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Institutional Review Board (IRB)

IRB Chairperson: W. Jerome Hauselt, PH.D.

Office:       Engleman Hall, Wing A, Room A110 A - B
Phone:        (203) 392-5243
FAX:          (203) 392-5221
Email:        Hauseltw1@SouthernCT.edu         

IRB Bulletin 1: Important Changes to the Regulations Governing Human Subject Research
The federal regulations governing human subject research are changing effective January 19, 2018. There are some important new requirements that all researchers who work with human participants need to be aware of and implement in IRB applications submitted AFTER January 19, 2018. To facilitate the implantation of these rules, a series of emails will be sent to the entire campus. This series of IRB Bulletins will describe the changes that we will have to make to remain in compliance. It is expected that additional changes will be made after the January 19, 2018 date as more information and guidance on the regulations are released by the federal HHS Office for Human Research Protections (OHRP). Some of the changes, such as those relating to informed consent, can be implemented immediately by researchers should they so choose. All IRB Bulletins will be archived on the IRB website for future reference. Each IRB Bulletin will include a description of the change and a discussion of the impact of the change at Southern Connecticut State University as seen by the IRB Chair as of the date of the bulletin. Please note that the discussion will likely change as more information and guidance is issued by the OHRP.

REGULATION: All research reviewed by the IRB must conform to the new rules starting January 19, 2018.
DISCUSSION: The new rule, as it is called, will require adjustment for both researchers and the IRB, and being prepared and educated will make the transition as smooth as it can be. As we go forward, please note:

  1. There will be changes to the IRB application to reflect what will need to be done, so researchers should download the application from the IRB website rather than rely on previously downloaded applications when new submissions are created.
  2. The new rules apply ONLY to research submitted  AFTER January 19, 2018. All research reviewed and approved BEFORE January 19, 2018 does not need to be "updated" next year to conform to the new regulations, though it may be at the discretion of the IRB. This will be down on a case-by-case basis, and in consultation with the researchers.
  3. While the new rules take effect on January 19, 2018, the SCSU IRB process will continue to adapt and changes as the rules are interpreted by the federal Office for Human Research Protections (OHRP) and other institutions after that date. The current SCSU review process, with only minor adjustments, will comply with the new rules, but there may be some opportunities for simplifying our application and review process as new information comes to light.
  4. As we move forward, please contact the IRB Chair, Dr. Jerry Hauselt (hauseltw1@southernct.edu) with any questions

 

Table of Contents
Introduction
The IRB Purview
IRB Tutorial
Institutional Review Board
IRB Application Packet for Human Research Review
Course Instructor Certification
External Investigators

Introduction:

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.
 

  IRB Tutorial:

Investigators who wish to submit an Application for Human Research Review must first complete an online tutorial and enclose: 1) a recent (within past three years) completion certificate with their application; and 2) a signed SCSU IRB Education Certificate. The Education Certificate may be found within the application packet.

The SCSU IRB is currently using the National Institutes of Health NCI Human Participant Protections for Research Teams course at:

http://phrp.nihtraining.com/users/login.php

Completion of the appropriate Collaborative Institutional Training Initiative (CITI) curriculum may be substituted for the NIC tutorial. An indicator of recent (within past three years) completion must accompany the IRB review application.


Institutional Review Board:

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. In order to submit an application to the IRB for review, the investigator must first complete the NIC tutorial and then submit an IRB Application Packet for Human Research Review. This packet provides an interactive application form and detailed instructions regarding how to fill it out.
 

 

IRB Application Packet for Human Research Review:

Instructions for forms completion and the IRB application forms may be found online. The address below will take you to the IRB Instructions and Forms Selection Page. Under IRB Application Packet for Human Research Review please select "Application Instructions." Please print these instructions and use them as a reference for completing the IRB forms. Once you have printed the instructions you may return to the IRB and select "Application Forms." Please follow all instructions on the forms and be sure to complete the IRB Tutorial prior to inserting your material.
https://www.southernct.edu/academics/graduate/research/institutionalreviewboard/hrpp.html

 

Course Instructor Certification:

At SCSU, student human research participant activities which are completed in partial fulfillment of requirements for a course may only need to be submitted to the course instructor for approval prior to the collection of data, provided the instructor has an approved Course Instructor Certification Form on file with the SCSU RPP. Applications for course instructor certification may be obtained on line at:

https://www.southernct.edu/academics/graduate/research/institutionalreviewboard/hrpp.html


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.