An amendment is required for any modifications to a full protocol from what was previously approved during the period for which approval was given. Changes in research procedures, the informed consent process, and/or the consent/assent document cannot be initiated by the investigator without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject. Should protocol changes be made without prior IRB approval, submit a memorandum immediately to the IRB addressing the nature of the change, why it was necessary, and the outcome.
An amendment is required to an exempt protocol for modifications that might affect risk to subjects or the exemption category, such as changes in procedures, data collection instruments, data plans, and investigators. Amendments are not required for modifications that will not affect risk to subjects or the exemption category, such as adding a class, increasing subject numbers, extending the time period.
Information relating to protocol modifications should be relayed to subjects when such information might relate to the subject’s willingness to continue to take part in the research. How this information will be relayed to the subject (e.g., through a re-consent process using a modified consent form, or a letter sent to the subject) should be included in a modification request, and IRB approval obtained prior to implementation. Approval of the submitted amendment is on the advice of the IRB chairperson or a designated representative unless the nature of the proposed changes warrants review by the full IRB. The IRB may determine the modification relates to subjects’ willingness to continue to participate in the research, and request that the PI relay pertinent information to subjects. The investigator is notified in writing of the IRB’s decision.
Associated Instructions and Forms