How to Get Your Project Past the NRES/NHS Research Ethics Committee

1. How to Get Your Project Past the NRES/NHS Research Ethics Committee Dr Niki Bannister Vice-chair Essex REC (Flags: CTIMP, MCA, Prison) Dr Niki Bannister

2. What is a REC? • A bunch of jobsworth busybodies putting unrealistic barriers in the way of would-be researchers? • An unpaid team of trained people from inside and outside the NHS and academia, who are charged with ensuring healthcare research is legal, decent, honest, and truthful for the participants, and the wider community? Dr Niki Bannister

3. A NRES REC can approve: • Research on Human Tissue • collected as a new sample • on surplus from NHS procedures • from archives • Trying out new ‘treatments’ • drugs without a licence (CTIMP) • devices not yet tested for effectiveness • unapproved procedures • in emergencies, including Public Health Dr Niki Bannister

4. A NRES REC can approve: • Collection of additional new data • directly from patients/relatives/carers • from healthcare staff • recordings and images • Access to ‘sensitive’ data • from medical records • from NHS databases • linking to other records (state-held, or independent) Dr Niki Bannister

5. A REC can approve: • Research on vulnerable groups • Life threatening illnesses • Children • Prisoners • Compulsorily detained under Mental Health Act • Research without direct consent • Research on the very young • Mental incapacity due to mental illness • Incapacity due to physical illness • Incapacity due to medical intervention • Anaesthesia, sedation, ITU/|HDU Dr Niki Bannister

6. A REC can approve: • High risk interventions • Ionising radiation • new drugs with high toxicity • High risk innovative surgery • New medical devices • New ways of working • Questionnaires • Risks to the researcher • Working in the community • Infected material Dr Niki Bannister

7. A NRES REC can approve: • Workplace research on staff • Low-risk research does not need REC approval • the workplace environment • training and performance • attitudes, interactions and feelings • ‘Clandestine’ activity • ‘blind’ studies • concealment of a true aim, or of the research activity, if essential to avoid bias Dr Niki Bannister

8. The Following Always Require Review at a Full REC Meeting: • CTIMP’s • Medical devices prior to CE marking • Adults lacking capacity MCA 2005 • Invasive basic science on healthy volunteers • Ionising radiation additional to routine clinical • Research tissue banks and databases • Prison research • Studies funded by the US Department for Health and Human Sciences Dr Niki Bannister

9. Proportionate Review • Studies which present minimal risk or burden for participants • To be reviewed by a sub-committee • Within 14 days of receipt of a valid application. • Not yet rolled out uniformly to all RECs • Http://www.nres.npsa.nhs.uk/applications/proportionate-review/link confirmed valid 27-11-2011 Dr Niki Bannister

10. Proportionate Review • Research using data or tissue that is anonymous TO THE RESEARCHER • Research using existing tissue samples already taken with consent for research • Research using “extra tissue” (e.g. further blood taken at time of routine sampling or tissue taken at “clinically directed” operation) Dr Niki Bannister

11. Proportionate Review • Questionnaire research that does NOT include highly sensitive areas or where accidental disclosure would NOT have serious consequences • Research interview / focus group that does NOT include highly sensitive areas or where accidental disclosure would NOT have serious consequences • Research surveying the safety or efficacy of established non drug treatments, involving limited intervention and NO change to the patients’ treatment Dr Niki Bannister

12. Is it Ethical? • Scientific validity (more on this later) • Is any potential harm justifiable, and is safety duly considered? • Is is voluntary, without affecting ‘normal’ care, and without undue persuasion? • Is it properly explained to participants? • Will data, samples, images etc be protected? Dr Niki Bannister

13. What are you trying to find out? • Is it Research? • Is it Audit? • Is it Service Evaluation? • Is it Public Heath Surveillance or practice? • Case study or satisfaction survey? • Equipment or systems testing? • http://www.nres.npsa.nhs.uk/applications/is-your-project-research/ Web address valid 27 Nov 2011 Dr Niki Bannister

14. Is Your Project Research? • Looking for new knowledge about a condition, treatment, diagnostic method, the personal experience or relationship. • a change of care • extra: interventions, biological samples or data collection from routine care, or new use of routine samples and/or data • May involve a questionnaire • May have staff as participants Dr Niki Bannister

