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

Patient awareness and approval for an opt-out genomic biorepository.

Author information

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

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