Institutional Review Board (IRB)
The IRB is a committee whose primary responsibility is to protect the rights and welfare of human research subjects. All research activities involving human subjects must be reviewed and approved by the IRB. Human subjects research is defined as any systematic investigation that is designed to contribute to generalizable (scholarly) knowledge, and which uses living humans or identifiable information about living humans.
In accordance with the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) regulations, the IRB reviews research proposals to ensure risks have been minimized and the potential for benefit has been maximized before human subjects participate in the research. The authority conveyed to the IRB includes decisions to approve, disapprove, require modifications, monitor, suspend and terminate research projects involving human subjects.
The IRB also ensures that human subjects volunteer to participate in research only after providing legally effective informed consent. Investigators may not solicit subject participation or begin data collection until they have received approval from the IRB.
All investigators and key personnel who participate in the design, conduct, or reporting of human subjects research must be trained in the protection of human subjects. South College uses the Collaborative Institutional Training Initiative (CITI) web-based human research courses to satisfy the requirement for training in human research subjects protection. Initial and continuing education (every 3 years) are required. Training must be completed prior to receiving initial or continuing IRB review of research. See the Forms section for instructions on completing Human Subjects Research Training.
Submitting a Human Subjects Research Protocol to the IRB
The U.S. Department of Health and Human Services revised the Federal Policy for the Protection of Human Subjects in Research (Final Common Rule). Most provisions of the Final Common Rule went into effect on Jan. 19, 2018. The South College IRB Policies and Procedures Manual for Human Subjects Research, and associated forms, have been revised to incorporate all provisions of the Final Common Rule. If you are submitting a new human subjects research protocol to the IRB, please refer to the updated manual and use the new forms, which are available at the two links above.
Page 28 in the IRB Policies and Procedures Manual for Human Subjects Research describes the steps in the IRB application and review process.
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The South College IRB is here to help you with your human subjects research!
Dr. Karen Mark, IRB Co-Chair
Dr. Ed Michaud, IRB Co-Chair
Ms. Ainsley Kerr, IRB Coordinator