Minimal or reasonable? Considering the ethical threshold for research risks to nonconsenting bystanders and implications for nonconsenting participants.
When research poses risks to non‐participant bystanders, it is not always practicable to obtain their consent. One approach to assessing how much research risk may be imposed on nonconsenting bystanders is to examine analogous circumstances, including risk thresholds deemed acceptable for nonconsent...
| Publicado en: | Bioethics Vol. 34; no. 9; pp. 923 - 933 |
|---|---|
| Autor principal: | |
| Formato: | Artículo |
| Publicado: |
Wiley-Blackwell
Nov2020
|
| Materias: | |
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ssf&AN=147131994&site=ehost-live header: @attributes: shortDbName: ssf uiTerm: 147131994 longDbName: Social Sciences Full Text (H.W. Wilson) uiTag: AN controlInfo: bkinfo: jinfo: jid: 02699702 6PJ jtl: Bioethics issn: 02699702 maglogo: Y pubinfo: dt: Nov2020 vid: 34 iid: 9 pid: 480 pub: Wiley-Blackwell artinfo: ui: 147131994 10.1111/bioe.12725 ppf: 923 ppct: 10 formats: tig: atl: Minimal or reasonable? Considering the ethical threshold for research risks to nonconsenting bystanders and implications for nonconsenting participants. aug: au: Fernandez Lynch, Holly affil: Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania su: United States Bioethics Informed consent (Medical law) Research ethics Human research subjects Risk assessment Risk management in business Patient selection sug: subj: Bioethics Informed consent (Medical law) Research ethics Human research subjects United States Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) Risk assessment Risk management in business Patient selection keyword: bystanders challenge trial minimal risk reasonable risk research risk risk thresholds third parties bystanders challenge trial minimal risk reasonable risk research risk risk thresholds third parties ab: When research poses risks to non‐participant bystanders, it is not always practicable to obtain their consent. One approach to assessing how much research risk may be imposed on nonconsenting bystanders is to examine analogous circumstances, including risk thresholds deemed acceptable for nonconsenting research participants and for nonconsensual risks imposed outside the research setting. For nonconsenting participants, US research regulations typically limit risks to those deemed to be "minimal." Outside the research context, US tort law tolerates a more flexible "reasonable" risk threshold. This article advances a preliminary case that nonconsenting participants and nonconsenting bystanders exposed to similar research risks may be entitled to the same level of protection, but that risks generated by research may not be special in kind. Thus, limiting research risks to those that are "reasonable," rather than demanding that they be held to the "minimal" standard, may be the best approach for both nonconsenting participants and nonconsenting bystanders. Further work is needed to establish whether the descriptive standards used to support the analogies relied on here are normatively justifiable, as well as the extent to which the minimal risk standard and the reasonable risk standard would lead to meaningfully different outcomes in practice. pubtype: Academic Journal doctype: Article src: R language: English refInfo: copyright: @attributes: flag: N holdings: @attributes: islocal: N |
|---|