SCSU Research Protection Office
Office: Engleman Hall, Wing D, Room D220
Phone: (203) 392-5243
Chairperson: W. Jerome Hauselt, PH.D.
Assistant Chair: William R. Lunn, PH.D.
COVID Update on Human Subjects Research
Although the campus has reopened, all research that involves human subjects and requires in-person (face to face) contact, including recruitment, data collection, testing, and lab meetings, remains paused.
We fully understand the disruptive challenges that the pandemic has brought to those conducting human subjects research. It remains the case that all research that involves human subjects and requires in-person (face to face) contact, including recruitment, data collection, testing, and lab meetings, remains paused.
However, in an effort to continue research within the confines of keeping all individuals safe while recognizing the critical need for research, the University has implemented a mechanism to allow those researchers who cannot conduct their research remotely and/or may face a catastrophic loss of external funding or other significant hardship to request a waiver, on a case-by-case basis, for consideration through a designated COVID-19 research approval process.
Information about the process and what must be submitted can be found at https://inside.southernct.edu/rpp/face-to-face-research.
Please note that this process does not replace IRB review, which should be accomplished prior to submitting the waiver request.
Waivers are not automatic. Individuals planning human subjects research for the Fall 2020 or Spring 2021 semesters, especially faculty who are advising student research, remain strongly advised to consider using online methods of data collection. Online methods of surveying and interviewing human subjects present no COVID-19 exposure risk, and for that reason have proceeded unhampered since the start of the pandemic. Moreover, research using these methods will be able to continue should the campus need to be closed again in the future. Guidance for informed consent and online research has been posted at https://inside.southernct.edu/rpp/irb/instructions-and-forms to assist with the creation of or transition to online data collection.
NOTE: Faculty mentors and supervisors are required to ensure any student who is pursuing research using human subjects adhere to the following guidelines.
I. EXISTING RESEARCH (reviewed prior to 5/15/2020)
- Online Research
Research that involves remote or online activities may continue without modification at this time.
- In-Person Research
- Waivers. Waivers for face-to-face research may be requested. Information on waivers can be found at: https://inside.southernct.edu/rpp/face-to-face-research. Waivers are not automatic, and researchers must document additional virus-related training, safety procedures, and the need for a waiver.
- Expiration of Approval. Researchers are reminded to check to see if the IRB approval for their research has expired. Expired research is considered closed and should not be continued or extended. If a research approval has expired since the start of the COVID-19 crisis and needs to be continued, the research must be presented as a new study using Kuali Protocols before data can be collected.
- Pauses. Pausing research does not require researchers to notify the IRB. It simply means that recruitment and data collection are halted at the discretion of the Principal Investigator. This research can be resumed when the crisis has passed and the proposed methods can be carried out without modification. Researchers need only notify the IRB if the research is to be amended, continued, or closed. Researchers are reminded to adhere to any existing dates for required continuing reviews or annual reports.
- 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 that 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 or approval has expired. If a human subject research study cannot be paused or amended due to the current crisis, it should be closed using the appropriate IRB notification process.
II. NEW RESEARCH.
Faculty and students planning human subjects research, especially faculty research advisors, are strongly advised to consider online methods of data collection. Research studies using these methods were not affected by the closure of the campus last semester and will be able to continue should the campus need to be closed again in the future.
Waivers for face-to-face research may be requested AFTER successful IRB review. Information on waivers can be found at: https://inside.southernct.edu/rpp/face-to-face-research. Waivers are not automatic, and researchers must document additional virus-related training, safety procedures, and the hardship resulting from the suspension of face-to-face research.
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 See https://inside.southernct.edu/rpp/irb/instructions-and-forms). Researchers should consult those documents prior to submitting any application.
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.