Author Archives: Editor

Lack of sense about sentience and statistics

Two recent events have inspired a slew of bad reporting in the UK about animal research. The first was a vote in Parliament rejecting a call to describe animals as sentient into British law. The second was the publication of the Northern Irish statistics.

On 15th November, Parliament voted down an amendment to the European Union (Withdrawal) Bill that stated “Obligations and rights contained within the EU Protocol on animal sentience set out in Article 13 of Title II of the Lisbon Treaty shall be recognised and available in domestic law on and after exit day, and shall be enforced and followed accordingly.” While there is no clear scientific definition of sentience, it has, in crude terms, been taken to mean the capacity to feel pain and/or emotion. The relevant part of the Lisbon Treaty (which Britain will withdraw from upon Brexit) reads:

In formulating and implementing the Union’s agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage.

The amendment was rejected 313 votes to 295 (roughly down party lines). A few days later a number of articles began reflecting on this. A well-shared article in The Independent by Yas Necati claimed that the Government had voted “that all animals (apart from humans, of course) have no emotions or feelings, including the ability to feel pain.”

What seems to have been ignored is that the protection of sentient animals is already embodied in British law. Most animal use is governed by the Animal Welfare Act, 2006, which protects any animals where an: “appropriate national authority is satisfied, on the basis of scientific evidence, that animals of the kind concerned are capable of experiencing pain or suffering”. The act also includes provisions to be extended to invertebrates if they seem to be able to suffer or feel pain. Essentially the Animal Welfare Act is an entire piece of UK domestic law dedicated to protecting sentient animals.

For animals in laboratories, the relevant legislation is not the Animal Welfare Act, but the Animals (Scientific Procedures) Act, 1986 (better known as ASPA). This act protects all vertebrate species, and invertebrates considered potentially able to suffer or feel pain (currently only cephalapods). The act covers all “regulated procedures” defined as those “which may have the effect of causing that animal pain, suffering, distress or lasting harm”.

Importantly, both of these acts are in domestic UK law, and so will not be affected by any future withdrawal from the European Unioin. So it seems odd that someone would claim the Government dos not believe that animals can feel pain.

It also seems odd that Necati would then claim that:

Under EU law it is illegal to test on animals for cosmetics like body wash and nail varnish. But this could easily be scrapped just like the recognition of animals as sentient beings has been.

We are looking at a very grim future for animals, where hunting is reintroduced, labs are free to test on animals with as much cruelty as they wish (and no pain relief) and farms are less and less regulated.

Necati may wish to note that the UK had already banned the use of animals to test cosmetics or their ingredients in 1998 – a full fifteen years before the EU laws came into effect. So it is unclear why this domestic ban would change upon leaving the EU. Similarly ASPA came into law in 1986 – 27 years before the EU Directive 2010/63 covering animals in research across the EU. Importantly, ASPA, 1986 was updated in 2013 to transpose aditional laws brought about by the EU Directive – this means that the EU Directive is effectively within UK law and will remain unaffected by Brexit.

The media frenzy whipped up over this issue has been such that many politicians have had to clarify the Government position, with the Prime Minister, Theresa May, also referring to it in her weekly Prime Ministers Questions:

We also recognise and respect the fact that animals are sentient beings and should be treated accordingly. The Animal Welfare Act 2006 provides protection for all animals capable of experiencing pain or suffering which are under the control of man. But I reaffirm to her that we will be ensuring that we maintain and enhance our animal welfare standards when we leave the EU.

Yas Necati was not the only one to be mistaken on this issue. Cruelty Free International (CFI) sent out a press release to Northern Irish press that combined a discussion of the annual statistical release with the parliamentary activities. As usual, there was a lot wrong with the CFI press release – not least that they managed to get the overall number of procedures in Northern Ireland wrong by mixing up the 2015 and 2016 statistics (this is literally the main number in the whole release). We decided to fully debunk the nonsense of the press release in a picture:

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This is not the first time CFI have misused the severity statistics by neglecting to include experiments involving breeding and maintaining GA animals. See the table below for the full statistics (CFI only looked at the column marked “total experimental procedures” despite clearly referring to all procedures in their press release (see first blue section).

CC-BY: www.speakingofresearch.com

Speaking of Research will continue to call out nonsense and misinformation wherever we see it.

Spain, Estonia and Northern Ireland release 2016 animal statistics

Speaking of Research try to keep on top of the latest statistics coming from governments around the world. This post will look at the 2016 statistical releases in Estonia, Northern Ireland and Spain.

