General Interest-Public Health Service- Guidelines for contracted production of custom polyclonal & monoclonal antibodies affect UK IACUC guidelines; January 15, 2009

Dear Investigators,

In an effort to maintain our Animal Use accreditation, the IACUC constantly evaluates whether our programs are in compliance with federal and Public Health Service (PHS) mandated regulations. During that review, we identified a long-standing deficiency in UK's compliance with the PHS mandated guidelines concerning the contracted production of custom polyclonal and monoclonal antibodies.  PHS requires that all investigators, who use commercial or noncommercial contractors to generate custom antibodies, must have an approved UK IACUC protocol, irrespective of whether they directly use animals in their research conducted at UK.  This regulation specifically covers the commercial production of antigen-specific antibodies in rabbits, mice, goats, chickens, and other vertebrates.  We need your help to rectify this deficiency.

            We realize that many of you are or will be engaged in this activity.  To lessen the hassle to you and to make the process more efficient, we have generated a Microsoft Word form which can be used to provide us with the required information (http://www.research.uky.edu/ori/univet/ab/streamlined_ab_form.doc).  This information will then be used by the ORI staff to create a protocol for you.  We request that you email the completed form to the ORI office (contact information is on the form).  Once submitted, your protocol will be processed rapidly so that you and the University will be in compliance as soon as possible.

            We recognize that this requirement will impose some additional regulatory burden on you the investigator, however, please note that this requirement is federally mandated.  PHS policy states that grant funds cannot be used for noncompliant activities.  If you have any questions please do not hesitate to contact Larry Iten DVM (aliten@email.uky.edu or phone 257-8295).

Thank you for your cooperation,

Sidney W. Whiteheart, Ph.D.

IACUC Chair