Types of Review
There are three types of review method that investigators can request of the IRB when submitting their research project for review: Full Board (Convened), Expedited, and Exempt. The nature of the research, level of risk, type of participants, and type of information being gathered all determine which review method will be used. The IRB has authority to approve, to require modifications, or to disapprove all research activities involving human subjects, as well as to determine the type of review method appropriate for all research proposals.
The Full Board (Convened) Review method is used when the research involves greater than minimal risk; the research participants are children, pregnant women, prisoners, or other vulnerable populations; and/or the type of information being gathered is identifiable or of a sensitive nature. When this method of review is used, the primary investigator may meet with the Board.
The Expedited Review method is used in accordance with federal guidelines when the research involves no more than minimal risk to subjects. When this method of review is used, at least two members of the Board will review the proposal.
The Exempt Review method is used for research with very minimal risk to human subjects, as determined by regulatory guidelines (45 CFP §46.101 (b) 1-6). The IRB is only able to exempt a project from continuing review after the application has been received and reviewed.
To request a Full Board or Expedited Research Review, submit the following forms:
- IRB Application Form (form IRB 1)
- Informed Consent Template (form IRB 7)
- Expedited Research Questionnaire
To request an Exempt Research Review, submit the following forms:
To indicate completion of your research project, submit the following form:
- Project Completion (form IRB 10)
To indicate continuance of your research project, submit the following form:
- Re-Approval /Continuation (form IRB 2)
To request a change to the research protocol for an already approved study, submit your revised IRB Research Application (include a second copy with the changes highlighted) and the following form:
- Amendment Review (form IRB 3)
To report a serious adverse event in your approved study, submit the following form:
- Adverse Event Report (form IRB 4)
To report a deviation from the approved research protocol, submit the following form:
- Protocol Deviation Report Form (form IRB 6)
Researchers not otherwise affiliated with Columbia College Chicago should submit the following form to request permission to conduct research activities on Columbia’s campus: