Patient and Public Engagement' Research Capability Programme

1
Patient and Public Engagement.Research
Capability Programme

• Tony Sargeant.
• PPI member. External Reference Group EHealth
  Research Records Board and Research Capability
  Programme..

2
My Health Research Background and PPI Experience.

• Long term patient benefiting from health
  research and contributing as subject to health
  research projects.
• Member of PCT PPI Forum with particular interest
  in use of electronic care records for health
  research. Bury PCT Early Adopter Site. Summary
  Care Record.
• UK Clinical Research Collaboration. Research
  Advisory Group.
• Lay Peer reviewer. National Institute Health
  Research. Applied Research Programme.
• Member. NW Service User Research Group. Lancaster
  University.
• Member. Advisory Group. Primary Care Research
  Unit . Manchester University.

3
PPI arrangements for the RCP.

• Three lay members RCP External Reference Group
• Attend Monthly Meetings during Enabling Phase
  RCP 2007-2008 and forthcoming Procurement
  Phase.2008-2009.
• Have opportunity to contribute to all 6
  work-streams RCP. Public Engagement and
  Communication work-stream stands referred to SUS
  and so far no opportunity for consultation re
  public engagement and consultation.
• Comment on Communication Strategy
• Contributed to O Gateway Review

4
The Public Context of E-Records and Health
Research. Public support in principle.

• Own experience and evidence from several surveys
  (MRC, MORI, Welcome Trust) and recent evaluation
  of Summary Care Record Early Adopter sites,
  confirm public support in principle for use of
  personal health records in medical research.
• A large percentage of population either have no
  particular view about use of their own records or
  are supportive of their use. This may be because
  they are unaware of the emerging e-record data
  base and its uses(SCR Evaluation suggests this)
  or simply dont care.

5
The Public Context of E-Records and Health
Research. Support conditional.

• Public support in principle is undermined by
• Major lapses in security of electronic data by
  government and private sector
• Apparent and real failures of controls on access
  to data within the health service due to
  carelessness.CfH admit to appox 4000 lost cards.
  GP Pulse magazine suggest the figure may be
  nearer 6000.
• NHS clinical staff failure to understand the
  correct procedures governing access to data or
  patient consent rules. SCR Early Adopter Site
  Evaluation.and anecdotal.
• Doubt that health researchers are equivalent to
  clinical staff in having access to personal
  health records or adherence to information
  governance requirements.
• Lack knowledge of concrete benefits of research.
  (Long term patients most likely to be interested
  in outcomes and benefits.)
• Total opposition from some patient interest
  groups and clinicians amounting to calls to
  boycott electronic records and refuse consent to
  upload personal records.
• Concern that research data base may be restricted
  by cost to large research teams and
  pharmaceutical industry using business model that
  favours refinement of existing treatments rather
  than tackling less common illness where financial
  returns are poor.
• Data sharing creep. Can electronic records really
  be protected from access by other Gov Depts?
  DWP,Security Services?
• Concerns of groups with sensitive health
  conditions (HIV,Mental Health) that they will be
  disadvantaged by an electronic record system
  accessible to people other than those with
  immediate responsibility for their treatment.

6

• It is public perception of risks and benefits
  that are likely to govern acceptance of
  legitimacy of creation of large scale data bases.
• The role of PPI members on RCP ERG is to satisfy
  themselves that public concerns and interests are
  credibly addressed

7
Issues of Significance for PPI

• PPI members need to be assured that the
  architecture, scope and procurement strategy of
  the research capability programme takes full
  account of patient and public concerns relating
  to
• Security and confidentiality of personal health
  records. Unauthorised and malign access. Loss and
  misuse of data.
• Data sharing for research purposes.
• Possible access to personal health data by third
  party interests such as government departments,
  private sector health organisations and research
  companies, insurance companies.
• Techniques used to pseudonymise, anonymise and
  aggregate individual patient records.
• Safeguards to protect patient confidentiality and
  wishes when research uses records from which it
  is possible to identify individual patients.
• Information governance and human resource
  standards required from Safe Havens and providers
  of Safe Haven services.
• Sharing with patients and public outcomes of
  research and opportunities to participate in
  research.

8
Are existing provisions for safeguarding
individual records transferable to aggregated
data?

• Existing law and governance arrangements relating
  to privacy, access to health records and informed
  consent to use data, focus primarily on
  individual records.
• Research ethics committees and protocols also
  have a contribution to make to assuring patients
  that data will be used ethically and properly
  safeguarded from unauthorised access. But
  sometimes gap between principles and practice.
• Strategies for creating and combining large
  scale data sources for research purposes
  potentially raise additional concerns for
  patients arising from the characteristics of the
  research process as distinct from clinical
  intervention.

9
PPI Issues Arising from Use of Aggregated Data.

• Do initial arrangements for patient consent to
  use personal records explicitly take account of
  use for secondary research and incorporation
  into aggregated data bases?
• Are there effective provisions to prevent
  re-identification of individuals in otherwise
  anonymised or pseudonymised data.
• Will data sharing rules provide adequate
  safeguards against use of data for malign
  purposes. I.e insurance companies using data to
  identify risks to be excluded from individuals
  insurance cover.

10
The current context of Patient and Public
Engagement with RCP.

• PPI engagement is encouraged and the cycle of
  meetings provide for inclusion of lay members.
• At the conclusion of the enabling phase PPI
  members feel that PPI engagement is flawed in
  practice.
• The public engagement agenda is addressed without
  reference to PPI members on ERG.
• Speed and complexity of development makes it
  difficult for PPI members to engage effectively.
• No joined up thinking.There are few if any easily
  identifiable channels to coordinate PPI
  involvement with related PPI stakeholders in
  other projects and programmes.
• Communication appears to be primarily focused on
  the research audience with public explanation and
  engagement an after-thought.
• Public scepticism about risks and value of
  e-records research is not as yet being engaged in
  terms of dialogue. Telling people is not the same
  as engaging with them.