Estonia

According to figures released by the Ministry of Rural Affairs, Estonia conducted 3,726 procedures on animals in 2016, a 10% fall from 2015.

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The number of all species used, with the exception of mice, dropped. The biggest was the change from 566 experiments on cattle in 2015 down to 0 in 2016. There was also a big reversal in last year’s rise in fish use. No dogs, cats or primates were used. While mice, rats, birds and fish are the most common species in most countries, it is surprising to find a country where these species account for 100% of animals used.

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Severity is slightly higher across the board than in previous years, however, given the small numbers involved these numbers are likely to vary more from year to year. All 403 severe studies were conducted in mice.

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Trend over time in animals used in research in Estonia. Click to Enlarge.

There is a downward trend in Estonian animal studies, however, given the small numbers and limited data it is hard to draw any conclusions. At 3,726 procedures, a large university in the UK or US might conduct 50X more experiments than the whole of Estonia.

Other information:

  • 93% was basic research of which: 50% of studies were into oncology, 18% for Nervous system studies, 16% into endocrine systems
  • 963 procedures (26%) involved genetically altered animals, and 2,763 procedures did not (74%)

Source of Estonian Statistics: https://www.agri.ee/et/loomkatse-korraldamine

See previous years’ reports:

Mice were the most common species used in Estonia, Northern Ireland, and Spain.
Image Credit: Jane Hurst, University of Liverpool.

Northern Ireland

Northern Ireland reports its animal experiments separately from the rest of the UK. While the UK Home Office regulates  (and compiles statistics for) animal research in Great Britain, the Department of Heath of Northern Ireland regulates for Northern Ireland. On 20th November they reported that 22,214 procedures were conducted on animals in 2016, this was down 1.3% from 2015. This accounts for approximately 0.6% of all animal research in the UK.

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A 7% rise in mice is offset by falls in farm animals and birds. Among other mammals, there were 155 procedures on cats, and 73 procedures on dogs, though most of these were for “animal diseases and disorders”. There were no studies on primates. Overall the most common species used was mice (82.3%) followed by farm animals (10.5%), and rats (2.6%).CC-BY: www.speakingofresearch.com

The combined severity statistics show around 57% is subthreshold, non-recovery or mild, 40% is moderate and 3.4% is severe. This gives a higher proportion of moderate or severe studies than in the rest of the UK. Nearly all severe experiments were on mice.

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Trend over time in animals used in research in Northern Ireland. Click to Enlarge.

Animal experiments have risen around 20% over the last decade, from about 18 thousand to a little over 22 thousand. In 2009 there was a one-off rise as a result of 3o,000 procedures on birds to address animal health concerns.

Other points to note:

  • The most common uses of animals were Basic Research (56.4%), Creation and Breeding of GA animals not used in experimental procedures (22.9%), and Translation/Applied research (17.3%). The low levels of regulatory research (1.4%) in N. Ireland is primarily because these studies are done elsewhere in the UK [Table 1]
  • 97% of animals were bred in the UK, with the remaining 3% being bred elsewhere in the EU [Table 2]
  • The number of animals used for the first time was 21,247. The remaining 67 procedures were from animals re-used after previous studies [Table 1a]
  • 36.5% of studies involved genetically altered animals, 63.5% did not [Table 4]

Source of Nothern Ireland Statistics: https://www.health-ni.gov.uk/publications/statistics-scientific-procedures-living-animals-northern-ireland

See previous years’ reports:

Spain

The Ministerio De Agricultura Y Pesca has published statistics showing Spain conducted 917,986 procedures on animals in 2016, up 7% from 2015.

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There were moderate rises in mice (up 10%) and fish (up 28%), with drops in birds (down 11%) and rabbits (down 10%). After a large rise in the use of Cephalalopoda (e.g. Octopuses, squid and cuttlefish) in 2015, the number has dropped back to its 2014 levels.

 

 

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Overall, 93% of procedures were conducted on mice, rats, birds or fish – about average in Europe. Dogs, cats, and primates together accounted for less than 0.2% of research in Spain.

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According to the retrospective assessment of animal suffering (mandated by the EU Directive), we can see 58% of experiments were mild or non-recovery (where the animal is anaesthetised before surgery and not woken up).

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Trend over time in animals used in research in Spain. Click to Enlarge.

The number of procedures in Spain has crept up since 2014, but is still over 40% below it’s historical highs in the late 2000s.

