Research funders call for closer attention to guidelines on reporting animal studies

by | 22nd May 2012 | News

The heads of the three leading funding bodies for bioscience research in the UK have called on universities and research institutes to make sure their scientists observe guidelines on reporting animal experiments drawn up by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs).

The heads of the three leading funding bodies for bioscience research in the UK have called on universities and research institutes to make sure their scientists observe guidelines on reporting animal experiments drawn up by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs).

The open letter to university vice chancellors, principals and heads of divisions from the chief executives of the Medical Research Council (MRC), the Biotechnology and Biological Sciences Research Council (BBSRC) and the Wellcome Trust notes that the three bodies recently signed up to the ARRIVE guidelines, compliance with which is a condition of their grant funding.

“As major funders of bioscience research in the UK we are committed to supporting the best science in terms of its conduct and impact,” state chief executives Professor Sir John Savill (MRC), Professor Douglas Kell (BBSRC) and Sir Mark Walport (Wellcome Trust).

“This is particularly the case with research involving the use of animals given the ethical implications, societal concerns and financial costs.”

ARRIVE guidelines

Developed by the NC3RS in consultation with the scientific community, the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines were published in July 2010 as a checklist of essential information for scientists writing up research for publication or involved in peer review.

The previous December, the NC3RS had reported the results of a survey, co-funded by the US National Institutes of Health/Office of Laboratory Animal Welfare, that revealed significant flaws in the design and reporting in peer-reviewed journals of many biomedical research studies using laboratory animals.

The ARRIVE guidelines, which set out information the NC3RS believes should be included in scientific publications describing animal research, have already been adopted by close to 100 journals, the Centre says.

Transposition of Directive 2010/63/EU

The research funders’ initiative came shortly after the UK government published its response to a public consultation on options for transposing Directive 2010/63/EU, on the protection of animals used for scientific purposes, into UK law.

EU Member States need to incorporate the Directive’s provisions into national legislation by 10 November 2012 and implement them from 1 January 2013. The expectation is that the UK government will publish the relevant regulations in July, before the start of Parliament’s summer recess.

The public consultation was launched on 13 June 2011 and closed on 5 September 2011, with responses from more than 13,000 individuals and 98 organisations.

Stricter standards

While the UK government intends to ‘copy out’ most of the provisions in Directive 2010/63/EU, which completed its passage through the European legislative system in September 2010, following nearly two years of delays, hard lobbying and impassioned debate, in a number of areas it plans to retain national standards higher than those in the Directive.

That includes special protection for dogs, cats, horses and non-human primates as well as maintaining all current UK care and accommodation standards stricter than those laid out in Annex III to the Directive.

The Directive also requires inspections of animal-research facilities in all Member States “but with a minimum frequency much lower than we currently practise in the United Kingdom”, pointed out Lynne Featherstone, Parliamentary Under Secretary of State for Equalities and Criminal Information.

“We propose to retain our current risk-based approach to inspection and are committed to maintaining a strong and properly resourced inspectorate and a full programme of inspections,” Featherstone said.

The government wants to retain the current requirement that individuals carrying out regulated procedures on animals in the UK must hold a personal licence authorising them to do so.

It will, however, explore opportunities “to simplify the detail of personal licence authorities and to remove current requirements which increase regulation without adding to the effectiveness of the licensing process”.

Generally welcomed

The consultation response was generally welcomed by groups such as Understanding Animal Research, the pro-research organisation formed from the Research Defence Society and the Coalition for Medical Progress, as well as animal welfare bodies like the Dr Hadwen Trust for Humane Research and the Royal Society for the Prevention of Cruelty to Animals (RSPCA).

But the British Union for the Abolition of Vivisection bemoaned the lack of a firm decision on a clause in the current Animals (Scientific Procedures) Act 1986 that protects details of animal experiments from disclosure in response to Freedom of Information requests. According to the BUAV, the government has been reviewing this clause since 2004.

Most respondents across all sectors “did not favour retention of section 24 in its current form, citing its incompatibility with the Directive’s commitment to transparency and the barrier it can be to the sharing of best practice and information on the 3Rs,” the consultation response notes.

“Most also recognised that personal details, intellectual property and commercial information will continue to require protection,” it added. “We have noted the consultation responses and will consider the options for revising section 24. We

will publish our conclusions separately, in due course.”

‘In due course’ “could mean another long delay”, warned BUAV chief executive Michelle Thew. “The public has the right to know what goes on, in their name, behind the closed doors of a laboratory – with due regard being paid to personal and confidential information. As things stand, we risk Britain lagging behind other European countries in maintaining secrecy.”

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