When and how to include vulnerable subjects in clinical trials.
There has been a good deal of discussion in the literature regarding which subjects are vulnerable in the context of clinical trials. There has been significantly less discussion regarding when and how to include vulnerable subjects in clinical trials. This lack of guidance is a particular problem f...
| Publicado en: | Clinical Trials Vol. 17; no. 6; pp. 696 - 703 |
|---|---|
| Autor principal: | |
| Formato: | algorithm Journal Article |
| Publicado: |
Sage Publications, Ltd.
Dec2020
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=146871687&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 146871687 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 17407745 AB6 jtl: Clinical Trials issn: 17407745 maglogo: N pubinfo: dt: Dec2020 vid: 17 iid: 6 pid: 33180 pub: Sage Publications, Ltd. place: <Blank> artinfo: ui: 146871687 146270245 146871687 146871687 10.1177/1740774520945601 146871687 ppf: 696 ppct: 7 formats: tig: atl: When and how to include vulnerable subjects in clinical trials. aug: au: Wendler, David affil: Department of Bioethics, National Institutes of Health, Bethesda, MD, USA sug: subj: Clinical Trials Special Populations Research Subject Recruitment Algorithms Professional Regulation Women Fetus Prisoners Child Institutional Review Fetus, conception to birth Child: 6-12 years ab: There has been a good deal of discussion in the literature regarding which subjects are vulnerable in the context of clinical trials. There has been significantly less discussion regarding when and how to include vulnerable subjects in clinical trials. This lack of guidance is a particular problem for trials covered by the US regulations, which mandate strict requirements on the inclusion of three groups: pregnant women/fetuses, prisoners, and children. For the past 30 years, funders, investigators, and institutional review boards have frequently responded to these regulations by excluding pregnant women/fetuses, prisoners, and children from clinical trials. More recent work has emphasized the extent to which a default of exclusion can undermine the value of clinical trials, especially pragmatic trials. A default of exclusion also has the potential to undermine the interests of vulnerable groups, in both the short and the long term. These concerns raise the need for guidance on how to satisfy existing US regulations, while minimizing their negative impact on the value of clinical trials and the interests of vulnerable groups. The present manuscript thus describes a six-step decision procedure that institutional review boards can use to determine when and how to include vulnerable subjects in clinical trials, including pragmatic trials, that are covered by US regulations. pubtype: Academic Journal doctype: algorithm Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|