Other information of note:

  • Most studies were for Basic research (48%), followed by applied/translational research (29%), and regulatory research (17% – the “animal testing” bit).
  • The 917,896 procedures were made up of 909,475 procedures on animals used for the first time, and 8,511 procedures on animals that were reused.
  • 99.8% of animals were bred within the EU

Source of Nothern Ireland Statistics: http://www.mapama.gob.es/es/ganaderia/temas/produccion-y-mercados-ganaderos/bienestanimal/en-la-investigacion/Informes_y_publicaciones.aspx

See previous years’ reports:

How to explain animal research on your institution’s website

Exactly three years ago, Speaking of Research published a page listing around 100 animal research statements of research institutions, universities, medical research charities, pharmaceuticals, scientific societies and more. After a year of building up this list, we introduced a rating system that let organizations know how good their statement was. We gave them marks according to how informative the core statement was, whether there was further, extensive information, whether they included case studies, and whether there were images or videos on the website. Ten institutions managed top marks in November 2015. Now, two years on, we have 350 statements of which 29 have scored full marks.

Not only have the number of statements increased over the years, but also the number of organizations which track them. This includes Americans for Medical Progress, Foundation for Biomedical Research, and the Concordat on Openness website (to sign the Concordat, organizations must first have a clear statement on their website). What makes the Speaking of Research list special is both its breadth (we are the only one covering multiple countries) and its rating system.

So what do we look for in an organization’s animal research pages? Let’s take an example from an institution that recently revamped its website into one that achieved full marks:

The Babraham Institute is a UK Government research institution run by the Biotechnology and Biological Sciences Research Council (BBSRC; who also have a great website) with a stated goal of undertaking “world-leading research into understanding the biology of how our body works”. The animal research web pages are easy to find and  clearly marked in the web address:

https://www.babraham.ac.uk/our-research/animal-research

As a result, if you search on the website for “animal research” or “animal testing” the webpage comes up. Similarly googling the organization name and “animal research/testing” brings up the website in the first link.

The opening statement is short but gives a clear indication of why animals are used. This statement also ensures the website appears on our statement list.

Babraham Institute scientists study fundamental processes in our cells: how they develop, survive, function, age and die. This basic biology underpins future medical advances, just as past research led to the treatments we receive today. The benefits will be felt in our children’s and grandchildren’s generations but without today’s basic science there will be no foundation for tomorrow’s medical research.

Mammals differ widely in size and shape but their cells and genes are broadly similar. Because of this, information from studies of mice or rats can be relevant to other mammals including humans, pets and farm animals.

Between this and the policy page, there is enough of a clear explanation of why the organization conducts animal research to grant it the first ✓ mark for “More information”.

There are many ways to get the second ✓ mark for “Extensive information”. Babraham manage it by providing additional information on their ethical review policies, implementation of the 3Rs (each R has its own detailed page including case studies), and a FAQs section which provides information not just on the use, but also the limits, of animal research.

The Examples page provides six case studies of how animal studies have helped research at the Babraham Institute. Further case studies of the 3Rs can also be found in the relevant section. This grants the website the “Case Studies” ✓ mark.

Finally, the website shows high-resolution images of animals in the facility. This allows them to get a ✓ mark for “Images / Videos”, though in the future we would love to see some videos showing how and why animals are used.

Image Credit: The Babraham Institute

So there we have it – a handful of ideas for improving your website. To provide a summary.

  1. >Make sure your organization has a clear online statement online explaining why animal research is conducted. (✓)
  2. Put the statement on an easy-to-find page on the website, preferably with the phrase “animal-research” in the URL. Try to avoid putting the statement in a PDF file.
  3. Make sure the statement can be found when people search your website or a search engine for it. Remember, some people will search “animal experiments” or “animal testing”, as well as “animal research”.
  4. Provide additional information about how the research is conducted and how it is regulated. This could be in FAQs, or on pages on regulation, ethics, statistics, animal welfare or research areas. (✓)
  5. Provide clear case studies that explain why animals were needed to solve a research question, and what happened to the animal. If possible provide information about how animal welfare was maintained. (✓)
  6. Put images and videos on your website to give readers an understanding of the high levels of care you have for your animals. Make sure these images are large, clear pictures of animals in your facility – not just small animal pictures. (✓)
  7. Add a link to the Speaking of Research website – this helps readers of your website find more information on animal research, and helps our Google ranking so we can continue to educate the public. Perhaps something like:
    For more information about the role of animals in research, we recommend checking out the Speaking of Research website.  
  8. Make sure your website appears on our list. If not, contact us on the form below.

