Informed Consent - Module 4s Sec 2


Module 4 Objectives
Continuing Review

Unanticipated Developments
Adverse Events
Consent Document Revisions

Unanticipated Developments

While performing continuing review, there are several points to
consider. One is the development of new findings that may affect the
balance of risks and benefits including any unanticipated risks or
benefits. For example, are the risks and benefits the same as when they
were first established? If not, have the proper steps been taken to
reduce the occurrence of risks and increase the occurrence of benefits?

Another point to
consider is the development of unexpected findings.
Unexpected results can affect the research project itself. The researcher
is responsible for informing the IRB of unexpected findings that can
affect the risk/benefit ratio. In addition, new knowledge attributable to
other research projects can also affect the risk/benefit balance.

These instances raise important questions for participants that should be
addressed during a continuous monitoring process. Establishment of a
system to monitor study feedback will alert researchers to unexpected
findings that will need to be corrected or controlled.

New findings, new knowledge, and adverse effects may need to be
communicated to the participants to determine whether their effects will
change the subjects’ willingness to participate. Consideration should
be given to whether or not the findings need to be shared with past
participants. Strategies for discussing this with participants should be