Laws

Laws

IACUC

The Animal Welfare Act (AWA) mandates that each research facility establish an Institutional Animal Care and Use Committee (IACUC). (1) The IACUC must consist of no less than three members and must include an attending veterinarian from the facility and one person not affiliated with the facility. (2) All members are selected by the facility’s CEO. (3)

The primary functions of this committee are to:

  • Approve the use of animals in all research proposals
  • Require changes to proposed studies if they are not in accordance with USDA regulations
  • Approve any significant changes to ongoing protocols
  • Ensure that procedures will “avoid or minimize discomfort, distress, and pain to the animals”
  • Verify that principle investigators [researchers] have considered alternatives to procedures that cause pain or distress
  • Assure that the procedure does not “unnecessarily duplicate previous experiments”
  • Review the facility’s “program for humane care and use of laboratory animals” and inspect all animals facilities for compliance with AWA regulations at least once every six months
  • Send reports of their evaluations to the facility’s CEO, including records of significant deficiencies and specific plans and schedules for dates to correct these issues
  • Investigate concerns involving the humane care of animals at the institution based on public complaints or non-compliance reports from lab employees (4)

The IACUC must provide an annual report including assurances that:

  • The facility is using “professionally acceptable standards” in regard to animal care and pain management
  • Each researcher has considered alternatives to painful procedures
  • The facility is adhering to the AWA. (5)

It must also provide a summary of all exemptions to AWA regulations, including all experiments involving pain or distress for which animals did not receive pain-relieving drugs. (6)

IACUC meeting minutes, records of attendance, activities and deliberations; proposed activities/changes and IACUC responses; and semiannual reports and recommendations are filed with the facility and are to be made available to USDA/APHIS inspectors on request (7) (under current APHIS/Animal Care policy this review may happen only every 2-3 years). (8)

The regulations state: “APHIS inspectors will maintain the confidentiality of the information and will not remove the materials from the research facilities’ premises unless there has been an alleged violation, they are needed to investigate a possible violation, or for other enforcement purposes.” (9)

Research studies cast doubt on IACUCs’ reliability

The IACUC system is deemed the cornerstone of animal protection within laboratories, but in reality it is a system plagued with loopholes that leave animals with little to no adequate protection. Repeated audits by the USDA’s Office of the Inspector General (OIG) have noted continuing issues with the IACUC system. Many of these issues stem from the fact that the facility’s CEO appoints all members, leading to the strong possibility of bias and a lack of objectivity in performing their duties, which could call into question practice and procedures of that very same facility. Further, even the purported member not affiliated with the facility is still handpicked by the facility’s CEO.

A September 2005 audit report by the OIG issued as one of its major findings: “Some IACUCs are not effectively monitoring research facilities.” (10) A 1995 OIG report raised similar issues. (11)

The OIG 2005 report noted that these failings included

  • Ineffective monitoring of animal care, protocols, and alternative research methods
  • Lack of or poor follow-up on the correction of deficiencies
  • Inaccurate annual reporting (12)

OIG’s conclusions noted the following problems—that IACUCs:

  • Only conducted reviews on a semiannual basis
  • Had high rates of member turnover
  • Failed to properly train committee members (13)

The audit stated: “As a result, the facilities are not conducting research in compliance with the AWA or, in some cases, not providing humane conditions for research animals.” (14) The report noted that despite its previous reports highlighting IACUC issues, the number of research facilities cited for violations has steadily increased in recent years. (15)

A 2001 IACUC study—published in Science and funded by the National Science Foundation also casts serious doubt on the reliability of IACUC to protect animals. (16)

The three-year study took a random sample of 50 IACUCs’ three most recently reviewed animal protocols. The protocols were then randomly assigned to be reviewed again by a second IACUC participating in the study. The results showed that approval decisions by the original IACUC vs. the second IACUC reviews were unrelated. A majority of the protocols approved by the first committee were not approved or were deferred by the second committee. The study concluded “the reliability of their proposal reviews is at chance levels—literally, a coin toss.” (17)

The results call into question the reliability of the IACUC protocol review and, thus, the effectiveness of animal research regulation. In a press release, the study’s authors, Plous and Herzog, anticipated that the results of their study “will prompt a reevaluation of the way animal research proposals are approved.” (18) Sadly, it has not.

