Ray French Research Governance Manager, ACCORD. SPONSORSHIP Ray French Research Governance Manager, ACCORD.

Evolution of Research Governance 1930s A mistake in a children’s syrup caused a number of deaths and led the FDA (US) to set up a product authorisation system. 1947 Nuremburg Code (Directives for Human Experimentation) 1950s Japanese government regulated sale of medicinal products 1960s Effects of thalidomide synthetic drug triggered review of practices in Europe 1964 Declaration of Helsinki 1968 Medicines Act (UK) 1989 WHO produced action plans for regulation of medical research 1990 First ICH meeting held between EU, Japan and US to harmonise practices 1996   ICH Guideline on Good Clinical Practice (GCP) 1998 Data Protection Act 2000 Adults with Incapacity (Scotland) Act 2000 2001 EU Directive on Clinical Trials (2001/20/EC) 2001 Research Governance Framework for Health and Social Care (UK) 2002 Medical Device Regulations (UK) 2004 Medicines for Human Use (Clinical Trials) Regulations 2004 (UK) 2004 Human Tissue Act 2005 EU Directive on Good Clinical Practice  (2005/28/EC) 2006 Research Governance Framework for Health & Community Care (Scotland) 2007 National Research Ethics Service (NRES) launches 2009 Integrated Research Application System (IRAS) launches 2010 Academy of Medical Sciences (AMS) reviews UK medical research regulation and recommends a number of changes 2011 Health Research Authority established to deliver the principles prescribed by AMS 2017 UK Policy Framework for Health and Social Care Research

A Sponsor is… “…the individual, organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project. All health and social care research has a sponsor. The sponsor is normally expected to be the employer of the chief investigator in the case of non-commercial research or the funder in the case of commercial research.” [UK Policy Framework for Health and Social Care Research 2017]

Not… © Ray French / movingstills.co.uk

But maybe…

PRINCIPLES: Principle 1: Safety Principle 2: Competence Principle 3: Scientific and Ethical Conduct Principle 4: Patient, Service User and Public Involvement Principle 5: Integrity, Quality and Transparency Principle 6: Protocol Principle 7: Legality Principle 8: Benefits and Risks Principle 9: Approval Principle 10: Information about the Research Principle 11: Accessible Findings Principle 12: Choice Principle 13: Insurance and Indemnity Principle 14: Respect for Privacy Principle 15: Compliance

PRINCIPLES: Principle 16: Justified Intervention **Principles that apply to interventional health and social care research** In addition to the principles above, the following principles apply to interventional research only, i.e. where a change in treatment, care or other services is made for the purpose of research: Principle 16: Justified Intervention “adequately supported by the available information (including evidence from previous research)” Principle 17: Ongoing Provision of Treatment “…explain the special arrangements, if any, after the research intervention period has ended (e.g. continuing or changing the treatment…introduced for the purposes of the research).”

PRINCIPLES: Principle 18: Integrity of the Care Record **Principles that apply to interventional health and social care research** In addition to the principles above, the following principles apply to interventional research only, i.e. where a change in treatment, care or other services is made for the purpose of research: Principle 18: Integrity of the Care Record “All information about treatment…provided as part of the research project… is recorded and stored [so] that it can be understood by others involved in the participant’s care….” Principle 19: Duty of Care “The duty of care owed by health and social care providers continues to apply when their patients and service users take part in research….If an unmanageable conflict arises between research and patient interests, the duty to the participant as a patient prevails.”

When is a Sponsor required? All research falling under the remit of the Secretary of State for Health must have a formal sponsor. This includes all research in health and social care that involve NHS patients, their tissue or their information (data). Similar requirements for research involving social care practitioners, clients and resources, where this falls under the Secretary of State for Health’s remit. Any research outside the NHS should also have a sponsor to take on the specific responsibilities of the role.

When is a Sponsor required? (contd.) If… You are a University of Edinburgh or NHS Lothian employee, or a UoE student Your research involves humans, their tissue or data, …contact ACCORD for confirmation of sponsorship of your research before the submission for any other approvals. Sponsorship must be in place before e.g. REC favourable opinion, MHRA authorisation, NHS R&D Management Approval are sought.

Sponsorship in practise. Both the University of Edinburgh and NHS Lothian can act as single sponsors. Single Sponsorship for UoE arises where no NHS patients, staff or facilities are involved. Obvious example: international studies. But NHS Lothian R&D staff still provide (eg) monitoring and QA functions. However, most clinical research is co-sponsored by NHS/UoE through a framework agreement (nb. co-sponsorship is different from joint sponsorship). NHS R&D departments also have a role in providing R&D (aka ‘management’) approval – see Kenny’s presentation. A sponsor can delegate specific responsibilities to any other individual or organisation (needs to be formally agreed and documented).

Sponsor Review. A Sponsor Representative is assigned from the lead Sponsor organisation. Draft documentation is submitted by the CI to ACCORD. Documentation should include as a minimum: Protocol Participant information sheet Informed consent form IRAS form Recruitment material, advertisements, GP letters…. IRAS* form can be quite daunting, and certain sections (eg Lead Sponsor contact details, insurance and indemnity details) may not have obvious answers. If in doubt, leave blank and your Sponsor Rep will advise. * www.myresearchproject.org.uk

Sponsorship Review (contd). Sponsor Rep undertakes review (collates comments from the non-lead Sponsor if study is co-sponsored). Comments back to CI within ca. 10 working days of receipt of documentation. Review comments take the form of a Word document; CI responses can be annotated to it. May be more than one comment-response cycle between Sponsor Rep and CI. Review will confirm the Sponsorship position and the required permissions for the study to commence. Review will anticipate possible comments from the REC and MHRA and will advise on these.

Sponsorship Review (contd). Review may identify need for additional submissions relating to privacy and confidentiality (CAG/PBPP and GDPR requirements) use of radioisotopes (ARSAC) use of human tissue, stem cells (HTA, HFEA) Review will confirm the need (or otherwise) for a formal Risk Assessment Mandatory for CTIMPs, FIH and regulated device studies May also be considered appropriate for other, higher-risk studies Review will also identify requirements for formal agreements and liaise with Research Support Office to initiate those Review will confirm Insurance and Indemnity position for the study

? Questions at the end after Kenny’s presentation…