Research Governance and Ethics
Research Ethics and Sponsorships
Research sponsorship
When researchers plan to include humans or animals in their research, they must first identify a Sponsor.
The Sponsor’s role is to:
- Manage funding and the approval process
- Oversee ongoing management, safety, and data integrity
- Provide indemnity to participants and researchers where necessary
When LSTM is the Sponsor, researchers must apply for and be granted Sponsor Approval before a study can commence.
Ethical approval for human research
All research involving humans, including their data and samples, requires ethical approval.
LSTM has a fully accredited Research Ethics Committee (REC, also known as an Institutional Review Board or IRB. The REC meets monthly to review applications and operates under International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) standards.
The REC’s purpose is to:
- Review all research proposed by LSTM staff, students or associated workers involving human data, samples, contact or any other intervention
- Protect participants (volunteers or patients) from possible harm or danger and preserve their rights
- Reassure the community and sponsoring organisations that ethical standards are being maintained
- Ensure procedures are carried out according to ICH Good Clinical Practice standards
External Applications: While most applications are from LSTM staff, external organisations may also request LSTM REC Favourable Ethical Opinion.
External organisations seeking more information about LSTM REC should contact the REC Secretariat at lstmrec@lstmed.ac.uk.
Concordat on Openness on Animal Research
Our research focuses on developing innovative new products, tools, diagnostics, therapeutics, and vaccines that can be implemented as affordable solutions within low-resource settings. These advances tackle life-threatening diseases such as TB, malaria, and emerging viral pathogens. We also undertake research in Neglected Tropical Diseases (NTDs) that can cause permanently disfiguring conditions, including worm infections and snakebite.
This research sometimes requires the use of animals when there is no practical alternative, or when regulators require it before a new treatment or vaccine can enter human testing.
Our commitment
LSTM will seek to minimise the use of animals in research while continuing to facilitate advances in science, research, and medical knowledge to achieve our mission. Every study is carefully designed to use the minimum number of animals necessary while maintaining scientific rigour and regulatory compliance.
We apply the principles of the ‘3Rs’ as outlined by the National Centre for 3Rs in Animal Research. Some of our research is supported by the NC3Rs where we proactively investigate solutions to:
- Replace animal research in areas where they otherwise would have been used.
- Reduce animal research by examining new methods and techniques to minimise the number of animals used consistent with scientific aims.
- Refine animal research with the objective of minimising pain, suffering, distress or lasting harm that research animals might experience.
Regulation
Animal research in the UK is strictly regulated by law and all research is overseen by LSTM’s Animal Welfare and Ethics Review Board.
The majority of animal research undertaken by LSTM researchers, either at our premises or at other sites in the UK, constitutes a ‘regulated procedure’ under the Animals (Scientific Procedures) Act 1986 (ASPA).
LSTM holds a Home Office Establishment Licence for this research and undergoes regular audit by government-appointed inspectors. Staff and students are trained, required to take a proactive interest in animal welfare, and ensure all work complies with ASPA and Home Office regulations.
Research that falls outside the ASPA regulatory framework is regulated by separate legislation including the Animals Act, the Wildlife and Countryside Act, and others. LSTM requires the same standard of welfare and ethics in these projects as expected in ASPA-compliant projects.
Where animal procedures are undertaken in collaboration with international partnering organisations receiving funding from LSTM, we expect similar high standards, sufficient training and alignment with UK regulatory compliance.
Welfare
LSTM, its staff, and students are committed to the welfare of animals in our charge and are required to treat all animals involved in research with respect and consideration.
LSTM upholds the highest standards of research integrity and good research conduct relating to our animal research. Any reported failures by LSTM staff or partnering organisations funded by LSTM to apply ethically approved welfare standards in animal research will always be taken seriously and appropriately investigated.
Openness
LSTM is a signatory to the Concordat on Openness on Animal Research in the UK, which has been developed by Understanding Animal Research in collaboration with leading research institutes.
The concordat aims to broaden understanding of humane animal use in biomedical research, and commits to public transparency about all aspects of research involving animals.
Disclosure on numbers and types of animals we use in our research
LSTM currently holds three project licences researching mechanisms of disease and preclinical development of new diagnostics and therapeutics for diseases of poverty.
We report the numbers and species of animals used in our research to the Home Office.
In the period January 2024 to December 2024, we used the following species and numbers of animals in our research:
| Species | Number |
| Gerbil | 20 |
| Mouse | 495 |
| Total | 515 |
In the period January 2023 to December 2023, we used the following species and numbers of animals in our research:
| Species | Number |
| Gerbil | 6 |
| Mouse | 670 |
| Total | 676 |