The study’s findings included

  • Decisions made by the original vs. the second IACUC differed significantly, even on research involving terminal or painful procedures—including procedures such as electric shock, food or water deprivation, surgery, and drug or alcohol research; protocols involving euthanasia; and protocols in which the reviewing IACUC expected animals to experience a significant amount of pain. The original and second IACUCs protocol reviews differed nearly 80% of the time (118 out of 150 reviews).
  • Only 43% of the reviewed protocols were seen as having justification for the type and number of animals used—a requirement of the AWA.
  • Nearly two-thirds (61%) of the reviewed protocols were judged as either “not very understandable” or “not understandable at all;” as having “poor” research designs and procedures; or as justifying the type and number of animals in a way that was deemed “not very convincing” or “not convincing at all.”

Proponents of animal use in research cite the establishment of IACUCs as a way to assure the caring public that the use of animals in research is well-monitored - an assurance this study scientifically calls into question.

APHIS Animal Care (AC) division has also noted its concerns about IACUCs’ effectiveness:

AC is concerned about the effectiveness of some IACUCs’ oversight of animal care and use, and the effectiveness of AC’s regulatory authority over these committees. This includes IACUC oversight of adequate pain and/or distress relief, and the use of alternatives to procedures that may cause more than momentary pain or distress. (19)
 

IACUC failures

An IACUC review is supposed to be an objective third-party check on the welfare of the animals involved in experiments. However, the potentially biased nature of these committees allows business and scientific interests to compete with concerns for the pain and suffering of the animals.

The potential for bias and other flaws in IACUC reviews include
Committees are typically comprised of employees of the facility—often researchers themselves. Since all members are appointed by the facility’s CEO, they could be less likely to support a decision that may conflict with the status quo.

  • Having researchers make decisions that would restrict the work of their peers could place additional pressure on them to acquiesce.
  • While one “non-affiliated” member is to represent the concerns of the general public, this member is also chosen by the CEO. If this member opposes a protocol, he or she can be out-voted by the other members.
  • The chairman has the authority to have only ONE qualified member review a protocol unless a full review has been requested. “That person shall review the activities and has the authority to approve, require modifications, or request a full committee review of the activities.”
  • The bi-annual evaluations of the facility and animals must include any minority views, (20) but these reports are not publicly accessible unless the facility is federally owned. (21)
  • If AWA violations at the facility are found, the report of the violation goes on file with the institution. Only if the problem is not corrected is the matter reported to APHIS. If the IACUC is part of a private institution or business, the public does not have access to these internal violation reports.

The major loophole: “exemptions” for science

While the AWA provides requirements for the care of animals in research, it allows IACUCs and researchers to make “exemptions” as they deem necessary for the needs of the experiment. This may involve such things as keeping an animal in prolonged isolation or withholding food or water for a specified period.

The most disturbing of these possible exemptions involves bypassing regulations to minimize an animal’s pain and distress.

The AWA allows for the withholding of tranquilizers, anesthesia, analgesia, or euthanasia “when scientifically necessary.” (22) Such exemptions are allowed when “specified by research protocol.” (23)

This language leaves critical judgments entirely in the hands of the principal investigators and their IACUC committees rather than defined by a stringent set of guidelines. If the IACUC agrees that pain medications will affect the outcome of the experiment or block the researcher’s ability to monitor the symptoms, these requirements may be waived.

Likewise, although there is a regulation stipulating that “no animal is used in more than one major operative experiment from which it is allowed to recover,” this, too, can be bypassed “in cases of…scientific necessity.” (24)

The reality is that many chimpanzees and other species have suffered tremendously in experiments. As a tragic example, read about Jerom.

Pain & distress: failure to acknowledge and report

The AWA requires that IACUCs report when animals are not provided with pain relief. However, the assessment of pain and stress is left to the interpretations of IACUC members and researchers.

