Protecting subjects and fostering research. Striking the proper balance.
Arch Gen Psychiatry
; 54(2): 121-3, 1997 Feb.
Article
em En
| MEDLINE
| ID: mdl-9040279
ABSTRACT
Bonnie reminds us of the heritage and limitations of human subjects research. He points out that over the years, the protection of human subjects in research has enjoyed progress, experienced false starts, and endured inflated expectations. Both he and Elliott call attention to the fact that IRB review rarely probes how researchers propose to deal with impairments to subjects' decision-making capacities. We agree to IRBs should be encouraged to rethink their roles. But, as Bonnie argues, this requires a systematic review of the roles and functions of IRB rather than ad hoc adjustments by individual institutional IRBs. His proposal that IRBs should be encouraged to be more vigilant and through in their monitoring of research is sound, especially if the subjects are vulnerable or the research is risky. A strength of Bonnie's review is that it suggests both specific ways to test competency and a range of options for IRBs to ensure that vulnerable subjects are protected from overzealous or overreaching researchers. His historical review and normative proposals are objective, balanced, and thoughtful. Elliott's critique seems to single out psychiatric research with depressed patients as a special problem area. Although his title emphasizes severely depressed patients, he sometimes appears to neglect the fact that depression ranges across a spectrum from mild to severe. Elliott's point is well taken that severely depressed patients who are clearly incompetent should not, unless proper safeguards are provided, be enrolled in research. But his analysis falters because his position does not in the end respect personal autonomy.
Palavras-chave
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Competência Mental
/
Experimentação Humana
/
Transtornos Mentais
Tipo de estudo:
Diagnostic_studies
/
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Arch Gen Psychiatry
Ano de publicação:
1997
Tipo de documento:
Article
País de afiliação:
Estados Unidos