Role description of lay panel member RPW (2)

advertisement
Role Description for Lay panel member
Role description of Lay panel member
Research Management Committee
‘Characterisation, commercialisation, and clinical studies of a long-term
antimicrobial urinary catheter’
Role Title
Lay panel member on the Research Management Committee (RMC) for the
‘Characterisation, commercialisation, and clinical studies of a long-term
antimicrobial urinary catheter’ research project.
Background
Project Summary: Urinary tract infection is a major problem in long-term
urinary catheters users and can result in repeated catheter removal, courses of
antibiotics, and often obstruction (mineral encrustation) of the catheter. No
antimicrobial catheter is currently available with the required long duration of
protective activity for long-term catheter users, as existing ones lose activity
after a few days. Therefore the aims of this project are to:

Confirm results showing protective activity for 80-100 days against
common infecting bacteria

Assess whether the catheter minimises antimicrobial resistance

Investigate the ability of the catheter to prevent mineral encrustation

Conduct a safety trial in patients with a long-term urinary catheters

Conduct a feasibility study to determine the number of sites needed to run
an efficacy clinical trial in the future
Start Date: May, 2015
End Date: April, 2018
Please note, you are welcome to leave the RMC at any time if you feel you are
no longer able to participate.
Funding: Three years of funding from the National Institute of Health Research
Invention for Innovation (NIHR i4i) programme. The NIHR i4i funds late stage
project development whether further testing and clinical studies will prepare the
technology for commercialisation and adoption by the NHS.
1
Role Description for Lay panel member
Academic Staff: This research project is sponsored by the University of
Nottingham, but has involvement from both the University and Nottingham
University Hospitals NHS Trust. These include:

Professor Roger Bayston- Professor of Surgical Infection
o

Mr. Richard Parkinson – Consultant Urologist
o

Nottingham University Hospitals NHS Trust
Dr. Gillian Shuttleworth-Licensing Executive
o

University of Nottingham
Business Engagement and Innovation, University of Nottingham
Miss Katherine Belfield-Research Associate
o
University of Nottingham
Aims and Objectives
Aims and objectives of Research Management Committee:

Keep research focused on delivering a long-term antimicrobial urinary
catheter designed with the users in mind

Advise on preparation of the application for Ethics for safety and feasibility
clinical study

Review progress to date and plan for future work

Advise on dissemination of results
Specific roles of the lay panel members:

Provide expertise of real-life experience

Highlight issues important to long-term catheter users

Assist in preparation of patient information leaflets and consent forms for
Ethics

Advise on recruitment to the clinical study

Provide feedback on progress of the research project

Help in dissemination of results to relevant user groups at the end of the
study
2
Role Description for Lay panel member
Roles and responsibilities the lay panel members
Duties:

Have the time and ability to attend meetings in person

Contribute to discussion within the Research Management Committee

To be available to respond to emails in regards to meeting attendance and
potentially in regards to preparing materials for Ethics.

Optional: Outside of the meetings to help with reviewing patient
information leaflets and consent forms. If you do choose to assist with
this, you will be reimbursed for your time.
Qualities:

Understanding the issues related to long-term urinary catheterization

Ability to provide a broad view on behalf of patient and carer groups
rather than a personal one

Be able to maintain confidentiality
Matters for consideration by the lay panel members
Considerations
What this means for you
As a representative of the ‘Characterisation,
commercialisation, and clinical studies of a long-term
antimicrobial urinary catheter’ at the University of
Confidentiality
Nottingham you are asked not to share confidential
information you may have received as a result of your
position. This should be discussed with the project group
and / or contact person and you will be asked to sign a
confidentiality agreement.
Meetings are likely to be arranged by email, and in
Internet Access
preparation for Ethics approval, further emails may be
circulated so internet access is preferable.
The Research Management Committee meetings will be held
Frequency of
4 times a year over the research project period (May 2015-
meetings
April 2018). This will be a total of 12 meetings. Each
meeting will last approximately 2-3 hours and refreshments
3
Role Description for Lay panel member
will be provided.
Location of
meetings
Meetings will be held at the University Park campus of the
University of Nottingham. Access requirements will be
discussed privately beforehand.
Reimbursement and Payments
All travel expenses and carer expenses will be reimbursed and you will be paid a
fee for your time in attending the meetings. If you would like we can arrange the
travel (such as a taxi) for you.
Reviewing patient information leaflets and consent forms outside of the meetings
will also be reimbursed according to the Reimbursement Policy, which will be
provided at the first meeting.
It is important to note that, with regard to payments, recipients are responsible
for notifying agencies such as Jobcentre Plus, the Department of Work and
Pensions or Her Majesty’s Revenue and Customs about additional income. For
this reason, Patients and carers may also like to know about INVOLVE's benefits
advice service: http://www.invo.org.uk/resource-centre/benefits-advice-service/
Training and Support
Lay panel members are able to access support from Katie Belfield (named
contact person for this work) and other members of academic staff:
Katie Belfield
Email: Katherine.belfield@nottingham.ac.uk
Telephone: 01158231113
Professor Roger Bayston
Email: roger.bayston@nottingham.ac.uk
Telephone: 01158231115
Please let us know if you would like any access to literature, such as scientific
journals, or NHS or University policies.
Training will be offered for those interested about why we have Ethics in
research. This is optional and will last approximately 3 hours.
4
Role Description for Lay panel member
Glossary
Term
Definition
Agent that kills or inhibits the growth of bacteria, viruses,
Antimicrobial
parasites, and/or fungi
‘Antibiotics and similar drugs, together called antimicrobial
agents…have greatly reduced illness and death from
Antimicrobial
Resistance
infectious diseases. However, these drugs have been used so
widely and for so long that the infectious organisms the
antibiotics are designed to kill have adapted to them, making
the drugs less effective’ (Centers for Disease Control and
Prevention)
A study in humans intended to discover or verify the effects
Clinical Trial
of a medical product, to identify adverse reactions and to
examine safety and efficacy
A legal agreement to protect confidential information revealed
during discussions or negotiations with another party. It
Confidentiality
Agreement
applies to both organisations and individuals and is likely to
contain clauses covering protection of people against the
copying or retention of confidential information, disclosing
information that is not already in the public domain to a third
party and remedy for a breach of the agreement
Communication of research findings to a wider audience
Dissemination
through, for example, publication in medical journals, the
media, and voluntary organisations’ newsletters
Complication of indwelling catheters caused by deposition of
Encrustation
minerals from the urine onto the surfaces of the urinary
catheter that can cause blockage of the catheter, urinary
retention, and trauma upon catheter removal
5
Role Description for Lay panel member
Term
Definition
The name given to the code of practice based on a set of
decent, fair and moral principles and guidelines that
Ethics
researchers should abide by. Research that will seek to gain
personal confidential information or to test a new intervention
on people must get ethical approval from a Research Ethics
Committee (REC)
Research
Ethics
Committee
(REC) groups of professionals and service users that review
the ethical considerations of research studies
6
Download