We are also happy to provide free advice and recommendations for how to improve your animal research pages. So please feel free to contact us on the form below. It helps our overall goal of providing accurate information about the role of animals in medical, veterinary and scientific research.

We hope this resource helps

Speaking of Research

Researchers Rally to Help Puerto Rico’s Monkey Island

A guest post by Lisa Howard of UCDavis explains the efforts by the National Primate Research Centers to help rebuild Cayo Santiago, better known as ‘Monkey Island’ rebuild after Hurricane Maria.

Primate researchers are rallying to help Puerto Rico’s “Monkey Island,” Cayo Santiago, which took a direct hit from Hurricane Maria in September. About a thousand rhesus macaques roam free on the 38-acre island, which is run by the Caribbean Primate Research Center and the University of Puerto Rico.

Although all the animals apparently survived, the island’s infrastructure and equipment – piers, buildings, rainwater collection systems, even the cages where researchers could eat lunch without it being stolen by monkeys – was destroyed. On the main island of Puerto Rico, the town of Punto Santiago, where the research center’s headquarters is located and where many staff live, was devastated, losing water, electricity and communications.

Directors of the seven U.S. National Primate Research Centers decided they needed to help Cayo Santiago rebuild. Professor John Morrison, director of the California National Primate Research Center at UC Davis noted:

We view CPRC as one of our sister centers, and fortunately, we were able to mobilize our response and deliver material in a very timely fashion. We are in constant communication with CPRC and stand ready to help in any way we can going forward,”

Each of the U.S. centers is contributing $5,000 to a fund to help Cayo Santiago. Darcy Hannibal, a project scientist at the CNPRC and colleagues worked to fill a shipping container with desperately needed supplies for both the field station’s staff and the research facility, including water, canned food, diapers, baby formula, tarps, water purification tablets and filters, chain saws and other equipment.

The researchers also prepared an emergency National Science Foundation grant application for Cayo Santiago to replace equipment.

Cayo Santiago, the oldest free-ranging research colony in the world for primates, took a direct hit from Hurricane Maria. The island’s infrastructure was obliterated. (Photo courtesy of Lauren Brent, University of Exeter)

Hannibal did her doctoral work at Cayo Santiago in 2004-5, observing feeding behavior in the monkeys. She and her colleagues at UC Davis hope they can get the word out about the importance of this unique research facility and get help for its people and animals.

All of the macaques on the island are descended from 409 monkeys brought to the island in 1938. All the animals are identified and their pedigrees are known, making it an invaluable resource for scientists who study primates. Researchers from universities in the United States and Europe use the island for a wide variety of primate behavior studies.

“There’s no other population that has so much long-term history,” said Hannibal. “It’s a remarkable resource for studying primates.”

In addition to supplies, Hannibal and other supporters are trying to raise cash for the facility. Two GoFundMe pages have been created, one for the staff, Relief for Cayo Santiago Employees, and one for the animals, Cayo Santiago Monkeys: Maria Relief. There is also a Facebook page, Friends of Cayo Santiago, where people can get updates about the damage and recovery efforts. Hannibal can be reached directly at dlhannibal@ucdavis.edu.

Lisa Howard

Openness by the numbers: Ten universities conduct one third of all UK animal research

The ten British universities which conduct the most animal research have come together to proactively publicise their exact figures to the public and media. The press release by the ten institutions was coordinated by Understanding Animal Research. It is the second time that universities have come together to publicise their numbers.

Of the 46 universities which are signed up to the Concordat on Openness on Animal Research in the UK, 29 of them have their numbers published openly on the website. These numbers include all vertebrates – every mouse, rat and fish, as well as larger species (but not invertebrates like fruit flies and nematode worms, which are not currently regulated species in any country).

The UK Home Office animal research statistics show 1,938,638 procedures on animals at universities and medical schools in Great Britain in 2016 (Northern Ireland conducted an additional 17,615 in 2015; 2016 figures are not available). Of the 28 that publish statistics (QUB are in Northern Ireland, which produces national statistics separately), their combined number of procedures is 1,703,657. This means 88% of all procedures at universities in Great Britain can be found in statistics freely available on university websites.

Image by Understanding Animal Research

The top ten universities accounted for over 70% of all animal research at universities in Great Britain.

