Optimising research ethics review: Combining regulatory support and ethics consultation to enhance efficiency of university research ethics review
DOI:
https://doi.org/10.22024/UniKent/03/ajpp.536Nyckelord:
Research ethics review, regulatory support, research ethics consultation, research administrationAbstract
A 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 participantsReferenser
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
##submission.downloads##
Publicerad
Referera så här
Nummer
Sektion
Licens
© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
AJPP requests that, as the creator(s)/author(s) of the manuscript you are submitting, that you assign certain rights to the manuscript to the AJPP in exchange for undertaking to publish the article in electronic form and, in general, to pursue its dissemination throughout the world. The rights the AJPP requests are:
- The right to publish the article in electronic form or in any other form it may choose that is in keeping with its role as a scholarly journal with the goal of disseminating the work as widely as possible;
- The right to be the sole publisher of the article for a period of 12 months;
- The right to make the article available to the public within a period of not more than 24 months, as determined by relevant journal staff of the AJPP;
- The right to grant republication rights to itself or others in print, electronic, or any other form, with any revenues accrued to be shared equally between the author(s) and the journal;
- The right to administer permission to use portions of the article as requested by others, seeking recompense when the AJPP sees it as warranted;
- The right to seek or take advantage of opportunities to have the article included in a database aimed at increasing awareness of it;
- As the author(s), the AJPP wishes you to retain the right to republish the article, with acknowledgement of the AJPP as the original publisher, in whole or in part, in any other pbulication of your own, including any anthology that you might edit with up to three others;
- As the author(s), the AJPP wishes you to retain the right to place the article on your personal Web page or respository of your university or institution. The AJPP askes that you include this notice: A fully edited, peer-reviewed version of this article was first published by the Advanced Journal of Professional Practice, <Year>, <Volume>, <Issue>, <Page Numbers>.
- You retain the right to unrestricted use of your paper for yourself or for your own teaching purposes.
BY AGREEING TO THE FOREGOING, YOU CONFIRM THAT THE MANUSCRIPT YOU ARE SUBMITTING HAS NOT BEEN PUBLISHED ELSEWHERE IN WHOLE OR IN PART, AND THAT NO AGREEMENT TO PUBLISH IS OUTSTANDING.
SHOULD THE ARTICLE CONTAIN MATERIAL WHICH REQUIRES WRITTEN PERMISSION FOR INCLUSION, YOU AGREE THAT IT IS YOUR OBLIGATION IN LAW TO IDENTIFY SUCH MATERIAL TO THE EDITOR OF THE AJPP AND TO OBTAIN SUCH PERMISSION. THE AJPP WILL NOT PAY ANY PERMISSION FEES. SHOULD THE AJPP BE OF THE OPINION THAT SUCH PERMISSION IS NECESSARY, IT WILL REQUIRE YOU TO PURSUE SUCH PERMISSSION PRIOR TO PUBLICATION.
AS AUTHOR(S), YOU WARRANT THAT THE ARTICLE BEING SUBMITTED IS ORIGINAL TO YOU.
Provided the foregoing terms are satisfactory, and that you are in agreement with them, please indicate your acceptance by checking the appropriate box and proceed with your submission.