The danger of a subjective interpretation of “pain and distress” is that animals are at the mercy of these individuals’ empathy or lack thereof. A 1993 study, “Savages, Drunks and Lab Animals: The Researcher’s Perception of pain,” of laboratories located in two research institutions in the New York City area concluded that: “Although researchers always acknowledged the ability of animals to feel pain, this knowledge remained an abstraction for most. Scientists rarely saw any pain or suffering in their labs.” (25) The provision of painkillers following surgery did not even occur to many:

Analgesics [painkillers] are routinely given to human patients following surgery…. In the animal laboratories, however, analgesics were rarely used. No one (with the possible exception of some animal welfare advocates) considers this a violation of the regulations, but rather a (more or less) legitimate interpretation of the “appropriate use” and “as required” clauses. Whereas the regulations were invariably interpreted to require anesthesia for surgery, they were not construed to require analgesic drugs under any specific conditions. Analgesics were considered when they were considered at all to be a matter for individual judgment. (26)

There are numerous cases of the under-reporting of pain and distress by laboratories. For instance, in the USDA’s Animal Care Annual Report of Activities—FY 2007, many states claim  doing no procedures causing pain and distress. However, these same states report conducting experiments known to cause severe pain and distress. These experiments range from infecting animals with Simian Immunodeficiency virus (similar to HIV) and West Nile virus, to causing cancer and stroke in animals. (27)The USDA sought public comment on proposed changes to the pain and distress classification system in 2000, but the agency has taken no action to date. (28)


Sources

(1) Animal Welfare Act. 7 U.S.C. § 2143 (b)(1).

(2) Ibid.

(3) Ibid.

(4) Animal Welfare Act. 9 C.F.R. § 2.31 (c - d).

(5) Animal Welfare Act. 9 C.F.R. § 2.36 (b)(1)(2)(3).

(6) Animal Welfare Act. 9 C.F.R. § 2.36 (b)(7).

(7) Animal Welfare Act. 9 C.F.R. § 2.35.

(8) United States Department of Agriculture. Animal and Plant Health Inspection Service. APHIS Factsheet, Animal Care, February 2002.

(9) Animal Welfare Act. 9 C.F.R. § 2.35 (f).

(10) United States Department of Agriculture-Office of Inspector General/Western Region - Audit Report - APHIS Animal Care Program Inspection and Enforcement Activities - Report No. 33002-3-SF, September 2005.

(11) Ibid, pp 5, 28.

(12) Ibid (Finding 4, p. 19-22).

(13) Ibid (Finding 4, paragraph1).

(14) Ibid (Finding 4, paragraph 1).

(15) Ibid, Results in Brief, pp. ii-iii.

(16) Plous, S., & Herzog, H. A., Jr. (2001). Reliability of protocol reviews for animal research. Science, 293, 608-609.

(17) http://www.socialpsychology.org/articles/scipress.htm (July 27, 2001 press release from Wesleyan University).

(18) http://www.socialpsychology.org/articles/scipress.htm (July 27, 2001 press release from Wesleyan University).

(19) United States Department of Agriculture. Animal and Plant Health Inspection Service. Strategic Direction for the Animal Care Program, January 2000. Executive Summary.

(20) Animal Welfare Act. 9 C.F.R. § Sect. 2.35 (a)(3).

(21) United States Department of Justice. The Freedom of Information Act 5 U.S.C. § 552, As Amended By Public Law No. 104-231, 110 Stat. 3048.

(22) Animal Welfare Act. Sect. 2.31 (d)(1) (iv)(A).

(23) Animal Welfare Act. 7 U.S.C. § 2143 (a)(3)(E).

(24) Animal Welfare Act. 7 U.S.C. § 2143 (a)(3)(E).

(25) Phillips, Mary T. Savages, Drunks, and Lab Animals: The Researcher’s Perception of Pain. An ethnographic study of laboratories located in two research institutions in the New York City. Society and Animals, Vol. 1, Issue 1, 1993.

(26) Ibid.

(27) United States Department of Agriculture. Animal Care Annual Report of Activities, 2007.

(28) The Humane Society of the United States. “Distress in Laboratory Animals Goes Unheeded.”

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