IACUC Talk

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Name:        Fl�via
Email:       flaviong@usp.br
Institution: University of S�o Paulo from Brasil
Date:        18 Sep 2007

Comments:

Scaw, I would like to know about decapitation of laboratories animals, Can I use this method? Which the best guillotine I should use?
Thank you very much

Responce:

Just to get something started, here is a brief response and a couple of attachments that may be of assistance to them. Anyone can feel free to edit or chime in.

There are several guidelines available that discuss acceptable euthanasia procedures. Three peer reviewed documents from the United States, Canada, and the European Union are attached to assist you in your decision process. The publication from Canada is still in draft form, but has some information that may be useful as well. Decapitation is discussed in all three documents as being an acceptable form of euthanasia under certain circumstances for rodents and small rabbits. These publications do not recommend specific equipment, but do state that the equipment should be designed specifically for this purpose and should be kept sharp, clean, and in good working order. Decapitation devices (guillotines) can be purchased from most research supply companies and in my experience all the brands that I have used have been equal in quality.

Recommended Guidelines

AVMA Guidelines on Euthanasia

CCAC Guidelines on: laboratory animal procedures-adopted guidelines on euthanasia

Recommendations for euthanasia of experimental animals: part 1

Name:        Lilly-Marlene Russow
Email:       lmrussow@hotmail.com
Institution: Purdue University
Date:        26 Mar 2007

Comments:

I recently moved to Elkhorn WI, and am interested in volunteering to serve as a community member on an IACUC in the Milwaukee-Madison area. I have a Ph.D. in philosophy, and was one of the first people in the country to teach courses in ethics and animals; I was also a frequent invited guest lecturer in both the Department of Animal Sciences and the School of Veterinary Medicine, as well as at philosohical and scientific conferences and workshops across the country. I am currently semi-retired, but wish to remain active in the field.

Very briefly, my general position on research on animals is this: it is absolutely necessary, and should be continued, but education, advances in relevant fields, and active IACUC's all can and should act together to make sure that such research be conducted in line with the "Three R's" , and as humanely as possible.

I served for many years on the Purdue University IACUC as a 'non-scientist' member. I have been active in SCAW (served on the Board of Directors for three years), and have published articles on animals in research in the ILAR Journal, SCAW newsletter, and many other places. If you are interested in contacting me for more information, I can be reached at: lmrussow@hotmail.com. or at (765) 490-4740.

Name:        bruce scharf
Email:       bscharf@downstate.edu
Institution: downstate medical school
Date:        05 Jan 2006

Comments:

If the community member of an IACUC committee dies one week before a regularly scheduled IACUC meeting can that particular IACUC have an official meeting on that regularly scheduled date having failed to replace the deceased community member with a new community member in time for the meeting?

Responce:

Subject: Maintenance of Properly Constituted IACUCs
Dear Colleague:

This letter provides guidance to Institutional Officials and Institutional Animal Care and Use Committees (IACUCs) on the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) regarding IACUC membership and functions.

The PHS Policy specifies that an IACUC shall consist of not less than five members, and shall include at least: one Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at the institution; one practicing scientist experienced in research involving animals; one member whose primary concerns are in a nonscientific area; and one individual who is not affiliated with the institution in any way other than as a member of the IACUC, and is not a member of the immediate family of a person who is affiliated with the institution (PHS Policy IV.A.3.b.). In addition, institutions are reminded that in order to be consistent with the provisions of the 1996 Guide for the Care and Use of Laboratory Animals, nonaffiliated members should not be laboratory animal users.

For a variety of reasons, IACUCs may find their membership lacking one or more of the requisite members specified by the PHS Policy. Although there is no requirement that all members be present at all IACUC meetings, the requirement that the IACUC be properly constituted in order to conduct official business is explicit in not only the PHS Policy and USDA Animal Welfare Regulations, but also in the corresponding authorizing statutes. Accordingly, the validity of IACUC actions is always predicated on the existence of a properly constituted IACUC.

When it becomes apparent that an improperly constituted IACUC has approved a research proposal or taken other official action, that action is, by definition, invalid. It follows that animal-related activities without valid approval must be suspended until appropriate review and approval have occurred. In addition, prompt reporting of such findings and corrective actions to OPRR, in accordance with the PHS Policy (IV.F.3.), is expected.

