Informed Consent - Module 4m Sec 1


Module 4 Objectives

Continuing Review
Unanticipated Developments
Adverse Events
Consent Document Revisions

Continuing Review

The 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.