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New Home Office guidance reflects dialogue results on Animals Containing Human Material

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On 11 February 2016, the Home Office published its ‘Guidance on the use of Human Material in Animals’. The guidance includes (as Part B) a summary of the Academy of Medical Sciences report, published in 2011, and states “The Home Office, HFEA and Department of Health have accepted the recommendations set out in the AMS report”. That AMS report draws directly on the results of the public dialogue project in 2010  on Animals Containing Human Material, supported by Sciencewise.

The publication of the Home Office guidance follows more than five years after the public dialogue was completed, but provides evidence of the impacts of many of the key points raised by dialogue participants – demonstrating the long timescales that can be involved in dialogue impacts as well as the value of this particular dialogue to policy and decision making.

The dialogue results were that the majority of participants would support research involving animals containing human materials if it was undertaken to improve human health and disease and was carried out within carefully considered boundaries and robust regulation. Boundaries and regulation became a key focus for the AMS Working Group report in 2011. The press release from the AMS on the new Home Office Guidance explicitly places the public dialogue results within their timeline for developing recommendations and final report (www.acmedsci.ac.uk/more/news/government-adopts-academy-recommendations).

Press coverage around the launch of the new guidelines includes mentions of the Academy’s 2011 report and highlights that the recommendations that had been accepted were informed by the public dialogue. For example, an item on BBC Radio 4 Today programme on 8th February 2016 included an interview with Professor Martin Bobrow, who chaired the Academy Working Group, who referred specifically to the public dialogue and how the results had informed the Academy report.

The new guidance uses the AMS report to identify three categories of experiments involving animals containing human material:

•    Category 1 covers experiments that do not present issues beyond those of the general use of animals in research.

•    Category 2 experiments require additional specialist scrutiny by a national expert body and covers experiments involving substantial modifications of an animal’s brain, experiments that may lead to the generation or propagation of functional human germ cells in animals, experiments that could be expected to significantly alter the appearance or behaviour or animals, and experiments involving non-human primates.

•    Category 3 experiments should not, for now, be licensed. At present, these include allowing the development of an embryo beyond 14 days of development; transplantation of human derived neural cells into a non-human primate which is likely to substantially modify the brain; breeding animals that may have or may develop human derived germ cells which could lead to the production of human embryos or true hybrid embryos within an animal.

The dialogue results have been directly used in two ways in the regulation of experiments involving animals containing human material:

•    defining the categories of experiments that require additional scrutiny, and

•    the establishment of an independent body to advise on future decisions.

The public dialogue identified the types of changes that were least acceptable to participants – those which changed an animal’s appearance, those that changed the brain of an animal where it might affect the animal’s cognition, and those that involved animal and human reproductive systems. Experiments involving these types of changes are clearly shown in Category 2 as requiring greater scrutiny and Category 3 as not currently being licensed at all.

Participants wanted to see regulation that focused on animal welfare, minimised risk and that reflected their views on the kind of animal that is created and the tissues and organ types involved. Animal welfare was important for many participants, especially concerns that some ACHM research might cause greater animal distress.

In terms of oversight, the two main factors for dialogue participants were the need for transparency and independent supervision, and for an independent body to advise on future decisions.

The new Animals in Science Committee (see below) is described in the new Home Office Guidance as “the national expert body envisaged by the AMS” (page 16). The Committee includes specific members concerned with animal welfare, scrutinises the categories of research identified as priorities within the dialogue, is independent and makes transparency a priority – with minutes of meetings published online.

In January 2013, the new Animals in Science Committee replaced the earlier Animal Procedures Committee. The new committee is an independent non-departmental public body sponsored by the Home Office and is responsible for providing impartial, balanced and objective advice to the Secretary of State (Home Office) and to local animal welfare and ethical review bodies on issues relating to the Animals (Scientific Procedures) Act 1986 (ASPA) and the use of animals in scientific procedures. Applications for project licences under ASPA which raise novel or contentious issues, or are likely to give rise to serious societal concerns, are referred automatically to the Animals in Science Committee for advice. These include applications involving Category 2 and 3 experiments, and some Category 1 experiments.

The Committee is expected to work in the public interest, and includes members with wide-ranging expertise. As well as members with expertise in the welfare of animals, veterinary science and neuroscience research, the Committee also includes lay members with an interest in the ethical issues arising from the use of animals in scientific research. Two NGOs are represented – People for the Ethical Treatment of Animals (PETA) and the RSPCA.

‘Guidance on the use of Human Material in Animals’ (Home Office Advice Note 01/16), dated January 2016.
www.gov.uk/government/publications/guidance-on-the-use-of-human-material-in-animals

See related project page: Animals Containing Human Material