Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to firstname.lastname@example.org so that we can defer those challenges. Your health and safety are paramount to us.
Posted 09 November 2012
Are Institutional Animal Care and Use Committees (IACUCs)-groups used to ensure research conducted on animals meets basic ethical standards-meeting their ethical responsibilities and the original intent of Congress? Not even close, argues a researcher in the latest issue of the British Medical Journal.
Writing in the 6 November 2012 issue of BMJ, Lawrence Arthur Hansen, a researcher at the University of California San Diego's Department of Neurosciences and Pathology, explains that IACUCs were originally formulated after a series of high-profile animal welfare abuse incidents.
One series of incidents in particular, famously characterized by the theft and death of a dog named Pepper, would lead to congressional action and eventually a new set of requirements that all animal testing should "respect society's concerns regarding the welfare of animal subjects."
While well intended, writes Hansen, the legislation never really filled in the details of what it meant by the ethical treatment of animals, leaving much of the task to federal regulators with the Public Health Service and US Department of Agriculture.
The basic ethical framework put forth by regulators would stipulate that animal testing should not be conducted unless there was a good chance of humans benefiting from a medical advancement and the harms suffered by animals was likely to be low. IACUCs were to safeguard this arrangement by overseeing and approving all study designs-a sort of Institutional Review Board (IRB) for animals.
That, at least, was the intent, explained Hansen.
"IACUCs did not assume the role of ethics committees, however, and one national authority on how they function frankly acknowledges that relevance of proposed animal research to human disease is immaterial in their deliberations, and any research procedures, even if painful, can be approved."
Continued Hansen: "Rather than making ethical judgments, IACUCs have restricted themselves to technical or advisory roles focused on reworking the details of some animal-use protocols, but ultimately approving almost all of them."
Though Congress may have been vague on the details when they passed the Animal Welfare Act in 1986, wrote Hansen, they were certainly clear on the intent: "To meet the public concern for laboratory animal care and treatment important in assuring that research will continue to progress."
IACUCs could actually stand to benefit greatly by emulating IRBs, argued Hansen, who noted that IACUCs are not required to be balanced among non-institutional and institutional members. "Better balanced IACUCs would lessen the risks of bias and groupthink and broaden their deliberations to include ethical dimensions of animal research," he wrote.
Even research funded by the National Institutes of Health, one of the US' most prestigious research bodies, exhibited strong bias toward staffing IACUCs with animal researchers and institutional veterinarians, with only 7% of IACUC members not belonging to either group. "It is not unduly cynical for animal welfare advocates to wonder if an animal-use committee system in which 82% of members and 93% of chairpersons have vested interests in continuing animal research might be subject to an approval bias," Hansen argued.
Such biases may be a driving factor in the committees' 98% average approval rating for in-house research proposals. In one study cited by Hansen, when such proposals were blinded and sent to other institutions they only received approval 61% of the time.
The shift toward an IRB model with minimum requirements for proper membership constitution would go a long way toward correct these deficiencies, as would more explicit direction regarding the use of ethical cost-benefit analyses for approving animal research, Hansen argued.
"IACUCs have chosen not to function as animal ethics committees because of their overwhelming proportions of animal researchers, laboratory animal veterinarians and other members with vested interests in seeing animal experiments approved," concluded Hansen.
"But since IACUCs are the only mechanism available for addressing the ethics of animal research, they should broaden their purely technical scope to consider larger ethical issues, including harm-beneﬁt determinations. Infusing greater ethical diversity into their memberships would further this goal."
Tags: Animal Welfare Act, Animal Research
Regulatory Focus newsletters
All the biggest regulatory news and happenings.