Building a Central Repository for Research Ethics Consultation Data: A Proposal for a Standard Data Collection Tool
Mildred K Cho1, Holly Taylor2, Jennifer B McCormick3
1Stanford University, Stanford, California, USA.
Clinical and Translational Science
|March 12, 2015
Summary
Clinical research ethics consultation services are improving through a standardized data collection approach. This framework supports quality improvement, education, and research, enhancing ethical research conduct across institutions.
Area of Science:
- Clinical Research Ethics
- Health Services Research
- Bioethics
Background:
- Clinical research ethics consultation services have grown in academic health centers.
- Standardized data collection is needed for quality improvement, education, and research.
- Collaboration within the CTSA consortium is key to developing these standards.
Purpose of the Study:
- To develop a standard approach for collecting clinical research ethics consultation information.
- To establish a foundation for quality improvement, education, and research in clinical ethics consultation.
- To explore challenges in sharing consultation data between institutions.
Main Methods:
- Developed a categorization system for research ethics consultation data.
- Defined descriptive information categories: requestor, project, ethical question, consult process, and consult note structure.
- Explored data sharing challenges including confidentiality, data quality, and informatics.
Main Results:
- A structured approach to documenting research ethics consultations was created.
- Identified key data points for consultation services.
- Highlighted challenges in inter-institutional data sharing.
Conclusions:
- Standardized data collection tools can advance clinical research ethics consultation.
- Improved consultation processes facilitate the ethical conduct of research.
- Further work is needed to refine data sharing and utilization.
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