Transcript Nana Theodorou - Association for Research Ethics

R&D – a perspective
Dr Nana Theodorou
Research Coordinator
Sheffield Clinical Research Office
Research Governance Framework
R&D: role and support
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Outlines principles of good governance that apply
to all research in health and social care
organisations, to ensure that all research is
conducted to high scientific & ethical standards
https://www.gov.uk/government/publications/rese
arch-governance-framework-for-health-and-socialcare-second-edition.
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Issued in 2001
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Implemented 2003
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Revised edition published in 2005 to include
the EU Directive on Clinical Trials guidance
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Currently under review
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Safeguard participants in research
Protect researchers/investigators (by providing
a clear framework to work within)
Enhance ethical and scientific quality
Minimise risk
Monitor practice and performance
Promote good practice and ensure lessons are
learned
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Research Governance Framework comprises:
Human Tissue Act (HTA)
National Research Ethics Service (NRES)
Mental Capacity Act (MCA)
Data Protection Act
Medicines for Human Use Regulations (MHRA)
The Ionising Radiations Regulations
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Study registration
At Grant stage
Pre-Authorisation
Post-Authorisation
Education and training
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Type of study
Student/staff
Lead/participating site
Clinical trial (drug/medical device)
Data only/Tissue bank
Chief/Principal Investigators
Sponsor
Commercial
Academic/NHS
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Identify suitable funding streams
Prepare and submit funding proposals
PPI
Provide costs for external bids
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Study set up and authorisation
Study documentation and scientific review
Regulatory and local approvals
Indemnity/insurance
Finance
R&D Approval
Guidance
RGF
Legislation
Agreements and Contracts
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Essential
Protocol
Additional
Participant information sheet
Consent form
Participant Invitation letter
Leaflets/posters
GP letter
Patient card/diary
Questionnaires
Ethics
University/NHS REC/None
MHRA
Drug/device
Confidentiality Advisory Group (CAG)
Gene Therapy Advisory Committee (GTAC)
Human Fertilisation and Embryology Authority
 New edition of GAfREC came into effect September
2011.
 Previously all clinical research involving the NHS was
automatically reviewed by REC.
http://www.dh.gov.uk/en/Publicationsandstatistics/Public
ations/PublicationsPolicyAndGuidance/DH_126474
Research involving previously collected,
nonidentifiable information
 Staff studies
 Clinical databases
 Extraction of information from notes by clinical care
team with removal of identifiers prior to analysis
Check with sponsor whether University ethics is
required.
Social or scientific value
Recruitment arrangements
Favourable risk benefit ratio
Care and protection of research participants
Informed consent process and participant
information
Suitability of the applicant and supporting
staff
Independent review
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• The IRAS is a single online system for applying for permissions
and approvals for health and social care/community research in
the UK.
• It streamlines the process for seeking relevant approvals, as
researchers no longer need to enter the details for a single
project in separate application forms.
IRAS can be accessed at www.myresearchproject.org.uk
Research has to have a confirmed sponsor,
appropriate approvals & written permission from
the care organisation before it commences
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 Amendments
 Finance and contract variations
 Performance management
 Accrual
 RTT
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Monitoring and audit
Pharmacovigilance
Study close out
Archiving
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The NHS REC letter lists all approved study
documents with version and date for each.
Any changes to the approved documents need
to be submitted as an Amendment (substantial
or non-substantial) and approved by the
original REC.
Huge variation in study documents and approval
letters.
Only receive the Ethics letter and not the ethics
form.
Favourable opinion v approval
http://www.sheffieldclinicalresearch.org
[email protected]
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