Quantifying the federal minimal risk standard: Implications for pediatric research without a prospect of direct benefit

Article Abstract:

The US federal regulations allow institutional review boards (IRBs) to approve pediatric research that does not offer a prospect of direct benefit only when the risks are minimal or when the risks are a minor increase over minimal risk. Data suggest that IRBs may be categorizing as greater than minimal risk many research procedures that qualify, under the federal regulations, as posing no greater than minimal risk to pediatric participants.

Product standards, safety, & recalls, Standards, Clinical trials

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How do institutional review boards apply the federal risk and benefit standards for pediatric research?

Article Abstract:

Different institutional review boards (IRBs) interpret the federal laws governing research on children differently, according to a survey of the chairpersons of 188 IRBs. The laws state that no study on children should be approved if it does not benefit the child and would expose the child to more than a minor increase over minimal risk of injury. Unfortunately, the laws are vague in defining what constitutes a benefit or a risk.

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Pediatric drug studies required by law

Article Abstract:

The US Food and Drug Administration now has the power to require pharmaceutical companies to test all drugs that will be given to children. Some doctors believe the FDA should create an expert panel to oversee this research. All researchers will have to follow strict guidelines to ensure that children will not be harmed by the drugs.

Pharmaceutical industry, Pediatric pharmacology

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