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 with terminal degrees (meeting federal requirement). The IRB reviews and approves, disapproves or requires modifications for research project proposals to determine whether it would follow ethical principles and federal regulations for the protection of human subjects. The mission of Gateway Technical College’s Institutional Review Board (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 submission form initiates the review process for research proposals. Please use this form to submit upcoming research studies at least one month in advance of your target start date. The length of review is determined by the complexity of the study, thoroughness of the submission and provision of required documents.
Before you submit, we ask that you use this decision tree to assist you in understanding what needs to be submitted for review. This decision tree is meant as a first step in the process of embarking on projects. 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 IRB form, the IRB examines all required, submitted materials to determine if the research participants are adequately protected. The IRB's consideration is based primarily on weighing 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? Would this population assess the risks and benefits differently?
IRB Authority
The U.S. Department of Health and Human Services oversees the Protection of Human Subjects, and sets policies that IRBs must adhere to. IRBs are administered on a federal level 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 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. IRB registration number IRB00010011 and Federal Wide Assurance: FWA00033808.
Protecting Special Populations
The Code of Federal Regulations requires the IRBs give special consideration to some classes of research subjects such as children, prisoners, pregnant women, mentally disabled persons 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@vikingragenetwork.net or 262-564-2404.