10/15/92

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How the A-PLAC committee keeps the paperwork (somewhat) under control

STANFORD -- "Every protocol has to be 40 pages long!" one researcher said, talking about the added paperwork for a project involving animal research.

While this is not entirely true - renewals and amendments may be much shorter - the animal-care approval requirement does add to a scientist's paperwork burdens.

Working with Kathy McClelland, the research compliance officer with the Office of Sponsored Projects, and Valerie Fratus, the animal subjects coordinator, here is how the Administrative Panel on Laboratory Animal Care (A-PLAC) tries to be both complete and streamlined:

• Every person who plans to use animals for research or teaching must submit a protocol to the committee. At Stanford, this applies even if the research receives no funding, from the government or any other source. It has long applied to small vertebrates like fish, rats and mice - animals that until recently were not accounted for by some government agencies. Every protocol must be renewed once a year. Changes in protocols - for example, if a new scientist joins a research team - must be filed for approval.
• Fratus presorts the protocols, identifying renewals with no changes and projects with standard operating procedures already approved for that research group. She may suggest improvements that will speed approval - for example , reminding the principal investigator to state whether the new scientist has been trained in rat anesthesia procedures.

A dialogue begins with the researcher.

• Thomas Hamm, chair of the Department of Comparative Medicine, or one of the department's other veterinarians, also screens the protocols and flags those of particular concern.
• A-PLAC panel chair Donald Stanski and his colleagues divide up the protocols to be considered; each is seen by at least three committee members, who pay particular attention to the flagged ones.

They pass their questions back to the investigators electronically, via McClelland and Fratus. They may ask: Does the project need this many animals? Won't that procedure cause unnecessary stress?

With questions resolved, most protocols are nominated for approval.

• Some protocols come before the whole committee for extra scrutiny because of unresolved questions about the research design. Sometimes it takes several rounds of questions before committee members are satisfied.

In a few cases, they ask that the project be monitored by veterinary staff until they are satisfied that it can be conducted humanely.

• The whole committee meets with every faculty member who uses live vertebrates in teaching. They meet in full session with those few researchers whose projects involve pain that cannot be relieved by anesthetics or analgesics. In such projects, such as a study of pain itself, the painkiller will nullify the data. Such projects are relatively few, involving 75 animals in a typical year.

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