Optimising research ethics review: Combining regulatory support and ethics consultation to enhance efficiency of university research ethics review
Keywords:Research ethics review, regulatory support, research ethics consultation, research administration
AbstractA significant factor in REC efficiency has been identified as the quality of administrative and regulatory support for researchers making applications to research ethics committees. Incomplete or poorly completed applications can result in significant delays for researchers. Evidence shows that good quality support for applicants prior to submission can facilitate efficient and expeditious review by improving the quality of applications. UK universities are urged to provide adequate resources to support provision of regulatory support and ethics consultancy services to researchers. In turn, this can reduce delays to research, and help ensure that research supported by universities is good quality and safeguards human research participants
Alexander, L., Moore, M. (2016), ‘Deontological ethics’ in Zalta, E.N. (ed.), The Stanford Encyclopaedia of Philisophy, [Online]. Available from: https://plato.stanford.edu/archives/win2016/entries/ethics-deontological/ [viewed 28.03.18]
Angell, E., Dixon-Woods, M. (2009), ‘Do research ethics committees identify process errors in applications for ethical approval?’, Journal of Medical Ethics, vol.35, no.2, pp130-132
Anthony, R. (2005), ‘Consistency of ethics review’, Forum: Qualitative Social Research, vol.6, no.1, art.5
Beskow, L.M., Grady, C., Iltis, A.S., Sadler, J.Z., Wilfond, B.S. (2009), ‘The research ethics consultation service and the IRB’, IRB, vol.31, no.6, pp1-9
Burris, S., Moss, K. (2006), ‘US health researchers review their ethics review boards: A qualitative study’, Journal of Empirical Research on Human Research Ethics, vol.1, no.2, pp39-58
Cleaton-Jones, P. (2010), ‘Process error rates in general research applications to the Human Research Ethics Committee (Medical) at the University of the Witwatersrand: A secondary data analysis’, South African Journal of Bioethics and Law, vol.3, no.1, pp20-24
de Melo-Martin, I., Palmer, L.I., Fins, J.J. (2007), ‘Developing a research ethics consultation service to foster responsive and responsible clinical research’, Academic Medicine, vol.82, no.9, pp900-904
De Panfilis, L., Merlo, D.F., Satolli, R., Coppola, T., Ghirotto, L., Constantini, M. (2018), ‘Clinical ethics consultation and research ethics consultation: A call for Italy’, The American Journal of Bioethics, vol.18, no.1, pp63-64
Department of Health (2005), Research Governance Framework for Health & Social Care, London: DH
Department of Health (2012), Governance Arrangements for Research Ethics Committees: A Harmonised Edition, Leeds: DH
Desai, P., Nasa, P., Soo, J., Jia, C., Berbaum, M.L., Fischer, J.H., Johnson, T.P. (2017), ‘Effects of regulatory support services on Institutional Review Board turnaround times’, Journal of Empirical Research on Human Research Ethics, vol.12, no.3, pp131-139
De Vries, R., DeBruin, D.A. (2004), ‘Ethics review of social, behavioural, and economic research: Where should we go from here?’, Ethics & Behaviour, vol.14, no.4, pp351-368
Dixon-Woods, M., Foy, C., Hayden, C., Al-Shahi Salman, R., Tebbutt, S., Schroter, S. (2016), ‘Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project’, BMJ Open, vol.6, no.9, pp1-13
Economic & Social Research Council (2015), Framework for Research Ethics, Swindon: ESRC
Fitzgerald, M.H., Phillips, P.A., Yule, E. (2006), ‘The research ethics review process and ethics review narratives’, Ethics & Behaviour, vol.16, no.4, pp377-395
Gillam, L., Guillemin, M., Rosenthal, D. (2006), ‘”Obstructive and power hungry?”: The Australian human research ethics process’, Monash Bioethics Review, vol.25, no.2, pps30-s38
Gillam, L., Guillemin, M. (2018), ‘Reflexivity: Overcoming mistruct between research ethics committees and researchers’, in Iphofen, R. & Tolich, M. (eds), The Sage Handbook of Qualitative Research Ethics, London: Sage, pp263-275
