What Is the Good of It—Ethical Controls of Human Subject Health Research?
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The term “ethics” covers a multitude of virtues and possibly some sins where ethical perspectives differ. Given the diversity of ethical philosophies there is a question about what common ground can, or should, inform health research ethics. At a minimum it must be consistent with the law. Beyond that, ethics embraces a variety of possible approaches. This raises the question—what criteria are applied in determining the appropriate approach and what standards by way of quality control are applied to its decisional application by ethics committees or other authorities exercising responsibility in this difficult area. The particular issue of ethical perspectives on the use of “big data” in medical research also raises complex issues for consideration.
KeywordsHuman research ethics Bioethics Big data Consent Privacy Research ethics
- Al-Lamee, R. 2017. Patient information leaflet, version 1.6, 15 April 2014, provided 7 November.Google Scholar
- Al-Lamee, R., D. Thompson, H.M. Dehbi, et al. 2017. Percutaneous coronary intervention in stable angina (ORBITA): A double-blind, randomised controlled trial. Lancet Nov 1: pii: S0140-6736(0117)32714-32719 [Epub ahead of print].Google Scholar
- Brody, H., S.E. Leonard, J.B. Nie, and P. Weindling. 2014. United States responses to Japanese wartime inhuman experimentation after World War II: National security and wartime exigency. Cambridge Quarterly Heath Ethics 23(2): 220–230.Google Scholar
- Caplan, A.L. 1989. The meaning of the Holocaust for bioethics. Retrieved from https://repository.upenn.edu/bioethics_papers/40. Accessed October 23, 2018.
- Care Act 2014 (UK) Ch 2 “Health Research Authority”; Medicine for Human Use (Clinical Trials) Regulations 2004 (UK).Google Scholar
- Chattopadyay, S., and R. De Vries. 2013. Respect for cultural diversity in bioethics is an ethical imperative. Journal of Medicine, Health Care and Philosophy 16(4): 639–645.Google Scholar
- Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine.1997. http://www.vib.be/VIBDocumentLibrary/EN/Convention_on_Human_Rights_and_Biomedicine.pdf. Accessed October 23, 2018).
- Craik, E.M. 2015. The Hippocratic corpus: Content and context. Routledge.Google Scholar
- Declaration of Helsinki (World Medical Association, 1964) art33 (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Accessed October 23, 2018.
- European Parliament Directive 2001/20/EC and of the Council, 4 April 2001 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf. Accessed December 2017.
- French, R. 2003. Ethics at the beginning and ending of life. http://www5.austlii.edu.au/au/journals/FedJSchol/2003/1.html#fn1. Accessed October 23, 2018.
- Johns, C.H.W. 1904. Babylonian and Assyrian laws, contracts and letters, 64 . Law Book Exchange Ltd.Google Scholar
- Kotata, G. 2017. Unbelievable: Heart stents fail to ease chest pain. New York Times, November 2. https://www.nytimes.com/2017/11/02/health/heart-disease-stents.html. Accessed October 23, 2018.
- Maclean, C. 1818. Results of an investigation respecting epidemic and pestilential diseases. London: Thomas and George Underwood.Google Scholar
- Maehle, A. 1999. Drugs on trial: Experimental pharmacology and therapeutic innovation in the eighteenth century. Clio Medica 53: 194–195. Wellcome Institute Series in the History of Medicine.Google Scholar
- McNeil, D.G. 2010. US Apologizes for syphilis testing in Guatemala. New York Times, October 1. http://www.nytimes.com/2010/10/02/health/research/02infect.html. Accessed October 23 2018 .
- Millum, J. 2012. Canada’s new ethical guidelines for humans: A critique and comparison with the United States. Canadian Medical Journal 184(6): 657–661.Google Scholar
- Mittelstadt, B.D., and L. Floridi. 2016. The ethics of big data: Current and foreseeable issues in biomedical contexts. Cham, Switzerland: Springer Netherlands .Google Scholar
- Moreno, J.D. 2005. Is there an ethicist in the house? On the cutting edge of bioethics. USA: Indiana University Press.Google Scholar
- National Statement on Ethical Conduct in Human Research 2007a (Updated 2018). The National Health and Medical Research Council, the Australian Research Council and Universities Australia. Commonwealth of Australia, Canberra. https://www.nhmrc.gov.au/guidelines/publications/e72. Accessed 23 Oct 2018.
- National Statement on Ethical Conduct in Human Research. 2007b (Updated 2018). Chapter 2.2, p16-18. The National Health and Medical Research Council, the Australian Research Council and Universities Australia. Commonwealth of Australia, Canberra. https://www.nhmrc.gov.au/guidelines/publications/e72. Accessed 23 Oct 2018.
- Schiller, F. A list of famous Fredrich Schiller quotes. Ranker 2017 https://www.ranker.com/list/a-list-of-famous-friedrich-schiller-quotes/reference?page=2. Accessed 23 Oct 2018.
- Swiss Academy of Medical Sciences. 2015. Research with human subjects: A manual for practitioners, 2nd ed.Google Scholar
- Singer, P. 2000. Writings on an ethical life. New York: Harper Collins Books.Google Scholar
- Somerville, M. 2000. The ethical canary—Science, society and the human spirit. Toronto: Penguin Books.Google Scholar
- Swift, T., and R. Huxtable. 2013. The ethics of sham surgery in Parkinson’s disease: Back to the future? Bioethics 27(4): 175–185.Google Scholar
- The Universal Declaration on Bioethics and Human Rights (United Nations Educational, Scientific and Cultural Organisation, 2005) art 3(2). http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights. Accessed October 23, 2018.
- Trials of War Criminals Before the Nuremberg Military Tribunals under Control Council Law No 10, US Government Printing Office 1949. 2: 181–182.Google Scholar