Patient Engagement in Clinical Development service: Information Sheet for Patients
Patient Engagement in Clinical Development Project
INFORMATION SHEET FOR PATIENTS
Version 1.0 – 2 October 2018
About the Service
What is the Patient Engagement in Clinical Development Service?
The Clinical Research Network launched the Patient Engagement in Clinical Development Service in October 2018 with the purpose of introducing and facilitating partnerships between Life Sciences Organisations (such as Pharmaceutical, biotech, medtech companies) and Patient Groups for Studies which are in the early stages of clinical development.
The Clinical Research Network has launched this Service with the aim of:
- Ensuring better study protocol design which could lead to better study delivery
- Encouraging and building positive relationships between the Life Sciences, the NIHR and patients
- Providing an opportunity for study protocols to be reviewed and tested by patients to identify issues before a study is open to recruitment at site level
What are the benefits of the Patient Engagement in Clinical Development Service?
Partaking in clinical research can be a rewarding, interesting and enjoyable experience. By involving Patients right from the start of the clinical development, we can ensure Patients are involved throughout the decision making process.
How will the Clinical Research Network introduce and facilitate working with Patient Groups?
The way it works is very similar to other NIHR Services, whereby, the Clinical Research Network using a network of organisations will identify, introduce and facilitate the partnership between Life Sciences Organisations and Patient Groups for studies which are in the early stages of clinical development.
Do you need to be part of a Patient Group to participate?
For the initial launch, you’ll need to be part of a Patient Group to participate.
What happens if you not currently part of a Patient Group
If you are not currently part of a Patient Group, then please visit our website where you’ll find information about how to contact your local Patient and Public Involvement and Engagement officer related to your therapeutic area. Your local PPIE will aim to signpost you to a relevant Patient Group.
Alternatively, on the website, there is a listing of Patient Groups affiliated as a stakeholder with the NIHR who are proactively recruiting members.
How to participate in the Service
How do I participate in the Service?
In brief, your Patient Group Facilitator will send you information about opportunities to participate in research which usually include attending focus groups and workshops in order to:
- Identify research priorities
- Comment upon and developing patient information leaflets or other research materials
- Review study protocols
- Simulate a study delivery approach
- Feeding back on marketing and recruitment materials
- Undertaking interviews with research participants
The information your Patient Group Facilitator will provide you regarding opportunities to participate in research usually includes:
- Therapeutic / Target Patient Group area
- A description of the study
- A description of the eligibility criteria
- A description of the ‘ask’ for Patient involvement
In the event you would like to participate and match the eligibility criteria, your Patient Group Facilitator will request for your consent to share your information with the Clinical Research Network in order to support with making the necessary arrangements.
The Clinical Research Network will then work with your Patient Group Facilitator in order to make arrangements with the Life Science Organisation for your participation (for example, a focus group, an interview or a workshop).
How will we safeguard your information?
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, your Patient Group 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. This includes the NIHR CRN Facilitator, the Head of Business Development and Marketing and the Stakeholder Engagement Manager at the NIHR Clinical Research Network.
Your information will be stored in a private Google Sheet hosted on the NIHR HUB.
The Clinical Research Network will receive your information from your Patient Group 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 patient information to Life Sciences Organisation either as part of the ‘referral’ or ‘facilitation’ or any other organisation. The NIHR Clinical Research Network will inform the Life Sciences that a number of Patients have been identified which match the eligibility criteria. Just to confirm, 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
Travel and accommodation arrangements
How will I arrange travel and accommodation?
The Clinical Research Network will book travel arrangements and where required accommodation. We’ll email you directly with booking reference numbers and confirmations of bookings. If you book a taxi or public transport on the day, then please keep your receipt and we’ll reimburse you for the expense.
Expenses and reimbursement
What will I be reimbursed for?
The Clinical Research Network will reimburse you directly for your involvement in any meetings or participating in the ‘Ask’ event. This will consist of:
- Payment for your time
- Any other subsistence costs
- Any other expenses incurred
We’ll reimburse you directly into the bank account details provided.
Please note: 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 INVOLVE guidance section 4.4 provides further details.
How much will I be reimbursed?
The Clinical Research Network will use the INVOLVE rates as a standard guide to calculate and agree on any costs.
Payment will be made directly into your bank account after you’ve participated in an event. Payment usually takes 4 to 6 weeks to be processed.
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.
Feedback, questions and complaints
How do I withdraw my registration on the Service?
Please notify your Patient Group Facilitator you no longer wish to participate. Your Patient Group Facilitator will inform the CRN.
How will question, complaints and problems be managed?
A feedback form can be found here.
How will the Clinical Research Network charge a Life Sciences Organisation for Patient participation?
The Clinical Research Network will charge Life Sciences Organisations for introducing and facilitating partnerships between Life Sciences Organisations (such as Pharmaceutical, biotech, medtech companies) and Patient Groups for studies that are in the early stages of clinical development.
The Clinical Research Network will charge Life Sciences Organisations for costs incurred (such as travel, Patient reimbursement costs, consumables, venue hire) and a 20% Sustainability Charge to cover the NIHR CRN’s costs in introducing and facilitating partnerships between Life Sciences Organisation and Patient Groups.
The 20% Sustainability Charge will cover Clinical Research Network’s efforts and administration to identify the Patient Group and make all the necessary arrangements for this to occur and to grow the deliverables of the Service.
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?
The 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 the patients with the company, only the named individual who is nominated as the lead facilitator at the company. The NIHR Clinical Research Network will have a separate agreement with the Patient Group Facilitator to share the Patient Group Facilitator personal information with the Life Sciences Organisation as required.
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.