The University of Oxford conducted the most procedures for the second year running. Last year (2015 statistics) the top five were:

  1. University of Oxford (226,214)
  2. University of Edinburgh (212,695)
  3. University College London (202,554)
  4. University of Cambridge (181,080)
  5. King’s College London (175,296)

The list is remarkably similar to 2016. In fact, the top seven universities have been identical for both years (though slightly reordered). These seven universities are also all in the Top 60 Universities in the World (according to THE World University Ranking; all of the 2016 Top 10 appears in the THE Top 150 Universities in the World). The University of Oxford, which uses the most animals in the UK, is also ranked the top of the World University Rankings.

The fact that these ten universities have chosen not only to publicise their animal numbers on their website but also to proactively press release it to national and local press, serves two purposes. Firstly, it shows a commitment to openness, embodied the Concordat on Openness. Secondly, it helps tackle misinformation from animal rights groups that make Freedom of Information (FOI) requests to universities and then press release the results with emotive headlines like “Disappointing lack of progress at UK universities as worst offenders for animal testing are revealed”(By Cruelty Free International). Animal rights groups have often skewed information when it comes to animal numbers in the UK, as happened when PETA described the animals used in the 2015 statistics.

By publishing the statistics themselves, the university cannot be accused of hiding away its animal research. It also allows them to provide some context to the numbers – allowing them to explain the types of research these animals are being used for. Take a look at this great infographic by the University of Manchester.

In publicising these numbers, Professor David Lomas, UCL Vice-Provost (Health) said:

“As a world-leading medical research institution, animal research forms a small but vital part of UCL’s biomedical research as we seek new ways to benefit human health. As there are many misconceptions about how animal studies are conducted and regulated, and the considerable benefit they yield, it is important that we talk about it clearly and openly to show how it contributes to medical advances and how we are working to reduce, replace and refine our use of animals where possible.”

We hope these universities continue to publicise their animal research in the future.

Speaking of Research

While mice remain the most common species used at universities in the UK, zebrafish are an increasingly popular model. Image of zebrafish at KCL. Image Credit: SpeakingofResearch.com

Ireland produces 2016 statistics on animal research

Speaking of Research try to keep on top of the latest statistics coming from governments around the world. Ireland’s 2016 statistics were recently released by the Health Products Regulatory Authority of Ireland (HPRA). Ireland carried out 226,934 procedures on animals in 2016, 1% less than in 2015.

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Animals used in research in Ireland in 2016. Click to Enlarge

A procedure is defined as “any use of an animal for scientific or educational purposes, which may cause the animal a level of pain, suffering, distress or lasting harm, equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.” This definition includes the development and care of any genetically modified animal in which pain or distress may result.

Mice continue to be the most commonly used species at almost 85%. Together, mice, rats, and fish account for 94% of all animal procedures. No non-human primates were used in Ireland in 2016. Dogs and cats accounted for less than 0.3% of all animals used. Dog numbers fell by almost 40%, while there was a large rise (65%) in the number of procedures on cats. Both species were used exclusively for veterinary research. Once again, 99% of animals used in Ireland were bred within the European Union (EU).

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There was a pig fall in cattle compared with 2015 (down 46%). According to the HPRA,  “cattle are used only for agricultural research studies (for the benefit of the species or the agricultural industry)”.

According to the HPRA report, 75% of the total number of animals used was for regulatory purposes, this is “use of animals in procedures with a view to satisfying legal requirements for producing, placing and maintaining products/substances on the market, including safety and risk assessment for food and feed“.  The next most common use was for basic research (13%) followed by translational and applied research (12%).

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Severity of animal research procedures in the Ireland in 2016

The report showed that 44% of procedures were classified as mild, 26% moderate, 29% severe, and 1% non-recovery. 99% of severe procedures were on mice. Page 17-18 of the report has definitions for mild, moderate, severe and non-recovery.

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Trend over time in animals used in research in Ireland. Click to Enlarge.

Since 2014, the number of animal procedures in Ireland has been fairly constant at around 230,000.

Source of Irish Statistics: https://www.hpra.ie/docs/default-source/publications-forms/newsletters/hpra-sap-annual-statistical-report-2016ca190a2697826eee9b55ff00008c97d0.pdf?Status=Master&sfvrsn=7

See previous years’ reports:

animal testing, animal research, vivisection, animal experiment

Mice are the most common species used in Ireland

FASEB report makes recommendations for animal research regulations

On October 24, a group of professional scientific organizations released a set of groundbreaking recommendations entitled, “Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden.” This report is the result of an April 17, 2017 workshop organized by the organizations: The Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges (AAMC), and the Council on Governmental Relations (COGR), with assistance from the National Association for Biomedical Research (NABR). The goal of the April workshop was “to provide actionable recommendations for promoting regulatory efficiency, animal welfare, and sound science.

