The Research Governance and Integrity Team provides a robust structure for the authorisation and management of Imperial's healthcare and human impact research portfolio and provides researchers with support in navigating and meeting the requirements of regulatory compliance
- The Medicines for Human Use (Clinical Trials) Regulations 2004 make working under the provisions of Good Clinical Practice (GCP) a legal requirement for clinical trials of investigational medicinal products. The College is also required to take on additional responsibilities for their initiation and conduct.
- The Research Governance Framework for Health and Social Care imposes specific standards on those involved in healthcare research, either as clinicians, researchers, Chief Investigators, employers or support staff. Perhaps most fundamentally, there must be an identified sponsor for any research within the NHS or social care.
- Other legislation also has an impact on the way in which healthcare research is conducted (e.g. Human Tissue Act 2004 and Mental Capacity Act 2005).