By Lainie Friedman Ross

Lainie Ross provides a rigorous severe research of the improvement of coverage governing the involvement of youngsters in scientific examine. She examines the shift in concentration from security of scientific learn matters, enshrined in post-World warfare II laws, to the present period during which entry is assuming better priority. notorious experiences similar to Willowbrook (where mentally retarded teenagers have been contaminated with hepatitis) are proof that sooner than the coverage shift safety used to be now not constantly sufficient, even for the main weak teams. extra safeguards for kids have been first carried out in lots of international locations within the Nineteen Seventies and Nineteen Eighties; newer rules and directions are attempting to advertise better participation. Ross examines no matter if the safeguards paintings, whether or not they are reasonable, and the way they observe in real examine perform, and he or she deals particular concepts to change present guidelines and guidance.

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Washington DC: US Government Printing Office, 1976, DHEW Publication No. (OS) 76–128, section 10, 10–7, 10–8. 83. , A Theory of Justice. Cambridge MA: Harvard University Press, 1972, 249 as cited by V. Worsfold, ‘A Philosophical Justification of Children’s Rights’, Harvard Educational Review, 44 (1974), 142–57, 154–5. Balancing Protection and Access in Pediatric Research 84. 85. 86. 87. 37 National Commission, Research Involving Children, 107. Ramsey, Patient as Person, 24. Beecher, Research and the Individual, 63.

Corson, J. , and Wilson, R. , ‘Effect of Thymectomy on Skin-Homograft Survival in Children’, New England Journal of Medicine, 270 (1964), 707–10. This is case study 6 in Beecher’s ‘Ethics and Clinical Research’. 28. Beecher, ‘Ethics and Clinical Research’, 1357. 29. Of note, Beecher was not the first to question the ethics of this study. , ‘Thymus Experimentation’, New England Journal of Medicine, 270 (1964), 1018–19, 1019. ’ The editors stated that ‘[t]he question is especially disturbing when it involves children .

The study raises a number of ethical issues similar to the Willowbrook study, in that it enrolled institutionalized individuals, particularly children and those with mental retardation. Enrolling institutionalized children for acne studies may be even more troublesome than the hepatitis research because the knowledge generated from the hepatitis studies would be of particular relevance to institutionalized children whereas the acne studies would not. [27] Eleven of the eighteen children would undergo an unnecessary thymectomy as part of the operation; the other seven would serve as controls.

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