The Home Office last week announced the publication of new guidance on the use of animals containing human material, such as cells, tissues and genetic information, based on the recommendations of the Academy's 2011 report ‘Animals containing human material’.
The Academy’s work has been vital in ensuring this important field of research can proceed within a carefully regulated environment. This piece takes a closer look at the report and the recommendations that have been adopted.
Animals containing human material (ACHM)
Animals containing human tissues, cells or genetic information play an important role in medical research, enabling treatments to be tried and tested when other alternatives are unfeasible or unethical. In 2009 the Academy set up a working group to consider the scientific, social, ethical, safety and regulatory aspects of research involving ACHM.
A major part of this study was a large programme of public dialogue which provided an opportunity for a broad spectrum of society to explore the ethical aspects of modifying animals and making them more similar to humans to advance our knowledge of treatment and disease. The study found the majority of participants would support this type of research if it was undertaken to improve human health and disease within carefully considered boundaries and robust regulation.
Boundaries and regulation became a key focus for the Academy’s working group, which published its report in July 2011 and set out key recommendations on categorising, regulating and delivering ACHM research.
Home Office guidance
The Home Office ‘Guidance on the use of human material in animals’ published 11 February 2016, writes:
‘The Home Office, HFEA [Human Fertilisation and Embryology Authority] and Department of Health have accepted the recommendations set out in the AMS [Academy of Medical Sciences] report and have agreed to work together to ensure a smooth regulatory process for UK investigators.’
Our report highlighted the complexity of the regulatory framework for research using ACHM, which can involve multiple government departments and bodies. The Academy is pleased that this guidance clarifies which regulatory pathways should be accessed for each category and type of ACHM research.
The Home Office guidance has adopted two key strands of the Academy report: (1) classifying ACHM research into three categories of regulation; and (2) ensuring contentious research is reviewed by a national expert body. This function will be assumed by the government’s Animals in Science Committee (ASC), which already provides impartial and objective advice to the Home Office on the regulation of animal research.
The three classifications categorise ACHM research into:
1. Experiments which do not present issues beyond those of the general use of animals in research and should be carried out under the normal regulatory structures that govern other non-ACHM animal research.
2. Experiments which are permissible, pending specialist review by the ASC.
3. A narrow range of experiments that should not be licensed due to lack of scientific justification or very strong ethical concerns.
The outcome of this guidance is clearer regulation for ACHM research and more accessible pathways for researchers to conduct important work that enables a better understanding of how the human body functions and the process and treatment of disease.
Timeline of Academy engagement
January 2009 – Academy sets up working group studying research on Animals Containing Human Material (ACHM) and initiates public dialogue
September 2010 – ACHM public dialogue report launched at the British Science Festival
July 2011 – ACHM working group publish final report along with policy recommendations
February 2014 – Academy holds a joint meeting with the Royal Society of Biology to give Dr John Landers, Chair of the newly-formed ASC, the opportunity to discuss the Committee's work and its engagement with the research community
February 2016 – Home Office publishes guidelines adopting Academy recommendations