Careful attention to PHS Policy language regarding IACUC membership, quorum, and procedures should prevent this problem from arising. Many institutions have found that appointing more than the minimum number of members who meet the respective PHS Policy criteria (paragraph IV.A.3.b.) obviates problems when an unexpected vacancy occurs.

Name:
Email:
Institution:
Date: 28 Oct 2005
Comments:
Did OLAW comply with NEPA when it was set up? Does it go through the NEPA
process with each assurance? If not why does it feel it is exempt? While lab
studies might qualify, field and endangered species studies do not and OLAW
is approving assurances involving them.

Further does OLAW undertake Section 7 consultations under the Endangered
Species Act with the U.S. Fish and Wildlife Service concerning assurances
when they may involve endangered animals?

Name: Scott Gardner Email: sgardner@lab4less.com Institution: Lab4less Date: 07 Mar 2005 Comments: We are a company in San Diego that buys and sells quality pre-owned vivarium equipment. We help you stretch your budget by providing quality equipment for a fraction of the cost, and by helping liquidate your surplus gear. Please send an email or check us out on the web at www.lab4less.com if you're interested.

Email: ruth.medina@umassmed.edu Institution: Date: 11 Feb 2005 Comments: I am looking for a service/software/templates that can help to create the Policies and Standard Operation Procedures for the IACUC. I am aware that for the Istitutional Review Bord (for human subjects)there are software created specifically for this purpose. Thanks for any help

Our IACUC wants to make sure that all animal tissue coming to the University is legally obtained in accordance with all laws and regulations (State and Federal).

Would anyone be willing to share what their institutions regulatory requirements are for bringing tissue into the institution?

What guidelines do you follow for maximum subcutaneous tumor burdens (volume) in adult mice?

We are a software development company and have developed a web-based solution that automates the IACUC processes. This system is used for electronic protocol submission, protocol routing/reviewing/tracking and management that enables the investigators, IACUC staff/members and research administrators to process protocol applications online. It is designed based on the flexible workflow processes that are adaptable to each and every organization.

If anyone is interested in a system like this for their organization, please contact us at 408-878-6336 or email us at jayar@keyusa.com

I am trying to get a feel for how much per diem charges other investigators are paying for mouse housing. If anyone has any information about their own institution that they are willing to share, or a listing of other institutions, that would be most appreciated. I am interested in finding per diem costs for mice in both conventional and barrier facilities.

It seems that the NCRR Publications on calculating per diem/rate schedules would be of help

Many attending veterinarians maintain a file with this info because they compare with each other on a regular basis. It is all over the map - there is no clear cut answer w/o knowing whether you're comparing apples and oranges.

This is a tricky question. Per diem rates are based upon how much it actually costs to care for a mouse at a specific facility. It is very difficult to compare these rates between institutions because of the number of variables involved. For example:

1) Is the faciliities operation subsidized by the Institution (i.e., veterinarians salaries, utility costs, waste disposal costs, health care costs, maintenance, etc.)

2) Is the facility centralized? The proximity of animal rooms to central supply and support areas affects costs.

3) What type of caging system is used? Conventional caging requires more cage changing activities than ventilated caging systems?

4) What type of watering systems are used? Bottle watering is more labor intensive than automatic watering.

5) Geographical location of the facility. Labor rates vary significantly across the country.

6) Numbers of mice housed per cage.

7) Types of protective clothing required for animal care and research personnel.

8) Cost of fringe benefits.

9) Many more variables could be added to this list.

I know that Vanderbilt University and Yale have both kept comparisons of animal facilty per diem rates. You may want to have the person contact these two facilities for more info.

Researching for questions/comments/statements for our annual in house IACUC training class.

Is there a central data base so that researchers can plug in to find our what projects are being conducted so that similar research is not duplicated and more animals being used than necessary?

What is your opinion on how to categorize the Morris Water Maze? We use the USDA system, even for rodents. This protocol involves mice.

I would like any information concerning procedures other universities have implemented regarding basic equipment purchase limitations. Within our university, we have the Office of Research Integrity and Compliance who provides for the upkeep and maintenance of the facility (physical plant or space), cage washers, etc. We do not, however, have a policy for the purchase of items, such as cages, that are specific to the research being conducted. Any information would be helpful.

I was interested in having information to defend a protocol regarding a safety/toxicity study employing a 28 day 3x per day oral gavage study in rats. The material is dosed in humans this way in pill form to derive the therapeautic effect and based on pre-IND criteria are encouraged to

I'd like to know if it is standard to use the FDA pain classification scale on animal protocols regardless of species (e.g., fill it out on mice and rats in addition to USDA-regulated species).

