You are here

Article Text

Article menu

Download PDFPDF

Research ethics
Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial
  1. Joseph E Andrews1,
  2. J Brian Moore1,
  3. Richard B Weinberg1,
  4. Mysha Sissine2,
  5. Sabina Gesell3,
  6. Jacquie Halladay4,
  7. Wayne Rosamond5,
  8. Cheryl Bushnell2,
  9. Sara Jones5,
  10. Paula Means1,
  11. Nancy M P King6,
  12. Diana Omoyeni1,
  13. Pamela W Duncan2
  14. on behalf of COMPASS investigators and stakeholders
  1. 1 Institutional Review Board, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA
  2. 2 Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA
  3. 3 Public Health Sciences Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA
  4. 4 Department of Family Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
  5. 5 Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA
  6. 6 Center for Bioethics, Health, and Society; Public Health Sciences Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA
  1. Correspondence to Dr Joseph E Andrews, Institutional Review Board, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA; jandrews{at}wakehealth.edu

Abstract

Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments.

Trial registration number NCT02588664, recruiting. This article covers the development of consent process that is currentlty being employed in the study.

  • informed consent
  • research ethics
  • ethics committees/consultation
  • clinical trials
  • regulation

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-2017-104478

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors JEA, RBW, JBM, PD, PM and DO contributed to the planning and conceptual design of the consent process discussed in this article from the perspective of the Institutional Review Board. They worked with the clinical trial investigators to design the innovative consent process. NMPK is a bioethicist who worked with the IRB and investigators to ensure that the ethical issues were fully explored and that the design chosen was acceptable. CB, WR, JH, SJ and SG contributed to the planning and design of the clinical trial itself, as well as the consent process discussed in this paper. CB, WR and JH contributed to the conduct of the clinical trial itself. SJ and SG contributed to the conduct of the study and the data acquisition and analysis. All of the authors contributed to and reviewed the manuscript prior to submission.

    • Funding This study was funded by the Patient-Centered Outcomes Research Institute, 10.13039/100006093 (Grant No: PCS-1403-14532) and the National Center for Advancing Translational Sciences, 10.13039/100006108 (Grant No: UL1 TR001420).

    • Competing interests None declared.

    • Patient consent Obtained

    • Ethics approval The Wake Forest University Health Sciences IRB.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    Other content recommended for you