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Clin Transl Sci. 2015 Aug;8(4):376-87. doi: 10.1111/cts.12268. Epub 2015 Mar 10.

Building a Central Repository for Research Ethics Consultation Data: A Proposal for a Standard Data Collection Tool.

Author information

1
Stanford University, Stanford, California, USA.
2
Johns Hopkins University, Baltimore, Maryland, USA.
3
Mayo Clinic, Rochester, Minnesota, USA.
4
University of California at Davis, Davis, California, USA.
5
Oregon Health & Science University, Portland, Oregon, USA.
6
Hutchinson Cancer Research Center, Seattle, Washington, USA.
7
University of Southern California, Los Angeles, California, USA.
8
University of Washington, Seattle, Washington, USA.
9
University of Cincinnati, Cincinnati, Ohio, USA.
10
The Ohio State University, Columbus, Ohio, USA.
11
University of Texas, Southwestern, Dallas, Texas, USA.
12
Indiana University School of Medicine, Indianapolis, Indiana, USA.
13
National Institutes of Health Clinical Center, Bethesda,, Maryland, USA.
14
Seattle Children's Research Institute, Seattle, Washington, USA.

Abstract

Clinical research ethics consultation services have been established across academic health centers over the past decade. This paper presents the results of collaboration within the CTSA consortium to develop a standard approach to the collection of research ethics consultation information to serve as a foundation for quality improvement, education, and research efforts. This approach includes categorizing and documenting descriptive information about the requestor, research project, the ethical question, the consult process, and describing the basic structure for a consult note. This paper also explores challenges in determining how to share some of this information between collaborating institutions related to concerns about confidentially, data quality, and informatics. While there is much still to be learned to improve the process of clinical research ethics consultation, these tools can advance these efforts, which, in turn, can facilitate the ethical conduct of research.

KEYWORDS:

FDA; biostatistics; consultation; ethics; quality improvement

PMID:
25758372
PMCID:
PMC4888071
DOI:
10.1111/cts.12268
[Indexed for MEDLINE]
Free PMC Article

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