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ECS SEC. Ethics and the School Ethics Committee. Lester Gilbert Learning Societies Lab University of Southampton Chair, ECS SEC Version 2 Updated September 2009. Ethical issues. The condition of humankind What is a life well (properly) lived? Moral theory What is right and wrong?
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ECS SEC Ethics and the School Ethics Committee Lester Gilbert Learning Societies Lab University of Southampton Chair, ECS SEC Version 2 Updated September 2009
Ethical issues • The condition of humankindWhat is a life well (properly) lived? • Moral theoryWhat is right and wrong? • Ethics in practiceWho gets the heart transplant?(The 30-year old alcoholic pedophile or the 70-year old upright professor of computer science?)
Ethical issues in ECS • Treatment of participants in research studies:Human, Animal • Treatment of participants’:Tissue, Data • The quality of the research, eg:Will it waste people’s time?Is the study likely to answer the research question?
Treatment of participants • Invasive • Intrusive • Risk of harm • Deception • Fully informed consent not (initially) obtained • Coercion / not able to withdraw at any time for any reason • Inappropriate inducement to participate
Participant data • Data Protection Act (DPA) 1998
Participant data • Data Protection Act (DPA) 1998 • Can any individual be identified from the data? • If so, steps must be taken to ‘protect’ it: • Retained for a limited period, then destroyed • Right of access to be given to participants • Not used or divulged apart from the agreed purpose of the study • Export from the EU is controlled • Held securelyThis usually involves some form of anonymisation where the bulk of the data is held separately from securely held names, addresses, and/or e-mails
Participant data • Data Protection Act (DPA) 1998 • Can any individual be identified from the data? • If not, • the DPA does not apply • expedited submission to the ECS SEC available(provided there are no issues arising from the treatment of the participants)
Participant data • Data Protection Act (DPA) 1998 • ‘Sensitive’ data: • racial or ethnic origin • political opinions • religious beliefs • trade union membership • physical or mental health • sexual life • commission of offences or alleged offences • ECS SEC would not normally consider any study which collected such data (though other SECs can)
University approval • Required for all research involving humans(and their data or tissue) • Complete the Research Governance Office (RGO) ‘IRGA’ (Insurance and Research Governance Application) form for non-expedited submissions • RGO provides insurance cover • RGO provides legal cover • Secured via School ethics committees • Teaching and learning activities involving student participants (eg laboratory practice, student projects) requires ECS SEC approval but not notification to RGO
After approval • Reference number prominently located on invitations to participate, information forms, consent forms, questionnaires, etc • Material changes to, or adverse outcomes during, the study must be notified
Summary • Approval is required if the study involves humans • Expedited submission if the only issue is the collection of data which may be subject to the DPA • Really good reasons will be required for intrusion, risk of harm, or deception • Studies involving invasive techniques, lack of informed consent, coercion or restrictions on ability to withdraw, or ‘sensitive’ data not normally considered (though other SECs can do so) • Reference number prominent on all communications • Material changes to, or adverse outcomes during, the study must be notified
Questions, comments? Site: https://secure.ecs.soton.ac.uk/ethics/ E-mail: ethics-chair@ecs.soton.ac.uk Forms: https://secure.ecs.soton.ac.uk/docpot/deptadmin/Ethics/ RGO: http://www.southampton.ac.uk/corporateservices/rgo/