Rationale:
Federal Guidelines state that prior to approving protocols that propose the production of monoclonal antibodies using the mouse ascites method, the following written documentation must be provided to the IACUC for consideration:

• Methods used that will avoid or minimize discomfort, distress, and pain (including in vitro methods) have been considered; and
• Why in vitro method(s) has been found to be unsuitable.

According to the Office of Laboratory Animal Welfare (OLAW) of the National Institutes of Health (NIH), it is the responsibility of the IACUC to critically evaluate the above criteria and appropriately document that they have been fulfilled. This is considered central to UT Southwestern’s compliance with its Animal Welfare Assurance and the PHS Policy.

Although special circumstances exist for use of the mouse ascites method (i.e. hybridoma cells grown in culture either failed to produce Monoclonal Antibodies (MABs) or fail to produce MABs with the proper reactivity needed to answer important research questions), there is considerable evidence that this method causes discomfort, distress, and pain to the individual mouse.  Since, practical in vitro methods exist which can replace the ascites method in many experimental applications without compromising the aims of the study the use of the mouse ascites method must be the exception.

Applicability:
This policy applies to the use of the ascites method for monoclonal antibody production in mice.

Policy:
The National Research Council of the National Academy of Sciences has determined that in vitro methods of monoclonal antibody production should be used whenever possible. In only those few cases where in vitro methods cannot produce satisfactory results, the investigator may use the mouse ascites method with prior approval from the IACUC.

Based on Federal Guidelines, the following steps must be followed when preparing a protocol:

• In vitro alternatives for producing monoclonal antibodies are the preferred method with the mouse ascites method being the exception.
• Document the reason for believing the in vitro system(s) tried was most appropriate and why it proved to be unacceptable
• Provide assurance that the antibody to be used is either not commercially available, or is biologically unsuitable for use.
• Scientific justification may not be based on cost or convenience.

Exceptions:
Exceptions to this policy require a prior written request and approval by the IACUC.  The exception request must provide adequate scientific justification for not following the policy.

Contact Information:
For any additional questions, please contact the IACUC Manager at 5-6420.