Children in medical research: balancing protection and access--has the pendulum swung too far?
ABSTRACT This paper examines the changes in policies regarding children in research between 1966 and 2003. The changes reflect a shift in focus from protection to access. The need for protection was brought to light in 1966, with the publication of Henry Beecher's "Ethics and Clinical Research," which described 22 research projects that he considered unethical. Four of these involved child subjects. Within a few years, Paul Ramsey and Richard McCormick debated the ethical acceptability of enrolling children in any non-therapeutic research. The first U.S. policies to address the protection of human subjects were written in the 1970s and 1980s, and additional protections (Subpart D) were provided to child subjects, who were considered particularly vulnerable. In the 1990s, however, several new policies were implemented by the National Institutes of Health, the Food and Drug Administration, and Congress, in which the focus had shifted from protecting children from research risks to ensuring access. The article describes the new policies, examines the motivations for the change, and describes some of the effects of these policies. It concludes by suggesting that greater attention must be paid to ensure that increased access is not achieved by undermining the additional protections to children provided by Subpart D.
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ABSTRACT: Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake of society and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects.Medicine Health Care and Philosophy 07/2014; 18(1). DOI:10.1007/s11019-014-9586-5 · 0.91 Impact Factor
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ABSTRACT: Subpart D of the Common Rule establishes 4 categories of research that may be conducted on children. One category, 45 CFR 46.406, permits research posing a minor increase over minimal risk and no prospect of direct benefit but expected to yield vital knowledge about the subjects' disorder or condition. To include other children in research posing a minor increase over minimal risk and no prospect of direct benefit requires federal review and approval of the Secretary of Health and Human Services under 45 CFR 46.407. It is widely held that children generally should not be exposed to more than minimal risk in research without the prospect of direct benefit. To justify deviating from this norm, as 406 allows, two claims must be true: (1) When there is vital knowledge to be gained from studying children, it is permissible to expose some children to a minor increase over minimal risk with no prospect of direct benefit; (2) It is permissible for locally reviewed and approved research to expose only children with the disorder or condition under investigation to greater risk with no prospect of direct benefit. The justification for (1) appears to be grounded in the magnitude of benefit to society combined with the need to study children. This article demonstrates that, even if the necessity and magnitude of benefit to society justify exposing children to increased risk, the decision to categorically restrict participation in such research to children with the disorder or condition under investigation (unless the study is federally reviewed and approved) is not justified. Subpart D should be revised.Accountability in Research 01/2007; 14(1):19-34. DOI:10.1080/08989620601104782 · 0.72 Impact Factor