In the last post I introduced the concept that the use of animals for research purposes in the US is a highly regulated activity involving both Federal law (the Animal Welfare Act; AWA) and Federal regulation (the Animal and Plant Health Inspection Service of the US Department of Agriculture; APHIS/USDA). I also introduced the concept of the local research institution's responsibility to convene an Institutional Animal Care and Use Committee (IACUC), and the AWA mandated inclusion of a veterinarian and a member of the public. This post will focus on some of the duties of the IACUC.
[Update 8/11/08: Isis the Scientist on the ongoing process of animal-use oversight]
With respect to activities involving animals, the IACUC, as an agent of the research facility, shall:
(1) Review, at least once every six months, the research facility's program for humane care and use of animals, using title 9, chapter I, subchapter A--Animal Welfare, as a basis for evaluation
(2) Inspect, at least once every six months, all of the research facility's animal facilities, including animal study areas, using title 9, chapter I, subchapter A-Animal Welfare, as a basis for evaluation
(3) Prepare reports of its evaluations conducted as required by paragraphs (c)(1) and (2) of this section, and submit the reports to the Institutional Official of the research facility
Oversight of the entire institution's use of animals is a major responsibility of the IACUC. These semi-annual inspections of animal housing facilities (vivariums) and animal research areas are serious business. Most places these inspections are unannounced although, of course, about once every 6 mo one might expect the IACUC to arrive. IME, anything goes. They open drawers and check for expired saline or syringe bodies. Examine the animal records where needed, any checklists that are supposed to be maintained, the animal care staff records, etc. Look at animals. Ask questions of the staff regarding the procedures that are underway. You know, inspect stuff. As they are supposed to. The local institutions have to do this or they cannot conduct animal research. Period.
The reports shall be reviewed and signed by a majority of the IACUC members and must include any minority views. The reports shall be updated at least once every six months upon completion of the required semiannual evaluations and shall be maintained by the research facility and made available to APHIS and to officials of funding Federal agencies for inspection and copying upon request.
Hmm. My experience is that the IACUC report is sent to APHIS like clockwork every year; there is no request required as far as I know. Perhaps the APHIS simply puts in a standing request. This has been the practice of every facility where I've been exposed to sufficient information to know about such practices. This is a serious function in my view: the IACUC must report on its own institution to the USDA with regularity. Furthermore any single member cannot be outvoted and quelled. Minority views have to be submitted. This is related to my prior emphasis of the unique roles of the non-affiliated member and the Attending Veterinarian on the IACUC.
The reports must contain a description of the nature and extent of the research facility's adherence to this subchapter, must identify specifically any departures from the provisions of title 9, chapter I,
subchapter A--Animal Welfare, and must state the reasons for each departure. The reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which, with reference to Subchapter A, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals.
There's more in this section about having a plan for correcting deficiencies but the most important thing here is the fact that the IACUC is under the responsibility of Federal law and regulation to report on itself. This is not optional. Perhaps even more importantly we get beyond any simple view of whistleblowing where if someone objects to health and welfare of research animals they can figure out how to report it. Rather, this makes it emphatically clear that it is the responsibility of the IACUC to report (and correct) deficiencies in their program.
This brings me to what may be a personal view. I believe that everyone that works with research animals has not merely the right, but rather the obligation to report situations that appear to compromise the health and welfare of the research animals.
Don't get me wrong, I have caveats. Of course. I am not saying that anyone who feels squeamish about a research practice should go running to the USDA right off. Far from it. Merely that anyone has the right to start up the chain of command in the labs and institutions in which they work. To ask "why do we do this, by what justification, and is this ok". The chain of command is basically the supervisor, then to the IACUC chair and/or the Attending Veterinarian. Perhaps next to the Office of Laboratory Animal Welfare (OLAW) of the NIH (we'll get to this eventually) and then the USDA/AHPIS. The major caveat is, however, that one had better make dang sure that he or she is on informed ground, understands the law and regulation. The answers that are offered should, of course, comport with the law and regulation (and established practices, which is a tricky thing). What it is not appropriate to do, in my view, is to pursue an animal rights agenda which at core basically rejects the permission extended by the AWA. It is not okay to say "Well, just because the US Congress, the USDA/APHIS, the local vets (and the professional veterinary associations), the local IACUC, many other IACUCs and local vets across the country who approve similar procedures, etc say this is okay, I still have a problem!". I'm not rejecting such positions out of hand. I'm just saying this is not the arena in which to satisfy such concerns- do not expect to make any headway on such topics.
With that said, I will reiterate my point for the legitimate actor: Each and every person who works with research animals has a responsibility to oversee animal health and welfare. In my view this follows naturally from the Federally mandated responsibility of the IACUC for oversight. What also follows, in my view, is that every person working with research animals should be at least passing familiar with the AWA and the APHIS / USDA regulations. These people should also be more than passing familiar with the NIH Guide for the Care and Use of Laboratory Animals and intimately acquainted with their specific animal protocol(s) approved by their IACUC.
I have a final thought which returns me to the original motivation for this little series. Some institutions that I've been around have a number of training classes that people who use animals in research have to attend. Two come to mind as being something that any interested party at a University might reasonably seek out. First is a class comprising a basic introduction to the humane use of animals in laboratory research. IME, the sort of class that everyone who works with animals should be taking. (Admittedly, I know next to nothing about how widespread various training practices actually are at the local level). Second, there might perhaps be an introduction to the IACUC and the IACUC protocol specifically, usually intended for the PI / lab head and perhaps some lab manager / staff scientist types. It seems to me that an undergrad who is interested in learning more might approach the IACUC office about attending such classes.