Towards a balanced approach to identifying conflicts of interest faced by institutional review boards
Theoretical Medicine and Bioethics 36 (5):341-361 (2015)
AbstractThe welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest faced by investigators and researchers in clinical investigations, an area that is less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection
Similar books and articles
Intrinsic Conflicts of Interest in Clinical Research: A Need for Disclosure.Sharmon Sollitto, Sharona Hoffman, Maxwell J. Mehlman, Robert J. Lederman, Stuart J. Youngner & Michael M. Lederman - 2003 - Kennedy Institute of Ethics Journal 13 (2):83-91.
A plea for pragmatism in clinical research ethics.David H. Brendel & Franklin G. Miller - 2008 - American Journal of Bioethics 8 (4):24 – 31.
Clinical Study Reflections: Another View: Commentary on: “Raising Suspicions with the Food and Drug Administration: Detecting Misconduct”.Patricia Spitzig - 2010 - Science and Engineering Ethics 16 (4):705-711.
Competing interests: The need to control conflict of interests in biomedical research.Daniel Steiner - 1996 - Science and Engineering Ethics 2 (4):457-468.
Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflict of Interest Committees, and Investigators.Kevin P. Weinfurt, Joëlle Y. Friedman, Michaela A. Dinan, Jennifer S. Allsbrook, Mark A. Hall, Jatinder K. Dhillon & Jeremy Sugarman - 2006 - Journal of Law, Medicine and Ethics 34 (3):581-591.
Toward a More Comprehensive Approach to Protecting Human Subjects: The Interface of Data Safety Monitoring Boards and Institutional Review Boards in Randomized Clinical Trials.Valery M. Gordon, Jeremy Sugarman & Nancy Kass - 1998 - IRB: Ethics & Human Research 20 (1):1.
Conflicts of Interest in Clinical Practice and Research.Roy G. Spece, David S. Shimm & Allen E. Buchanan (eds.) - 1996 - Oxford University Press.
Managing financial conflicts of interest in clinical research.Jordan J. Cohen - 2002 - Science and Engineering Ethics 8 (3):401-406.
Health service research: the square peg in human subjects protection regulations.L. S. Gittner, M. J. Roach, G. Kikano, S. Grey & N. V. Dawson - 2011 - Journal of Medical Ethics 37 (2):118-122.
Symposium: Human Subjects Research and the Role of the Institutional Review Boards: Conflicts and Challenges.J. A. Goldner - 2000 - Journal of Law, Medicine and Ethics 28:379-404.
Internet research ethics and the institutional review board: current practices and issues.Elizabeth A. Buchanan & Charles M. Ess - 2009 - Acm Sigcas Computers and Society 39 (3):43-49.
Financial conflicts of interest in research with human subjects : a clinical research organization's perspective.Douglas Peddicor - 2010 - In Thomas H. Murray & Josephine Johnston (eds.), Trust and Integrity in Biomedical Research: The Case of Financial Conflicts of Interest. Johns Hopkins University Press. pp. 241.
Clinical study reflections: Another view commentary on: “Raising suspicions with the food and drug administration: Detecting misconduct”.Patricia Spitzig - 2010 - Science and Engineering Ethics 16 (4):705-711.
Ten Questions Institutional Review Boards Should Ask When Reviewing International Clinical Research Protocols.Daniel W. Fitzgerald, Angela Wasunna & Jean William Pape - 2003 - IRB: Ethics & Human Research 25 (2):14.
A commentary on Dr. Kennedy's perception of the impact of Institutional Review Boards on cancer research.Herman Wigodsky - 1984 - Journal of Bioethics 5 (1):33-40.
Added to PP
Historical graph of downloads
Citations of this work
Dangers of neglecting non-financial conflicts of interest in health and medicine.Miriam Wiersma, Ian Kerridge & Wendy Lipworth - 2018 - Journal of Medical Ethics 44 (5):319-322.
Pharamaceutical Promotion and Its Influence on Perscription Behavior: Ethical Issues and Legal Framework in India.Pankhuri Agarwal & Sharon Kaur - 2017 - Asian Bioethics Review 9 (1-2):73-85.
References found in this work
Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making.David J. Rothman - 2003 - Aldinetransaction.
Conflicts of interest in medicine: a philosophical and ethical morphology.Edmund L. Erde - 1996 - In Roy G. Spece, David S. Shimm & Allen E. Buchanan (eds.), Conflicts of Interest in Clinical Practice and Research. Oxford University Press. pp. 12--41.
Factors influencing the effectiveness of research ethics committees.C. A. Schuppli & D. Fraser - 2007 - Journal of Medical Ethics 33 (5):294-301.
Moral reasoning and the review of research involving human subjects.Lisa Eckenwiler - 2001 - Kennedy Institute of Ethics Journal 11 (1):37-69.