15. The REC doesn’t need to see: • Audit • Service evaluation • Research on anonymised data (new rules) • Research on material with previous consent if held appropriately • Public Health Surveillance/practice • Beyond scope of this talk • Identification of cause and treatment of disease outbreak Dr Niki Bannister

16. Is It Service Evaluation? • What level of service do we achieve? • No standard for comparison • No change in care is involved • Not looking for new knowledge about the condition or treatment • E.G. How long are our referrals made to wait? • Might involve a simple interview or questionnaire • May have ethical issues, but not for the REC Dr Niki Bannister

17. Audit: • Are we doing it like we should? • There is a standard that should be met: • No change in care is involved from usual • Not looking for new knowledge about the condition, treatment, staff or patient attitudes • Might involve a simple interview or questionnaire to gather relevant data • May have ethical issues, but not for the REC • e.g. do we meet the 2-week wait target for suspected cancer referrals Dr Niki Bannister

18. Previously Collected, Non-identifiable Information • Research limited to secondary use of information previously collected in the course of normal care is generally excluded from REC review, • Provided that the patients or service usrs are not identifiable to the research team. • A care team using information previously collected in the course of care for their own patients or clients, • Provided that data is (pseud)anonymised . • Alternative sources of ethical review may be available e.g. from a university REC. Dr Niki Bannister

19. Previously Collected, Non-identifiable Tissue Samples • previously collected, non-identifiable material consisting of or including cells in accordance with the terms of donor consent is generally excluded from REC review. • But terms and conditions apply Dr Niki Bannister

20. REC review if: • Consent for research has not been given, or the research is not within the terms of the consent • The samples will be held on premises in England, Wales or Northern Ireland without a licence from the Human Tissue Authority to store relevant material for scheduled purposes • The research also involves removal, storage or use of new samples from the living or the deceased • The research also involves use of identifiable information held with the samples. Dr Niki Bannister

21. Public Health • Public Health Surveillance/practice • Identification of cause and treatment of disease outbreak • collecting personal data and samples with the intent to manage an incident. • analysis of existing data or administration of interview or questionnaire to those exposed. Dr Niki Bannister

22. Is your objective educational ? • Consider Audit or Service Evaluation • Biological samples and the Human Tissue Act: don’t store for future use. • Avoid personal data: use surplus material or data, anonymised by the care team • Research on health care staff: go outside your own workplace if you can • Questionnaires are not risk free. Dr Niki Bannister

23. The Integrated Research Application System (IRAS): • A single system for research in the UK • Enables you to enter the information about your project once • Uses filters to ensure that the data collected and collated is appropriate to the type of study, and the permissions and approvals require • Helps meet regulatory and governance requirements • https://www.myresearchproject.org.uk/ Dr Niki Bannister

24. At an early stage sort out: • A protocol (a set of instructions for someone else who knows nothing about the field) • The forms: IRAS (beyond the scope of today’s talk) • The Participant Information Sheet (PIS) read the NRES guidance and make sure you follow it Dr Niki Bannister

25. The Protocol: • Why are you doing it (background) • What you are trying to find out • What you plan to do • Show your method is ‘good science’ • Identify foreseeable risks • How will unforeseeable risks be detected • Is all the legal stuff in order: indemnity, data, disclosure • Publication policy • Informed consent (PIS) Dr Niki Bannister

26. Consult Service Users: • A participant’s perspective on the research. • Highlight (and resolve in advance) issues related to the burden of the research: • When and how appointments are given out, • Access to venues, time of day, bus routes, expenses, child care, privacy, • Feedback of research outcome (or maybe participant’s own data verification). Dr Niki Bannister

27. Local Support Groups • Usually pleased to be consulted, especially if part of a national organization such as for cystic fibrosis, motor neurone disease, age concern etc. • Do not be worried about ‘bothering’ people: they may be highly motivated. • A problem might be managing their expectations Dr Niki Bannister

28. Taking the PIS • Participant Information Sheet: • does it fully inform about what they are letting themselves in for, and why? • does it reflect the protocol • Aims • Methods • Risks • Etc etc etc • http://www.nres.npsa.nhs.uk/applications/guidance/consent-guidance-and-forms/?1311929_entryid62=67013 • Web address valid 27 Nov 2011 Dr Niki Bannister

