Neonatologists' opinions about the 'foreseeable risks' in comparative effectiveness research: Results from an online survey.

Document Type

Article

Publication Date

3-1-2017

Identifier

DOI: 10.1038/jp.2016.228

Abstract

OBJECTIVE: To examine how neonatologists determine which risks require inclusion for informed consent per the 'Common Rule' and 'Draft Guidance' regulations in comparative effectiveness research (CER).

STUDY DESIGN: Neonatologists active in research were invited to complete an online survey. Questions focused on clinical practices for treating hyperbilirubinemia in premature infants and about risk disclosure related to a hypothetical randomized trial.

RESULTS: Response rate was 57%. 43% were primarily researchers; 31% primarily clinicians. 69% had conducted CER. 81% thought hypothetical study enrollment was not riskier than receiving routine care. 76% labeled the study 'minimal risk' by comparing study risks to clinical care risks. Respondents would not currently disclose many of the treatment risks but would disclose more if the Draft Guidance were enacted into law.

CONCLUSION: Findings suggest the Draft Guidance requires disclosure of more risks than does the Common Rule; applying either rule results in disclosure of more risks than in standard clinical care.

Journal Title

Journal of perinatology : official journal of the California Perinatal Association

Volume

37

Issue

3

First Page

311

Last Page

314

MeSH Keywords

Attitude of Health Personnel; Comparative Effectiveness Research; Humans; Hyperbilirubinemia; Infant, Newborn; Infant, Premature; Informed Consent; Neonatologists; Practice Guidelines as Topic; Practice Patterns, Physicians'; Risk Assessment; Surveys and Questionnaires

Keywords

Newborn; Risk Assessment

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