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103.9 Organization Policy on Review of Changes in Approved Research

May 2005

The Organization requires IRB review and approval of proposed changes in approved research prior to initiation of any changes, with one exception.  The exception is a change in research necessary to eliminate apparent immediate hazards to a research participant.  In cases where changes were made to eliminate apparent immediate hazards, it is the responsibility of the PI to inform the IRB promptly of the change and the IRB must determine if the modified research is consistent with ensuring participants’ continued welfare. 

Changes in research may encompass amendments, addenda, deletions, or revisions to either the protocol or consent document associated with a protocol.  The PI must submit information to allow the IRB to determine if the proposed change may be approved.   Materials submitted in support of changes will distributed to IRB members in accord with Operations Procedure No.109.5.  IRBs delegated responsibility for review of changes in research are authorized to conduct the process in accord with federal regulations using either (a) an expedited review process (see Policy No. 110.1), which is restricted to review of only minor changes in the research or consent document; or (2) a convened review process (see Policy No. 111.1) for all changes that are not minor.  Changes in research involving drugs, biologics, or CAMs must be reviewed by the designated IRB P&T member for either an expedited review or a convened review.  The P&T member may serve the dual role of primary reviewer and P&T reviewer. Changes or modifications reviewed through an expedited review process will be reported to the IRB members on a list as noted in Policy No. 110.1, and complete files of the research project will be made available to any member upon request for further review.

IRBs conducting review of changes in research are authorized to alter the approval period for the research based on degree of risk posed by the change in research or to retain the original approval period granted at initial review.  IRBs have the authority to require revisions to consent documents and require notification to enrolled participants of approved changes in research that may affect the participants’ decision to continue in the research.

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