The University of New Haven’s Institutional Review Board (IRB) oversees the use of human participants in research. The IRB is composed of UNH faculty, UNH administrators, representatives from the community, and experts regarding protected populations (e.g. children and prisoners). The IRB’s purpose is to enable UNH faculty, staff and students to conduct ethical human research while ensuring that the rights and welfare of participants are upheld in accordance to the United States Department of Health and Human Services (HHS) regulations (45 CFR 46).
What projects must undergo review?
All research projects, including student projects, using human participants must be approved by the IRB PRIOR to any data collection.
Types of Projects
There are three types of IRB reviews: Exempt, Expedited and Full.
Exempt projects undergo initial review and then are exempted from further review. For a list of types of projects that may be considered Exempt follow this link.
In general, Expedited projects are non-Exempt projects that involve only a minimal risk (not beyond what is expected in normal daily life or due to everyday physical activities) to the participants. These proposals are reviewed by one or two committee members. Full reviews are projects that involve more than minimal risk. Projects involving protected populations (minors, persons with physical or mentally delays, pregnant women or prisoners) must undergo Full review. Click here for Expedited/Full Review Applications.
Exempt and Expedited proposals usually take 10 days to review. Projects requiring Full review usually take 6-8 weeks to convene a committee meeting. PI’s are informed of the date and time of the meeting. PI’s are encouraged to attend the full committee meeting.
Minor Changes/Continuing Review/End of Project
Once a project is approved, approval is valid for one calendar year. If during that year, a project must undergo modifications, then PI’s must submit a “Request for Revision Form” (click here for a Request for Revision Form). The IRB will decide if these modifications require Expedited or Full review and proceed accordingly.
If the project must extend beyond one calendar year, then the PI must submit a “Continuing Review Form” (click here for Continuing Review Form). Project approval may be extended for one calendar year at a time. Every one year extension requires the submission of a new “Continuing Review Form”. Under most circumstances, extensions undergo Expedited review. However, in special cases, a Full review might be required.
Once the project has ended, the PI must submit a “Research Completion Form” (Click here for a Research Completion Form). If more data collection is required after the submission a “Research Completion Form” a new IRB application must be submitted.
If Something Goes Wrong
In the event that an undesirable and unintended, although not necessarily unexpected, result of intervention or a data breach occurs, the IRB must be informed immediately. The PI should inform the chair of the IRB by phone or email as soon as possible. Then the PI should submit an “Adverse Event/Data Breach Form” (click here for Adverse Event/Data Breach Form). The IRB will review the events and provide feedback to the PI regarding how to proceed.
The IRB may, at any time and without prior warning, audit the files and/or facilities of any projects under its purview. It is the responsibility of the PI to provide access to any files or facilities requested by the IRB.
If you have any questions regarding the role, policies or procedures of the IRB, please contact the chair of the IRB at email@example.com.