Managing Research in Hospices
Paul Perkins
Why?
We need to know what the best treatments are for our patients and their families
Duty
We have a duty to contribute: Conducting research
Finding patients for researchers and singposting them
The Aim
Research is seen as core business
Think about mentioning it in leaflets or on your hospice website
Ideas
Journal clubs Read papers
Go to conferences
What’s important to your patients?
Talk to Management
Better patient care
Enhanced job satisfaction Staff retention
Build a team
You can’t do this alone – it’s not doable and it’s no fun
Find people locally
Contact national / international experts and see if they want to collaborate
Research Nurses
ESSENTIAL!!!
Ask management if they will appoint 1 part-time Look for a trust fund to support their
salary for the first year
Think about external studies e.g. drug company to help fund
Volunteer for studies
It doesn’t take long to get a reputation as a centre
Look on the UK Clinical Research Network Website
Ask colleagues in other units who are recruiting to recommend you
Sponsorship
All research needs a sponsor This isn’t just about funding
Sponsor Responsibilities
The governance of research from conception to final completion – design, management, finance
Sponsor has to satisfy itself that appropriate checks have been undertaken
Risks of Sponsorship
Financial – claims for damages to participants Legal – prosecution by Medicines and
Healthcare products Regulatory Agency (MHRA) (or other regulatory authority) for breach of Clinical Trials Regulations
Reputation – failure of the study, failure to meet required standards to satisfy MHRA auditors, or from prosecution
What a sponsor does
Risk assessment:
All responsibilities listed in the Research Governance
Framework and the Clinical Trials Regulations accepted Is this good science? Peer review
Competence of the Chief Investigator and host organisation
Appropriate training in research methods and Good Clinical Practice for members of the research team Audit and monitoring of the study
What a sponsor does
Legally responsible for some things:
Request clinical trial authorisation and ethics approval Allow inspection of premises by MHRA if required
Give notice of amendments to the protocol to MHRA and ethics committee
Give notice a trial has ended
Research Governance Framework (DH 2005)
What a sponsor does
Legally responsible for some things:
Keep records of all adverse events reported by investigators
Ensure recording and prompt reporting of suspected unexpected serious adverse reactions (SUSARs)
Ensure investigators (e.g. in other sites) are informed of SUSARs
Ensure all SUSARs entered into European database Provide annual list of SUSARs and a safety report
What a sponsor does
Responsible for ensuring indemnity is in place for the study
Research Governance Framework (DH 2005)
My advice
Don’t do it
Find a Sponsor
Go and talk to:
Your local NHS Trust R&D Management Team Local university
Find a Sponsor
Indemnity
There are questions about this on the ethics form:
What arrangements will be made for insurance and/or indemnity to meet the potential legal
liability of the sponsor for harm to participants arising from the research
management? design?
Indemnity
Indemnity
Talk to the hospice insurers about the kind of research you want to do
If what you are planning doesn’t vary much from standard practice there may not be any additional cost
Indemnity
Human Resources
Your staff engaged in research will need to
have this covered in their employment contract External staff will need some kind of access
Governance
How are you going to decide what to approve?
Is it the sort of thing we should be doing?
Standard Operating Procedures
Borrow them from someone else
Talk to your local NHS Trust research and development management team
Lawyers!!
There will need to be contracts E.g. for us:
Drug company – hospice
Hospice – Principal Investigator Drug company – hospital
Dedicated time
Ideally there should be time in job plans for research
Patience
Patience – Ascites Study
September 2008 protocol v1 May 2010 final protocol
April 2011 completed recruitment September 2011 submitted to BMJ December 2011 submitted to BJC March 2012 submitted to Pall Med July 2012 resubmitted to Pall Med
October 2012 resubmitted to Pall Med January 2013 resubmitted to Pall Med
January 2013 accepted for publication in Pall Med September 2013 published in Pall Med
Progress
Been consultant since 2004
No governance structures in place
Agreements to participate in trials – battles with lawyers
Recently
New charity-wide research policy issued Jan 2010
Research Governance Group looks at Sue Ryder research nationally – meets monthly
Role of RGG
Is the research relevant to the charity’s aims and objectives?
Has researcher followed correct processes?
Identify a list of requirements and ensure that they are complied with before research can go ahead
RGG - Membership
Quality Manager, Sue Ryder (Chair) Clinical Quality Lead /Lead Nurse Medical Director Sue Ryder
External member with research experience x 2 Service User Lead
Trustee (with research interest/experience) Legal Services Representative
Insurance Officer
Business Development Team Representative Neurological Care Representative x 2
Palliative Care Representative x2 Co-opted when required:
Researcher, Mentor, Human Resources, Research Interested Staff, Marcomms, Sue Ryder International, Finance
RGG – last meeting
Quality Manager, Sue Ryder (Chair)
Clinical Quality Lead /Lead Nurse Medical Director Sue Ryder
External member with research experience x 2 – just 1 Service User Lead
Trustee (with research interest/experience)
Legal Services Representative Insurance Officer
Business Development Team Representative Neurological Care Representative x 2
Achievements
Homegrown projects: Qualitative focus group and interview studies Questionnaire studies
RCT – acupressure Pilot RCT – drug
Drug company funded: RCTs
Achievements
2 fantastic part-time research nurses
1 has led on a project from protocol to publication
What we haven’t achieved
The future
We have achieved little so far
What you’ll need to make research
happen in your hospice
Management support
Local networks – collaborators, sponsors Legal support
Human resources support
Some kind of governance process / checklist Dedicated time
Useful references
Research Governance Toolkit
http://www.nischr-cancerrrg.org/research/
Payne S, Preston N, Turner M, Rolls L. Research in
