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Chapter 17 - Informing Patients, Consent, Governance and Good Clinical Practice

Published online by Cambridge University Press:  04 August 2017

By
Anthony Wrigley ,
Jonathan A. Hughes  and
Nicola Leighton
Edited by
P. M. Shaughn O'Brien  and
Fiona Broughton Pipkin
P. M. Shaughn O'Brien
Affiliation:
Keele University School of Medicine
Fiona Broughton Pipkin
Affiliation:
University of Nottingham
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Information
Introduction to Research Methodology for Specialists and Trainees , pp. 142 - 149
Publisher: Cambridge University Press
Print publication year: 2017

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References

International Covenant on Civil and Political Rights, Article 7 https://treaties.un.org/doc/publication/unts/volume%20999/volume-999-i-14668-english.pdfGoogle Scholar
Charter of Fundamental Rights of the European Union, Article 3 www.europarl.europa.eu/charter/default_en.htmGoogle Scholar
World Medical Association, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects www.wma.net/en/30publications/10policies/b3/17c.pdfGoogle Scholar
Council of Europe’s Convention for the Protection of Human Rights and Dignity with Regard to the Application of Biology and Medicine, Article 5 http://conventions.coe.int/.Google Scholar
Gillon, R. (1986) Philosophical Medical Ethics. John Wiley & Sons, Chichester, p. 113.Google Scholar
Beauchamp, TL, Childress, JF. (2009) Principles of Biomedical Ethics. Oxford University Press, Oxford.Google Scholar
Jonas, M. (2007) Competence to Consent. In: Ashcroft, RE, Dawson, A, Draper, H & McMillan, J (eds.) Principles of Health Care Ethics. John Wiley & Sons, Chichester, pp. 255–62.Google Scholar
British Psychological Society (2009) Code of Ethics and Conduct. www.bps.org.uk/system/files/Public%20files/bps_code_of_ethics_2009.pdfGoogle Scholar
British Sociological Association (2002) Statement of Ethical Practice for the British Sociological Association. www.britsoc.co.uk/equality-diversity/statement-of-ethical-practice/Google Scholar
Wendler, D. (2000) Informed consent, exploitation and whether it is possible to conduct human subjects research without either one. Bioethics 14 (4), 310–339.Google Scholar
Wrigley, A. (2010) Vulnerable and Non-Competent Subjects. In: Hughes, J., Hunter, D., Sheehan, M., Wilkinson, S., Wrigley, A.. European Textbook on Ethics in Research. Publications Office of the European Union, Luxembourg, ch. 3, pp. 49–74. https://ec.europa.eu/research/science-society/document_library/pdf_06/textbook-on-ethics-report_en.pdfGoogle Scholar
Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002, guideline 5. www.cioms.ch/index.php/printable-publications?task=view&id=48&catid=57.Google Scholar
Walker, T. (2012) ‘Informed Consent and the Requirement to Ensure Understanding’. Journal of Applied Philosophy 29 (1), 50–62.Google Scholar
ICH Topic E6 (R1) Guideline for Good Clinical Practice, 1996. www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.htmlGoogle Scholar
Medicines for Human Use (Clinical Trials) Regulations, 2004. www.legislation.gov.uk/uksi/2004/1031/contents/madeGoogle Scholar
Department of Health, Research Governance Framework for Health and Social Care, 2nd edn., 2005. www.gov.uk/government/uploads/system/uploads/attachment_data/file/139565/dh_4122427.pdfGoogle Scholar
Health Research Authority, Consent and Participation Information Sheet Preparation Guidance, 2014. www.hra-decisiontools.org.uk/consent/docs/Consent%20and%20PIS%20Guidance%20Mar3rd2014.pdfGoogle Scholar
General Medical Council, Good practice in research and consent to research, 2013. www.gmc-uk.org/Good_practice_in_research_and_consent_to_research.pdf_58834843.pdfGoogle Scholar
Royal College of Nursing, Informed consent in health and social care research, second edition, 2011. www.rcn.org.uk/professional-development/publications/pub-002267Google Scholar
Department of Health, Mental Capacity Act, 2005. www.legislation.gov.uk/ukpga/2005/9/pdfs/ukpga_20050009_en.pdfGoogle Scholar
Health Research Authority, Participant Information Sheet and Consent form templates, 2014. www.legislation.gov.uk/ukpga/2005/9/pdfs/ukpga_20050009_en.pdfGoogle Scholar

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