Abstract
Applying for research ethics approval is an exercise that many clinicians will have to conduct at least once in their career. In the UK, obtaining REC approval for clinical research is a legal obligation, and many journals will require you to confirm the approval prior to publication.
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Some research, of course, raises no material ethical issues. An example is research on existing tissue samples where consent to do so has already been obtained. In such cases, it may be possible for researchers in the UK to expedite the application process through ‘proportionate review’, where a sub-committee of the REC will review the proposal. Consult the NRES website for further details: http://www.nres.npsa.nhs.uk/applications/proportionate-review/.
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Several readers of a draft of this book have asked if, in an act of redemption, I offered the woman the £50. I did not.
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Ideally, the person recruiting the participants should not be involved in their medical care. If this is not possible or practicable, explain why and describe the ways in which any pressure will be minimised.
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It is common for researchers to promise strict confidentiality when, in fact, they are willing to breach it if there is serious risk to the participant or others, or if there is an admission of serious professional misconduct or criminal behaviour. It is conceivable, for example, that in an interview-based study on how surgeons prepare themselves psychologically for major operations, or pilots before a long-haul flight, a participant may reveal that he drinks alcohol to calm his nerves. Would guaranteeing absolute confidentiality be appropriate in such cases? It is important, therefore, to anticipate possible revelations which may put participants or others in danger. Needless to say, it is improper to promise strict confidentiality if this cannot be guaranteed. Participants must be told if there are circumstances in which their confidentiality will be breached.
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Questions on mental health, childhood and other potentially sensitive issues can awaken unpleasant memories in participants and cause emotional distress. It is advisable to show the REC that you are aware of this possibility and, if appropriate, to offer participants the contact details of an appropriate counselling service.
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It is generally unreasonable to expect participants to bear the costs of travelling to the venue if the sole purpose of the visit is to take part in the research.
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There is nothing unethical in itself with offering money to cover participants’ time and expenses. What must be avoided is offering such a substantial sum of money that potential participants may feel unduly influenced. You must therefore be prepared to justify why the payment is reasonable in the circumstances. Another commonly ignored issue with payment is how much, if anything, the participant who withdraws early from the study will receive.
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Ideally, researchers should give potential participants at least 24 h to decide on participation. If that is not possible, you must be prepared to justify the shorter period to the REC.
References
National Research Ethics Service (2011) http://www.nres.npsa.nhs.uk/. Accessed 2 Aug 2011
Hunter D (2011) A hands-on guide on obtaining research ethics approval. Postgrad Med J. Online first doi:10.1136/pgmj.2010.109348
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Sokol, D.K. (2012). Submitting an Application to a Research Ethics Committee (REC). In: Doing Clinical Ethics. SpringerBriefs in Ethics, vol 1. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-2783-0_4
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DOI: https://doi.org/10.1007/978-94-007-2783-0_4
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