Highlights of applying for NHS Ethical and Trust approval

1. Highlights of applying for NHS Ethical and Trust approval Corinne Gale Research and Research Development Manager, Derbyshire Mental Health Services NHS Trust

2. Summary • Definition of Research • Legislation and Regulations • Research Process • Obtaining Ethical and Trust Approval • Integrated Research Application System • Key Points

3. Definition of Research

4. Research is… • Research is defined as work which aims to provide new knowledge. This new knowledge should be: • Potentially of value to those facing similar problems elsewhere  • Open to critical examination • Accessible to all who could benefit from it (Department of Health, 1997)

5. 1. Intent The primary aim of research is to derive generalisable new knowledge, whereas the aim of audit and service evaluation projects is to measure standards of care. Research is to find out what you should be doing; audit is to find out if you are doing planned activity and assesses whether it is working. Some projects may have more than one intent, in which case a judgement will need to be made on the primary aim of the project. 2. Treatment/service Neither audit nor service evaluation uses an intervention without a firm basis of support in the clinical or health community. 3. Allocation Neither audit nor service evaluation allocate treatment or service by protocol. It is a joint decision by the clinician and patient. 4. Randomisation If randomisation is used, it is research. (NRES, 2009) Research, Audit or Service Evaluation?

6. Legislation and Regulations

7. Legislation and Regulations • 1947 Nuremberg Code • 1964 Declaration of Helsinki • 1997 ICH Guidelines on Good Clinical Practice • 1998 Human Rights Act • 1998 Data Protection Act • 2001 EU Directive on Clinical Trials • 2001 Research Governance Framework • 2004 Medicines for Human Use (Clinical Trials) Regulations • 2004 Human Tissues Act • 2005 EU Directive on Good Clinical Practice • 2005 Research Governance Framework (2nd Edition) • 2005 Mental Capacity Act

8. Research Governance Framework • Research Governance is one of the core standards for health care organisations • “Proper governance of research is essential to ensure that the public can have confidence in, and benefit from, quality research in health and social care” • RGF sets out standards, principles and requirements for research bringing together good practice and law

9. Research Governance Framework • Describes transparent decision-making processes, clear allocation of responsibilities and robust monitoring arrangements • Applies to clinical and non-clinical research undertaken by NHS or social-care staff, using NHS or social care resources, or within health care systems that might have an impact • Health care organisations have to have systems to ensure principles and requirements of the RGF are applied consistently

10. Research Governance Framework • RGF standards are in 5 domains: • Ethics • Science • Information • Health and Safety • Finance and Intellectual Property

11. Ethics • Safeguard the dignity, rights, safety and well-being of participants • All NHS research must have an independent ethical review • Informed consent – particularly important consideration for those who lack capacity, children and vulnerable adults • Patient data – consider appropriate use and protection (confidentiality and security of systems) • Involvement of service users in research process • Risk – in proportion to benefit, kept to a minimum

12. Science • Consider all existing sources of evidence, especially systematic reviews • Research which duplicates other work or is not sufficient quality is unethical • Research proposals need to be reviewed by expert in the relevant field, offer independent advice on its quality, in proportion to scale of research e.g. external review panel or university supervisor • Projects led by experienced individuals, inexperienced researchers must be supervised

13. Information • Research is conducted for the benefit of patients, users, care professionals, public in general • Free access to information on research being conducted and findings of research in a format understandable by the public • Research must be open to critical reviews, findings made accessible to participants and those who may benefit e.g. publication or other means

14. Health and Safety • Safety of participants and research staff must be given priority • Health and safety regulations adhered to at all times • Risk assessments • Standard Operating Procedures • Training • Supervision • Honorary contracts

15. Finance • Transparency and accountability in the use of public funds that support research • National research register • Annual report • Compensation for negligent / non-negligent harm • Intellectual property – new and novel ideas and methods

16. Research Process

17. Prepare Protocol • Summary • Background – literature review • Aims & Objectives • Methods: • Subjects, criteria, recruitment and consent process • Sample size/power analysis • Details of research to be performed • Data Analysis • Funding/Resources • Ethical Issues • Time scale • References

18. Prepare Protocol Seek service user involvement • ‘If research reflects the needs and views of the public, it is more likely to produce results that can be used to improve health and social care services.’ (INVOLVE) • Different levels of involvement: • Consultation - asking service users for their views on research • Collaboration - active, on-going partnership with members of the public in the research process • User led research - actively controlled, directed and managed by service users and service user organisations • www.invo.org.uk

19. Prepare Protocol Seek service user involvement • How is your project going to be funded? • DMHST Research Innovation Fund • Department of Health (www.nihr.ac.uk) • Research for Patient Benefit • Research for Innovation, Speculation and Creativity (RISC) Project Scheme • Invention for Innovation Research Programme • Wellcome Trust • Medical Research Council (MRC) • Professional Bodies • www.rdfunding.org.uk • www.researchresearch.com Consider funding issues

20. Prepare Protocol Seek service user involvement • Purpose: • To ensure the proposed research has sufficient scientific quality and that it will be able to inform practice • How many: • Ideally projects should have 2 peer reviews • Who: • An expert in the relevant field who is able to offer independent advice on its quality • In proportion to scale of research • In the case of student projects the Academic Supervisor can undertake the peer review Consider funding issues Obtain Peer Review (s)

