Ethics and research

1. Ethics and research Elaney Youssef Doctoral Researcher

2. Overview • My route to research • Research funding • The need for research ethics • UK rules around research ethics • IRAS • The research ethics committee meeting

3. My background • Degree in Physiology and Masters in Public Health • Not followed formal academic training scheme • Working in the HIV research unit • HIV data coordinator • HIV prevention researcher - clinical • Research assistant - academic • Application for an NIHR DRF • Special interest • HIV and ageing, HIV testing, Late diagnosis of HIV

4. My route to research • Developed an interest • Get a supervisory team. • DrJuliet Wright, Prof Kevin Davies, Dr Valerie Delpech • Developed a question • Developed a study protocol: • Several workstreams • Aims and objectives • Realistic methodology to answer these • Get funding: • NIHR Doctoral Research Fellowship application • Get skills: • This is a good opportunity to learn • Local courses: • Lit searching, bibliography software, databases and spreadsheets, stats.

5. Getting funding Very difficult even with a heavyweight team behind you. Not knowing how research ‘works’ The processes of: Grant writing Protocol development How funding bodies work What approvals you need (sponsorship, ethics, R&D) A different pace. Who does what? The move to a non-clinical role Working alone Working in an ‘office’ environment Loss of routine Missing the patients? A feeling of inertia Getting started takes time Sometimes achievements are small Time scales are different Goal setting helps Writing/publishing helps. Challenges

6. Funding • UK funding bodies: • Wellcome Trust • Medical Research Council • National Institute of Health Research (NIHR) • Charities and trusts • Medical societies • Universities • The deanery (MSc bursary) • Comprehensive research network (CRN) • NIHR support available through adoption • http://www.crncc.nihr.ac.uk/about_us/ccrn/gm/industry/nihr-porfolio

7. What is research ethics? • It is the application of ethical principles to the design, conduct and outputs of research studies • General ethical principles applied to research with human subjects: • Autonomy • Beneficence • Justice • We are familiar with these principles in medical contexts

8. Why should we worry about ethics in research? • To protect research participants • Respect their autonomy • To ensure their safety during the conduct of the study • Is this research beneficial? • It demonstrates research integrity • Respect for other researchers • Trust in the methodology and research outputs • Avoids personal and institutional scandal/disrepute • To allow your research to happen • Considers areas of risk • Often needs consideration for grant applications • Will need research ethics committee approval before you can start

9. How should we assess ethical aspects of research? • The validity of the research • How important is the question and to whom? (current or future patients) • Has the question been asked before? • Can the proposed research answer the question? • Are the researchers suitably qualified/equipped? • The welfare of research subjects • What will be involved if an individual agrees? • Are there any risks/costs and are they acceptable? • Are necessary legal requirements in place • The dignity of research subjects • Confidentiality • Consent • Protection against coercion

10. Ethical guidelines • Declaration of Helsinki • Various iterations- research protocols often state which version they are following • Duties of a doctor according to this • Good clinical practice in research • Expectation that you have this if you plan to conduct research

11. Main issues • Valid question • Sound methodology • Informed consent • Minimising harm to participants • Respecting confidentiality • Integrity in reporting results

12. The process of ethical approval • Firstly is it research? • Could it be audit, service improvement • If so ethics approval not needed, sponsorship may still be needed. • HRA algorithm • http://www.hra-decisiontools.org.uk/research • Ethical issues still exist in non-research studies • Particularly around issues of confidentiality

15. Have your question, write your protocol • Then easier to see what potential ethical issues may be • Worth having a section in your protocol on it • These need to be reflected in the information you give to potential participants • The participant information sheet • NRES/HRA have templates for a lot of these • Doing it at this stage will make the ethics form easier to write • You will need sponsorship from your institution • An example….

