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Ethics and research

Ethics and research. Elaney Youssef Doctoral Researcher. Overview. My route to research Research funding The need for research ethics UK rules around research ethics IRAS The research ethics committee meeting. My background. Degree in Physiology and Masters in Public Health

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Ethics and research

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  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

  13. 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….

  14. 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

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

  16. 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

  17. 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

  18. 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?

  19. Integrated research application system (IRAS)

  20. 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

  21. Integrated research application system (IRAS)

  22. 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.

  23. 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

  24. 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?

  25. 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

  26. 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

  27. 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

  28. Any questions?

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

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