Patient and Public Involvement

Since 2013 the INHA has held the role of “Patient and Public Involvement” (PPI) in many research studies in Ireland and internationally.

Patient and public involvement (PPI) in research is where research is being carried out ‘with’ or ‘by’ members of the public not just ‘to’, ‘about’ or ‘for’ them. The slogan ‘nothing about us without us’, which is believed to be over five centuries old encapsulates this argument.

Involving the public in research in this way is important for both moral and pragmatic reasons. Morally, PPI is advocated on the grounds that people affected by a condition, or the wider public in the case of public health research, have a right to have a say in decisions about research that may affect them. This includes how research is designed and undertaken and how research findings are disseminated and implemented once a study is complete.

PPI in research envisages a relationship built throughout the lifespan of a research project between academics, clinicians and PPI colleagues in order to inform, plan, execute and, in due course, disseminate and translate research. There is a growing consensus that effective public and patient involvement (PPI) in research is instrumental in improving the quality of research projects, strengthening their relevance and impact and is beneficial to patients, the public and the health service.

Traditional views of PPI in research have placed patients in a consulting role, where major decisions are made by academics and clinicians, rather than in a meaningful and engaged dialogue, collaborating from the outset and ensuring that the patient voice is heard throughout the research lifecycle.

PPI ensures a focus on topics that concern health service users the most, and conversations between PPI and researchers promote learning for both parties. PPI has also helped create participant documentation and adapt academic language into plain English, thereby widening accessibility. Presentation of findings by PPI groups can also encourage further implementation of research findings and more effective dissemination. These positive developments have contributed to a significant drive to embed PPI within health and social care research, and it is becoming a prerequisite in funding applications.

Researchers who have embedded PPI in their studies report gaining a greater understanding of patients’ experiences and an appreciation of the problems they face, hence reinforcing motivation to continue their research.

Patient Engagement Roadmap (EUPATI)

The following infographic outlines the various stages of a Clinical Trial:

Opportunities for PPI engagement in Clinical Trials





Setting Research Priorities

  • Gap analysis
  • Early horizon scanning
  • Matching unmet needs with research
  • Defining patient-relevant added value and outcomes





Protocol Synopsis

  • Design
  • Target population

Protocol Design

  • Relevant endpoints
  • Benefit/risk balance
  • In/exclusion criteria
  • Diagnosis procedures
  • Quality of life and patient reported outcomes
  • Ethical Issues
  • Data Protection
  • Mobility issue/logistics
  • Adherence measures

Patient Information

  • Content
  • Visual design
  • Readability
  • Language
  • Dissemination

Informed Consent

  • Content
  • Visual design
  • Readability
  • Language
  • Dissemination





Trial Steering Committee

  • Protocol follow-up
  • Improving access
  • Adherence

Information To Trial Participants

  • Protocol amendments
  • New safety information

Investigators Meeting

  • Trial design
  • Recruitment
  • Challenges
  • Opportunities
  • Can trigger amendments

Study Reporting

  • Summary of interim results
  • Dissemination in patient community

Data & Safety Monitoring Committee

  • Benefit/risk
  • Drop-out issues
  • Amendments





Health Technology Assessment

  • Assessment of value
  • Patient-relevant outcomes
  • Patient priorities

Post Summary Communication

  • Contribution to publications
  • Dissemination of research results to patient community/professionals

Regulatory Affairs

  • MAA Evaluation
  • EPAR Summaries
  • Lay summary of results
  • Package leaflets
  • Updated safety communication