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Patient Engagement in Clinical Development Service Charter

 

Contents

Patient Engagement in Clinical Development Service Charter
Version 1.0 – 2 October 2018

 

What the NIHR Clinical Research Network Coordinating Centre will do as part of the Service:

For Life Sciences Organisations:

  • Acknowledge all registrations by Life Sciences Organisations on the Company Expression of Interest form.  (free of charge).
  • Identify whether or not we can fulfil the remit of the ‘ask’ for involving Patient Groups and, if applicable, provide a reason why we may not be able to fulfil the remit of the ‘ask’ for involving Patient Groups (free of charge).
  • Feedback whether or not we have an existing Patient Group to introduce you to and facilitate this relationship, or would need to source a Patient Group from our extensive network (free of charge).
  • Use our extensive network to identify Patient Groups where possible (free of charge).
  • Where a suitable Patient Group has been identified, introducing you to the Patient Group and providing support with facilitating the remit of the study ‘ask’ (cost associated).
  • Comply with the guidance provided in the Information Sheet for Life Sciences Organisations.

For Patient Groups:

  • At every possible opportunity, involve patients within the remit of the study ‘ask’.
  • Make necessary arrangements for patient involvement in the study ‘ask’, such as arranging travel and expenses.
  • Support patients through their involvement in the remit of the study ‘ask’.
  • Reimburse patients directly for their involvement in remit of the study ‘ask’ using the NIHR INVOLVE guidelines.
  • Keep patients informed of the outcome of their involvement in the remit of the study ‘ask’.
  • Comply with the guidance provided in the Patient information sheet

What the NIHR Clinical Research Network Coordinating Centre will not do as part of the Service

  • Be held accountable for the open and honest feedback Patient Groups provide Life Sciences Organisations on study designs.
  • Substitute the involvement of the Patient Group as the means of gaining ethical approval for study design.
  • Be held accountable for liability of any loss, damage or expenses resulting from the sharing of Study information with Patient Groups.
  • The NIHR CRNCC is a not-for-profit organisation. Any income received from delivering the Service will be used for cost recovery and Service capacity building

Important information for Life Sciences Organisations

In the event a suitable Patient Group is matched to the remit of the ‘ask’, we will facilitate the introduction to the Patient Group and set up any arrangements for two way communication to take place (for example, a focus group, an interview or a workshop).

In the event during the two way communication between your Company and the Patient Group you deem there may be commercially sensitive information shared, then based on your company policy you may need to make these arrangements directly with the Patient Groups before the event takes place (and not with the Clinical Research Network Coordinating Centre). It is recommended to take on board the principles provided by NIHR INVOLVE to ensure patients feel valued in participating. It is recommended to include a Patient Participation Information Sheet explaining the ground rules and principles patients should adhere to in relation to any commercially sensitive information which may be shared.

Please remember that patients are volunteering their time to participate in research and for some it may be the first time they become involved. This may be due to a condition they have been diagnosed with and therefore, we would encourage a cooperative approach when collaborating with Patient Groups and a focus on the principles of two way involvement.