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Protocol Amendment Form

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Protocol Amendment Form

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

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

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.