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Clinical ethics
Paper
Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees
  1. Rebecca H Li1,
  2. Mary C Wacholtz2,
  3. Mark Barnes1,3,
  4. Liam Boggs4,
  5. Susan Callery-D'Amico5,
  6. Amy Davis6,
  7. Alla Digilova10,
  8. David Forster7,
  9. Kate Heffernan8,
  10. Maeve Luthin8,
  11. Holly Fernandez Lynch9,
  12. Lindsay McNair6,
  13. Jennifer E Miller11,
  14. Jacquelyn Murphy12,
  15. Luann Van Campen13,
  16. Mark Wilenzick14,
  17. Delia Wolf15,
  18. Cris Woolston16,
  19. Carmen Aldinger1,
  20. Barbara E Bierer17
  1. 1Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Boston, Massachusetts, USA
  2. 2Janssen R&D, Johnson & Johnson, Raritan, New Jersey, USA
  3. 3Ropes & Gray LLP, Boston, Massachusetts, USA
  4. 4The Global Health Network/Oxford University, Oxford, UK
  5. 5Quality Assurance, AbbVie, Chicago, Illinois, USA
  6. 6WCG (WIRB- Copernicus Group), Olympia, Washington, USA
  7. 7Health Care Group, Verrill Dana LLP, Boston, Massachusetts, USA
  8. 8Public Responsibility in Medicine and Research, Boston, Massachusetts, USA
  9. 9Petrie-Flom Center, Harvard Law School, Cambridge, Massachusetts, USA
  10. 10Morgan Lewis, New York, NY, USA
  11. 11NYU Langone Medical Center, New York, New York, USA
  12. 12Colorado School of Public Health Anschutz Medical Campus Aurora, CO
  13. 13Eli Lilly and Company, Indianapolis, Indiana, USA
  14. 14International AIDS Vaccine Initiative, New York, New York, USA
  15. 15Harvard School of Public Health, Boston, Massachusetts, USA
  16. 16Sanofi, New York, New York, USA
  17. 17Multi-Regional Clinical Trials Center, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA
  1. Correspondence to Dr Rebecca Li, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, 14 Story Street, 4th Floor, Cambridge, MA 02138, USA; RLi{at}bwh.harvard.edu

Abstract

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval.

  • Clinical Ethics
  • Clinical trials
  • Ethics
  • Ethics Committees/Consultation

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/medethics-2014-102540

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    • Correction
      Correction
      BMJ Publishing Group Ltd and Institute of Medical Ethics
      Journal of Medical Ethics 2016; 42 449-449 Published Online First: 11 Apr 2016. doi: 10.1136/medethics-2014-102540corr1

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