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Patient Engagement in Clinical Development service: Information Sheet for Patients


Published: 30 May 2019

Version: 1.0

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Patient Engagement in Clinical Development Project
Version 2.0 – 13 January 2020

About the Service

What is the NIHR Patient Engagement in Clinical Development Service?

This video provides an overview of how the service works (fewer than 4 minutes). Further detail is provided in the document below.

The Patient Engagement in Clinical Development Service creates opportunities for patients and the public to contribute to the design process of company-led clinical trials.

Patient insight into clinical trial design brings a wealth of benefits. It provides protocol writers with a unique insight into living with the condition of study, highlighting points that may not have previously been considered and helping to identify areas of an excess burden that may be off-putting or restrictive for participation in the trial.

Why should I participate in the Patient Engagement in Clinical Development Service?

This is an exciting opportunity to be involved in the design of a company-led clinical trial. By contributing to the service you will be helping to improve the delivery and accessibility of clinical trials, potentially leading to better health outcomes for all.

What would I be expected to do if I did participate?

The Patient Engagement in Clinical Development Service supports companies in a number of different ways to ensure the patient voice is heard during the trial design process.

For example, you may be asked to review a Patient Information Sheet, either remotely or face-to-face or take part in a round table discussion where you will talk about your experiences of living with a condition and consider whether the demands of a proposed trial protocol would be achievable.

Topics often discussed when reviewing a trial design include:

  • The number of study visits required and how viable this in the balance of day to day living
  • Potential procedures that may need to be carried out, and whether the length and duration of these are realistic
  • If the burden placed on a participant would simply be too much and if a solution is required to resolve this

By sharing your own experiences and insight you can help identify and resolve these issues prior to a study opening to recruitment. This will make it easier for others to enroll and complete the trial.

Do I need experience of clinical trials to participate?

You do not require experience of clinical trials or to have been involved in similar activities previously to register your interest in participation.

Often, and where possible, we will try and gather a range of experiences and opinions from a diverse group including age, gender and trial experience. Providing a range of experiences and opinions helps us to better represent the patient population the trial is hoping to enroll.

All participants in the service will have unique experiences. Everyone’s opinion is both valid and welcome.

How to participate in the Service

How do I find suitable activities to participate in?

There are four ways in which you may see an opportunity advertised:

Do I need to be part of a Patient Organisation to participate?

You do not need to be part of a Patient Organisation to participate.

Please note that Patient Organisations who have registered their interest in the Patient Engagement in Clinical Development Service may circulate opportunities to their membership directly.

Where will these meetings take place?

In the event that the activity is a face-to-face meeting, we will try to deliver these in a convenient location for all parties. Where possible, we try to ensure that this is an independent venue, such as an NIHR office space.

The likely date and location will be highlighted in the opportunity advert. Please note however that sometimes a date cannot be confirmed until we have sufficient numbers registered to go ahead - the NIHR Facilitator will keep you updated with proposed times and dates if this is the case.

Expenses and reimbursement

What will I be reimbursed for?

The Clinical Research Network will reimburse you directly for your involvement in any meetings or activities as part of this Service. This will consist of:

  • Payment for your time
  • Any other subsistence costs
  • Any other expenses incurred

We’ll reimburse you directly into your bank account, though please note that this can take up to 6 weeks.

You are required to notify HM Revenue and Customs local office of fees received only if your annual income exceeds your personal income tax allowance at the end of the financial year. You are responsible for calculating whether you need to pay any tax or National Insurance. The NIHR provides guidance on Tax and National Insurance.

How much will I be reimbursed?

The Clinical Research Network will use the payment structure set out in the Policy on payment of fees and expenses for members of the public actively involved as a standard guide to calculate and agree on any costs.

You are not obliged to fulfill any activities and are free to withdraw at any time. You will not be charged or invoiced if you decide to withdraw at any time. If you have incurred any costs and then subsequently decide to withdraw, the Clinical Research Network will reimburse you for these.

How will I arrange travel and accommodation?

The Clinical Research Network will manage travel arrangements and, where required, accommodation. We’ll provide you with booking reference numbers and confirmation details.

If you use a taxi or public transport on the day, then please keep your receipt and we’ll add the expenses to your total reimbursement.

What happens afterward?

Do I get to see the results?

On the conclusion of the activity, we are actively encouraging our life science partners to share the results of the session. This may include what amendments have been made to a document or study protocol from your insights and suggestions.

