caa a22 4500 606170863 CHVBK 20210128100719.0 cr unu---uuuuu 210128e20150301xx s 000 0 eng 10.1007/s10728-012-0233-0 doi (NATIONALLICENCE)springer-10.1007/s10728-012-0233-0 Resnik David National Institute of Environmental Health Sciences, National Institutes of Health, Box 12233, Mail Drop CU 03, 27709, Research Triangle Park, NC, USA aut Paternalism and Utilitarianism in Research with Human Participants [Elektronische Daten] [David Resnik] In this article I defend a rule utilitarian approach to paternalistic policies in research with human participants. Some rules that restrict individual autonomy can be justified on the grounds that they help to maximize the overall balance of benefits over risks in research. The consequences that should be considered when formulating policy include not only likely impacts on research participants, but also impacts on investigators, institutions, sponsors, and the scientific community. The public reaction to adverse events in research (such as significant injury to participants or death) is a crucial concern that must be taken into account when assessing the consequences of different policy options, because public backlash can lead to outcomes that have a negative impact on science, such as cuts in funding, overly restrictive regulation and oversight, and reduced willingness of individuals to participate in research. I argue that concern about the public reaction to adverse events justifies some restrictions on the risks that competent, adult volunteers can face in research that offers them no significant benefits. The paternalism defended here is not pure, because it involves restrictions on the rights of investigators in order to protect participants. It also has a mixed rationale, because individual autonomy may be restricted not only to protect participants from harm but also to protect other stakeholders. Utility is not the sole justification for paternalistic research policies, since other considerations, such as justice and respect for individual rights/autonomy, must also be taken into account. Springer Science+Business Media New York (outside the USA), 2012 Informed consent nationallicence Justice nationallicence Paternalism nationallicence Research participation nationallicence Risks nationallicence Utilitarianism nationallicence Health Care Analysis Springer US; http://www.springer-ny.com 23/1(2015-03-01), 19-31 1065-3058 23:1<19 2015 23 10728 https://doi.org/10.1007/s10728-012-0233-0 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10728-012-0233-0 text/html Onlinezugriff via DOI NATIONALLICENCE 100 1- Resnik David National Institute of Environmental Health Sciences, National Institutes of Health, Box 12233, Mail Drop CU 03, 27709, Research Triangle Park, NC, USA aut NATIONALLICENCE 773 0- Health Care Analysis Springer US; http://www.springer-ny.com 23/1(2015-03-01), 19-31 1065-3058 23:1<19 2015 23 10728