To enable research using human materials the team drives projects through the Health Research Authority (HRA) and NHS Research Ethics Committee (REC) approval pathway, liaises with NHS R&D departments on behalf of the research teams at the Institute, and acts as the sponsor’s contact for GRL sponsored studies, enabling GRL to fulfil its responsibilities as a sponsor of research studies.
To enable research using animal materials, the team works with researchers to ensure that the proposed materials are acquired legally according to national and international laws and are ethically sourced.
Other Genetic Resources
To enable research using ‘genetic resources’ as defined by the Convention on Biological Diversity (CBD), the team drives the activities required in order to obtain the appropriate permissions and documentation to ensure compliance to Access and Benefit Sharing regulations globally, the Nagoya Protocol and the implementing UK regulation.
What we do
The team liaises with regulators, such as the Human Tissue Authority, the Health Research Authority, other statutory bodies aligned to health research, and government departments, such as the Department for Business, Energy and Industrial Strategy (BEIS) and Animal and Plant Health Agency (APHA). We undertake audit and monitoring activities, and support and guide researchers throughout the lifecycle of their research projects, providing specialist advice and expertise.
We have specialist expertise in research laws and regulations. In particular, for human studies we are able to provide advice on developing research protocols, research participant information sheets and consent forms, and other associated documentation prior to NHS REC and HRA review. We assist with enabling NIHR Clinical Research Network (CRN) Portfolio adoption of studies.
Where research utilises non-human materials, we are able to provide the most up to date knowledge and advice specific to the type of, and source of the material you wish to obtain and actively work with researchers, their collaborators and national authorities both in countries overseas as well as within the UK to enable access to and use of these research materials.
Members of the team act as the Executive Secretariat for the Institute’s Animal Welfare and Ethical Review Body (AWERB) and the Sanger Institute Connecting Science Research Ethics Committee (SICS-REC).
The team manages a system to enable the efficient in-house approval of studies using human materials – the Sanger Institute Human Materials Form electronic system (HuMFre). The team also enables the permanent recording of all ‘genetic resource’ use site-wide in order to facilitate internal or external audit events.
The Research Governance team is responsible for drafting and implementing relevant Institute research policies. Each policy covers a particular topic and outlines the Institute’s position and the requirements researchers must fulfil during the lifecycle of their research projects.
If you have any queries regarding regulatory compliance or any other aspects of research governance, please contact us by email at firstname.lastname@example.org