Children in Medical Research: balancing protection and access: has the pendulum swung too far?
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.
Available from: Marcin Waligora
- "The next step was the recognition of the importance of evidence based medicine. The main premises here are that only evidence based medicine can be really and consistently beneficial and that no population should become therapeutically orphaned and left without safe and proven therapies (Ross 2004). Consequently, the involvement of children in biomedical research was justified by two important principles of medical ethics: beneficence and justice. "
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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.
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ABSTRACT: Efforts to make physical therapy more evidence based have increased demand for human participants, raising concerns for their safety and welfare. This study examined how often research articles in physical therapy journals report basic ethical protections.
We carried out a retrospective audit of research articles in 6 physical therapy journals between 1996 and 2001.
Of 806 articles reviewed, 48% documented both research ethics committee approval and informed consent. Articles reporting clinical interventions had the highest reported rate (64%) of both protections. Articles reporting qualitative methods, chart reviews, and case reports had the lowest rates of documentation of both requirements: 30%, 17%, and 11%, respectively. Reported rates of both requirements in vulnerable populations were 55% for children, 48% for students, and 33% for employees. Twenty-six percent of articles included confidentiality assurances. Case reports were most likely and chart reviews were least likely to mention confidentiality: 88% and 8%, respectively.
There is no uniform editorial policy among physical therapy journals for reporting basic ethical requirements. Physical therapy journals should standardize ethical protections and make documentation of compliance a prerequisite of publication.
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