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

2. The process so far!

3. 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.’

4. 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?

5. 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.

6. 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

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

8. 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

9. The current system and personal experience of ethics review
Register for an account on CRN Learn at:
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

10. 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.

11. 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

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

13. 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

14. Discuss the detail and accuracy required

15. 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?

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

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

20. 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!

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

22. 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