On the Alleged Right to Participate in High-Risk Research

TitleOn the Alleged Right to Participate in High-Risk Research
Publication TypeJournal Article
Year of Publication2015
AuthorsRózynska, J
JournalBioethics
Volume29
Issue7
Pagination451-461
Date Published09/01/
Publication Languageeng
ISBN Number0269-9702
AbstractReigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and nonminimized. Where the research has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition that risks should not exceed a certain minimal threshold. In this article, I address the question of whether there should be limits of permissible risks in nontherapeutic research involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely risky research and that research ethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have "a right to participate in high-risk research". I argue that this idea is ill-founded, as it does not take into account the social mission and complex collaborative nature of research practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protect research enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries on research risks is to leave the judgment of risk acceptability to research ethics committees.
NotesCover Date: SEPT 2015.Source Info: 29(7), 451-461. Language: English. Journal Announcement: 49-4. Subject: BIOETHICS; CLINICAL RESEARCH; ETHICS; HUMAN SUBJECT; PARTICIPATION; PROTECTION; RESEARCH ETHICS; RIGHTS; RISK-BENEFIT. Update Code: 20160112.
DOI10.1111/bioe.12146

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