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Monitoring for Harm
As researcher, you are responsible for carrying out sound research that is consistent with what the IRB approved. This includes obtaining and documenting informed consent of subjects (when applicable), ensuring that pre-approval is obtained from the IRB for any modifications to the research, and ensuring that ongoing communication is submitted to the IRB office in accord with continuing review requirements. In addition, researchers should monitor participants to promptly detect harm, by using their judgment to minimize risks and by modifying study procedures to eliminate apparent immediate hazards. Changes intended to eliminate an apparent immediate hazard may be implemented immediately provided the IRB is notified in accord with federal regulations.
Ten Days to Report
When applicable, researchers are required to provide prompt reporting of any unanticipated problems involving risks to participants or others (see UPIRTSO reporting requirements). In addition, prompt reports of serious or continuing non-compliance with regulations or local policies must be forwarded to the IRB office within 10 working days.
Researchers minimize risks of study participation by implementing research that includes sound study design. Sound study design includes ensuring that participants’ autonomy is maximized, ensuring that benefits are maximized and risks are minimized; employing fair and equitable participant section practices, and verifying the importance of the knowledge that may reasonably be expected to result from the research. In addition, researchers may minimize potential risks of participation by using procedures already performed for diagnostic or treatment purposes.
Risks Cannot Be Minimized
Greater than minimal risk research should include procedures to minimize potential risks, which may likely require use of a Data Safety Monitoring Board. These procedures include frequent monitoring and reporting. The researcher should carefully review research data in a timely fashion and, when necessary, revise the study protocol to minimize risks that were not initially expected. The researcher should monitor all adverse events and unanticipated problems that arise during the study and provide prompt reporting of these reports to the IRB.
Ultimately, researchers are responsible for monitoring the research study and for protecting the rights and welfare of human research participants
Data Safety Monitoring
Refer to the following web site for additional resources and information regarding Data Safety Monitoring