There are three types of IRB review. The UI IRB reviews HawkIRB applications at the lowest level of regulatory oversight allowed by the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46).

Expedited

There are nine categories of research that qualify for expedited review. Expedited review is only allowed for research projects that are no more than minimal risk to subjects. The IRB review is conducted by an IRB Chair or Chair Designee (IRB Member). Expedited review does NOT mean that the research project will be reviewed quickly. HawkIRB submissions are reviewed in the order that they are received. 

The IRB Chair (or his/her IRB member designee) retains discretionary right to require full board review of any project, even when the project appears to meet the criteria for expedited review.

Exempt

There are eight categories of research that qualify for exempt status, but the UI IRB only uses the first six categories. These categories are described in the federal regulations (45 CFR 46.104) and in the Exemption Tool on the Human Subjects Office website. When an IRB Chair determines that a research project meets criteria for exempt status, the is not required to comply with certain regulations for human subjects research, including: documentation of informed consent and continuing review on an annual basis. HawkIRB Modification forms are not required for minor modifications to exempt projects. See the UI Investigators Guide\IRB Standard Operating Procedures, Section I, Part 13 (Modifications to an Exempt Application).

Full Board

Human subjects research that does not qualify for exempt status or expedited review must be reviewed by the full IRB at a convened meeting. These are closed meetings that are not open to the public. On occasion, a PI may be invited to attend an IRB meeting to provide additional information about a project and answer questions from board members.

Full board review is required in the following instances:

  • The study involves investigational drugs, devices or biologics that require an Investigational New Drug (IND) or Investigational Drug Exemption (IDE) from the FDA
  • The study involves prisoners as subjects (except retrospective review of records or minor modifications to an existing study)
  • Continuing review for studies that were initially reviewed by the full board (except when the board has determined that there is no more than minimal risk and no additional risks have been identified)
  • When there is risk of criminal or civil liability to subjects
  • When participation in the research may be damaging to subjects financial standing employability, insurability, reputation or be stigmatizing (unless appropriate protections are implemented)
  • Classified research involving human subjects
  • The study needs a Non-Significant Risk Determination because it is a Non-Significant Risk device
  • When there is a Conflict of Interest that needs to be managed

ADDITIONAL RESOURCES: