Risk Levels
The Risk Levels section of the Protocol page displays risk level information entered during protocol approval-related actions. It is not required that risk level information be entered by the IRB. Risk levels are typically defined by the implementing institution, and so the categories that list different levels of risk shown in the example below may differ at your institution.
Figure 1105 Protocol Document, Protocol Page, Risk Levels Section Example
Table 321 Protocol Document, Protocol Page, Risk Levels Section Field Descriptions
|
Field |
Description |
|
Risk Level |
Examples of possible values are: 1. No greater than minimal risk. 2. Greater than minimal risk but potential for direct benefit for participant. 3. Moderate Risk. 4. Research involving greater than minimal risk, with no potential for benefit to participant, but likely to yield generalizable knowledge about the participant's condition. 5. High Risk. |
|
Date Assigned |
Required if Risk Level is entered. The date that the document was updated after the risk level was first specified. This does not change if the risk level is subsequently updated. |
|
Date Inactivated |
The date that the risk level was inactivated. |
|
Status |
Required if Risk Level is entered. This displays both Active and Inactive risk level records that identify the current state of the Risk Level. |
|
Comments |
This displays textual comments provided by the reviewers regarding the risk level assignment. |