Organisational Involvement

Organisational Involvement

Consumer involvement at a strategic level helps to ensure that an organisation’s research policies and practices reflect the real-life needs and preferences of consumers.

The foundations on which consumer involvement is built is critical to ensure that organisations provide a strong basis for their partnerships with consumers/consumer organisations.

It is often useful to ensure that a dedicated person is responsible for coordinating activities and developing relationships with consumers/consumer organisations.

Research organisations seeking ways to work with consumers can access many useful resources. The Clinical Trials Transformation Initiative and the European Patients’ Academy on Therapeutic Innovation provide guidance and tools to support effective involvement with consumer organisations.

The working relationship between consumers/consumer organisations and research organisations can be documented in many ways; for example, through Terms of Reference, working agreements, and confidentiality agreements. 

A lack of a strategic approach to working with consumers may impede your plans for consumer involvement.  Developing a Consumer Involvement Strategy can help cultivate your organisation’s ethos and culture around the inclusion of consumers in core activities. It can also help improve and facilitate awareness and understanding of consumer involvement within the organisation. A customisable template is available here.

Consumers partnering with commercial companies

Life science companies have long recognised that they must avoid conflict of interest or promotion of the investigational products when working with consumers.  The Working Together Guide from Medicines Australia and the Consumers Health Forum provides similar practical advice for successful collaboration. In addition, the Association of British Pharmaceutic Industry Guidance Working with Patients and Patient Organisations Sourcebook, provides guidance on the content of patient agreements and good practice in involving consumers in events and meetings and the research and development process in general. The principles that underpin the relationship between a life science company and consumers are illustrated in this Company Directive

When commercially sensitive information is being shared with consumers/consumer groups, more formal contracts may be considered; however, it is important to ensure that contracts are not excessive. The following Guiding Principles on reasonable agreements may be useful.


Further Reading

  • Drug Information Association (DIA): Considerations Guide to Implement Patient Centric Initiatives in Health Care Product Development
  • EFPIA Code of Practice on Relationships between Pharmaceutical Companies and Patient Organisations (2011)
  • Smith, MY et al. Patient engagement at a tipping point—the need for cultural change across patient, sponsor, and regulator stakeholders: insights from the DIA conference, ‘Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products’. Ther Innov Regul Sci. (2016);50:546–53
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