21. Prepare Protocol Revisions Seek service user involvement No Consider funding issues Obtain Peer Review (s) Passed Peer Review? Yes

22. Produce study documents • Information sheets and consent forms on headed paper • CV for all researchers involved • Questionnaires and/or interview schedules • Invitation letter for participants • GP or consultant information sheets and letters • Confirmation of sponsorship details • Statement of indemnity arrangements • Research passport application (where necessary) • See www.nres.npsa.nhs.uk for guidelines

23. Produce study documents • Integrated Research Application System (IRAS) • Single system for applying for research approvals, including ethics and R&D • Form is completed online • Information is entered once • Filters ensure information is appropriate to type of study and approvals required • www.myresearchproject.org.uk Complete IRAS form

24. Produce study documents • All studies require management authorisation • The project should be submitted to the appropriate manager, depending on size of study • Projects recruiting service users from particular teams to go to the manager which would cover the whole project (depending on size of study) • The manager should sign the ‘authorisations required prior to R&D approval’ section of the IRAS application form Complete IRAS form Obtain management authorisation

25. Produce study documents • All research involving NHS patients, staff or premises needs Research Ethics Committee (REC) approval • A REC is an independent advisory body including expert and lay members • Its purpose is safeguarding the rights, dignity and welfare of people participating in research in the NHS • There are different types of REC depending on type of research Complete IRAS form Obtain management authorisation Submit for ethical approval

26. Produce study documents • Research undertaken in the NHS must have R&D approval from all NHS organisations hosting the research • Evaluates the impact of the project on the NHS Trust as host of the research and in relation to the NHS Trust’s duty of care to its participants Complete IRAS form Obtain management authorisation Submit for R&D approval Submit for ethical approval

27. Managing the Project • Have clear objectives • Use the objectives to devise a project plan, include clear milestones and deadlines in your plan, and stick to them. • Seek support, talk to other researchers • If something goes wrong, seek help/report it

28. Study File • Ethical approval letter • R&D approval letter (s) • Current versions of study documents e.g. protocol, information sheet, consent form • CVs/honorary research contracts • Details of any amendments • Screening logs

29. Dissemination • Clinical Research Committee • Clinical Reference Groups • Research and Audit Showcase • Talks to service users • Talks to staff members • Conferences • Publication • Influence Change

30. Obtaining Ethical and R&D Approval

31. Research Ethics Committee (REC) Approval • All research involving NHS patients, staff or premises needs REC approval • A REC is an independent advisory body including expert and lay members • Its purpose is safeguarding the rights, dignity and welfare of people participating in research in the NHS • There are different types of REC depending on type of research

32. Research and Development (R&D) Approval • Research undertaken in the NHS must have R&D approval from all NHS organisations hosting the research • Evaluates the impact of the project on the NS Trust as host of the research and in relation to the NHS Trust’s duty of care to its participants

33. Integrated Research Application System (IRAS) • Single system for applying for research approvals, including ethics and R&D • Form is completed online • Information is entered once • Filters ensure information is appropriate to type of study and approvals required

34. Integrated Research Application System www.myresearchproject.org.uk

39. Section 3: Purpose and design • A12 – this is your background information • A13 – this should be a detailed summary of what will happen to participants, these should include: • Hypotheses • Study design and methodology – description and explain why it has been chosen • Overview of recruitment and study procedures • Timetable for the stages of the research • Do not just copy and paste your methodology section of your protocol

40. Section 3: Purpose and design • A14-1 – as a minimum, service users should be consulted on the purpose of the study and the information sheet, they could also help with your lay summary • Try approaching voluntary agencies or service user involvement organisations e.g. Derbyshire Voice or Making Waves • A17 – include justifications for criteria

41. Research Procedures, Risks and Benefits • A18 – include consent, questionnaires, interviews etc. • A21 – this is the total time e.g. 2 hours (for an interview) or 20 weeks (for intervention) • A22 – there are always risks or burdens, even if it is just the inconvenience of completing a questionnaire • A24 – if there are no benefits, be honest • A26 – risks to researchers includes visiting people at home

42. Recruitment and Informed Consent • A27-1 and 2 – these questions are about how you will be identifying participants • A29 – this is about who will approach them – you or a member of their care team • A30-1 – this needs to be a detailed description of the consent process, you should give people at least 24 hours to consider participation

43. Confidentiality • A36 – it is useful to give an overview of what personal data is collected • Paper questionnaires entered onto an electronic database • Will you have contact details? • Will you record interview/focus group – what will you do with the recording?

44. Confidentiality • A37 – storage during the study • Secure filing cabinet/locked office • Password protected file/secure network • A38 – assigning ID codes/pseudonyms? • A39 – only applies to using identifying data without consent, for most this will be N/A • A44 – usually this is 7 years • A45 – storage after the study

45. Publication and Dissemination • A51 – remember to tick ‘other’ and specify DClinPsy thesis • A53 – it is good practice to offer participants a summary of the results if they are interested, consider presenting to voluntary organisations who helped you

46. Scientific and Statistical Review • A54 – as a minimum your project should have been reviewed by your supervisor • A62 – please give more details than ‘it will be analysed using SPSS/N*Vivo’

47. Details of Research Sponsor • A64 – University or NHS Trust • A68 – generally this will be Corinne Gale, Jayne Simpson or Dianne Tetley • A74 – if the NHS is sponsor, usually they will also take on the role of monitoring and auditing projects, the University should also oversee the project