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 & FamiliesAdvice on Submitting a Research ProposalMrs Jackie Casey & Mrs Yvonne Usen

2. Learning OutcomesTo 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 GovernanceMechanism 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 ResearchEthics are the rules of practice by which the researcher should behave towards the research participants (potential and actual), and towards society in general.

5. Purpose of ethical reviewFor all NHS research it is a legal requirement to seek formal ethical approval prior to commencing the research study.

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);

10. Justice .Purpose of ethical review (2)Ensure that there is community benefitIntegration of results into the health systems of the communityScientific validity (approp methodology)Avoid exploitation of vulnerable subjectsEqual risk distribution within society

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 reviewLocal to site – linked often with research governanceUniversity – student/ researcherNational - 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 TrustEnsure quality

14. Types of ethical review (3)University Learning process or experienced staff?Within a Faculty review processOften category of risk & vulnerability will determine level of University reviewWho is chief investigator/ principal investigatorIPCan 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.ukNumber of committees throughout UK with different focus. Specific paperwork for this applicationOnline system for application plus need hard copy delivered to officeProcess involved (60days from valid application)Collaboration with USA/ USA funding ?

16. Important other detailsResearch ProposalComplete training in eg. Good Clinical PracticeIdentify the team for the research project and contact detailsIdentify the team member roles at the offsetQuality assurance and audit trail (pre-, during, post)SponsorshipIndemnity Contracts neededCultural issues

17. Potential ethical issues?

18. Informed consentFull & overt detail on process

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)

26. Any likely costs/ inconvenience to be incurredInformed consent (2)Consider the format of obtaining informed consentWho will obtain this? and why that person?Consent for this study only?Cool off periodConsequences of withdrawing/ declining?Coercion potential Deception

27. ConfidentialityOf participants/ staff/ institutionMeasures to secure and protectData access eg. People & coding systemData storage – physical, electronic, cataloguing, sharingWhere risk is identified then follow up/ reporting procedureNB. Not the same as anonymity.

28. Conflict of interestWho 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 & promotionsFame & publications Third party impartial opinion essential

29. Risk to participantNew intervention with unknown outcomesRCT and use of a control group (equal opps/ equitable exposure)Pain/ discomfortTime 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 intrusionDisclosurePrivacyIdentification of new issues (eg. caregiver stress; neglect; unsafe practice) - protocol

31. Risk to researcherLone workerExperience/ support/ trainingTransference Reflective experiences (use log book)Intellectual property issues & authorship

32. Vulnerable groupsChildrenWomen of childbearing age (pregnancy)PrisonersPeople with mental illnessPeople with intellectual impairmentGood practice to consider – Relationship of participant with researcher

33. World War II ExperimentsPrisoners 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.