Managing Research in Hospices
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- Megan Webb
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1 Managing Research in Hospices Paul Perkins Consultant in Palliative Medicine Gloucestershire Hospitals NHS Foundation Trust and Sue Ryder Leckhampton Court Hospice Cheltenham
2 Why? We need to know what the best treatments are for our patients and their families Research is the only way of finding out
3 Duty We have a duty to contribute: Conducting research Finding patients for researchers and singposting them Freeing up time for researchers Providing infrastructure / finance
4 The Aim Research is seen as core business Think about mentioning it in leaflets or on your hospice website
5 Ideas Journal clubs Read papers Go to conferences What s important to your patients? What are the clinical problems you are faced with? What s important to your staff?
6 Talk to Management Better patient care Enhanced job satisfaction Staff retention Centre of excellence
7 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 APM Research Champions
8 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
9 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 Helps hospice staff to get the feeling this is what we do
10 Sponsorship All research needs a sponsor This isn t just about funding
11 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 Research Governance Framework (DH 2005) Medicines for Human Use (Clinical Trials) Regulations 2004
12 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
13 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 Research Governance Framework (DH 2005) Medicines for Human Use (Clinical Trials) Regulations 2004
14 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) Medicines for Human Use (Clinical Trials) Regulations 2004
15 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 Research Governance Framework (DH 2005) Medicines for Human Use (Clinical Trials) Regulations 2004
16 What a sponsor does Responsible for ensuring indemnity is in place for the study Research Governance Framework (DH 2005) Medicines for Human Use (Clinical Trials) Regulations 2004
17 My advice Don t do it Certainly don t do it for drug studies Research Governance Framework (DH 2005) Medicines for Human Use (Clinical Trials) Regulations 2004
18 Find a Sponsor Go and talk to: Your local NHS Trust R&D Management Team Local university What s in it for them?
19 Find a Sponsor Whoever you work with will probably ask the hospice to take on some of the sponsor s responsibilities
20 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? conduct?
21 Indemnity Use NHS links if you can Honorary contracts?
22 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
23 Indemnity People worry about non-negligent harm Try not to
24 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 permission
25 Governance How are you going to decide what to approve? Is it the sort of thing we should be doing? Are there any risks for our patients / families? Is there risk for us? Are there costs for the organisation e.g. time?
26 Standard Operating Procedures Borrow them from someone else Talk to your local NHS Trust research and development management team
27 Lawyers!! There will need to be contracts E.g. for us: Drug company hospice Hospice Principal Investigator Drug company hospital Intellectual property issues
28 Dedicated time Ideally there should be time in job plans for research Often done at weekends / evenings
29 Patience Things will take time You need to surround yourself with positive people
30 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
31 Progress Been consultant since 2004 No governance structures in place Agreements to participate in trials battles with lawyers Started with questionnaire studies Pilot RCT of acupressure wristbands for nausea Pilot RCT of fan for breathlessness
32 Recently New charity-wide research policy issued Jan 2010 Research Governance Group looks at Sue Ryder research nationally meets monthly
33 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 Safeguard the wellbeing of participants employees, volunteers
34 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
35 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 Palliative Care Representative x2 just 1 Co-opted when required: Researcher, Mentor, Human Resources, Research Interested Staff, Marcomms, Sue Ryder International, Finance
36 Achievements Homegrown projects: Qualitative focus group and interview studies Questionnaire studies RCT acupressure Pilot RCT drug Drug company funded: RCTs Questionnaire study
37 Achievements 2 fantastic part-time research nurses 1 has led on a project from protocol to publication The other will do the same Survived an MHRA inspection Self-sustaining?
38 What we haven t achieved Successful research bid
39 The future We have achieved little so far Just because it s hard doesn t mean it shouldn t be done Hospice patients deserve the best treatments we need to have the research to tell us what these are
40 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 Patience
41 Useful references Research Governance Toolkit Payne S, Preston N, Turner M, Rolls L. Research in palliative care: can hospices afford not to be involved? A report for the Commission into the Future of Hospice Care Help the Hospices 2013
42 Questions
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