When and how to include vulnerable subjects in clinical trials.
Clin Trials
; 17(6): 696-702, 2020 12.
Article
em En
| MEDLINE
| ID: mdl-32806931
ABSTRACT
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.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos como Assunto
/
Sujeitos da Pesquisa
/
Populações Vulneráveis
Tipo de estudo:
Clinical_trials
/
Guideline
/
Prognostic_studies
Limite:
Child
/
Female
/
Humans
/
Male
/
Pregnancy
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Clin Trials
Assunto da revista:
MEDICINA
/
TERAPEUTICA
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Estados Unidos