There are three review mechanism for research with human subjects. The mechanism required for a given study depends largely on the level of risk to the subjects. As the level of risk increases so does the level of scrutiny.

Studies with negligible risks to subjects may be reviewed through an administrative procedure, called screening for exemption.

Studies with no more than minimal risk may be eligible for review by the IRB's expedited review process.

If the risk is more than minimal the study will be reviewed at a meeting of the full IRB.

The vulnerability of the proposed subjects is also a factor in determining the appropriate type of review. For example, the federal regulations provide additional protections for children and Duke policy provides additional protections for students and employees of researchers.

Finally, the proposed research activity is a factor. Eligible activities for exempt and expedited review are defined in the regulations. The categories for each type of review are similar, including interviews, surveys, observation, focus groups, data analysis and other activities common to research social and behavioral science.

Timing

Applications for screenings for exemption and for expedited review may be submitted to the IRB staff at any time. Applications for review by the full IRB must be received two weeks prior to scheduled meetings.