigators from external agencies who wish to conduct human participant research on the SCSU campus with SCSU students, faculty, staff and administrators. Depending on the level of external research involvement, investigator responsibilities will vary. Please see External Investigator Responsibilities online here.