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All modifications to human subjects research must receive prior IRB approval before subjects are involved in the revised protocol. Prior to implementation, modifications must be submitted on a Research Amendment Form and reviewed and approved by an IRB committee or the IRB Office.
Minor modifications to previously approved projects include those that do not alter the risk-benefit assessment for the research. Examples include changes in the investigators, minor wording or formatting changes in the consent form(s), recruiting materials, interviews, or questionnaires; minor changes in compensation, time of participation, or subject recruitment; or the use of a new site that is not materially different from a previously approved site. Minor modifications may also include changes to other parameters, whereby the investigator provides the subjects with more accurate information as a result of additional experience with the protocol.
Major modifications include significant protocol changes that would cause subjects to engage in activities not previously approved; or that involve an increased level of risk to the physical, emotional, or psychological well-being of participants (including the loss of confidentiality); or that involve a decreased benefit; or that otherwise result in alteration of the risk-benefit assessment for the research. For example, adding a new subject population, changing inclusion or exclusion criteria, changing the informed consent process, and changing procedures affecting subject confidentiality all constitute potentially major modifications.