Research using human samples is an important component of our research into understanding the biological mechanisms that control how we develop, grow, fight disease and function.
Research at the Institute uses some human samples as part of our research. This includes samples obtained commercially and from tissue banks, and stem cell lines. We are committed to upholding the highest levels of integrity when conducting human research in line with statutory and regulatory requirements and best practice.
Research using human samples is an important component of our research into understanding the biological mechanisms that control how we develop, grow, fight disease and function, in addition to understanding what happens when these systems fail or become deregulated. The Institute’s research has a special focus on what changes as we age. If we can understand the biological changes that contribute to ageing and disease, we can find ways of modifying or counteracting these to maintain better health in later years.
Research using human samples is one way we replace the use of animals in research. However, the complexities of our bodies means that sometimes the only way to explore and fully understand a system is to study it as a whole, meaning that sometimes animal use is unavoidable.
Legal and regulatory framework
Human research at the Institute is subject to rigorous legal and governance requirements to ensure quality and reproduceable research, whilst treating participants, their material and data with respect and transparency.
The Babraham Institute has implemented seven core principles to ensure our research meets the ethical, legislative, regulatory and governance requirements. These include: ensuring the potential benefits outweigh risk to participants and donors of data or samples, appropriate and valid consent has been given, and all human research projects have obtained ethical approval.
Human research is governed by numerous rules and regulations including the Human Tissue (Quality and Safety for Human Application) Regulations 2007, the Human Fertilisation and Embryology Acts 1990 and 2008, and the Data Protection Act 2018. The primary piece of legislation governing the use of human biological materials in research is the Human Tissue Act 2004. The Human Tissue Act applies to the removal, storage and use of relevant material (as defined by the Act) in England, Wales, and Northern Ireland.
Research involving human ova, embryos outside the body, and gametes fall within the remit of the Human Fertilisation and Embryology Act 1990 as amended in 2008, and is regulated by the Human Fertilisation and Embryology Authority (HFEA).
UK General Data Protection Regulations (UK GDPR) sits alongside the Data Protection Act 2018 to form primary data protection law in the UK. There is also a common law (case law) duty of confidentiality. The principle being that when someone shares personal information in confidence, it must not be disclosed without legal authority or justification.
All research undertaken at the Institute which directly recruits participants, uses or stores relevant material, bodily material (as defined by the Human Tissue Act) including for analysis of DNA/RNA, gametes human embryos, including for the derivation of new cell lines, and personal identifiable data must be approved by a Research Ethics Committee. The ethical review process will check the arrangements for participation, consent, storage and use of samples and data. Where NHS premises, patients or staff are involved for research taking place in England or Wales (except when working with tissue banks), Health Research Authority approval is also required.
Governance of human tissue research at the Babraham Institute
The governance of human research projects at the Institute ensures that legislative and good practice requirements, including the Codes of Practices of the Human Tissue Authority, are followed. The Institute’s Human Research Team oversees all research involving human material, including providing guidance for researchers on ethical approval, applicable regulations, study set up, data management and informed consent.
Research using human embryos
Some research at the Institute involves human embryos and embryonic stem cells. Research involving human embryos, including derivation of embryonic stem cell lines, requires a licence from the HFEA.
No research is allowed on human embryos over 14 days old or the appearance of the primitive streak, whichever occurs first. As the generation of embryonic stem cell lines involves harvesting cells from early human embryos, these activities are also overseen by HFEA.
The UK Stem Cell Steering Committee is an independent national committee which oversees the UK Stem Cell Bank and research involving established human embryonic stem cell lines, whether obtained from the Bank or from elsewhere. All researchers wishing to work with human embryonic stem cell lines within the UK (whether accessed from the UK Stem Cell Bank, from other sources in the UK or oversees) must inform the Steering Committee.
Induced Pluripotent Stem Cells
Induced pluripotent stem (iPS) cells have similar properties to human embryonic stem cells but are derived from foetal and adult cells. Research involving the derivation of induced pluripotent stem cell (iPSC) lines from human tissue is subject to the Human Tissue Act 2004.