Carol Smee Email & Phone Number

I lead a team of amazing research governance professionals 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 help 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. 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 CRN as required. The team leads 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.As a previous member of an NHS REC for over 9 years, I reviewed clinical trial applications and research studies, and I also co-led on the formal training of NHS REC members for the HRA on the Human Tissue Act and Genetics/Genomics in Research.Prior to the closure of the Research Support Facility in 2021, I led the very committed Animal Welfare and Compliance team, acted as the contact for the Home Office (ASRU) Inspector and was Secretary of the Sanger Animal Welfare and Ethical Review Body (AWERB) and the East Anglia Regional AWERB Hub. I was actively involved in the Concordat on Openness on Animal Research.I implemented initial processes relating to the Nagoya Protocol, which Catherine McCarthy broadened to compliance with Access and Benefit Sharing (ABS) regulations, and we initiated a project with UK universities and interested organisations, such as the UKRIO, UKRI and NC3Rs, to create a practical framework for the ethical assessment of materials from sentient animals.I have a PRINCE2 Foundation qualification in project management (AXELOS).As a manager, I strive to promote a leader-leader culture within the team, with a focus on individual development, coaching, mentoring and team growth.As a trained teacher with a PGCE in secondary education, I use the skills I acquired from my time as a teacher/lecturer in training staff and NHS REC members.I am a member of the Association of Research Managers and Administrators (ARMA).