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Stop animal Exploitation Now! (S.A.E.N.)
1081-B St. Rt. 28 #280
Milford, Ohio 45150
513-575-5517
www.saenonline.org

August 2, 2011

Dr. Francis Collins, Director
National Institutes of Health Office
9000 Rockville Pike
Bethesda, Maryland 20892

Daniel R. Levinson
Office of the Inspector General, HHS
330 Independence Avenue, Room 5250
Washington, DC

Dr. Collins, Mr. Levinson,

I am contacting you today regarding an incident of serious non-compliance with the NIHGPS at
Vanderbilt University, a substantial recipient of NIH grants.

As you know, the National Institutes of Health Grants Policy Statement says:

“Charges to NIH grant awards for the conduct of live vertebrate animal activities during periods of time that the terms and conditions of the grant award are not upheld are not allowable. Specific situations under which charges are not allowable are:

1. The conduct of animal activities in the absence of a valid Animal Welfare Assurance on file
   with OLAW.
2. The conduct of animal activities in the absence of a valid IACUC approval of the activity.
   Absence of IACUC approval includes failure to obtain IACUC approval, expiration, or
   suspension of IACUC approval.

. . . In cases where charges have been made for unauthorized animal activities, appropriate adjustments must be made to the grant to remove those charges.”

In a USDA inspection report for Vanderbilt University dated 6/13/11 (attached), the facility is
cited for a violation of section:

“2.31 Institutional Animal Care and Use Committee (IACUC) (c) IACUC functions. With respect to activities involving animals, the IACUC, as an agent of the research facility shall: (7) Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities:

Protocol M/06/552 as approved includes a description of a craniotomy procedure that involves
placement of a polymer and replacement of the bone flaps but does not mention placement of any permanent chambers. Medical records for NHP 4414 show that a craniotomy with placement of a permanent chamber was performed. Medical records show repeated medical problems related to the chamber culminating in removal of the chamber 3 months later. To ensure the IACUC has knowledge of proposed activities and can review them to ensure that they meet requirements, the IACUC must review and approve, require modifications in to secure approval or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities.”

This inspection report further cites Vanderbilt for other relevant violations:

“Section 2.31 Institutional Animal Care and Use Committee (IACUC) (d) IACUC review of activities involving animals. (1) In order to approve proposed activities or proposed significant changes in ongoing activities, the IACUC shall conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with this subchapter unless acceptable justification for a departure is presented in writing; . . . Further, the IACUC shall determine that the proposed activities or significant changes in ongoing activities meet the following requirements: (viii) Personnel conducting procedures on the species being maintained with be appropriately qualified and trained in those procedures;

A researcher who is not listed as an approved surgeon on protocol M/06/52 performed a craniotomy surgery on NHP 4414 in September. 2010. Immediately post-surgery the NHP presented with complications requiring treatment by the veterinary staff. Additional imaging and surgical procedures were conducted in Dec. 2010 and in April 2011 by three other persons also not approved on the protocol. The IACUC must be made aware of personnel conducting procedures on species being studied on a protocol in order to be able to assess that the persons are qualified and trained in the procedures that will be required for that protocol. In order to approve proposed activities the IACUC shall determine that the personnel conducting procedures on species being maintained or studied will be appropriately qualified and trained in those procedures.”

It is clear that the staff of Vanderbilt University were in violation not only of the Animal
Welfare Act for performing unapproved and therefore illegal surgical procedures on a primate, but also because the unapproved procedures were in fact performed by a surgeon who was not approved as participating in the protocol, and the botched surgery led to additional unapproved surgical procedures performed by no less than three additional unapproved surgeons.

Therefore, since multiple unapproved surgical procedures were performed on NHP 4414 by multiple unapproved surgeons, it is patently obvious that in the instance of this animal, Vanderbilt University was in violation of the above quoted section of the NIHGPS as listed above, and the NIHGPS also states that:

“In cases where charges have been made for unauthorized animal activities, appropriate adjustments must be made to the grant to remove those charges.”

Therefore, I must insist that the National Institutes of Health, in conjunction with the Office of
the Inspector General, immediately launch an investigation of all use of non-human primates at
Vanderbilt University to discern an overall quantity of unapproved surgical procedures performed on animals by unapproved surgeons, and that following this determination, a refunding of relevant grant amounts be required of Vanderbilt University.

I am sure that the National Institutes of Health and the Office of the Inspector General are both
very concerned with insuring that grantees follow all parts of the NIHGPS and that insuring that
serious offenders be required to return illegally used NIH funding.

I hereby request a copy of all documents regarding this investigation under the federal Freedom
of Information Act, 5 U.S.C. sec. 552. at the completion of this process.

Sincerely,

Michael A. Budkie, A.H.T.,
Executive Director, SAEN

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