Likewise, if you have raised concerns or suggestions to help improve these and the company has been unable to make these suggested changes, we have asked them to let you know why this is e.g. it may be down to scientific or regulatory reasons.

Feedback and continuous improvement

After the activity has been completed, we’ll approach you to provide your feedback on the activity. It’s our intention to ensure that this is an interesting and enjoyable experience and we want to understand what we’ve done well and equally, what we can do better in the future to improve this process.

Your feedback is optional but would be greatly appreciated and is captured using an online Google Form which will be circulated to you.

Future opportunities

Hopefully, you enjoyed the opportunity and would like to be involved again. Unfortunately, at this time, we are unable to register individuals to highlight future activities to. However, do please continue to monitor the sources where we regularly advertise (as mentioned above).

You may also be interested in other Patient and Public Involvement opportunities which can be found at the Patients, carers and the public section of the NIHR website.

How will we safeguard your information?

Will any of my information be shared with the Life Sciences Company?

Throughout the process, we will ensure your details are kept anonymous from the company with whom we’re partnering with to deliver the opportunity.

You may be asked to share your gender, age and trial experience but your identity will not be shared.

For a face-to-face insight session, it is up to you how much information you wish to share with the company, however, only information relevant to the activity will be recorded.

What type of information will be shared with the Clinical Research Network?

In the event you would like to participate and match the eligibility criteria, the NIHR Facilitator will request for your consent for the following information to be shared with the Clinical Research Network:

  • Your name
  • Your address
  • Your email address (if available)
  • Your telephone number (if available)
  • Your bank account details (for receipt of reimbursement of payment)

Please note: Your bank account details would be required only to reimburse you for any expenses incurred and a contribution to your involvement in the study. You will not be charged for participating in the Service. You will not be charged for withdrawing at any point.

Who at the Clinical Research Network will be able to see my information and will this be shared?

Only approved members of staff based at the NIHR Clinical Research Network will be able to access your information.

The Clinical Research Network will receive your information from the NIHR Facilitator in order to process payments as part of the ‘facilitation’ part of the service e.g. remuneration for your time spent and reasonable expenses.

The Clinical Research Network will not pass on any of your personal information to Life Sciences Organisations either as part of the ‘referral’, or ‘facilitation’, or to any other third party organisation. The NIHR Clinical Research Network will inform the Life Sciences Organisations that a number of patients have been identified which match the eligibility criteria.

The Clinical Research Network will not disclose any of your personal information such as the following with the Life Sciences Organisation:

  • Your name
  • Your address
  • Your email address
  • Your telephone number
  • Your bank account details

Feedback, questions and complaints

How do I withdraw my registration on the Service?

If you cannot, or simply no longer wish to participate in an activity, please let the NIHR Facilitator know - this will not impact on your ability to participate in future activities, nor will you be charged for any expenses incurred.

How will questions, complaints and problems be managed?

Use our feedback form to ask questions or make a complaint.

How will the Clinical Research Network charge a Life Sciences Organisation for Patient participation?

The NIHR Clinical Research Network Patient Engagement in Clinical Development Service is a cost recovery service. As such, the NIHR CRN will charge the Life Sciences Organisation for introducing and facilitating the delivery of the activity.

The Clinical Research Network will charge Life Sciences Organisation for costs incurred (such as travel, Participant reimbursement costs, consumables, venue hire) and a 20% Sustainability Charge to ensure we can continue to offer this Service and facilitate these relationships.

The NIHR Clinical Research Network is a not for profit organisation hosted by the University of Leeds.

Terms of Service

Will any information related to this service be published?

Both the NIHR and the company may disclose or publish the nature and terms of this agreement for any legitimate purpose, including the disclosure of payments to healthcare professionals and organisations. Your personal information will not be shared as part of this.

How will personal data be managed?

he NIHR Clinical Research Network shall comply with its obligations under the applicable data protection laws. The NIHR Clinical Research Network will not share the personal data of participants with the company.

Your personal information is held and used in compliance with the General Data Protection Regulation 2016 (GDPR). The Department of Health and Social Care (DHSC) is the Data Controller under the provisions of the Regulation. Under GDPR, we have a legal duty to protect any information we collect from you and DHSC is committed to protecting privacy and to processing all personal information in a manner that meets the requirements of the Regulation. We will not pass your details to any third party or government department unless you give us your explicit consent to do so. 

Get in touch

We value your views. If you would like to provide feedback or have any comments or questions about the service, please complete this feedback form.

Alternatively please contact our Study Support Service Helpdesk:

Phone: 0113 343 4555