What flexibility does the IRB have in applying the Common Rule?
The purpose of the federal regulations is to obtain the benefits of research for society while minimizing the risks of harm to human research participants. To further this goal the regulations encourage IRBs to make independent informed judgments, using common sense and expertise to apply a standard set of rules to diverse research situations, and to document the procedure followed in arriving at its judgment. For example, sections 116 (c), (d), and 117 (c) discuss flexible procedures that may be used to administer informed consent, depending on the specifics of the research project. Informed consent is the procedure by which the researcher respects the autonomy of research participants (as discussed in the The Belmont Report). Since written documentation of informed consent can create harm for research participants in some circumstances, it should not be routinely required in all cases. For example, research should not use signed forms when the focus is on illegal behavior, or on part
