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Research ethics. Jan Deckers School of Medical Sciences Education Development Email: Objectives. To think about the ethical issues associated with research ethics committee applications To reflect on frequently identified problems

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Research ethics

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    1. Research ethics Jan Deckers School of Medical Sciences Education Development

    2. Objectives • To think about the ethical issues associated with research ethics committee applications • To reflect on frequently identified problems • To develop good practice in making applications to research ethics committees

    3. What is ethics?

    4. Why do we need ethics? • Many (or all?) people feel the need to justify their behaviour – to explain why their behaviour is (un)acceptable = subjective aspect • Many (or all?) things deserve moral consideration = objective aspect

    5. Why is ethics important? • Realisation that “not everything goes” • The need for justification

    6. Two dimensions • Law and professional guidelines • Reflection

    7. How does it work? • Establishing knowledge of the relevant legal and professional guidelines • Exercise your ability to reflect........How?

    8. The tools of the trade • Principle of non-contradiction • Analogies

    9. Principle of non-contradiction/consistency • Example: A researcher who carries out research on patients with advanced dementia says the following: “I believe that researchers who want to carry out research on patients should only proceed if patients give their voluntary, informed consent to taking part in the research.”

    10. Analogies • Example: - When a research project is likely to kill human subjects, research should not proceed • When a research project is likely to kill non-human subjects, research should not proceed Is this a valid analogy?

    11. Some ethical theories • Consequentialism • Deontology • Principlism

    12. Consequentialism • Focus on consequences Example: Utilitarianism: consequences are measured in terms of whether or not they produce happiness

    13. Deontology • Focus on rules and motives

    14. Principlism The ‘four principles’ approach: 1. Autonomy 2. Beneficence 3. Non-maleficence 4. Justice 1&4 are deontological; 2&3 are consequentialist = a very popular approach in bioethics

    15. Practical tips on making research ethics applications

    16. Accuracy and clarity of the information • Have spelling and grammatical problems been avoided? Particularly in the consent and/or participant information sheets • Is the information consistent across the whole application? E.g. the consent sheet and application text • Will potential participants understand the aims and methods of the study? • Is unnecessary jargon and technical detail used? Or, have they been explained?

    17. Confidentiality and data sharing Is there an appropriate balance between: • Confidentiality and data protection (right to privacy) • Data sharing

    18. The right to withdraw • Have participants been informed of their right to withdraw? • Should they be allowed to withdraw? Concerns about sample size!

    19. Deception • Is deception ever acceptable? • If so, participants could be told: “The experiments you will be participating in will also be used to examine something that we will not tell you about yet as this may affect the outcomes. We will tell you about this aspect of our study later on.” (or something similar)

    20. Incentives • Is it acceptable to provide financial or otherincentives to potential research participants? • If so, might this impair the ability of the participants to give voluntary consent?

    21. The “How would you feel....” test (Or “don’t do unto others what you would not want others to do unto you”) Example: Offering a financial incentive to encourage participation, and then not giving it at the end of the activity

    22. Healthy scepticism • Absence of evidence of reasons to think the research might cause distress/risk should not be construed as evidence of absence that it might cause distress/risk • It is not because the Government recommends something that it should be recommended. • …

    23. Research duplication • Why is this an issue?

    24. Information about funding source • Disclose the funding source of the study to (potential) participants