29. The invitation to participate • In general the researcher should only know the identity of those giving consent • Is the researcher already on the ‘care team’ • How will ‘recruits’ be found, and by whom • Who issues the invitation, and how • How is the participant notified to the researcher once consent given? • Will non-responders be reminded? Dr Niki Bannister

30. Personal data (PID) • PID allows a participant to be identified to an outsider • Name, address, postcode, dob, images, etc • Anonymised study data is not PID • Unless identification is possible from other data • Do you need to know or store PID? • Use a study number instead. • Do you need to keep a link to the PID? • How is the link stored, by whom, for how long? Dr Niki Bannister

31. Methodological Pitfalls • Is the research question valid? • Does the method address the question? • Case selection bias • Historical controls • Failures of blinding • Questionnaire validity • randomisation Dr Niki Bannister

32. Scientific validity • A REC need not reconsider the quality of the science, as this is the responsibility of the sponsor and will have been subject to review by one or more experts in the field (known as ‘peer review’). • The REC will be satisfied with credible assurances that the research has an identified sponsor and that it takes account of appropriate scientific peer review. Dr Niki Bannister

33. REC Attendance by Supervisor Ethical review of student research Guidance for students, supervisors and Research Ethics Committees (NRES) • In the case of any study undertaken mainly for educational purposes, it is highly desirable that both the supervisor and the student should attend the REC meeting wherever possible, whether or not the student is the named CI on the application. Dr Niki Bannister

34. Common Qualitative Pitfalls • The aim of the study is not clear • The research method doesn’t match the aim • Interviews and questionnaires: • What if a participant gets upset? • What if a participant discloses ‘at risk’, criminal or unprofessional activity? • Permission to approach relatives and carers • audio or video recording, and transcription • Use of direct quotes • Home visits: Lone worker policy • Workplace research: in work time? Dr Niki Bannister

35. Common Quantitative pitfalls • Does your method match your aim? • Defined endpoint? • Randomisation • Sealed envelopes? • Block randomisation? • Power calculation • Numbers for statistical significance depend on size of expected difference • start with the numbers of cases you expect to handle and work backwards to the effect size: is it realistic? • Is it really a pilot study? Dr Niki Bannister

36. ’The Usual’ Recurring Common Ethical Issues • Does the title, or short title, reflect the study aims and make sense to a layperson? • Identification and recruitment of participants: how is the invitation made? • Procedure- and medicine-related safety, including possible distress for questionnaires and interviews/focus groups, and pregnancy for medicines: possible termination? • Researcher safety in home visits etc. Dr Niki Bannister

37. Common Ethical Issues • workplace and employment protection for studies on health care or other workers • recording and transcription, and use of quotes (permission required) • could any ‘at-risk’ activity be revealed? • data protection and storage, compliance with DPA and Caldicott • if biological materials from participants are involved, HTA compliance on material, including storage, transfer and disposal Dr Niki Bannister

38. Common Ethical Issues • scientific review of the submitted protocol by an appropriate disinterested body or person to confirm each study question is relevant, and that the methods will answer them (PhD level) • indemnity for protocol and study risks. • dissemination of results, will results be valid if used to modify a service? Dr Niki Bannister

39. PIS Common Ethical Issues • title and headed paper • readability by target group, • is the protocol reflected appropriately, • is the burden on the participants set out; • are non-study alternatives set out • is randomisation explained for RCTs • NRES compliance, for content Dr Niki Bannister

40. Final Message • Point yourself at the NRES website at an early stage • Attend the REC meeting with your supervisor • Not compulsory, but much appreciated by the REC • The student should do the talking • Be ready to defend the scientific review • Be ready to answer questions about indemnity Dr Niki Bannister

41. Conclusions • Bypass the REC with Audit or Service Evaluation if you can • Tell participants everything a caring intelligent relative would want to know • Make the PIS readable by an 11 year old • Read and follow the NRES Guidance when you fill in the forms • Ask for help and advice (NRES or REC chair) Dr Niki Bannister

42. Thanks to: • Members and chair of Essex NRES REC • Too many researchers and their supervisors to list • The NRES website • http://www.nres.npsa.nhs.uk Dr Niki Bannister