Limited IRB Review is intended to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens. Limited IRB review involves making and documenting the determination that adequate provisions are in place for protecting privacy and maintaining confidentiality.
The IRB has the authority to approve, require modifications in, or disapprove research, including exempt research activities under Federal Regulation for which limited IRB review is a condition of exemption.
1. Exempt from Federal Regulation
Research activities involving human subjects in which there is minimal or no risk. Categories of research ineligible for consideration as Exempt from Federal Regulation are listed on the IRB Exemption Guidelines.
If the research meets the qualifications of Exempt Status, researchers should submit the IRB Exempt Status Review Form found on the forms page of this website. Projects that qualify for exempt status must, however, receive formal IRB certification of such exempt status. This certification serves as an assurance that the project 1) qualifies for exempt status in accordance with federal regulations, and 2) is designed to ensure that the rights and welfare of human subjects are protected. If you know the research does not meet the qualification for Exempt status please submit the Full IRB Application form for consideration as an Expeditated Review.
2. Expedited Review
Research activities involving no more than minimal risk but which to not meet Exempt Status will be reviewed as Expedited under the Federal Guidelines. Researchers should submit the full IRB Application form for Expedited Review. In this procedure, three members of the IRB review the project and vote for Approval, Conditional Approval pending modifications, or Disapproval. If two out of three reviewers vote Disapproval, the project the researcher will be notified, and the Application will move to a Full Board Review.
3. Full Board Review
All projects involving human subjects that do not qualify for Exempt or Expedited review will be reviewed by the full IRB at an official meeting. After submission of an IRB Application, the IRB chairperson can determine that the research requires Full Board consideration at an IRB meeting. The researcher is informed that the project will be reviewed at the next scheduled IRB meeting and provided the date and time. The researcher will be invited to attend this meeting to answer any questions the Board may have regarding the project.