If an animal, opossum, is not available commercially, but typically humanely destroyed by Local Animal Control Authorities; Can an investigator obtain the dead animal and harvest tissue from it? Since the animal is not being killed for the purpose of the research is IACUC review and approval necessary? In what capacity? Would it be only a Health and Safety Concern at the point of introducing the carcass into the laboratory?

refer them to IACUC 101, IACUC Advanced, the December SCAW meeting, www.IACUC.org, and the ARENA/OLAW Institutional Animal Care and Use Committee Guidebook, 2nd Edition, available at http://grants1.nih.gov/grants/olaw/olaw.htm

Name:       Margaret Lawrence
Email:       mlawrence@sbi.criver.com
Institution: Sierra Biomedical
Date:        10 Jul 2003

Comments:

I 'm looking for any information that will enable me to obtain knowledge and learn new skills regarding IACUC policies, procedures, record keeping, coordinating reports to various agencies.
Can you help?

Name:      Julie Morrow
Email:       julie.morrow@ttu.edu
Institution: USSDA-ARS and Texas Tech University
Date:

Comments:

I have reviewed an ACUC protocol for establishment of a rodent breeding
colony. I was very uncomfortable with the maximum number of animals the
colony could produce (240 pups every 21 days). I wanted some assurance in
the protocol that the number of excess animals that needed to be euthanized
because they were not needed for research could be as low as possible. The
attending vet argued that commercial breeders commonly euthanize surplus
animals and don't require any verification of how many animals they need to
produce. How do other committees view breeding colonies and the
justification for number of breeding pairs allowed???

I do know that many places do pay an honorarium to IACUC members. It is entirely appropriate as long as the amount is in line with what they give others and is not excessive.

Name:        Jim Gnadt
Email:       jgnadt@sunysb.edu
Institution: SUNY at Stony Brook
Date:

Comments:

The IACUC at SUNYSB is considering the issue of some nominal compensation
for our public members, since there is no "institutional service" credit
like the university memebers enjoy. Is there any compiled data on how
common and how much this might be among the major research universities
where the work load can be substantial? Is the equivalent of an acedemic
honorarium appropriate?

Name: Wendy Burns
Email: wburns@nhgri.nih.gov
Institution:NIH/NHGRI
Date: 22 May 2003
Comments:
Our ACUC was wondering what USDA pain category was designated by other institutions for mice/zebrafish involved in ENU mutagenesis research?

Name: Lee Krulisch, Executive Director, SCAW
Email:
Institution:
Date: 21 May 2003
Comments

From previous discussions I thought that PHS Policy required the responsibility to follow the dollars, i.e., who "owns" the animal at the time, and that USDA policy required responsibility to follow the animal, i.e. location of animal. After asking for clarification, it is more involved than I thought for the case you describe. USDA essentially follows ownership; the owner of the animal is responsible for ensuring compliance with AWA for that animal. USDA (according to Dr. >DeHaven/Animal Care/USDA) will recognize prior contractual arrangements made between two parties (e.g., an institution using a contractor), but there needs to be a clear shifting of responsibility; otherwise, USDA may hold both parties liable for AWA compliance. Often there are two IACUCs >involved, and it is crucial that they communicate and share information. It is true that PHS policy generally requires that responsibility follow the dollar/"ownership" of the animal; OPRR's authority is based on the source of support. However, PHS policy may not be applicable in this case. Dr. >Garnett (OPRR/NIH) has commented that "For our purposes, the technical issue >of ownership is not particularly relevant to assignment of responsibility." First, the awardee institution is responsible for ensuring that all animal work and performance sites (including subgrantned of subcontracted work) are specified in the grant application and done at an Assured institution in accordance with PHS Policy. That automatically places collaborating >institutions on somewhat equal footing and allows certain assumptions to be >made about the program, IACUC review, etc. Some latitude is allowed for two >Assured institutions to determine who is responsible for what, but that should be made clear in advance. The performance site is the best position to exercise appropriate control and oversight.

Note: Another question regarding "responsibility" for animals is what does >the IACUC do when field research is conducted in a different state or >different country? What do IACUCs do? To clarify the situation further, an >example would be a professor doing behavior research on nonhuman primates in Africa during the summer break, or, more invasive, a professor capturing butterflies in Guatemala to take certain physiological measurements.

