Abstract
Although there seems to be a consensus that research on personal data and/or biological material differs from other types of research, there is no agreement on how these differences should be regulated. Earlier solutions have been criticized as representing biobank exceptionalism, which is not justified or leads to a slippery slope. The present work discusses whether the distinction between interventional and non-interventional types of human biomedical research could be a criterion based on which the difference is justifiable, and whether it could form the basis for different solutions in regulatory frameworks. Current regulatory approaches and the dissimilarity of risks are elaborated. Based on David Wendler’s normative criteria about the active role of investigators, it is shown that it is relevant to make the distinction between interventional and non-interventional research.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
Biobank exceptionalism is a view that biobank research is so special that it requires different moral and legal standards (either more stringent or more lax, often the latter).
- 2.
It has also been argued that the research participation can be seen as passive (see Wendler 2011).
- 3.
- 4.
This notion was first introduced by Baroness Onora O’Neill in her article in 2001.
- 5.
This lack of interaction should be viewed as a type of non-interventional research, which could be seen in the European context as non-interventional due to the lack of psychological harm. Psychological harm here should be understood as it is explained in the explanatory report of the Additional Protocol.
References
Corrigan O, Petersen A (2008) UK Biobank. Bioethics as a technology of governance. In: Gottweis H, Petersen A (eds) Biobanks. Governance in comparative perspective. Routledge, London, pp 143–158
Council of Europe (1997) 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. http://conventions.coe.int/Treaty/en/Treaties/html/164.htm. Accessed 06 Dec 2011
Council of Europe (2005) Additional protocol to the convention on human rights and biomedicine concerning Biomedical Research. http://conventions.coe.int/Treaty/en/Treaties/html/195.htm. Accessed 06 Dec 2011
Council of Europe Committee of Ministers (2006) Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin. https://wcd.coe.int/wcd/ViewDoc.jsp?id=977859. Accessed 06 Dec 2011
Department of Health and Human Services, National Institutes of Health, and Office of Human Research Protections (2005) The common rule, title 45, code of federal regulations, part 46. http://ohsr.od.nih.gov/guidelines/45cfr46.html. Accessed 06 Dec 2011
Emanuel EJ et al (2008) An ethical framework for biomedical research. In: Emanuel EJ, Grady C, Crouch RA, Lie EK, Miller FG, Wendler D (eds) The Oxford textbook of clinical research ethics. Oxford University Press, Oxford, pp 123–135
Hansson MG (2005) Building on relationships of trust in biobank research. J Med Ethics 31(7):415–418
Hansson MG, Levine M (2003) Biobanks as resources for health. Research program ethics in biomedicine, Uppsala
Hansson SO (2011) Do we need a special ethics for research? Sci Eng Ethics 17(1):21–29
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2006) Guideline for good clinical practice. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf. Accessed 06 Dec 2011
Levine C (1988) Has AIDS changed the ethics of human subjects research? Law Med Health Care 16(3–4):167–173
Lõuk K (2010) Eetilised raamistikud inimuuringute eetikas. Tartu Ülikool, Tartu
Nõmper A (2005) Open consent—a new form of informed consent for population genetic databases. Tartu Ülikooli Kirjastus, Tartu
O’Neill O (2001) Informed consent and genetic information. Stud Hist Phil Biol Biomed Sci 32(4):689–704
Takala T (2007) Setting a dangerous precedent? Ethical issues in human genetic database research. Med Law Int 8(2):105–137
Wendler D (2011) What we worry about when we worry about the ethics of clinical research. Theor Med Bioeth 32(3):161–180
Wilson J, Hunter D (2010) Research exceptionalism. Am J Bioethics 10(8):45–54
World Medical Association (2008) Declaration of Helsinki: ethical principles for medical research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/. Accessed 06 Dec 2011
Acknowledgments
This paper is a contribution to the research project “Critical analysis of relativism and pluralism regarding truth and knowledge, norms and values” funded by the Estonian Ministry of Education and Research from 2008 to 2013. This support is gratefully acknowledged, however, the information provided is the sole responsibility of the author and does not represent the opinion of the Estonian Ministry of Education and Research. The paper is based on a presentation at the conference “Human Medical Research: ethical, economical and socio-cultural aspects” at Ruhr University Bochum, Germany, 7−11 February 2011. I have benefited from helpful questions and comments from the audience and from the reviewers of the paper. The organisers of the conference and the support from the Bundesministerium für Bildung und Forschung are gratefully acknowledged. My special thanks go to Prof. Margit Sutrop for useful comments and to Mari Järve for help with my English.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2012 Springer Basel AG
About this chapter
Cite this chapter
Lõuk, K. (2012). Rethinking the Ethics of Human Biomedical Non-Interventional Research. In: Schildmann, J., Sandow, V., Rauprich, O., Vollmann, J. (eds) Human Medical Research. Springer, Basel. https://doi.org/10.1007/978-3-0348-0390-8_15
Download citation
DOI: https://doi.org/10.1007/978-3-0348-0390-8_15
Published:
Publisher Name: Springer, Basel
Print ISBN: 978-3-0348-0389-2
Online ISBN: 978-3-0348-0390-8
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)