The workshop was convened, in part, in response to the 2016 passage of the 21st Century Cures Act (Cures), which directs leadership of the National Institutes of Health (NIH), the United States Department of Agriculture (USDA), and the Food and Drug Administration (FDA) to “complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals” within two years of the bill’s enactment (which occurred on December 13, 2016).

The recommendations in the report are directed to federal agencies that are involved in the oversight of federally funded animal research, particularly the NIH and the USDA. The recommendations stem from the workshop’s identification of requirements that demand significant administrative effort without demonstrating enhanced animal welfare. Thus, the recommendations consist of steps that agencies and Congress can take to reduce these inefficiencies.

A Veterinary Technician works with rodents

The aim of the report is to find ways of maintaining animal welfare while reducing administration

Speaking or Research applauds the thorough and thoughtful process of deliberation this group of organizations went through, as well as the transparency provided in the report. We believe that such transparency will allow for a public discussion of the system and of the potential for improvement. Here, we provide a high-level summary of the recommendations. The full report and set of recommendations are freely available at FASEB’s website.

The Major Recommendations are geared toward several major governing and oversight bodies: 1) The Executive Office of the President and Congress, 2) Both the NIH and USDA, and 3) the NIH and USDA separately.

1. Recommendations to The Executive Office of the President and Congress

The Executive Office of the President (EOP) and the Office of Management and Budget (OMB) should consolidate animal research oversight under a single Federal office or entity with one primary set of regulations and guidance documents. A committee of experts engaged in animal research, comprised of institutional administrators, Institutional Animal Care and Use Committee (IACUC) members, investigators, and veterinarians, should be invited to assist with this consolidation effort.

The EOP and OMB should require at least a 60-day comment period on the merits and impact of any proposed policies, guidance documents, frequently asked questions (FAQs), or interpretive rules before they are issued. Final policies and guidance should reflect germane comments received from the regulated community.

Congress should amend part of the Animal Welfare Act (AWA) to require only annual inspection by the IACUC, and should revise the requirement for annual USDA inspection.

2. Recommendations to both the NIH and the USDA

Appoint an external advisory group of experts engaged in animal research, from entities that receive federal research funding, to serve as advisors. The advisory group should include institutional administrators, IACUC members, veterinarians, and investigators engaged in animal research.

Have all Public Health Service (PHS) and USDA regulations, policies, guidance documents, FAQs, and interpretive rules, as well as the process for generating them, reviewed by an external advisory group of the very experts engaged in animal research (from entities receiving federal funding). As above, this group should consist of institutional administrators, IACUC members, veterinarians, and investigators engaged in animal research. This review will ensure that the documents emphasize matters of core importance to animal welfare identified in the regulatory language, and that they are consistent with current scientific and technological knowledge and approaches.

Establish a risk-based process for review of animal research protocols, similar to that which is used for human subjects research. Through a Notice in the Federal Register, NIH and USDA could amend the protocol review requirement to define types of studies that are low-risk, noninvasive, or minimally invasive. These studies could then be subject to less stringent review criteria than higher-risk, more invasive studies.

3a.    Recommendations to NIH

Use the Guide for the Care and Use of Laboratory Animals (Guide) as it was intended – as a guide, not as a regulatory document. IACUC-approved strategies stemming from recommendations in the Guide should not be not be required to be included in semiannual reports to the Institutional Official.

Eliminate the requirement for verification of protocol and grant congruency in the NIH Grants Policy, so as to allow for reasonable advances, discoveries, and other developments in overall research objectives.

Revise NIH guidance regarding prompt reporting to include only those incidents that jeopardize the health or well-being of animals.

Streamline the assurance for animal research. For Category 1 institutions, allow proof of accreditation in lieu of the detailed program description.

3b.   Recommendations to USDA

Revise the relevant section of the AWA to specify IACUC reviews of animal research protocols at least once every three years, and at appropriate intervals as determined by the IACUC. This modification would make review frequency consistent with PHS Policy.

Revise the USDA Animal Care Policy #14 to reflect the language that exists in the AWA and the AWA Regulations (AWR), so that multiple survival operative procedures may be allowed at the discretion of the IACUC and as justified for scientific and animal welfare reasons. This modification will aid the research community in reducing the number of animals involved in research.

Align language in the USDA Animal Care Policy #12 with respect to literature searches with language in the AWR that charges the IACUC to determine “that the principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources…”

We urge people to read the report and come to their own conclusions. If you have any thoughts on the recommendations made, please do share them in the comment section.