Failed Oversight

The Self-regulation of Animal Labs


The National Institutes of Health (NIH) is the largest funder of biomedical research in the world. In 2023, NIH spending for animal research totaled approximately $19 billion, or at least 40 percent of NIH’s total budget of $47.8 billion. These numbers are estimates because NIH does not track or report the amount of money spent on animal research.

The division of NIH that oversees animal labs is the Office of Laboratory Animal Welfare (OLAW), which operates under the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. OLAW is supposed to oversee all scientists and laboratories receiving federal funds, but in practice OLAW operates under the concept of “enforced self-regulation.”

Under this system, institutions are asked to provide a statement of “Animal Welfare Assurance,” describing how they will comply with PHS policy. According to OLAW’s Web site: “Once an institution has prepared an Animal Welfare Assurance and the Assurance has been approved by OLAW, the institution is in a position to regulate itself.”

How will we know if the institution is failing to regulate itself? That would only happen if the institution, or someone else who has that information, reports the problem to OLAW, since OLAW conducts an investigation only in response to a complaint.

“Enforced self-regulation” is analogous to allowing banks to audit themselves with no federal audits, or hospitals being allowed to operate without any outside scrutiny or accrediting agencies. It is a unique system, unlike any other in a profession bearing great responsibility.

Researchers regulate themselves, with no formal requirements for licensing. They conduct highly invasive surgery on animals, administer drugs, and make animals sick, disabled or genetically altered. Graduate students and even laboratory assistants with little significant training or oversight engage in these activities, including carrying out “euthanasia.”

As expected, self-regulation is replete with inherent problems.

Animal review committees at most institutions are dominated by people unlikely to challenge or question research on animals

As part of this system of “enforced self-regulation,” every research institution using animals must have what is known as an Institutional Animal Care and Use Committee (IACUC). The IACUC is required to oversee the use of animals in research under the institution's “Animal Welfare Assurance” statement. (See above).

Most IACUC members demonstrate a predisposition to readily approve the use of animals in the research projects. Each member is hand-picked by the CEO of the facility, and they are frequently colleagues of the principal researcher whose protocol is being reviewed. Often they engage in animal research themselves.

The IACUC requirements include a token community member whose stated duty is to represent the public’s interest in the research and use of animals. However, members of the public are not allowed to have any contact with this “community member” regarding questions and concerns.

This is not the case with the analogous Institutional Review Board (IRB), the entity that reviews all human research at an institution.  IRBs are generally represented by members from many diverse scientific and academic disciplines. This provides a system of checks and balances to make sure that unnecessary or inhumane research is not done on people undergoing studies, and to make sure that others, outside the scientific community and within the institution, raise any issues of concern. This is in marked contrast to the IACUC governing the use of animals in experiments.

Audits by the Office of the Inspector General criticize oversight of animal labs

The United States Department of Agriculture (USDA) is supposed to conduct annual inspections of all animal labs, but due to the overwhelming numbers of facilities, and a shortage of inspectors, this is simply not possible. As a result, USDA implemented a “risk based” system in 1998, allowing facilities without identified deficiencies to go two or three years without inspections. Inspections, when they do occur,  are typically pre-arranged, allowing facilities to address deficiencies before the visit.

The U.S. Office of the Inspector General (OIG) has conducted three separate audits of the Animal Care division of USDA, in 1992, 1995 and 2005. All three audits were highly critical of USDA’s weak oversight, including the failed operations of the Institutional Animal Care and Use Committees. The 2005 OIG audit in particular highlighted that many IACUCs are not effectively monitoring animal care activities or reviewing protocols. The same report also faulted the inspection process, which allots only 100 inspectors to cover 8,800 facilities, of which 1,100 are research labs. (The rest are animal breeders and dealers.)

The OIG’s 2014 audit mirrored findings from almost a decade prior — citing that failed oversight and inadequate fines made penalties for violators “basically meaningless.” The report noted that more than 500 IACUCS collectively amassed 1,379 violations of the Animal Welfare Act, including not adequately exploring alternatives to painful procedures on animals, misrepresenting the number of animals used in experiments, and not providing proper veterinary care to suffering animals. The OIG also found that the Investigative and Enforcement Services division closed dozens of serious cases without properly investigating them, fined serious violators an average of only 14 percent of the maximum fines authorized per violation, and wasted $115,000 instead on investigating facilities that didn’t even have animals (and some that had not had animals for more than a decade).

The Government Accountability Office and the OIG also in 2010 reported that the USDA’s enforcement action was “ineffective” for dealers licensed to sell randomly sourced dogs and cats to research facilities. Inspectors noted numerous violations, including inadequate veterinary care and housing for the animals.

The voluntary accrediting of the Association for Assessment and Accreditation of Laboratory Animal Care is of little practical value

Despite its impressive sounding name, the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) offers accreditation that is entirely voluntary. Accreditation through AAALAC is maintained through a pre-arranged site visit by AAALAC once every three years. Research institutions like to refer to AAALAC as “the gold standard” for denoting the highest caliber of animal care but, as with the USDA inspections, the advance notice allows the facilities to mask deficiencies.

It is disturbing to contemplate life as a research subject under these circumstances, in which your welfare is "protected" by a committee made up of scientists predisposed to approving your use and under only an honor system to report any problems.

If this makes us uncomfortable, then we need to speak out about our tax dollars being spent on animal experiments in which the primary regulating institution is the same institution that receives the money.