Patient awareness and approval for an opt-out genomic biorepository

Kyle B Brothers; Mathew J Westbrook; M Frances Wright; John A Myers; Daniel R Morrison; Jennifer L Madison; Jill M Pulley; Ellen Wright Clayton

doi:10.2217/pme.13.34

Patient awareness and approval for an opt-out genomic biorepository

Per Med. 2013 Jun;10(4):10.2217/pme.13.34. doi: 10.2217/pme.13.34.

Authors

Kyle B Brothers¹, Mathew J Westbrook², M Frances Wright², John A Myers³, Daniel R Morrison⁴, Jennifer L Madison⁵, Jill M Pulley⁵, Ellen Wright Clayton⁶

Affiliations

¹ Center for Biomedical Ethics & Society, Vanderbilt University, Nashville, TN, USA ; Department of Pediatrics, Vanderbilt University & the Monroe Carell Jr.Children's Hospital at Vanderbilt, Nashville, TN, USA ; Kosair Charites Pediatric Clinical, Research Unit, Department of Pediatrics, University of Louisville, School of Medicine, Louisville, KY, USA.
² Center for Biomedical Ethics & Society, Vanderbilt University, Nashville, TN, USA.
³ Child Health Services Research Unit, Department of Pediatrics, University of Louisville School of Medicine, Louisville, KY, USA.
⁴ Center for Biomedical Ethics & Society, Vanderbilt University, Nashville, TN, USA ; Social Science Division, Pepperdine University, Malibu, CA, USA.
⁵ Office of Research, Vanderbilt University School of Medicine, Nashville, TN, USA.
⁶ Center for Biomedical Ethics & Society, Vanderbilt University, Nashville, TN, USA ; Department of Pediatrics, Vanderbilt University & the Monroe Carell Jr.Children's Hospital at Vanderbilt, Nashville, TN, USA.

Abstract

Aim: In this study, we sought to assess patient awareness and perceptions of an opt-out biorepository.

Materials & methods: We conducted exit interviews with adult patients and parents of pediatric patients having their blood drawn as part of their clinical care at Vanderbilt University Medical Center (TN, USA).

Results: 32.9% of all patients and parents of pediatric patients report having heard of the opt-out biorepository, while 92.4% approve of this research effort based on a brief description. Awareness that leftover blood could be used for research increased among adult patients during the study period, from 34.3 to 50.0%.

Conclusion: These findings will inform ongoing assessments of the suitability of opt-out and opt-in methods as alternatives to written informed consent for inclusion in a biorepository.

Keywords: exit interviews; human nonsubjects biorepository; iorepository; opt-out research; research ethics.

Abstract

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