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ii.Describe process for reviewing and approving amendments, modifications, and revised protocols/projects. If applicable, include a description of “major” vs. “minor” amendments.

c.Special Considerations for IACUC/OB Review [Guide, pp. 5; 27-33]

i.Experimental and Humane Endpoints [Guide, pp. 27-28]

Describe how criteria for determining alternatives to experimental (humane) endpoints are developed, approved, and applied. Include a description of monitoring systems in place for studies for which information on alternative endpoints are not available.

ii.Unexpected Outcomes that Affect Animal Well-being [Guide, pp. 28-29]

Describe how unexpected outcomes of experimental procedures (e.g., unanticipated phenotypes in Genetically Modified Animals) are identified, interpreted, and reported to the IACUC/OB.

iii.Physical Restraint [Guide, pp. 29-30]

Note:  This section is to include only those protocols that require prolonged restraint.  Brief restraint for the purpose of performing routine clinical or experimental procedures need not be described.

1)Briefly describe the policies for the use of physical restraint procedures or devices.

2)Describe animal restraint devices that are used or have been used within the last three years.  For each device, briefly describe the duration of confinement, acclimation procedures, monitoring procedures, criteria for removing animals that do not adapt or acclimate, and provision of veterinary care for animals with adverse clinical consequences.

iv.Multiple Survival Surgical Procedures [Guide, p. 30]

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