Regulating "Higher Risk, No Direct Benefit" Studies in Minors
Westra, Anna E
Wit, Jan M
Sukhai, Rám N
de Beaufort, Inez D
The American journal of bioethics : AJOB 2011 Jun; 11(6): 29-31
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Acceptable Risks and Burdens for Children in Research Without Direct Benefit: A Systematic Analysis of the Decisions Made by the Dutch Central Committee Westra, Anna E; Sukhai, Rám N; Wit, Jan M; de Beaufort, Inez D; Cohen, Adam F (2010-07)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 ...