Name: Richard W. Diters
Email: rick.diters@Primedica.com
Institution: Primedica Corporation
Date: 20 May 2003

I would be very interested in comments from other IACUC members regarding how your IACUC/Facility handles studies that originate in your facility but animals later transfer to another location for holding and/or monitoring. We have encountered this situation a few times especially for medical device work where the intitial device implantation and postoperative care is done at one location. Subsequently, the animals are moved to another location for longterm holding. The study director remained the same and was located at the facility where the surgery was performed. My impression is that the IACUC of the latter facility should assume oversight since the IACUC and IO of the former facility have no authority to assure compliance with the AWA at the second facility. Further it would seem prudent that the 2 IACUCs share information to facilitate the process.

Name: kurt samson
Email: kjsamson@aol.com
Institution: AAMI
Date: 04 May 2003

I am looking for any recent figures (1995 - ) on use of the Draize test in industry. The latest I have are from 1991.

Name: Lee Krulisch
Email: info@scaw.com
Institution: SCAW
Date: 11 May 2003

There are several books and articles out on nonhuman primate enrichment. Your first source probably should the ILAR GUIDE (if you need a copy, ask SCAW). Kathryn Bayne, Sandy Dexter, Melinda Novak, Victor Reinhardt and others have written articles for LAB ANIMAL (Nature Publishing, 345 Park Avenue South, NY, NY 10010-1707) and LABORATORY PRIMATE NEWSLETTER (e-mail: primate@brownvm.brown.edu) For instance, in the October 1998 issue of Laboratory Primate Newsletter are articles about pair housing of adult macaques. The Primate Information Center also published CURRENT PRIMATE REFERENCES, address: Primate Info. Center, University of Washington, 1101 Westlake Ave. North, Seattle, WA 98109-3527. The ANIMAL WELFARE INSTITUTE also published "Environmental Enhancement for Caged Rhesus Macaques," address: AWI, PO Box 3650, Washington, DC 20007. I know that NIH is interested in promoting appropriate pair housing. One thought that has been presented to them is that if investigators have concerns that pair or group housing might interfere with the science, that we need to remember that animals do not have to be housed together ALL THE TIME -- they can be separated when necessary to do the protocols. These are just a few suggestions.

Name: Stacy N. Barnes
Email: sbarnes@biosupport.com
Institution: SNBL USA Ltd.
Date: 11 May 2003

I am interested in finding information on Primate enrichment requirements. Also, I would like to get ideas on others enrichment programs which are both cost effective, and productive. I would like to see our primates(rhesus macaque's) in a pair housing environment, but their are questions, concerns; about the safety of the animals. In my experience, the animals have profited from social contact, but some of my colleques feel this will cause more harm than good...

Name: Loretta Polite
Email: lcp1@mhg.edu
Institution: Medlantic Research Institute
Date:

We are a small research institute in Washington DC, with a small animal facility that handles dogs, rats, mice and pigs. We are currently seeking to hire a contract vetinarian and need some information about the average salary range for this type of position.

Name: Steven Nitka
Email: snitka@cptclabs.com
Institution: Consumer Product Testing
Date:

I am interesting in obtaining protocols useful in determing the efficacy of an orally ingested analgesic. Are there alternatives or refinements to the Mouse Hot Plate assay and others of that type? Please advise.

Name: Jacqueline Poore
Email: jpoore@lifespan.org
Institution: Rhode Island Hospital
Date:

RE: Inspections We also use the OPRR sample inspection form for our semi-annual tour and program evaluation. It is clear, concise and easy to use.

RE: Community Represenattives: We have 3 members who are non-affiliated, non-scientists serving on our 15 member panel. Their input is invaluable, especially in removing the 'science blinders' from our eyes. Try recruiting from area universities and high school teachers.

RE: Animal tissue At our institution, the investigator donating the unused tissue, post mortem, would be required to obtain IACUC permission in the form of a 'change to protocol request' We have reviewed several requests for post-mortem use of limbs for orthopaedic studies after the completion of an unrelated experiment. The number of animals used is reduced, and there is no increase in pain/distress.

Name: Mary Lou James
Email: mljames@mo.net
Institution: Consultant Regultaory Compliance, Research Animal Welfare
Date:

In response to Barbara Smith's March 16, 1999 question re: scientific merit review ("Where can I find written recommendations for peer-reviewing protocols (for scientific merit) that are not funded by outside agencies."), I suggest that the following publication may be helpful: Scientific Merit Review: The Role of the IACUC. Prentice, ED et al, ILAR News, 34, 1992 (1-2): 15-19.

