Citations 2
Building a Central Repository for Research Ethics Consultation Data: A Proposal for a Standard Data Collection Tool
Cho, Mildred K. , Anderson, Nick, Barnard, David , Boyle, Mary B., Capron, Alexander Morgan , Dorfman, Elizabeth, Havard, Kathryn, Reider, Carson, Sadler, John Z. , Sharp, Richard R. , Wilfond, Benjamin S. , McCormick, Jennifer B, Taylor, Holly A. , McCormick, Jennifer Blair , Anderson, Nick, Schwartz, Peter H. , Danis, Marion , Sharp, Richard R
Clinical and Translational Science | March 10, 2015 | Volume: 8 | Issue: 4 | Pages: 376-387
AbstractClinical 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.
The Establishment of Research Ethics Consultation Services (RECS): An Emerging Research Resource
Sharp, Richard R. , Ottenberg, Abigale L., Reider, Carson, Wilfond, Benjamin S. , McCormick, Jennifer Blair , Taylor, Holly A. , Sharp, Richard R
Clinical and Translational Science | December 6, 2012 | Volume: 6 | Issue: 1 | Pages: 40-44
AbstractEmphasis on translational research to facilitate progression from the laboratory into the community also creates a dynamic in which ethics and social policy questions and solutions are ever pressing. In response, academic institutions are creating Research Ethics Consultation Services (RECS). All Clinical Translational Science Award institutions were surveyed in early 2010 to determine which institutions have a RECS in operation and what is their composition and function. Of the 46 institutions surveyed, 33 (70%) have a RECS. Only 15 RECS have received any consult requests in the last year. Issues that are common among these relatively nascent services include relationships with institutional oversight committees, balancing requestor concerns about confidentiality with research integrity and human subjects protection priorities, tracking consult data and outcomes, and developing systems for internal evaluation. There is variability in how these issues are approached. It will be important to be attentive to the institutional context to develop an appropriate approach. Further data about the issues raised by requestors and the recommendations provided are necessary to build a community of scholars who can navigate and resolve ethical issues encountered along the translational research pathway. Clin Trans Sci 2013; Volume 6: 40–44