Comments for: Implementation of the Revised International Guiding Principles for Biomedical Research Involving Animals

For more information, see NIH Guide Notice (NOT-OD-13-096) and Federal Register Notice, Doc# 2013-20740 (PDF)

Comment Period: August 1, 2013 - September 30, 2013

Name of Organization	City and State	Comment 1:
		My concerns are: 1-Science has advanced to the point now where we know that animal research is severely flawed in terms of applicability to humans. There are superior options. 2-This research causes suffering to animals, which can not be an acceptable choice particularly given the genuine lack of benefit in terms of outcomes for health. 3-Thoughtless, profit-driven animal research lacks integrity.
NIH	Bethesda, MD	I am completely 100 % against the use of ANY animals for the use of medical research. This is based on two principles. I believe that it is bad science and that any information obtained about how a chemical interacts with an animal is not in any way applicable in an authentic way to how it would interact with a human and human illnesses. The US is quantum leaps behind other countries in using proven alternatives to animals in research. Secondly, it causes incomprehensible suffering and death to animals that have the same right to life that we do. Thank You
Canton Animal Hospital LLC	Canton, CT	The Guidelines reinforce the need to allow science to progress, for the mutual good of animal and human patients. The use of animal models of disease and in testing medications to be used on animal and human patients remains essential to allow scientific progress and healthier lives. It is common sense to minimize suffering wherever it is found, and research now may lead to less suffering later when disease is cured or new medications allow control. Respect for animal life and the humane use of animals for biomedical research to benefit people and animals, are not mutually exclusive goals. These guidelines make this clear while offering a philosophic framework with which such use may be understood and accepted. Bravo to the writers whose task it was to strike the correct balance between competing positions on these issues. Well done!
---	Fort Collins, CO	It is not clear in NOT-OD-13-096 that this is for foreign institutions or if this needs to be added to all Assurances in the future. A statement that this is necessary for foreign institutions only would be most helpful. Thank you for your consideration.
University of Puerto Rico School of Medicine	San Juan, PR	All publications under such funding should include the protocol number as approved by ithe nstituional animal care and welfare committee. This could appear in the Methods Section of the manuscript where the animal study is described and/or under Acknowledement.
		Over the past 10 years a significant effort has been initiated by neurological disease societies and organizations (i.e. stroke, Alzheimer's, Parkinson's, NINDS, NIMH) to improve the quality of animal studies by insisting on methodological rigor in study design. These efforts follow recognition that lack of methodological rigor in animal studies has led to over-estimation of benefit that does not translate in clinical trials; investigators fail to replicate the results from animal studies when tested in rigorous human trials. The poor track record of successfully translating "bench to bedside" has led to skepticism regarding the value of animal research. However an ethical dilemma exists as a tenet of human research rests on "probability of a safe and beneficial outcome" based on preclinical studies. To address this problem, research organizations are beginning to insist on similar methodological rigor in development of animal studies as is used in clinical studies. Sample size is often discussed (as well as methodologies to address bias); for example, Scott et al. (Amytroph Lateral Scler 2008; 9:4-15) state that "the probability of seeing an effect by chance alone is significant even with 10 animals per group." Ludolph et al. (Amytroph Lateral Scler 2010; 11:38-45) state that "an absolute minimum for any study of survival (time to loss of righting reflex), 12 animals of a single sex must be used unless justified by a power analysis with data shown in supplemental figures or tables." From an ethical point-of-view, underpowered studies are undesirable as they might lead to false conclusions that lead intervention is without efficacy and all animals will have been used to no benefit. Overpowered studies are also unethical but these studies are much less prevalent. I therefore recommend that you modify this paragraph to specifically state that use of too few animals is equally unethical as the use of too many animals. I recommend altering Principle III to indicate that underpowered studies present a much greater ethical dilemma because they might lead to a human jeopardy in clinical trial. The use of too few animals is, in my opinion, is quantifiably more unethical than the use of too many animals. I also recommend that you include a statement in one of the principles, perhaps Principle VIII, that methodological rigor, with attention paid to sample size and methods to address bias, are needed to insure integrity of the animal study. Reference Principle VI, last sentence: "Appropriate veterinary care should always be available and provided as necessary by a veterinarian." In my opinion this sentence does not go far enough as too many research facilities rely heavily upon husbandry staff (rodent facilities) and/or technicians to assess and treat animals during off-duty hours I suggest strengthening the sentence to make it clear that a veterinarian should respond within a reasonable amount of time, 24 hr/7 days/wk.
U S CITIZEN	NOT AVAILABLE NJ	NO ANIMALS EXCEPT MICE CAN BEUSED FOR ANY TESTS OF ANY KIND. NO TESTS SHOULD EVER BE DONE USING AMERICAN TAX DOLLARS IN ANY FOREIGN COUNTRY. AMERICAN TAX DOLLARS ARE GIVEN TO THIS AGENCY TO BE SPENT IN AMERICA AND THE MEETING S AUTHORIZING SPENDIN G NEED TO BE OPENED UP TO THE PUBLIC INSTEAD OF BEING SNEAKY SECRETIVEMEETINGS. THS IS PUBLIC US TAXPAYER DOLLARS AND THE TAXPAYERS HAVE A RIGHT TO KNOW HOW WHERE AND WHO IS GETTING THEIR TAX DOLLARS. UNANNNOUNCED SURPRISE VISITS NEED TO BE MADE TO THESE LABS EVERY 6 MONTHS NOT EVERY TEN OR TWELVE YEARS AND YOU NEED TO STOP GIVING ADVANCE NOTICE YOU ARE COMING. THE LABS ARE PRESENTLY TOTALLY ABUSIVE TO ANIMALS, WHO SUFFER IN THESE LABS. THAT IS DISGUSTING AND DEPRAVED. PIGS ARE AS INTELLIGENT AS 2 YEARS OLD KIDS - WOUDL YOU LAB THEM? DOGS ARE VERY INTELLIGENT TOO STOP ABUSING ANIMALS.
		Several times in the revised Guiding Principles it is written that animal care and well being (sic) be under supervision of veterinarian or "scientist" with training and experience in animal care and well being, etc etc. This is not enough guideline because as described, "scientist" could be a of person low training and education, on the job "training " , someone who could do great harm to the animals via ignorance or intent. I propose document be modified to add that such staff be under the direct supervision of a veterinarian. You wouldn't have a study with patient care by some I'll defined "trained" person, wouldn't then refer to that person as scientist, would not be adequate. Doctor is a must.
University of Oregon	Eugene, OR	I fully support the revised Guiding Principles to provide veterinarian supported health care for animals involved in biomedical research. These animals sacrifice themselves for our benefit and we should provide them with pain reduction and health conserving professional care.