SCAW does offer the service of making comments, questions on IACUC TALK anonymous. Since IACUC TALK is open to everyone, and not a listserve, we felt this was an important option.

Name: Lynn Willis
Email: willisl@iupui.edu
Institution: Indiana University School of Medicine
Date:

I am curious what policies other IACU Committees have in regards to use of animal tissues once an animal has been euthanized under an >IACUC-approved protocol.

For us, this depends on whether the investigator will take only tissues or the whole animal (dead or alive). If only tissue, (and the approved donor performs the euthanasia), we ask the investigator who will receive the tissues to write a letter to the IACUC describing what he/she plans to do with the tissue. The IACUC reviews and votes on that request. This is to head off any question about IACUC approval if the results of that study eventually get published. If the investigator wants to take the entire animal, even though it will be dead, we require a full animal-use application. We do this because the Animal Welfare Act defines an animal as either alive or dead.

In the case of the tissue-only investigators, we encourage them to submit a new protocol in any case. We ask them what they will do if their supply of donated tissue dries up. If they will go no further with the research unless they can get the tissues from other investigators, no problem and the letter to the IACUC will suffice; however, if in a shortage of donors they will want to acquire the tissues from their own animals, we remind them that they will need an approved protocol to order such animals. It is therefore expedient for them to have an approved protocol in the file even if they never use it (under those circumstances, they need fill out only a small relevant portion of the apllication form).

Name: Lynn Willis
Email: willis@iupui.edu
Institution: Indiana University School of Medicine
Date:

On the subject of having 1 or 2 non-affiliated members on the IACUC, I'd say it's up to the local IACUC to decide. Moreover, I take serious issue with the notion that "protocol review meetings were not satisfactory if the nonaffiliated member did not attend because then the community point of view would not be heard." The "community point of view" on animal research, seems pretty clear to me: "Conduct animal research but do it responsibly." It would be a pretty sad situation if the presence of the NA member was the only guarantee of a "satisfactory" review of protocols. The IACUC members should be able to understand the ethics of animal research, the requirements of the Animal Welfare Act, and the elements of responsible animal husbandry, and act accordingly whether there's an NA there or not.

As it happens, we have two NA members on our IACUC, but not for any special reason other than the past chairman thought they'd be valuable members of the committee (he was correct). Often, only one is able to attend our meetings. Sometimes neither one can make it. Both of these folks are vocal and assertive, and I'd expect them to tell me (I'm the current chairman) if they thought the quality of the reviews suffered when they weren't there.

Name: Stuart Johnson
Email: stu-johnson@nwu.edu
Institution: VA Chicago Health Care System- Lakeside
Date:

I am curious what policies other IACUCommittees have in regards to use of animal tissues once an animal has been euthanized under an IACUC-approved protocol. For instance, If an investigator wants to test a new assay or perform a preliminary experiment using, say a mouse liver, and a colleague has euthanized a mouse under his/her protocol and is willing to donate the liver, what type of oversight is felt necessary by the IACUC? The benefit might be to spare additional animals purchased and sacrificed for this purpose. I would appreciate any comments.

Name: Mary Ann Jurgus
Email: mjurgus@wpo.it.luc.edu
Institution: Loyola University @ Medical Center

I've noticed a few comments from non-disclosed names, institutions, etc. It would be great if people remembered to include this information. It's always nice to know to whom you are talking.

To the individual who discussed "inspections" -- does the institution you are referring to use inspection sheets?

Question: There has been talk about recommending that two nonaffiliated/community members serve on IACUCs. What do you think? Are there ethical reasons to do this? Practical reasons? What are the problems with this?

Now, I can reply! The premise heard at the SCAW workshops for nonaffiliated and nonscientists members was that IACUC protocol review meetings were not satisfactory if the nonaffiliated member did not attend because then the community point of view would not be heard. This puts a lot of pressure on the NA member to attend every protocol review. However, it is often difficult to find one NA member; two might be much more difficult. So, what else?

