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Ethics are the rules of practice by which the researcher should behave.
Make friends with the REC coordinator. Fountain of knowledge and advice.
GOAL was to find out how to prevent typhus/ malaria in the prisoner of war camps.
Eg. Act always in such a manner as to promote and safeguard the interests and wellbeing of patients and clients……..
Submitting a research proposal
COTSS - Children, Young People & Families<br />Advice on Submitting a Research Proposal<br />Mrs Jackie Casey <br />& Mrs Yvonne Usen<br />
Learning Outcomes<br />To have a greater understanding of the purpose of ethical review, the review process and research governance;<br />To be aware of a range of ethical issues that should be considered in submitting your research proposal;<br />To be aware of what should be included in your research proposal for submission to review.<br />
Research Governance<br />Mechanism for managing certain parts of the research process.<br />Helps ensure that each research project has been well designed and is properly conducted in terms of viability, science, ethics, recruitment & reporting. <br />
Ethics of Research<br />Ethics are the rules of practice by which the researcher should behave towards the research participants (potential and actual), and towards society in general. <br />
Purpose of ethical review<br /><ul><li>For all NHS research it is a legal requirement to seek formal ethical approval prior to commencing the research study.
Pilot studies are included in this requirement to seek ethical approval.
About protecting and maintaining the balance between science to improve the health and wellbeing of society, and the rights of research participants.
Justice .</li></li></ul><li>Purpose of ethical review (2)<br />Ensure that there is community benefit<br />Integration of results into the health systems of the community<br />Scientific validity (approp methodology)<br />Avoid exploitation of vulnerable subjects<br />Equal risk distribution within society<br />
Purpose of ethical review (3)<br />Ensuring that the research involving human subjects is conducted appropriately.<br />Ethical issues must be addressed within the research deign to show how potential issues have been considered, minimised or eliminated. <br />Ethical review is a central part of research governance structures in the NHS/HPSS and in many universities. <br />
Types of ethical review<br />Local to site – linked often with research governance<br />University – student/ researcher<br />National - OREC<br />
Types of ethical review (2)<br />Local <br />Seeking consent and institutional support to undertake project. <br />Can vet the project before submitting to outside agencies. <br />What else happening within Trust<br />Ensure quality <br />
Types of ethical review (3)<br />University <br />Learning process or experienced staff?<br />Within a Faculty review process<br />Often category of risk & vulnerability will determine level of University review<br />Who is chief investigator/ principal investigator<br />IP<br />Can inform and disseminate good practice in research by pooling expertise. <br />
Types of ethical review (4)<br />Central Office of Research Ethics Committees (COREC)<br />www.nres.npsa.nhs.uk<br />Number of committees throughout UK with different focus. <br />Specific paperwork for this application<br />Online system for application plus need hard copy delivered to office<br />Process involved (60days from valid application)<br />Collaboration with USA/ USA funding ? <br />
Important other details<br />Research Proposal<br />Complete training in eg. Good Clinical Practice<br />Identify the team for the research project and contact details<br />Identify the team member roles at the offset<br />Quality assurance and audit trail (pre-, during, post)<br />Sponsorship<br />Indemnity <br />Contracts needed<br />Cultural issues <br />
What is participant being asked to do (where, when, how, frequency)
Any likely costs/ inconvenience to be incurred</li></li></ul><li>Informed consent (2)<br />Consider the format of obtaining informed consent<br />Who will obtain this? and why that person?<br />Consent for this study only?<br />Cool off period<br />Consequences of withdrawing/ declining?<br />Coercion potential <br />Deception <br />
Confidentiality<br />Of participants/ staff/ institution<br />Measures to secure and protect<br />Data access eg. People & coding system<br />Data storage – physical, electronic, cataloguing, sharing<br />Where risk is identified then follow up/ reporting procedure<br />NB. Not the same as anonymity. <br />
Conflict of interest<br />Who is doing the research?<br />Who is gathering the data?<br />Sponsors/ vested interest?<br />Developer on team?<br />Furthering science or providing for welfare of patient?<br />Career interests & promotions<br />Fame & publications <br />Third party impartial opinion essential <br />
Risk to participant<br />New intervention with unknown outcomes<br />RCT and use of a control group (equal opps/ equitable exposure)<br />Pain/ discomfort<br />Time <br />Personal sharing (invasive?)<br />Upsetting (focuses attention on something emotional; stirs up feelings)<br />
Risk to participant (2)<br />Questioning style or questions cause distress (eg. Anxiety created by asking about possible side effects) – psychological intrusion<br />Disclosure<br />Privacy<br />Identification of new issues (eg. caregiver stress; neglect; unsafe practice) - protocol<br />
Vulnerable groups<br />Children<br />Women of childbearing age (pregnancy)<br />Prisoners<br />People with mental illness<br />People with intellectual impairment<br />Good practice to consider – Relationship of participant with researcher <br />
World War II Experiments<br />Prisoners were infected with malaria from mosquitoes carrying the infection. Then anti-malarial drugs were tested on them.<br />Individuals were injected with anti-typhus vaccine & then infected with typhus. Individuals who had been allocated to the control group received no vaccine. <br />GOAL was to find out how to prevent typhus/ malaria in the prisoner of war camps. <br />
Bound by<br />The researcher is bound by:<br /> the legal guidelines issued by NHS Management Executive<br />Own code of professional conduct. <br />
Strategies to be successful <br />Research the need for the project (stakeholders? Who stand to gain?)<br />Consult with service users on purpose and design<br />Resources (personnel, funding, time, participants (access & recruitment), other organisations<br />Research proposal (clear, detailed, logical) <br />
Activity<br />What projects are happening around room?<br />
Research Proposal – <br />what should be included?<br />
Research proposal<br />Title of the research project – clear & concise; may need a shorter running title<br />Background & Literature review<br />Research objectives<br />Research team<br />Summary of project<br />Sponsor & investigator details<br />Research design <br />
Research proposal (2)<br />Sample (source, size, method of recruitment, sampling; eligibility criteria)<br />Consent <br />Methods of data collection<br />Methods of data analysis & consultation with a statistician<br />Ethical considerations<br />Time frame and main project milestones<br />Dissemination plans and methods<br />
Research proposal (3)<br />List of references<br />Flowchart of study phases/ stages <br />CVS of team members<br />
Discussion<br />On specific audience research projects<br />Possible ethical issues to be considered<br />Possible solutions to minimise these <br />
Remember:<br />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. <br />