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HRA Perspective Dr Janet Messer, HRA
HRA Perspective
Dr Janet Messer, HRA
The Health Research Authority
• Regulatory functions • Standardising behaviours
and processes through leadership, consensus and accreditation, rather than through inspection, enforcement and licensing
• Duties for the HRA and others
Announcement March 2011 Established December 2011 - Special Health Authority To become Non-Departmental Public Body 2014/15
HRA Approval
Programme
Research Ethics
Committees
Confidentiality Advisory Group
Collaboration Programme
Gene Therapy Advisory
Committee
CAG and IG Toolkit
Access to patient information without consent: Applying for ‘Section 251’ support • HRA Confidentiality Advisory Group advises • Approval given by HRA (research using data
generated in England) • Review of appropriate security &
governance arrangements by HSCIC - IG toolkit (confirmed satisfactory by HSCIC directly to the CAG)
Need for security assurance: Regulation
Restrictions and exclusions • 7. (1) Where a person is in possession of confidential patient
information under these Regulations, he shall not process that information more than is necessary to achieve the purposes for which he is permitted to process that information under these Regulations and, in particular, he shall— …
(c)ensure that appropriate technical and organisational measures are taken to prevent unauthorised processing of that information;
• Similar to Data Protection seventh principle requirement
Need for security assurance – policy • Broader context: HMRC data loss • NHS Information Assurance Programme • Department of Health & Information Commissioner’s Office (ICO)
joint guidance issued to SHA, PCT, Trusts, Regulators 05 September 2011
“All NHS organisations (and others with access to NHS patient information) should be using the NHS Information Governance
Toolkit to assess and publish details of performance”
Why complete the IGT?
• Processing identifiable patient information without consent (‘s251’)
• Prior to this, individual system level security policies used as assurance method – ranged from review of organisational policy documents, different templates for SLSP, dependent on one person in DH reviewing.
• DH policy for all those processing patient information
• Accepted by National Information Governance Board in 2012
Benefits in context of ‘s251’ applications
• Standardised approach to assurance • Repeated annually -up to date public confidence • Published via IG toolkit portal - accessible • Can be submitted in advance of making an
application to the CAG (advised) so no delays if approval to process patient information is provided.
Tips to note:
• Can be issues experienced in first submission however once in place expected to be less intensive
• Where an improvement plan exists, the CAG may wish to assess the extent of improvements
Wider HRA Developments
Care Act 2014
• Places our functions on a statutory footing • Gives duties to the HRA and to others • Authority – including policy, advice and
guidance • Brings the policy context and operational
functions to the same organisation
Functions of HRA in Care Act
• Co-ordination and standardisation of practice relating to the regulation of health and social care research: – Reduce duplication – Streamline
• Guidance – including replacement of RGF – NHS and local authorities must ‘have regard’
• Promote transparency in research
• Simplify approvals pathway • Manage variation of review • Increase reliability of review through
centralisation, where appropriate, and quality assurance
• Improve flow by reducing unnecessary waiting times
• Enable local support and delivery
HRA Approval - Aim
One application, one assessment and one approval for the NHS
Single application
• Application to HRA
• Single validation
HRA Approval
• Assessment • REC opinion
Site selection & feasibility
Site set-up
ready to deliver
Site set-up
ready to deliver
HRA Approval
HRA
NHS
single entry and
validation
contracting
clinical support service review
Research Passports
participant interests
compliance and delivery
Site set-up and local decision to deliver
• Putting arrangements in place ready to start straight away
• Deploy nurses – in accordance with network arrangements
• Local HR arrangements – based on HRA Assessment
• Local arrangements – based on single technical review in HRA Assessment
• Sign contracts – based on model agreement and costing template/ ACAT
Sponsorship Toolkit Training Escalation
Funders Lay Summaries
Progress Reporting Protocol
templates
Application Management
Pharmacy Radiation Interim Policies
Improving application
quality
Implementation Approach
• Phased roll out (no pilot sites) • Roll out components – pharmacy / radiation • Roll out proportionate approaches – rare
diseases, cell therapy • Roll out by study type – health services,
primary care • Information systems to enable processes to
be embedded
Timetable and approach
• Now: Application management – rolling out pharmacy and radiation single technical reviews, supporting complex applications early through interim policies
• Now: Recruiting new staff • 2014: primary care, staff research, health
services research • By end 2015: all research
EU Clinical Trials Regulation – 2016/17
• Will require coordination of CTA, REC opinion and site suitability
• HRA plans integrate and coordinate processes
• Application for CTA will be through EU Portal • New requirements for IRAS
What do we want to achieve for IG?
• No local interpretations of IG requirements • No local queries about processing of identifiable
data or anonymisation processes • No local forms • Provide sites with the information and
assurances they need
What can we change?
• What should the assessment consider? • Who should assess when s251 not required? • What should be assessed with/ without CAG
review? • What information is needed – protocol/ IRAS? • How does the IG Toolkit fit in?