GUIDELINES FOR INSPECTION. The OPRR has an excellent sample document on the website. It is rather lengthy because it covers all types of facilities. This form was used for the first time during our last inspection. Each member was given a copy to check off approval or make comments on. The Chairman and Attending Veterinarian explained and looked for issues on the list from one room to the next. Questions were asked by members throughout the inspection that especially was helpful to new members. The list were collected at the end of the inspection and a report was submitted at the next meeting. You can customize the OPRR suggested list for your facility. Our committee was pleased with the results and it was an inspection that was more detailed than usual and pointed out issues not thought about before.

Name: Ralph B. Dell
Email: rdell@nas.edu
Institution: Institute for Laboratory Animal Research
Date: 15 Apr 1999

Timing of elective surgery is an issue in which the IACUC should be involved. The committee can work with the investigator, reason, explain why it is good for his/her animals and her/his research. If this doesn't work then charge the investigator extra money for people to work overtime.

Most IACUCs do not include training for inspections, if they have training programs for IACUC members. My experience as a new nonaffiliated member of an IACUC has been: Somewhat familiar with the "Guide" and institutional policies, on the first inspection, you listen and find out what others on the inspection are looking at and commenting about. And of course, you look at the animals and learn what species are used in that institution, and also historically what the problems have been. On the next inspection, maybe you are the first one to spot an uncovered food storage container or lack of an animal record card on a cage or an animal that doesn't look right. And so it goes; it seems that experience is the basis for information about facility inspections.

Name: William L. Wade, LVT, LATG
Email: w-wade@nwu.edu
Institution: Northwestern University
Date: 15 Apr 1999

What are your guidelines for inspection of laboratory areas? Use of checklists, references, the Guide, etc. What types of training do your IACUC members receive in this area? Comments and insight greatly appreciated.

Name: Lisa Alper
Email: alperl@pamf.org
Institution: Palo Alto Medical Foundation, Research Institute
Date: 13 Apr 1999

We are currently having an issue regarding the time that elective surgery is being performed on animals. The investigator refuses to do this elective surgery early in the morning so as to monitor the animal's recovery during the remainder of the day. Instead, the investigator believes he should be able to perform surgery at his choice of time. If surgery is performed later in the day, this would mean that he or his technican must return to the building at some point during the night to check the animal. This is a difficult thing to monitor, since office hours are only until 5:30 PM.

Name: theron s. rumsey
Email: trumsey@lpsi.barc.usda.gov
Institution: BARC - Livestock and Poultry Sciences Institute
Date: 05 Apr 1999

A current issue for us has been the use of electrostatic air filters in laboratory animal rooms, particulary the use of portable units in dog and cat rooms. What is the efficiency of these units for reducing allergens/aerosolized allergens. Our understanding is the reduction can be significant but have found no literature to this point that directly addresses the issue.

Name: Calixta Diez
Email: calixta_d@hotmail.com
Institution: Kildare College
Date: 05 Apr 1999

Name: Lee Krulisch
Email: info@scaw.com
Institution: SCAW
Date: 25 Mar 1999

At the April 1999 meeting sponsored by NCAB/AALAS and SCAW, one session will be on the relationship between IACUC and principal investigators. I am looking for scenarios, anonymous case studies that highlight this relationship. Also, are there any questions you might want to be addressed? For example, (1) how often do IACUC members meet PIs, especially nonaffiliated members? Usually, these meetings take place on semi-annual inspections or if the PI is asked to appear before the IACUC to answer questions; (2) how often do PIs try to go "above" the IACUC, say to the Institutional Official, to override a decision by the IACUC? Debi Faryna and I want to make this session interesting and stimulate some thought, so anything you all can contribute will be a great help.

Name: Ron McLaughlin
Email: mclaughlinR@health.missouri.edu
Institution: University of Missouri
Date: 25 Mar 1999

RE: Barbara Smith's request for "written recommendations for peer-reviewing protocols (for >scientific merit). One basis for requiring merit review is that the PHS Policy and the lab animal >"Guide," and the new Ag animal "Guide" eitherincorporate or strongly endorse the US U.S. >Government Principles as fundamental to the humane care and use of animals in experimentation. >Among these principles is: >II. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the >advancement of knowledge, or the good of society. > >A more simplistic reason, on the surface, hinges on a cost benefit relationship between the amount of animal pain and distress and the probability of >worthwhile scientific results. If the ethical cost in terms of animal pain and distress is high, then there is a sense that there should be a >correspondingly high probability of a scientific result of substantial value. If there is no pain or distress, then concern for humaneness is not an issue, >and concern for the merit of the science, vis-a-vis humaneness, is not an issue.