Institutional Review Board (IRB)

SCSU Research Protection Office
Office: Engleman Hall, Wing D, Room D220
Phone: (203) 392-5243

Chairperson: W. Jerome Hauselt, PH.D.
Email:  Hauseltw1@SouthernCT.edu 

Assistant Chair: William R. Lunn, PH.D.
Email:  Lunnw1@SouthernCT.edu

Resuming Face-to-Face Human Subjects Research

The CSCU System Office has set June 1, 2021 as the start date for a fuller return.  This page presents a method to accomplish this reopening for research that involves human participants.

SCSU will phase in face-to-face human subjects research according to the level of COVID-91 exposure risk presented by the research.  Some research may require a safety review in addition to regular IRB review.  Changes to the restrictions will be announced by email and this webpage.  The COVID-19 Exposure risk levels are:

Low Level:  Research involving minimal contact (interpersonal contact within 6 feet of participants for less than 15 minutes) and does not include methods that may produce aerosols.  Examples: Behavioral experiments or interventions with individuals or groups without physical contact.

Medium Level: Research involving increased contact (interpersonal contact within 6 feet of participants for more than 15 minutes) and does not include methods that may produce aerosols.  Examples: Research involving some level of physical contact, such as noninvasive instruments [e.g., eye tracking, physical examinations, balance testing and neurological exam], blood pressure measurements, sleep evaluations, audiology assessment) the collection of blood, saliva samples.

High Level: Research involving increased contact (interpersonal contact within 6 feet of participants for more than 15 minutes) and does include methods that may produce aerosols.  Examples: Research involving the collection of blood, urine, saliva samples, exercise, cardiovascular stress testing, pulmonary function tests, infant-child studies that may induce crying, and research studies involving active COVID-19 patients.

 

Beginning June 1 2021, research at the Low Level of exposure risk can be conducted following only normal IRB review.  The current university guidelines for social distancing and masking within the space to be used must be followed.  The number of participants and researchers cannot exceed the determined capacity of the room to be used.  Low Level of exposure risk research generally includes behavioral experiments or interventions with individuals or groups without physical contact.

Research at the Medium and High Levels can be conducted following normal IRB review AND a review of safety practices by the Research Waiver Committee. At all times, labs must adhere to guidelines for masking and distancing.  Additional PPE measures may be required depending upon the nature of the research.  The number of participants and researchers cannot exceed the determined capacity of the room to be used.

Researchers whose studies are at the Medium and High levels of exposure risk MUST request a waiver, on a case-by-case basis, from the Research Waiver Committee using the designated approval process following IRB review. 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.

Individuals planning human subjects research for the Fall 2021 semester, 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.

 

Personal Contact Level

Study Activities and Examples

Mitigation Strategies

No Contact

 

No COVID-19 Exposure Risk

  • Studies conducted using fully online/distance methods or remote activities.

Example Activities:  Online surveys, web-based experimental tasks, virtual interviews and focus groups, phone interviews, remote chart/record review.

N/A

Minimal Contact

 Social distancing within 6ft for LESS than 15 minutes total

Low COVID-19 Exposure Risk

  • In-person interactions and procedures that require no or only minimal physical contact and that can maintain social distancing between all individuals. Exchanging paper or other materials allowed.
  • Can be conducted with limited number of research team members.

Example Activities:  Group behavioral experiments or interventions without physical contact, computerized tasks, onsite chart/record review     

  • Personnel training on handwashing, face coverings, disinfection
  • Social distancing plan to maintain 6 ft between all individuals.
  • No more than University-determined room occupancy.
  • Face coverings for researchers and participants
  • Increased cleaning/disinfecting.

 

 

 

 

Increased Contact

 

Interpersonal contact  within 6ft for MORE than 15 minutes total.

Highest

 

Medium COVID-19 Exposure Risk

  • In-person non-invasive interactions and procedures that require physical contact more than 15 mins total.
  • Can be conducted with limited number of research team members.

Example Activities:  Instrument setup including MRI, TMS, ERP, DEXA, eye tracking, physical examinations such as balance testing and neurological exam, blood pressure measurements, sleep evaluations, audiology assessment, studies with infants and young children that are not anxiety-provoking.

  • Personnel training on handwashing, wearing PPE, disinfection.
  • COVID-19 symptom screening for researchers and participants
  • Social distancing plan to minimize physical contact and otherwise maintain 3 ft between all individuals.
  • No more than University-determined room occupancy.
  • Face coverings/Surgical grade mask,
  • Increased cleaning/disinfecting 

High COVID-19 Exposure Risk – nonaerolsolizing methods

  • In-person interactions, interventional activities and procedures that require physical contact more than 15 mins and involve collection of biofluid samples through non-aerosolizing methods.
  • Activities and procedures that require direct or close physical contact lasting more than 15 mins.
  • Studies involving face-to-face interaction with patients with current COVID-19 diagnosis, under investigation, or those with active symptoms consistent with COVID-19.

Example Activities:  Studies involving exercise, cardiovascular stress testing, pulmonary function tests, infant-child studies that may induce crying, research studies involving COVID-19 patients

  • Personnel training on handwashing, wearing PPE, disinfection.
  • Procedures for safe handling of biofluid samples where required.
  • COVID-19 symptom screening for researchers and participants
  • Social distancing plan to minimize physical contact time.
  • No more that 30% normal room occupancy.
  • Surgical grade mask, gloves for researchers
  • Additional PPE including gown and eye protection may be required for post-collection processing of biofluid samples.
  • Increased cleaning/disinfecting 

High COVID-19 Exposure Risk – aerolsolizing methods

  • In-person interactions, interventional activities and procedures that may or may not require physical contact but likely produce aerosols.
  • Activities and procedures that require direct or close physical contact lasting more than 15 mins.
  • Studies involving face-to-face interaction with patients with current COVID-19 diagnosis, under investigation, or those with active symptoms consistent with COVID-19. Studies involving exercise, cardiovascular stress testing, pulmonary function tests, infant-child studies that may induce crying, research studies involving COVID-19 patients
  • Personnel training on handwashing, donning/doffing full PPE, disinfection.
  • Procedures for safe handling of biofluid samples where required.
  • COVID-19 symptom screening for researchers and participants.
  • Social distancing plans to minimize physical contact time.
  • No more than University-determined room occupancy.
  • Full PPE for researchers including N-95 grade mask, gloves, gown, eye protection.
  • Increased cleaning/disinfecting.
  • COVID-19 testing of study participants prior to intervention.
  • Adequate ventilation.

    
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Adequate ventilation:  Where possible, research in the HIGHEST exposure category should be conducted in spaces with negative-pressure ventilation.  If negative-pressure ventilation is not available, pauses between participants should be included to allow for adequate air circulation, air replacement, and disinfecting.  Guidance can be obtained through Facilities Management.   

Adapted from Johns Hopkins University

Revised at SCSU May 10, 2021

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

 

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.

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.

IRB Instructions and Forms Selection Page

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. 

 

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: https://inside.southernct.edu/rpp/irb/instructions-and-forms

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.