A Standard Operating Procedure (SOP) is a written description of a method for some task or operation. SOPs are often posted in laboratories to make it clear to workers exactly how tasks are to be done. An SOP which describes routine or recurring procedures can be submitted to the IACUC by an investigator or a research team. An SOP, however, does not replace a protocol.
Benefits of an SOP
The advantages of filing an SOP include: saving time in the preparation of a protocol application; streamlining the review process (reviewers would be assured that the SOP-part of a project had already received IACUC approval); and improving consistency of reviews (SOPs minimize the possibility of a procedure being accepted in one protocol application and rejected or questioned in another). New SOPs are reviewed and approved by the full IACUC.
SOPs are approved indefinitely. Once approved, SOPs can be referenced in existing or future protocol applications. A protocol amendment must be submitted adding an SOP to an existing protocol. The Principal Investigator can reference an SOP and include other procedures as part of the protocol application.
SOPs are reviewed annually by the IACUC Executive Committee (IEC). Authors must submit a completed Annual Review form noting if they are going to change the SOP based on any improvements made in the procedure in the past year, and if any new information on refinement, replacement or reduction has emerged from their lab or has been published in the past year.
The author may amend an SOP at any time. All amendments are submitted to the IEC for review and determination of significance. If the IEC determines the proposed changes are significant, the SOP is sent to the IACUC for full committee review. The full committee review procedures are followed. If the SOP is determined not significant, then the IEC, as designated reviewer, approves the amended SOP. Subsequent amendments to an SOP will be numbered distinguishing it from the original SOP (ex. 05-01.1).
SOPs not referenced in a protocol submission over a 3 year period may be allowed to expire without renewal unless the author requests otherwise. If the author leaves UM or is no longer interested in maintaining an SOP, then the IACUC shall seek a new author from among other faculty who have referenced that SOP in their protocol. If no one agrees to maintain the SOP, then it expires without renewal, and all protocols referencing that SOP shall be revised to take into account the expired SOP.
An SOP should include the following: purpose and scope; materials and equipment; required or specialized personnel training on procedure; safety concerns; definitions; a detailed description of the procedure in the step-by-step instructions on how to conduct the procedure; records to be kept; identification and emphasis of ‘critical steps’ in procedure; copies of forms to be used, drawings of apparatus, tables, figures, etc; and references, i.e. operating manuals, published techniques, other SOPs, etc. Because the SOP is a stand-alone document, it may need to be presented in some context for proper evaluation.