The primary determinant of review type is the level of risk to which human subjects may be exposed. Federal guidelines define the categories of review, and the appropriate level of review is assessed by the HSRB.
Expedited review is permissible when the human subjects research in question exposes human subjects to no more than minimal risk and meets the following criteria:
- The research activities fall into a federally-approved expedited review category.
- The research is not classified.
- Identification of subjects would not put them at risk of criminal or civil liability, or be socially or economically damaging.
Full board review
A research project with human subjects that involves greater than minimal risk requires approval by the full HSRB. Examples include, but are not limited to:
- Non-exempt research that involves minors or other vulnerable populations (e.g., those who are incarcerated, those with cognitive disabilities, those who are pregnant)
- Research that involves experimental drugs or devices -Research that involves invasive procedures -Research that involves deception
- Research that involves sensitive questions or information about sexual practices or illegal behavior
- Any survey or interview that has a high likelihood of being particularly stressful for participants
Exempt from review
Researchers may assess their human subjects research as exempt from review. If so, they are expected to file an Exempt Research Form with the HSRB as part of ensuring that human subjects protections are handled appropriately. Research involving more than minimal risk is not exempt, and certain minimal risk projects might not be exempted if, in the opinion of the HSRB, the research contains procedures that should be periodically re-reviewed. All human subjects research, whether exempt or not, must be conducted in accordance with Metropolitan State University policies, federal guidelines and ethical principles set forth in the Belmont Report. To assist with determination of whether or not a study may be exempt from review, see this federal guidelines decision tree or the Exempt Research Form.