Original Article | Published:

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

Journal of Perinatology volume 37, pages 311314 (2017) | Download Citation

Subjects

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To examine how neonatologists determine which risks require inclusion for informed consent per the ‘Common Rule’ and ‘Draft Guidance’ regulations in comparative effectiveness research (CER).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 Respondents would not currently disclose many of the treatment risks but would disclose more if the Draft Guidance were enacted into law.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Findings suggest the Draft Guidance requires disclosure of more risks than does the Common Rule; applying either rule results in disclosure of more risks than in standard clinical care.

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Acknowledgements

We thank the neonatology researchers for their time in sharing their views with us. We thank NorthShore University HealthSystem Evanston Hospital for providing financial support for Dr Feltman’s subscription to the online survey tool used for this study. The funder had no direct role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication.

Author information

Affiliations

  1. Division of Neonatology, Department of Pediatrics, Evanston Hospital, NorthShore University HealthSystem, Evanston, IL, USA

    • D M Feltman
  2. University of Chicago Pritzker School of Medicine Chicago, IL, USA

    • D M Feltman
  3. Children’s Mercy Hospital, Kansas City, MO, USA

    • J D Lantos

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Competing interests

Dr. Lantos receives royalties on five books he has written about bioethics. He receives occasional honoraria for lectures, including lectures about research ethics. Dr Feltman currently serves on her center’s Institutional Review Board, although did not at the time of data collection.

Corresponding author

Correspondence to D M Feltman.

Supplementary information

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DOI

https://doi.org/10.1038/jp.2016.228

Supplementary Information accompanies the paper on the Journal of Perinatology website (http://www.nature.com/jp).