Protecting subjects who cannot give consent: toward a better standard for "minimal" risks.

When children and incapacitated adults are enrolled in research that cannot directly benefit them, they can be exposed to no more than "minimal" risks, according to guidelines accepted around the world. We need a new standard for what "minimal" risks are, however--one that recognizes that participating in non-beneficial research is like participating in a charitable activity. Such a standard appears likely to provide more stringent protections for these vulnerable populations.