Dr Birgit Whitman, Research Governance Manager

1. Dr Birgit Whitman, Research Governance Manager Research Governance and the Human Tissue Act

2. What is our aim? The University is committed to: • build on its current strengths • establish an international profile based on world-class cutting-edge research • the provision of a world-class education to the most talented students from all backgrounds • to the transfer of knowledge • to develop a positive culture of discovery and enterprise

3. How are we going to achieve this? The University will: • Establish a stable and sustainable financial base • Ensure effective leadership and management • Create a positive research environment • Work collaboratively • Maximise performance in future research assessments, in particular RAE 2008

4. What do we need to do? Funded research: Answer questions on the University Costing Form: 1. Does your project involve human participants (including questionnaires, interviews, human samples and clinical research)? 2. Does your funder require a research sponsor? 3.If ‘Yes’ to one or both questions, complete a research registration checklist & submit it to the finance office. http://www.bris.ac.uk/research/governance

5. What do we need to do? Non-funded and student research: 1. Does your project involve human participants (including questionnaires, interviews, human samples and clinical research)? 2. Do you need a research sponsor? 3.If ‘Yes’ to one or both questions, complete a research registration checklist & submit it to the Research Governance Officer. http://www.bris.ac.uk/research/governance

6. We will guide you through: • The Medicines for Human Use (Clinical Trials) Regulations 2004 • The NHS Research Governance Framework for Health and Social Care (Science, Ethics, Health and Safety, Finance, IP, Dissemination) • The Human Tissue Act • Data Protection Act and Freedom of Information • Home Office regulations for research involving animals

7. Conditional Sponsor approval (if needed) Process for research (UoB employees) Proposal and Protocol – UB Costing & Checklist Obtain Funding Ethics MHRA NHS approval(s) Final Sponsor approval Start Research

8. Who should be your sponsor? UoB employee UBHT employee Yes Yes Does the study involve UBHT staff or patients or do any aspects take place on UBHT premises? Does the study involve any ‘clinically invasive procedures’ including those on healthy volunteers? Yes Yes No No Follow application process for UBHT Sponsorship Follow application process for UoB Sponsorship

9. We will work in close collaboration • With you • With our research collaborators and funders such as the NHS Trusts, Research Networks, Research Councils, DH • Aim for streamlined processes • Auditors (internal audits and statutory inspection)

10. Challenges for the University • Multicentre trials and “co-sponsorship” • Independent peer review of research proposals • Insurance http://www.bris.ac.uk/secretary/insurance/questions.html • Must capture ALL relevant research (Including student projects, unfunded pilot trials/feasibility studies)

11. Monitoring • Routine monitoring of 10% of studies by UBHT • Internal audit October 2007 • MHRA inspection 12th – 15th February

12. University of Bristol Ethics Structure University Council University Senate University Ethics of Research Committee Engineering Med Vet Med Dent Science Social Science & law Arts

13. Faculty Ethics Officers Faculty of Arts: David Punter Faculty of Engineering Stephen Gundry Faculty of Med Vet Eugene Lloyd Faculty of Med Dent David Jessop Faculty of Science Peter Rogers Faculty of social Science and Law: Tim Bond

14. The Human Tissue Act There must be a license in place to carry out the following activities: • Storing the body of a deceased person • Removing tissue for a scheduled purpose • Storing human tissue for research or other scheduled purpose • Conduct post mortems

15. Licensing for storage of tissue for research No licence required Diagnostic purposes (taken from living only) See guidance on obtaining a licence for carrying out a post mortem, public display or anatomy Other purposes What is the primary purpose you store organs, tissue or cells for? Are you storing organs, tissue or cells for a specific research project with ethical approval (NRES)? Are you storing organs, tissue or cells for a future undefined project or a project without ethical approval? Is the material you are storing created outside of the human body (e.g. a cell line?) Are you storing organs, tissue or cells to distribute to other researchers? No Research purposes (taken from living or deceased) No No Yes Yes Yes Yes No licence required You will need a licence to store this tissue from 1/9/06 No licence required You will need a licence to store this tissue from 1/9/06 © Human Tissue Authority

16. The Human Tissue Act implementation • University Audit prior to 1/9/2006 • 10 Licences • HTA Working Group • Internal audit • External audit by HTA

17. Was tissue retained for research before 1st Sept 2006? Consent not required Yes No Is tissue to be used for DNA analysis?* Qualifying consent is required (see Human Tissue Act) Yes No Is the tissue from the deceased? Appropriate consent is required Yes No Will the tissue be identifiable to the researcher? Is the tissue from an adult lacking in capacity? Yes No Yes No Has ethical approval for research without consent been given? Appropriate consent is required No Yes See Clinical Trials Regulations 2004, Mental Capacity Act 2005 and Human Tissue Regulations Seek ethical approval for use without consent Consent not required

18. Contact Details Birgit Whitman - Research Governance Manager Birgit.Whitman@bristol.ac.uk 0117 3317130 Rachel Ginham – Human Tissue Co-ordinator Rachel.Ginham@bristol.ac.uk 0117 3317709 Anna Brooke – Research Governance Officer Anna.Brooke@bristol.ac.uk 0117 3317709 http://www.bris.ac.uk/research/support/governance/ For checklist, guidance and useful links