responsible sponsorship a case study dr birgit whitman, head of research governance
TRANSCRIPT
Responsible Sponsorship A case study
Dr Birgit Whitman, Head of Research Governance
Plan for this session
• Sponsorship definitions
• Sponsorship responsibilities
• University of Bristol case study
• Implementation of the Concordat in the University of Bristol
Research Governance Framework (RGF)
• The Research Governance Framework for Health and Social Care sets out the broad principles of good research governance
• It includes all clinical and non-clinical research within the NHS and Social Care systems
What is a Sponsor?
“the organisation taking primary responsibility for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting…”
Research Governance Framework
Who can be a Sponsor?
• Any organisation with the infrastructure in place
- Larger NHS organisations
- Higher Education institution
- Commercial companies
- [Some funding bodies]
Relevant legislation and guidance:
• The Medicines for Human Use (Clinical Trials) Regulations 2004
• The Human Tissue Act 2004
• Data Protection Act 1998 and Freedom of Information Act 2005
• Mental Capacity Act 2005
• The NHS Research Governance
Framework for Health and Social Care
Sponsorship responsibilities• Peer review• Infrastructure and training• Regulatory requirements: Medicines & Healthcare products Regulatory Agency Human Tissue Authority • Favourable ethical opinion• Data protection• Organisational approval • Insurance / Health & Safety• Financial Probity • Intellectual Property• Dissemination / Impact
University of Bristol
• 25 academic schools which are arranged into six faculties.
• Number of staff: 5,700
• No of undergraduate students: 13,500
• No of postgraduate students: 5,500
It all started in 2006
• manage the University’s compliance with legislation and guidance for research involving human participants (data and / or tissue)
• Foster standards that enhance research integrity and safeguard the public
Dedicated Resources
• Research Governance Officer since 2006
• Research Governance Manager 1FTE since 2007
• Research and Human Tissue Specialist since 2007
• Senior Project Manager since 2008
• University Research Ethics Co-ordinator since 2011
Research Registration Checklist
• Starts the research governance process
• Makes the RGT aware of a study and potential support needs
• Annual risk review
Peer review
• Independent Peer Review of research proposals
• Research has identified a gap in the evidence
scientific quality, value for £
Infrastructure and training
• Research teams have expertise
• Researchers have access to necessary resources
• Training needs are met
• Agreements
MHRA / CTA
• Request Clinical Trial Authorisation from the MHRA to conduct the study
• Safety reporting
• Amendments
• Fee
Ethics• Favourable Opinion from an NHS REC or
SCREC
• Governance Arrangements for Research Ethics Committees (Gafrec)
• Integrated Research Application System (IRAS)
• University ethics approval
University of Bristol Ethics Structure
University Council
University Senate
University Ethics of Research Committee
Arts Engineering Med Vet Med Dent Science
Social Science & Law
Applying for Ethics Approval
• Lay language
• Care of participant
• REC meeting
• REC members
Informed Consent• Purpose
• Methodology
• Intended potential use of the research
• What does participation in the study entail
• What risk / benefit / indemnity issues
• Confidentiality
• Right to withdraw
Informed Consent
• Provided in written form and signed by research participant and researcher
• Use alternative ways of consenting as necessary especially addressing age, cultural context, mental capacity.
• Ongoing and open ended process
• Openly and without deception unless no other approach is possible
Data Protection Act 1998• Collecting personal data? • Initial contact with the participants?• Access to data?• Obtaining consent from the data subject?• Does the information sheet provide sufficient
information for the participants to comply with the Data Protection Act?
• Sufficient detail provide as to how data will be stored?
• Archiving plan
NHS Research & Development or Organisational Approval
• Organisational approval
• Passport / Letter of access
Insurance, Liability, Health and Safety
• Insurance letter
• Extra insurance required for certain studies eg drug studies
Financial probity
• Accurate costing; tracking of finances addressed by Finance Department
Intellectual property
• Intellectual property issues addressed by Research Commercialisation Team
Dissemination
• Plans for dissemination• REF • Impact
Concordat to support Research Integrity
1. Maintaining the highest standards of rigour / integrity
2. Ensuring research conducted according to appropriate
ethical, legal and professional frameworks
3. Supporting a research environment underpinned by a
culture of integrity, based on good governance
4. Using transparent, robust and fair processes in
relation to allegations of research misconduct
5. Working together to strengthen integrity of
research by regular and open review
Key elements of the QA framework• Senior Management support• Risk management processes• Policies and Guidance• Training for staff and students • Hands on support• Annual audit programme• Monitoring programme• Reporting to Council Committees
Policies and Guidance
• The UoB has policies and procedures in place that govern good research and guide the investigation and reporting of potential misconduct.
• Research Governance and Integrity Policy• Ethics of Research Policy and Procedure• Regulations on Research Misconduct• Policy on Public Interest Disclosure
Implementation of policies • Policies are available on the website• Regular staff development sessions take
place • Staff attend the course ‘Introduction to
Research Governance’ which highlights all relevant policies.
• In addition a specific policy and /or policy amendment has an agreed dissemination plan.
Regular training
• Staff Development Course every term • Access to NIHR Good Clinical Practice (GCP)
training• MRC e-learning for researchers working with
human tissue• Social and Community Based Medicine
Randomised Controlled Trials (RCT) and Research Governance course
•
Mandatory Training
• Mandatory Data protection e-learning
• Mandatory Health & Safety training
• Mandatory Diversity in the Workplace training
• Up to 5 compulsorily training modules have to be completed before a researcher is able to obtain a Home Office licence.
Training
• MSc workshops
• PhD workshops
• Research team specific courses
Monitoring
• Routine monitoring of 10% of studies
• Statutory inspection by regulatory bodies eg MHRA, Human Tissue Authority
• Internal audits
Implementing the Concordat
• Since the launch of the Concordat to Support Research Integrity (2012) the UoB has undertaken a comprehensive review and mapping exercise to ensure that the requirements of the Concordat are met.
• An action plan has been developed
Responsible Sponsorship
• Understand Sponsorship responsibilities
• Establish how these can be met in your institution - University of Bristol just one of many models
• Implementation of the Concordat at your institution
