Striving and thriving in the ethics review process 24/10/16 Josie Roberts Macmillan Lung Nurse Specialist The Rotherham NHS Foundation Trust

The process so far!

Start at the beginning! ‘Under the Department of Health Research Governance Framework 2005, no study involving patients, staff or their data can commence on NHS premises without NHS Permission (also known as R&D or Research governance approval). This is granted in the form of an approval or permission letter by the Director of R&D.’

Why research? Interest in research and evidence based practice Research and the CNS Clinical √ Education √ Audit √ Research X Explain the reasons for wanting to do the research How many CNS’s do research yet it is part of our job description?

Audit of patient case load in December 2014 Understanding research more, participating in research projects & attendance at conferences inspired me to do more NLCFN committee member representing the Cancer Nursing Partnership, Living with and Beyond Cancer Audit of patient case load in December 2014 Identified the number of patients alive 2 years post diagnosis Participation in research projects in both lung cancer and palliative care. Compared to many other tumour sites I felt that the recovery package for people with lung cancer was different when acknowledging the patients that I had met and supported throughout their disease trajectory. Audit of the patient caseload identified the changes in the disease trajectory and the numbers of patients having surgery.

January 2015 Applied for the RIG small grants project Successful application confirmed in March 2015; What do people living with and surviving lung cancer or mesothelioma want and need from a recovery care package? On-going service development plan for the lung CNS team Level 3 HCA commenced in October Emphasise the time element and the issue that the original support for the lung CNS team was declined and provided for urology

ESSENTIAL MEETING 19th August 2015- Waitrose Café, Sheffield Angela Tod This may have been more helpful!

Points of discussion Rationale including importance to patients and the NHS Hypothesis Study design Outcomes being assessed Number of participants Ethical issues Challenges in conducting the study Public and patient involvement Timeline

The current system and personal experience of ethics review Register for an account on CRN Learn at: https://learn.nihr.ac.uk Contact the Clinical Research Network for your network Clinical Research Network Yorkshire and Humber National Institute for Health Research Apply and complete the Good Clinical Practice (GCP)course and register the certificate

R&D process Is my project research? Register the project- R&D co-ordinator Set up meeting Research passports Costs and contracts Study approvals Regulatory approvals Local approvals NIHR portfolio adoption NHS permission Discuss the issues involved, a whole new language and learning set; compare to patients and careres trying to understand new terminology and explanations in the lung cancer pathway.

Site File Core study documents eg. protocol,PIS Independent scientific review Ethics eg approval letter, amendments, correspondence Regulatory governance (MHRA/IB/safety reports) Research governance (project registration,SSI, authorisation, indemnity) Financial including funding Investigators CV and delegation log Participation information including consent forms Project management Monitoring and audit Study closure

Ethics Online through IRAS (integrated research application system) at www.myresearcproject.org.uk ADVICE Start at the beginning Don’t reinvent the wheel (lots of people have shared this pain!) It takes longer than you think

April 2016 Submitted the IRAS application 3 patients who initially showed interest in the project died during this time diagnosed with NSCLC in 2005 who had surgery twice, chemotherapy, radiotherapy and TKI 2 patients with mesothelioma in 2010 and 2012 had wanted to participate in any available clinical trials and research

Discuss the detail and accuracy required

Points to consider Is your research question/objectives clearly stated? Have you provided a clear outline of your study design? Have you provided full details of all funding secured for your study? Have you checked that all contact details are correct and current?

Application submitted THEN… Emails Phone calls Application validation Administrative pre-review Ethical review HRA approval Further information required for assessment Proportionate review Requested changes to the documentation

May –August 2016 IRAS application resubmitted Any issues needing clarity were identified and returned Numerous emails received Each resubmission required telephone conversations and new appointments

Tips and advice BE prepared Seek help and advice from your Research & Audit department Excellent support received throughout Understand fully what the research question is, try to dismiss any pre-conceived ideas Seek help from anyone who has completed the IRAS application Allow plenty of time Don’t give up!

The process so far! Where I am and where I want to be

Acknowledgements Dr Angela Tod Dr Philippa Collins and the R&D team at The Rotherham NHS Foundation Trust Dr Vicky Athey, consultant physician and the lung cancer MDT Suzanne Davies, Traci Gray, Denise Hadfield (and all my colleagues for putting up with me!) NLCFN and the RIG THANK YOU