Human Materials 

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.

Animal Materials 

To enable research using animal materials, the team works with researchers to ensure that the proposed materials are acquired in accordance with relevant Access and Benefit Sharing regulations (including the Nagoya Protocol) 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 Office for Product Safety and Standards (OPSS). We undertake audit and monitoring activities, and support and guide researchers throughout the life-cycle 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, material research teams 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.

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 resources’ used 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 fulfill during the life-cycle of their research projects.

Queries regarding regulatory compliance, or any other aspects of research governance, can be directed to researchgovernance@sanger.ac.uk