An extremely important piece of information is missing from this scenario: who funds Baker's project? If it is federally funded, the addition of the proposed surgery could change the approved scope of the project, which would require prior approval by the NIH Grants Management Officer (GMO). The GMO's disapproval overrules any IACUC opinion. Not all significant changes constitute changes in scope, however1,2.

Both Martin and the IACUC director are partially mistaken. Baker's amendment should be reviewed by a duly constituted IACUC to determine whether it meets institutional and regulatory requirements and whether the changes require a new protocol submission. The outcome of the IACUC's vote represents a fair decision of a majority of the committee that takes into account the opinions of both the IACUC Chair and Martin. Problem solved. If desired, dissenting members can submit a minority opinion following the IACUC vote.

On the other hand, the IACUC Chair's decision to approve a surgical procedure on the basis of a “brief description of the work to be done” is inappropriate. A well-written amendment includes sufficient justification and a detailed description of any new procedure. For this purpose, a separate surgical or procedural attachment is used by many institutions. Such attachments require detailed descriptions of surgical procedures, including the identity of each surgeon and his or her related experience. This information should satisfy Martin's well-intended need for details and might convince her that an amendment will suffice.

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