Informed Consent - Module 4m Sec 2


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

Unanticipated Developments

hile 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 developed.


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