An Institutional Review Board (IRB) is an objective committee within a college or university that reviews research protocols. This committee is composed of cross-functional subject matter experts meeting federal membership requirements.
The IRB reviews research project proposals to determine whether they would follow ethical principles and federal regulations for the protection of human subjects participating in the research. To that end, the IRB has the authority to approve, disapprove or require modifications to those research project proposals to maximize any benefits and minimize any risks to the research participants. The mission of Gateway Technical College’s IRB is to ensure the protection of human participants in research, maintain federal regulatory compliance and facilitate research at Gateway Technical College.
The IRB Submission Process
The IRB Application initiates the review process for research proposals. Please use this application form to submit research proposals at least 1-2 months in advance of your target recruitment start date. The length of review is determined by the complexity of the study, thoroughness of the submission and provision of required documents. Please note that you cannot begin participant recruitment for human subjects research before receiving IRB approval.
If you are unsure whether your project requires IRB review, please use this decision tree or feel free to contact irb@gtc.edu for more information. This will support and safeguard our staff, faculty and students from either unintentionally performing research or unintentionally exposing others to undue risk(s).
Once you submit your complete IRB application, the IRB examines all submitted materials to determine if the research participants are adequately protected. The IRB's consideration is based primarily on weighing the risks and benefits of the research. Risks may be physical, psychological, social or economic. Benefits include both those to the individual research participant and to society as a whole. The IRB also considers the population being studied – Is it a special population that may require additional protections? (See below for more information on special populations.)
IRB Authority
The U.S. Department of Health and Human Services oversees the Protection of Human Subjects in research and sets policies that IRBs must adhere to. IRBs are federally regulated by the Office for Human Research Protections (OHRP), an office within the Department of Health and Human Services. OHRP assists IRBs in their work and receives and investigates claims of inappropriate research practices.
The institution that the IRB serves provides administrative support for its activities, including the designation of an individual within the institution to oversee research and IRB functions. The institution also files an Assurance with the federal government that describes the procedures and guidelines that the IRB must follow.
Gateway’s IRB Information
IRB registration number: IRB00010011
Federal Wide Assurance number: FWA00033808
Protecting Special Populations
The Code of Federal Regulations requires the IRBs to give special consideration to some categories of research subjects, such as children, prisoners, pregnant women, those with impaired decision-making abilities and economically or educationally disadvantaged persons. The IRB carries out this charge in a number of ways. In many cases, the IRB may approve of research with these subjects only when it involves minimal risk or when the benefits apply to the subject directly. Additionally, if the IRB frequently reviews protocols involving one of the special groups, they may have a community member whose primary interests are with one of these groups.
Questions? Please contact Michelle Borckardt, Manager of Research Services, at borckardtm@gtc.edu or 262-564-2404.