This document provides advice on submitting a research proposal for ethical review. It outlines key learning outcomes around research governance and ethics. Important components of a research proposal are identified, including background, objectives, methods, ethical considerations and dissemination plans. Potential ethical issues that should be addressed are informed consent, confidentiality, conflict of interest, risks to participants and researchers, and considerations for vulnerable groups. Examples of past unethical experiments are provided to illustrate the importance of ethical review.

1. COTSS - Children, Young People & Families Advice on Submitting a Research Proposal Mrs Jackie Casey & Mrs Yvonne Usen

2. Learning Outcomes To have a greater understanding of the purpose of ethical review, the review process and research governance; To be aware of a range of ethical issues that should be considered in submitting your research proposal; To be aware of what should be included in your research proposal for submission to review.

3. Research Governance Mechanism for managing certain parts of the research process. Helps ensure that each research project has been well designed and is properly conducted in terms of viability, science, ethics, recruitment & reporting.

4. Ethics of Research Ethics are the rules of practice by which the researcher should behave towards the research participants (potential and actual), and towards society in general.

6. Pilot studies are included in this requirement to seek ethical approval.

7. About protecting and maintaining the balance between science to improve the health and wellbeing of society, and the rights of research participants.

8. Respect for persons (dignity);

9. Beneficence (do no harm; weigh risk-benefits);

11. Purpose of ethical review (3) Ensuring that the research involving human subjects is conducted appropriately. Ethical issues must be addressed within the research deign to show how potential issues have been considered, minimised or eliminated. Ethical review is a central part of research governance structures in the NHS/HPSS and in many universities.

12. Types of ethical review Local to site – linked often with research governance University – student/ researcher National - OREC

13. Types of ethical review (2) Local Seeking consent and institutional support to undertake project. Can vet the project before submitting to outside agencies. What else happening within Trust Ensure quality

14. Types of ethical review (3) University Learning process or experienced staff? Within a Faculty review process Often category of risk & vulnerability will determine level of University review Who is chief investigator/ principal investigator IP Can inform and disseminate good practice in research by pooling expertise.

15. Types of ethical review (4) Central Office of Research Ethics Committees (COREC) www.nres.npsa.nhs.uk Number of committees throughout UK with different focus. Specific paperwork for this application Online system for application plus need hard copy delivered to office Process involved (60days from valid application) Collaboration with USA/ USA funding ?

16. Important other details Research Proposal Complete training in eg. Good Clinical Practice Identify the team for the research project and contact details Identify the team member roles at the offset Quality assurance and audit trail (pre-, during, post) Sponsorship Indemnity Contracts needed Cultural issues

17. Potential ethical issues?

19. What to include:

20. Purpose of the study

21. Why the study is being undertaken

22. Who is in charge

23. Who is in research team

24. Who to ask for more information

25. What is participant being asked to do (where, when, how, frequency)

27. Confidentiality Of participants/ staff/ institution Measures to secure and protect Data access eg. People & coding system Data storage – physical, electronic, cataloguing, sharing Where risk is identified then follow up/ reporting procedure NB. Not the same as anonymity.

28. Conflict of interest Who is doing the research? Who is gathering the data? Sponsors/ vested interest? Developer on team? Furthering science or providing for welfare of patient? Career interests & promotions Fame & publications Third party impartial opinion essential

29. Risk to participant New intervention with unknown outcomes RCT and use of a control group (equal opps/ equitable exposure) Pain/ discomfort Time Personal sharing (invasive?) Upsetting (focuses attention on something emotional; stirs up feelings)

30. Risk to participant (2) Questioning style or questions cause distress (eg. Anxiety created by asking about possible side effects) – psychological intrusion Disclosure Privacy Identification of new issues (eg. caregiver stress; neglect; unsafe practice) - protocol

31. Risk to researcher Lone worker Experience/ support/ training Transference Reflective experiences (use log book) Intellectual property issues & authorship

32. Vulnerable groups Children Women of childbearing age (pregnancy) Prisoners People with mental illness People with intellectual impairment Good practice to consider – Relationship of participant with researcher

33. World War II Experiments Prisoners were infected with malaria from mosquitoes carrying the infection. Then anti-malarial drugs were tested on them. Individuals were injected with anti-typhus vaccine & then infected with typhus. Individuals who had been allocated to the control group received no vaccine. GOAL was to find out how to prevent typhus/ malaria in the prisoner of war camps.

34. Bound by The researcher is bound by: the legal guidelines issued by NHS Management Executive Own code of professional conduct.

35. Strategies to be successful Research the need for the project (stakeholders? Who stand to gain?) Consult with service users on purpose and design Resources (personnel, funding, time, participants (access & recruitment), other organisations Research proposal (clear, detailed, logical)

36. Activity What projects are happening around room?

37. Research Proposal – what should be included?

38. Research proposal Title of the research project – clear & concise; may need a shorter running title Background & Literature review Research objectives Research team Summary of project Sponsor & investigator details Research design

39. Research proposal (2) Sample (source, size, method of recruitment, sampling; eligibility criteria) Consent Methods of data collection Methods of data analysis & consultation with a statistician Ethical considerations Time frame and main project milestones Dissemination plans and methods

40. Research proposal (3) List of references Flowchart of study phases/ stages CVS of team members

41. Discussion On specific audience research projects Possible ethical issues to be considered Possible solutions to minimise these

42. Remember: All research that involves human participants must be conducted in a manner that respects the dignity, safety and rights of research participants and that recognises the responsibilities of the researchers.

43. Useful sources Research governance department Local university programme DOH R&D office COT R&D office (Anna Clampin & Dr Liz White) OREC site ERIC

44. Contact Details Jackie Email: j.casey2@ulster.ac.uk Yvonne Email: yvonnieusen@googlemail.com