I am Head of the Human Studies team and Deputy Leader for the Food Microbiome and Health institute strategic programme.

I am responsible for the Institute’s research involving human subjects and human tissue. One of my key roles is to advise on, and oversee, compliance with the International Conference on Harmonisation-Good Clinical Practice (ICH-GCP); the UK Policy Framework for Health and Social Care Research, the Medicines for Human Use (Clinical Trials) Regulations 2004, and the Human Tissue Act 2004.

I am Chair of the Institute’s Human Research Governance Committee and QIB representative at the Joint Research Governance Committee, Early Phase Acceptance Panel and NIHR Norfolk Clinical Research Facility Joint Management and Strategy Committee of the Norfolk and Norwich University Hospitals (NNUH) and University of East Anglia (UEA). I am member of the UEA Human Tissue Committee and Norwich Research Park Biorepository Access Committee. I also sit on the Anglia Ruskin University Research Ethics Committee as an external member with professional expertise.

I have a proven track record of successful human study set up in academic and clinical settings in UK and LMICs (Low- and Middle-Income Countries). I have an active role in designing and delivering training on Good Clinical Practice (GCP) and ethical/legal issues in research involving human subjects or human tissue. I am also highly engaged in activities with research participants, patients, and the wider public to promote transparency and awareness of human research.

Education and training

• MSc in Pharmacy, degree awarded summa cum laude, University of Messina, Italy
• Pharmacist Licence, School of Pharmacy, University of Messina, Italy
• PhD in Toxicology, degree awarded with distinction, University of Messina, Italy

Responsibilities

• Represent the QIB in research operations and governance committees across the Quadram Institute partnership and the Norwich Research Park
• Act as a member of external Research Ethics Committees.
• Act as the Authorised person on behalf of the institute for human trials (QIB Sponsor’s representative).
• I chair the QIB Human Research Governance Committee (HRGC) that adheres to the UK Policy Framework for Health and Social Care research. QIB HRGC has 13 members, including 7 members of QIB staff with different areas of expertise in conducting human studies, 4 independent external experts on the committee who are experienced in either conducting or overseeing human studies and a lay member.
• I lead the Human Studies Training programme consisting of 8 courses (trainers from QIB, NBI Health and Safety, NRP Biorepository, QI Clinical Research facility) open to staff and students across the NRP.
• I oversee all projects recruiting human subjects, including ethics and regulatory compliance and the use of the QI Clinical Research Facility by QIB staff.
• I oversee all projects using human tissue samples including ethics and regulatory compliance (Human Tissue Act, 2004), and the use of NRP Biorepository and other tissue banks/Biorepositories.
• I manage the quality assurance for human studies including review of Standard Operating Procedures (SOPs) and Code of Practices to be used across QI/NRP in cooperation with NBI Quality Assurance team.
• I support principal investigators at QIB and the NBI Contracts office to fulfil clinical trial requirements for grants and contracts.
• I work in partnership with patients/members of the public and external researchers to carry out effective patient and public involvement (PPI) activities to support the design, conduct, and dissemination of health and social care research.
• I collaborate on externally funded projects including Clinical Trials of Investigational Medicinal Products (CTIMPS)