SCSU Research Protection Office
Office: Engleman Hall, Wing D, Room D220
Phone: (203) 392-5243
Dear SCSU Researchers,
As you are all aware, we are in a period of time when close contact with others increases risks for both individuals and society. Therefore, all human subjects research that involves in-person contact, including recruitment, data collection, and lab meetings, should be paused. While it is likely that much of this has already happened due to the loss of access to university facilities and the request of the Governor, any in-person human subjects research that remains active should cease by pausing, amending, or closing the research and notifying the SCSU IRB as appropriate.
COVID-19 makes the risks of the in-person recruitment and data collection greater than the benefits of the research, and research that is not devoted to the public health crisis is not essential. Therefore, investigators are urged to find methods that allow for remote recruitment of and data collection from research participants.
Researchers who feel that their in-person human subjects research is essential to society should present the reasons for that conclusion.
Research that involves remote or online activities may be continued at this time.
Pauses. Pausing research does not require researchers to notify the IRB. It simply means that recruitment and data collection is halted at the discretion of the Principal Investigator. This research can be resumed when the crisis has passed. Researchers need only notify the IRB if the research is to be amended or closed.
Amendments. Any amendment to approved research must be submitted to the IRB. If an in-person research study is to be moved to online activities, an amendment which outlines the new procedures and includes all relevant updated documents must be submitted for review and approved before the changes can be implemented. These amendments can be submitted through Kuali Protocols. PLEASE NOTE: It should be clear in the amendment request as to whether the amendments SUPPLEMENT or REPLACE in-person activities. If the amendments will replace in-person activities, an amendment will also be needed when this crisis ends, and in-person research activities resume.
If currently enrolled participants will move from in-person to online research procedures, a second consent process should be conducted as the conditions under which they decided to participate have changed.
If a project was submitted prior to August 2019, researchers should email the IRB Chair (firstname.lastname@example.org). As research approved prior to August 2019 was submitted using the old paper application, a new application may need to be submitted through Kuali Protocols.
Closures. Investigators have the responsibility of closing their research when data collection has ended. If a human subjects research study cannot be paused or amended due to the current crisis, it should be closed. Research that will be ended as a result of the pandemic should be closed using the appropriate IRB process, either in Kuali Protocols or the form found on the IRB website.
Please also know that while the protocol submission process and review is now online through Kuali Protocols, the ability of the IRB to conduct reviews will likely be affected by the switch to becoming an online university for the semester. In general, we expect that it will take longer than usual to review protocols. Researchers should plan accordingly.
W. J. Hauselt, PhD., Chair, Institutional Review Board
Christine C. Broadbridge, PhD., Executive Director, Research & Innovation
Robert Prezant, PhD., Provost and Vice President for Academic Affairs
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.
Previously approved research protocols submitted using a hard copy application will continue to use the paper forms until that research is completed. The forms MUST be submitted in hard copy to the IRB through the Office of Sponsored Programs and Research (EN B213).
All submissions are reviewed in the order in which they have been received. IRB review normally takes two weeks, so plan accordingly.
Research found to include more than minimal risk (research that involves risks to participants that are greater than those presented by everyday life) must be reviewed at an IRB meeting. The schedule of meeting and submission dates for more than minimal risk research is below. All other research will be reviewed within two weeks of submission.
Before submitting a new protocol, please read through the IRB bulletins webpage for updated news regarding the IRB application that will be effective January 19, 2018!
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 http://inside.southernct.edu/spar.
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.
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: https://inside.southernct.edu/rpp/irb/instructions-and-forms
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.