Carol Smee

Head of Research Governance for Trusted Global Compliance

The Research Governance team includes myself, Joanne Doleman (Head of Research Governance for Trusted Human Research), Sarah Collison, George Martin, Selay Pamir and Charlotte Tomlinson (Research Governance Managers), Adetutu Odesanya (Quality Officer), Vasyl Aloshyn (Research Governance Officer), Sinead Calnan and Jamie Davis (Wildlife Compliance Officers), and Mary Liberante and Jessica Petty (Research Governance Assistants). I lead the 'non-human materials' sub-team within Research Governance. The wider Research Governance team is responsible for advising members of Sanger Institute staff about compliance with the Human Tissue Act, Access and Benefit Sharing (ABS) regulations (including the Nagoya Protocol) and associated Institute policies. We also carry out ethical assessments when materials from sentient animals are to be used in research, and I led the Animal Materials Working Group in creating the Ethical Framework for Obtaining Materials from Sentient Animals which is published on the UKRIO website (see link below). The team helps achieve compliance through the initiation, administration and development of internal processes, audit and monitoring, and communicate regulatory and policy requirements using a variety of means, including team talks, induction and training sessions, and face-to-face meetings. In addition to enabling regulatory compliance and assisting researchers maintain high ethical standards in their work, the team helps researchers drive studies through the Health Research Authority (HRA) and NHS Research Ethics Committee (REC) approvals pathway, liaising with NHS Trusts and the NIHR RDN as required. We lead on consultation responses for the Institute where national or international proposals for changes to relevant research legislation may impact on our research, or where we wish to join the debate on ethical research practice. 

The Research Governance team works closely with Faculty, researchers, Research Administrators, Heads of Operations, laboratory managers, and many other staff in the scientific programmes, Scientific Operations and Management Operations, to promote and monitor regulatory compliance, enable the maintenance of high ethical standards in research, provide advice and guidance on research regulation and associated internal policies, and enable GRL to fulfill its responsibilities as a sponsor of research studies.

My timeline

• Head of Research Governance, Wellcome Sanger Institute

• Regulatory Compliance Manager, Wellcome Sanger Institute

• Regulatory Adviser, Wellcome Trust Sanger Institute

• Senior Scientist, Prolysis Ltd., Oxford

• Research Assistant, Structural Genomics Consortium, Oxford

• Education and Outreach Officer, Brewhouse Theatre and Arts Centre, Taunton

• Chief Microbiology Technician, University of West of England

• Senior Microbiology Technician, University of West of England

• Fermentation Technician, University of East Anglia

• Research and Development Technician, Continental Wine Experts Ltd., Norfolk

• Education Officer with the National Trust (Dunwich Heath Nature Reserve) and River Inspector (Broads Authority, Norfolk Broads)

• Microbiology Researcher, University of Luton

• Secondary School and Sixth Form Teacher (Biology/Chemistry)