Informed Consent - Module 4s Sec 1


Module 4 Objectives
Continuing Review
Unanticipated Developments
Adverse Events
Consent Document Revisions

Continuing Review

he purpose of continuing review is to analyze a study and to determine if the anticipated risks and benefits are reflected in the actual experience of the subjects. It is also designed to make certain that the safeguards that were in place at the original approval phase are indeed adequate to insure the safety of the subjects. The initial IRB approval is based on the researcher’s best estimate of the anticipated risks and benefits to the subjects. It is only after research has begun that the real risk is established and the actual risk/benefit ratio can be calculated. Responsible researchers stay involved in continuous reevaluation of a project since risks and benefits are always better understood after the research has begun.

The continuing review process for the IRB is done by completing progress reports on a project. The investigator submits regularly scheduled reports at least annually and sometimes more frequently. The higher the risk of the research, the more frequent the review. The minimum terms of review are outlined when the original IRB approval is granted.

There must also be "ongoing monitoring" that the researcher performs. This is intended to alert investigators to changes in the project that may affect the participant’s decision to continue involvement in the research. The responsibility of ongoing monitoring is just as important as continuing review by the IRB. Both types of review are an ongoing process and not a one-time step. Procedures need to be established for the continuous monitoring of the research activity.


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