Research involving animals containing human tissue or genes could overstep ethical boundaries if regulation is not brought up to speed with scientific advances, a new report warns.

Published by the Academy of Medical Sciences, the report indicates that the fast moving pace of science might go beyond current ethical and regulatory boundaries with concerns that genetically engineering animals to contain human material could lead to the development of what some might term Frankenstein monsters.

Based on comments from a variety of experts in academia, government, industry, animal welfare groups and professional bodies, the report concludes that regulation must stay ahead of emerging research practices. However, the majority of participants support animals containing human material for research to improve human health or to combat disease.

“This is a complex research area and there should be ongoing dialogue between scientists, regulators and the wider public to address emerging issues,” said Professor Martin Bobrow, chair of the Academy working group that produced the report. “Our report recommends that the Home Office put in place a national expert body, within the existing stringent system of animal research regulation, to provide specific advice on sensitive types of ACHM research.”

The report recommends classifying research with animals containing human material into three categories. The first would be the majority of experiments that would present no additional issues and would proceed under current regulation. A second category would be for a limited number of experiments that may be permissible but subject to scrutiny of the body recommended by the report. A third category would be those that should not be undertaken, at least until the potential consequences are more fully understood. According to Bobrow, the Academy is not aware of research of the third type taking place in the UK currently.

Experiments that were of concern to both the public and the scientific community focus on research studies involving modification of the animal brain that could potentially lead to human-like ‘cerebral’ function, experiments that might lead to fertilisation of human eggs or sperm in an animal; and modification of an animal to create characteristics perceived as uniquely human, such as facial shape, skin texture or speech. The BUAV, in response to the Academy’s report, has called for a moratorium on the genetic modification of animals.

However, many in the scientific community welcomed the report. Said David Pruce, Interim Chief Executive, Understanding Animal Research: “The Academy’s report is an important insight into this innovative area of research, and associated ethical and regulatory challenges. It is particularly timely in light of the current Home Office consultation about the regulation of animal research. The UK’s animal research regulations need to be proportionate, effective, and consistent with others across Europe – to protect animal welfare while being sufficiently forward-looking to keep pace with scientific progress. The recommendations from the Academy should ensure sufficient expert oversight of future developments. This is a timely report that provides sound advice to Government on an area that requires careful oversight. It is important that the report’s recommendations are taken into account by the Home Office as it prepares to implement the incoming EU Directive on the use of animals in research.”

Likewise, Dr Philip Wright, chief executive, The Physiological Society, agreed the report was timely and provided sound advice for the government. “Setting future-proof regulation now is essential to not hinder progress in the future. The regulatory uncertainty and delays that were experienced around the HFE Bill and human-animal hybrid embryos in 2007 will hopefully be avoided for research involving ACHM, if these plans are adopted. The three-tiered level of regulation is a smart approach and recognises the need to tailor regulation rather than impose unnecessary ‘blanket bureaucracy’ on all forms of research in this area. For this to work however, existing regulatory authorities need to work closely with the proposed expert body to ensure this framework is delivered effectively.”

The Home Office has welcomed the report and confirmed it will “consider the recommendations carefully”.