Greenbaum, D. (2018), ‘Hotline bling: Late-night ethics calls as an alternative to research ethics consultation’, The American Journal of Bioethics, vol.18, no.1, pp61-62
Guillemin, M., Gillam, L., Rosenthal, D., Bolitho, A. (2012), ‘Human research ethics committees: Examining their roles and practices’, Journal of Empirical Research on Human Research Ethics, vol.7, no.3, pp38-49
Haggerty, K.D. (2004), ‘Ethics creep: Governing social science research in the name of ethics’, Qualitative Sociology, vol.27, no.4, pp391-414
Keith-Spiegel, P., Koocher, G.P., Tabachnick, B. (2006), ‘What scientists want from their research ethics committee’, Journal of Empirical Research on Human Research Ethics, vol.1, no.1, pp67-82
Klitzman, R. (2011), ‘The ethics police? IRB’s views concerning their power’, PLoS ONE, vol.6, no.12, pp1-7
Master, Z., Martinson, B.C., Resnik, D.B. (2018), ‘Expanding the scope of research ethics consultation services in safeguarding research integrity: Moving beyond the ethics of human subjects research’, The American Journal of Bioethics, vol.18, no.1, pp55-57
McCormick, J.B., Sharp, R.R., Ottenberg, A.L., Reider, C.R., Taylor, H.A., Wilfond, B.S. (2012), ‘The establishment of research ethics consultation services (RECS): An emerging research resource’, Clinical & Translational Science, vol.6, no.1, pp40-44
Nicholls, S.G. (2018), ‘Commentary on “Regulatory support improves subsequent IRB/REC approval rates in studies initially deemed not ready for review: A CTSA institution’s experience’, Journal of Empirical Research on Human Research Ethics, (online first) pp1-3
O’Reilly, M., Dixon-Woods, M., Angell, E., Ashcroft, R., Bryman, A. (2009), ‘Doing accountability: A discourse analysis of research ethics committee letters’, Sociology of Health and Illness, vol.31, no.2, pp246-261
Paquette, E.T., Ross, L. (2018), ‘The challenges of incorporating research ethics consultation into institutional human subjects protections programmes’, The American Journal of Bioethics, vol.18, no.1, 49-51
Patel, D.I., Stevens, K.R., Puga, F. (2013), ‘Variations in Institutional Review Board approval in the implementation of an improvement research study’, Nursing Research & Practice, vol.2013, pp1-6
Porter, K., Danis, M., Taylor, H.A., Cho, M.K., Wilfond, B.S. (2018a), ‘The emergence of clinical research ethics consultation: Insights from a national collaborative’, The American Journal of Bioethics, vol.18, no.1, pp38-45
Redshaw, M.E., Harris, A., Baum, J.D. (1996), ‘Research ethics committee audit: Differences between committees’, Journal of Medical Ethics, vol.22, no.2, pp78-82
Schrag, Z. (2011), ‘The case against ethics review in the social sciences’, Research Ethics, vol.7, no.4, pp120-131
Silberman, G., Kahn, K.L. (2011), ‘Burdens on research imposed by Institutional Review Boards: The state of the evidence and its implications for regulatory reform’, The Milbank Quarterly, vol.89, no. 4, pp599-627
Sonne, S., Gentilin, S., Sampson, R., Bell, L., Mauney, T., Young, S., Flume, P. (2018), ‘Regulatory support improves subsequent IRB/REC approval rates in studies initially deemed not ready for review: A CTSA institution’s experience’, Journal of Empirical Research on Human Research Ethics, (online first) pp1-6
Tinker, A., Coomber, V. (2004), University Research Ethics Committees: Their Role, Remit and Conduct, London: King’s College London
Trace, S., Kolstoe, S.E. (2017), ‘Measuring inconsistency in research ethics committee review’, BMC Medical Ethics, vol.18, art.65, pp1-10
Tzeng, D., Wu, Y., Hsu, J. (2015), ‘Latent variable modelling and its implications for institutional review board review: Variables that delay the reviewing process’, BMC Medical Ethics, vol.16, art.57
Universities UK (2012), Concordat to Support Research Integrity, London: UUK
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