A modification is defined as any change to a protocol from what was previously approved during the period for which approval was given. Changes in research procedures, study personnel, 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 to eliminate apparent hazards to the subject(s), submit a protocol violation immediately to the IRB addressing the nature of the change, why it was necessary, and the outcome.
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.
Discontinuing a study (e.g., PI leaves UK) or completion of a study is considered a change in the protocol’s status and therefore the IRB should be promptly notified in writing. See the Continuation Review SOP and the Study Closure SOP for procedures on reporting an activity status change to the IRB. If the investigator fails to notify the IRB about discontinuation or completion of a study, then they will continue to be responsible for completing the Continuation Review report requests.
Approval of the modification request 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.