Role of the National Institutes of Health Office of Laboratory Animal Welfare and the Public Health Service Policy on Humane Care and Use of Laboratory Animals

Publication Details

Nelson L. Garnett

The laws, regulations, and policies in the United States have three main sources of which two are government and one is a private voluntary accreditation body: (1) the US Department of Agriculture (USDA), (2) the Department of Health and Human Services, and (3) the American Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). In this presentation, I will focus mostly on the Public Health Service (PHS) contribution, although there are many similarities among the three sources.

I am responsible for a portion of the US system. To reiterate, we start with a law, the Public Health Service Act. It is the same law that authorized the establishment of the National Institutes of Health (NIH) many years ago. The PHS Act was amended in 1985 to include the PHS Policy on Humane Care and Use of Laboratory Animals, implemented by my office, the Office of Laboratory Animal Welfare (OLAW). It is interesting to note that the PHS Policy preceded the legislation that authorized it, so it was ready to be implemented almost immediately after passage. We believe that Congress was very familiar with the contents of the PHS Policy and provided a strong endorsement by authorizing it virtually unchanged.

The latest version of the PHS Policy was reprinted in 2002 with minor changes to reflect updated references, addresses, and a name change for our office. Otherwise, it is unchanged from the 1986 version. I will provide the websites where you can download this and many other relevant documents in the discussion. The PHS Policy spells out the requirements for animal care that must be followed by all institutions wishing to be eligible to receive funding from any of the PHS agencies. The PHS Policy also requires that institutions receiving PHS support design their programs to conform with the Guide for the Care and Use of Laboratory Animals (the Guide).

You have already heard much about the Guide as it relates to AAALAC, but it has always been linked to compliance with the PHS Policy as well. One more example of the harmonization of the regulations and policies is the fact that almost all of the institutional animal care and use committee (IACUC) procedures in the USDA regulations were drawn from the PHS Policy. Many of the existing USDA cage size requirements were taken verbatim from the earlier version of the Guide.

OLAW is part of the NIH, the primary government funding source for biomedical research. My immediate boss is responsible for the arm of NIH that funds billions of dollars worth of research at universities and other institutions in the United States and abroad. About half of that research includes some animal component. OLAW is composed of three major components: Assurances, Compliance, and Education. The total staff has recently grown to 10, including seven professionals and three support staff. We are responsible for monitoring approximately 1000 institutions that receive PHS support.

The applicability of the PHS Policy includes all animal-related activities conducted or supported by the PHS. The main PHS agencies involved in funding animal research are the NIH, the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). This coverage is very broad and includes intramural and extramural research, grants and contracts, subcontracts, training grants, cooperative agreements, domestic and foreign activities, and even some collaborations and purchase orders. It applies to all live vertebrate animals supported by the PHS, without exception. In addition to the PHS agencies, many others such as the National Science Foundation, Howard Hughes Medical Institute, and American Heart Association have adopted the PHS Policy for their own funding programs. These endorsements have greatly expanded the influence of the policy beyond its original intent.

All PHS-supported activities must be conducted at an assured institution and must be reviewed and approved by an IACUC. PHS awarding units are responsible for ensuring that these requirements have been met before considering proposals for funding. Each grant applicant must address “Five Points” within the body of the application before the scientific peer review. Applications without this information are considered “incomplete.” These points are number and space rationale descriptions of use procedures to minimize pain methods of euthanasia.

The US Government Principles (at the back of both the PHS Policy and the Guide) provide the foundation for all federal regulations regarding animals, and the PHS Policy was expressly written to implement these principles. I should also mention that these principles are virtually identical to the International Guiding Principles, which are applicable worldwide. It is also important to note that these principles apply not only to biomedical research, but also to testing as well as training (teaching).

Briefly, OLAW is responsible for the implementation and interpretation of the PHS Policy, the negotiation and approval of Assurances, the evaluation of noncompliance, and a nationwide education program. The current PHS Policy was already in existence and ready to be put into place almost immediately after the legislation that passed in 1985 had mandated it. It was patterned after the widely accepted human subjects protections that were implemented out of the same office until several years ago. The key elements of the PHS Policy include the philosophy of enforced self-regulation, an Assurance mechanism with oversight by a local institutional committee, and appropriate reporting and documentation. The policy applies to all PHS-supported activities and covers all vertebrate animals.

The PHS concept of enforced self-regulation includes a reliance on performance standards wherever possible, and recognizes the need for flexibility and professional judgment. To be effective, it must be self-monitoring, self-correcting, and self-reporting.

WHAT IS AN ANIMAL WELFARE ASSURANCE?

The Assurance is a written document that provides the basis for a trust relationship between the institution and the government. It describes your unique program of animal care and use and, once approved, becomes a criterion for future evaluation. An approved Assurance is required for eligibility to receive PHS support. The Assurance describes, in some detail, the program of animal care and use and must address all of the following elements of that program: applicability, lines of authority and responsibility, the IACUC, procedures to implement PHS Policy, veterinary care, occupational health, personnel qualifications, facilities, and species. The Assurance must be signed by the Institutional Official, someone in the institution who is authorized to make commitments on behalf of the institution and to ensure that the conditions of the PHS Policy are met.

Many of you are familiar with the role of the IACUC in protocol review and facility inspections. What is not always understood is that the IACUC is usually advisory to, or acting on behalf of, the Institutional Official in carrying out its duties. Two other responsibilities that do not always receive the attention they deserve are the review of programs and the investigation of animal welfare concerns.

Protocol review procedures include the following:

  • Review of all animal-related activities;
  • Provision for designated reviewer(s) to conduct a review (after all members have had an opportunity to call for a full review);
  • Ability to consult experts if needed;
  • Requirement to review all significant changes before their initiation; and
  • Monitoring ongoing activities (perhaps one of the most frequently overlooked responsibilities).

The IACUCs are expected to take the following considerations:

  • Animal procedures involving analgesia and anesthesia, euthanasia;
  • Environmental conditions;
  • Veterinary medical care;
  • Personnel qualifications.
  • Specific USDA requirements to verify that (1) proposals avoid unnecessary duplication, and (2) the Principal Investigator has considered alternatives to painful procedures.
  • Review of certain broad general elements of “the science” (e.g., relevance to human/animal health, advancement of knowledge, good of society, species and numbers, and consideration of nonanimal methods). IACUCs are not expected to conduct scientific peer review, but instead to consider certain basic ethical issues as inseparable from the science.

Every 6 months, the IACUC is required to conduct animal facility and program evaluations. Reports of these evaluations are submitted to the Institutional Official and describe the institution's adherence to, or departures from, the Guide. Reasonable and specific plans and schedules are then developed for correcting those deficiencies.

Annual reporting is considered vital to OLAW's ability to provide oversight. These reports are to include the dates of semiannual evaluations, significant program or facility changes, change in accreditation status, and changes in IACUC membership; and they must allow for minority views to be expressed. Prompt self-reporting of problems is an essential part of our trust relationship. The majority of compliance issues with which we deal are brought to our attention by the institutions themselves. We view the reporting of problems, along with the corrective actions taken, to be a positive sign that the system is working as expected.

Finally, I would like to add a few words about the most important ingredient in our animal welfare oversight system—education. Education is the preventive medicine in our business. OLAW cosponsors an entire series of animal welfare educational activities throughout the year, with active participation from all of the other players, including the regulated community. The wealth of information is beyond the scope of this presentation, but I invite you to visit this website (http://grants.nih.gov/grants/olaw/olaw.htm) and explore the many resources and links that it has to offer.