Researchers whose work involves the introduction of human DNA sequences into animals, or the mixing of human and animal cells or tissues, will be subject to new guidance and oversight from today.
The new guidance published by the Home Office will ensure this area of work continues to be highly regulated and all those working under it are aware of their duties and responsibilities. The new guidelines are based on the Academy's report Animals containing human material (ACHM), published by the Academy in 2011.
The report considered what new ethical and regulatory issues might arise in future that would be specific to the creation and use of ACHM and also included a public dialogue around their use.
Among others, the report recommended that research involving ACHM should be classified in three categories, depending on the level of scrutiny they should undergo before their authorisation. It also recommended clarity on which regulator and regulations they should be assessed by, based on their "human" content. These recommendations were taken onboard by the Home Office in its guidelines.
Professor Martin Bobrow FMedSci, chair of the working group that produced the report, welcoming the new guidelines, said:
"Research using animals containing human material (ACHM), is an area of huge potential, but one that also requires a robust ethical and regulatory framework to develop within.
"In 2011 I chaired a report that considered the many scientific, social, ethical, safety and regulatory aspects of research involving ACHM and we identified some areas that were at the borderline between three different areas of legislation. We recommended guidance for researchers to ensure they are properly regulated so I am pleased that this guidance has now been published by the Home Office.
Professor Sir Robert Lechler, President of the Academy of Medical Sciences, said:
"Research involving introducing human tissues or genetic information into animals has the potential to yield great advances in biomedical science, especially in the understanding and treatment of disease.
"I am delighted to see that the Home Office followed the Academy's recommendation and has developed its guidance to bring clarity in the regulatory pathways for this research; guidance aimed at ensuring a co-ordinated and consistent approach to regulating this field of research.
"Along with the great potential of this research to advance our knowledge of health and diseases, there are important moral and ethical issues that must continue to be explored."