Nonbeneficial Research With Individuals Who Cannot Consent: Is It Ethically Better to Enroll Healthy or Affected Individuals?
Wilfond, Benjamin S.
IRB: Ethics and Human Research 2003 July-August; 25(4): 1-4
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How Do Institutional Review Boards Apply the Federal Risk and Benefit Standards for Pediatric Research? Shah, Seema; Whittle, Amy; Wilfond, Benjamin; Gensler, Gary; Wendler, David (2004-01-28)CONTEXT: Federal regulations allow children in the United States to be enrolled in clinical research only when the institutional review board (IRB) determines that the risks are minimal or a minor increase over minimal, ...
Wendler, David; Shah, Seema (2003-09)The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable ...