title: Building a Central Repository for Research Ethics Consultation Data: A Proposal for a Standard Data Collection Tool.
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.
authors.affiliation: Stanford University, Stanford, California, USA.
authors.forename: Mildred K
authors.initials: MK
authors.lastname: Cho
authors.affiliation: Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Holly
authors.initials: H
authors.lastname: Taylor
authors.affiliation: Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Jennifer B
authors.initials: JB
authors.lastname: McCormick
authors.affiliation: University of California at Davis, Davis, California, USA.
authors.forename: Nick
authors.initials: N
authors.lastname: Anderson
authors.affiliation: Oregon Health & Science University, Portland, Oregon, USA.
authors.forename: David
authors.initials: D
authors.lastname: Barnard
authors.affiliation: Hutchinson Cancer Research Center, Seattle, Washington, USA.
authors.forename: Mary B
authors.initials: MB
authors.lastname: Boyle
authors.affiliation: University of Southern California, Los Angeles, California, USA.
authors.forename: Alexander M
authors.initials: AM
authors.lastname: Capron
authors.affiliation: University of Washington, Seattle, Washington, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Dorfman
authors.affiliation: University of Cincinnati, Cincinnati, Ohio, USA.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Havard
authors.affiliation: The Ohio State University, Columbus, Ohio, USA.
authors.forename: Carson
authors.initials: C
authors.lastname: Reider
authors.affiliation: University of Texas, Southwestern, Dallas, Texas, USA.
authors.forename: John
authors.initials: J
authors.lastname: Sadler
authors.affiliation: Indiana University School of Medicine, Indianapolis, Indiana, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Schwartz
authors.affiliation: Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Richard R
authors.initials: RR
authors.lastname: Sharp
authors.affiliation: National Institutes of Health Clinical Center, Bethesda,, Maryland, USA.
authors.forename: Marion
authors.initials: M
authors.lastname: Danis
authors.affiliation: University of Washington, Seattle, Washington, USA.|Seattle Children's Research Institute, Seattle, Washington, USA.
authors.forename: Benjamin S
authors.initials: BS
authors.lastname: Wilfond
mesh_terms: D003625:Data Collection / Q000379:methods*; D033061:Ethics Consultation; D032984:Ethics, Research; D006801:Humans
keywords: FDA; biostatistics; consultation; ethics; quality improvement