Acceptable risks and burdens for children in research without direct benefit: a systematic analysis of the decisions made by the Dutch Central Committee
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
Learn more about PhilPapers
Journal of Medical Ethics 36 (7):420-424 (2010)
Objectives To evaluate whether the requirement of “minimal risk and burden” for paediatric research without direct benefit to the subjects compromises the ability to obtain data necessary for improving paediatric care. To provide evidence-based reflections on the EU recommendation that allows for a higher level of risk. Design and setting Systematic analysis of the approval/rejection decisions made by the Dutch Central Committee on Research involving Human Subjects (CCMO). Review methods The analysis included 165 proposals for paediatric research without direct benefit that were reviewed by the CCMO between January, 2000, and July, 2007. A separate, in-depth analysis of all drug studies included 18 early phase drug studies and nine other drug studies without direct benefit. Results 11 out of 165 studies were definitively rejected because the CCMO did not regard the risk and/or burden to be minimal. In three of these 11 cases (including two early phase drug studies) the requirement of minimal risk and burden was cited as the only reason for rejection. Four other early phase drug studies also involved risks and/or burdens that were not regarded to be minimal but were nevertheless approved. Conclusions The requirement of minimal risk and burden, aiming to protect research subjects, occasionally leads to rejection of protocols. Early phase drug studies relatively often do not comply with the requirement. Committees may find ways to approve important studies that formally should be rejected, but that is not a desirable solution. The regulatory framework should be revised to make such occasional exceptions to the requirement legitimate and transparent
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
David Wendler (2012). A New Justification for Pediatric Research Without the Potential for Clinical Benefit. American Journal of Bioethics 12 (1):23 - 31.
Alexander Friedman, Emily Robbins & David Wendler (2012). Which Benefits of Research Participation Count as 'Direct'? Bioethics 26 (2):60-67.
Georg Spielthenner (2012). Risk-Benefit Analysis: From a Logical Point of View. [REVIEW] Journal of Bioethical Inquiry 9 (2):161-170.
Annette Rid & David Wendler (2011). A Framework for Risk-Benefit Evaluations in Biomedical Research. Kennedy Institute of Ethics Journal 21 (2):141-179.
Barry Lyons (2012). Solidarity, Children and Research. Bioethics 26 (7):369-375.
David Wendler & Seema Shah (2003). Should Children Decide Whether They Are Enrolled in Nonbeneficial Research? American Journal of Bioethics 3 (4):1 – 7.
Janet Malek (2007). Understanding Risks and Benefits in Research on Reproductive Genetic Technologies. Journal of Medicine and Philosophy 32 (4):339 – 358.
David Wendler (2005). Protecting Subjects Who Cannot Give Consent: Toward a Better Standard for "Minimal" Risks. Hastings Center Report 35 (5):37-43.
Ana S. Iltis (2011). Justice, Fairness, and Membership in a Class: Conceptual Confusions and Moral Puzzles in the Regulation of Human Subjects Research. Journal of Law, Medicine & Ethics 39 (3):488-501.
Gillian Nycum & Lynette Reid (2007). The Harm-Benefit Tradeoff in "Bad Deal" Trials. Kennedy Institute of Ethics Journal 17 (4):321-350.
Christian Munthe, Susanna Radovic & Henrik Anckarsäter (2010). Ethical Issues in Forensic Psychiatric Research on Mentally Disordered Offenders. Bioethics 24 (1):35-44.
Teresa Moore & Kristy Richardson (2013). The Low Risk Research Ethics Application Process at CQUniversity Australia. Journal of Academic Ethics 11 (3):211-230.
Eric G. Yan & Kerim M. Munir (2004). Regulatory and Ethical Principles in Research Involving Children and Individuals with Developmental Disabilities. Ethics and Behavior 14 (1):31 – 49.
Anna E. Westra, Jan M. Wit, Rám N. Sukhai & Inez D. de Beaufort (2011). Regulating “Higher Risk, No Direct Benefit” Studies in Minors. American Journal of Bioethics 11 (6):29 - 31.
Charles Weijer & Paul B. Miller (2007). Refuting the Net Risks Test: A Response to Wendler and Miller's "Assessing Research Risks Systematically". Journal of Medical Ethics 33 (8):487-490.
Added to index2010-09-13
Total downloads7 ( #440,687 of 1,911,679 )
Recent downloads (6 months)2 ( #322,162 of 1,911,679 )
How can I increase my downloads?