February 21, 1996 To: Addressees From: Deputy Director for Intramural Research, NIH Subject: Reporting Animal Care and Use Concerns within the NIH Intramural Research Program The purpose of this memorandum is to reiterate my commitment to maintaining full and open communications regarding animal care and use in the NIH Intramural Research Program (IRP). While this memo was prompted by a finding identified during an Office for Protection from Research Risks evaluation of our program, I feel strongly that a clear and thorough understanding of NIH management and administrative practices by all IRP staff will enhance our research environment. The care and use of animals in biomedical research carries with it the requirement to comply with federal laws, regulations and policies, as well as recognized standards and guidelines. That collection of regulations, policies and standards governs all aspects of our animal-related activities, including our relationships with other NIH employees and contractors. Anyone in the NIH IRP who has any concerns regarding any aspect of the care and use of animals in research here at NIH is encouraged to voice that concern. At the animal facility level, each facility veterinarian has the authority and responsibility for ensuring compliance with all animal care and use standards and is the appropriate individual to receive initial concerns related to that facility. The Chairperson of the ICD Animal Care and Use Committee (ACUC) is the most appropriate individual to field concerns about animal research procedures or techniques, especially those that might be performed in laboratory settings. Concerns that might not be directly related to a particular facility or ICD, or are not appropriately dealt with at a local level should be addressed to the Office of Animal Care and Use (OACU), Office of Intramural Research, or to me. Concerns received by any of these individuals or offices will be reviewed and corrective measures instituted if appropriate. Allegations of potential wrong-doing at the local level should be reported to the facility veterinarian or the Chair of the ACUC having responsibility for activities in that facility. The immediate responsibility for reviewing, and if necessary, investigating allegations rests with the ACUC Chair. In some cases, persons may be unwilling or reluctant to make allegations at the local ICD level. In those cases, such individuals may contact the Director, OACU or me directly, and I will decide on appropriate action. The Director, OACU, must be promptly informed of ail such allegations, and is responsible for informing me, as the Institutional Official, of these allegations; I will determine the level at which the allegation should be pursued, including activating the NIH Ombudsman, who would conduct an immediate assessment of the alleged conditions, as outlined in the NIH Animal Research Advisory Committee Guidelines (section on NIH Ombudsman attached). If I so direct, the ACUC Chair will assemble an investigative team made up of scientists, veterinarians and other administrative or management officials, as appropriate, to assure a balanced and thorough assessment of the allegation. That team will be made up of intramural, intramural and extramural, or totally extramural individuals with expertise in biomedical research, personnel management, and/or other specialty fields deemed appropriate to the situation at hand. Alternatively, I may decide to conduct an investigation out of my immediate office. In summary, any individual who has concerns related to our use of animals in biomedical research is encouraged to voice those concerns at whatever level of NIH authority that is appropriate. To that end, I wish to stress that the NIH will not tolerate any reprisal against an individual who has come forward with concerns or allegations of wrong-doing involving the care and use of animals here at NIH. Such reprisal is prohibited under the Department of Agriculture regulations implementing the Animal Welfare Act and the Public Health Service Policy on Humane Care and Use of Laboratory Animals, and perpetrators are subject to sanctions. Individuals who feel that a personnel action has been taken against them because of their reporting of an apparent violation of animal care and use requirements, should present their case to their supervisor, their ICD Director, the NIH Director, the Office of the Inspector General, or the Office of Special Counsel. If individuals allege any form of discrimination, they should file their complaint with the Office of Equal Opportunity. Any questions or comments regarding the intent or contents of this memorandum should be directed to me or to the Director, Office of Animal Care and Use. Michael M. Gottesman, M.D.