TY - JOUR
T1 - The Emergence of Clinical Research Ethics Consultation
T2 - Insights From a National Collaborative
AU - on behalf of the Clinical Research Ethics Consultation Collaborative Repository Group
AU - Porter, Kathryn M.
AU - Danis, Marion
AU - Taylor, Holly A.
AU - Cho, Mildred K.
AU - Wilfond, Benjamin S.
AU - Capron, Alexander M.
AU - Cho, Mildred K.
AU - Danis, Marion
AU - Hester, D. Micah
AU - Limehouse, Walter E.
AU - Reider, Carson
AU - Sharp, Richard R.
AU - Taylor, Holly A.
AU - Wilfond, Benjamin S.
AU - Yarborough, Mark
N1 - Funding Information:
This work was supported by the National Center for Advancing Translational Sciences of the NIH to the Institute of Translational Health Sciences: UL1 RR025014-04S1 (Research Bioethics Consultation Standardization and Data Sharing). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The authors were part of the following CTSAs: Institute of Translational Health Sciences (UL1 TR000423), Johns Hopkins Institute for Clinical and Translational Research (UL1 TR001079) and The Stanford Center for Clinical and Translational Research and Education (UL1 TR001085). This work was also supported by the Department of Bioethics at the Clinical Center which is part of the intramural program of the National Institutes of Health. ■
Publisher Copyright:
© 2018, Copyright © Taylor & Francis Group, LLC.
PY - 2018/1/2
Y1 - 2018/1/2
N2 - The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards (IRBs), to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation (REC) services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research.
AB - The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards (IRBs), to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation (REC) services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research.
KW - Institutional Review Board (IRB)
KW - ethics consultation
KW - human subjects research
KW - informed consent
KW - research ethics
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U2 - 10.1080/15265161.2017.1401156
DO - 10.1080/15265161.2017.1401156
M3 - Article
C2 - 29313771
AN - SCOPUS:85041136963
SN - 1526-5161
VL - 18
SP - 39
EP - 45
JO - American Journal of Bioethics
JF - American Journal of Bioethics
IS - 1
ER -