16. My Study • Qualitative study (multi-centre) – looking at barriers and facilitators to testing for HIV in people age ≥50 years • Eligible participants identified and initially approached by a member of the local clinical team • One-off study visit • Receive informed consent, demographic screening questionnaire, healthcare utilisation questionnaire, qualitative interview • Notes screen (optional) • No follow-up but results will be fed back to participants and recruiting clinics

17. What might be the ethical issues and how might you allay an ethics committees fears?

18. Ethical concerns • Participant identification & information transfer • Potential for breach of confidentiality • Identified by clinical team, procedure for transfer of patient details • Study visit • Potential harm for me • Work on hospital site (not visiting participants in their home) • Interview • Potential for patient to become upset and/or need additional support • Data protection • Potential for breach of confidentiality • Optional parts of the study • Potential for coercion

19. Setting up a study at BSUH • Have an idea, develop a research question • Protocol review panel • Initial review: the committee will give advice on the concept and way to develop • Formal review: • Submit your protocol, and participant information sheets and the IRAS ethics form • Two members review and present to the committee • Flag any issues and make recommendations • Respond in writing • Research Governance and Quality Assurance Committee (RGQAC) • Make the formal decision on behalf of the Trust regarding sponsorship approval • If approved can proceed to regulatory approvals

20. Top tips from the Panel • Your protocol is like a recipe, anyone should be able to recreate the study using just the information in the protocol. • Please use the HRA protocol template! • Provide detail about what is being done and by whom • If BSMS labs are involved, contact the BSMS technical supervisor. If CIRU labs are involved, contact the senior lab assistant. • If blood samples are being taken, detail how much will be taken, where this will be stored and analysed. • Which database will be used? Where will data be stored? How will data be transferred? • Is the sample size justified? Has a statistician been consulted?

22. Integrated research application system (IRAS)

23. IRAS • Open project • Filter questions • Determines type of research, location, subjects • This creates your form with the appropriate questions • So best to get this bit right! • Also determines if can submit for proportionate review • Proportionate review is completed outside of an ethics meeting for studies with no inherent ethical issues- eg studies involving anonymised data/samples • Once you’ve completed a question it will go green • Use ‘lay’ language • Avoid spelling mistakes • Have consistent answers – across all documents • Question specific guidance available on IRAS itself • Then need to get the expert and regulatory signatures • For example IRMER, R&D • Then when you have it all ready can submit and book your ethics meeting

24. Integrated research application system (IRAS)

25. The Research ETHICS committee • To protect research subjects from exposure to unethical risks or invasion of privacy • To facilitate ethically acceptable attempts to identify new and better treatments from which everyone may benefit.

26. What do ethics look for? • Title (and agreements across documents) • Section A6- summary and main considerations • Methodology • Have you thought about ethical concerns? • Patient information sheet and consent form • Patient involvement? • Consent process • Who will be receiving consent • Confidentiality and how it will be protected

27. Ethics: The insiders view • Lay language not used across IRAS and patient documents • Readability index- http://gunning-fog-index.com/ • Be consistent across documents, inconsistencies introduce doubt • Questions are repetitive but we are very aware of cutting and pasting • Text doesn’t quite match the question • Be comprehensive in what might be considered a risk or burden • Make sure these are in the PIS • Don’t oversell the benefits • If none, be up front and say so • Make your aims and outcomes clear • Do they match? • Will the study answer the question? • Pilot study??? What will it lead to?

28. Ethics: The insiders view • We are very keen on: • PPI- Jaffa panel here at BSUH- bsuhlaypanel@gmail.com • Registering trials on a database somewhere- this is tricky • participants to be informed of the results • Be clear as to the recruitment pathway • Who will make first contact? • How will they express interest? • Who will receive consent? • If using promotional material- we will want to see it • Be clear about confidentiality • Anonymised? Unlinked? • Keen for Statistics- some people are very fussy about stats • Sample size especially for pilot studies

29. The ethics meeting • Potential for a lot of people to be there • Lay members • Statistical expert • They will undoubtedly ask questions • So know your project and protocol • Avoid being defensive • They provide written feedback with outcome: • Favourable • Favourable with conditions • Provisional with conditions • Unfavourable • No opinion • Whole process from submission should take no longer than 60 days

30. Does it stop at ethics? • No! • Then have to get local R&D approval for all sites involved • Via IRAS • Time scale 30 days • Recruitment • Monitoring • Annual report required • May need to make amendments- dedicated form on IRAS

31. Any questions?

32. References: • Health research Authority • http://www.hra.nhs.uk/ • National Research Ethics Society • http://www.nres.nhs.uk/ • IRAS • https://www.myresearchproject.org.uk/