Children as research subjects: A dilemma

A complex problem exists about how to promote the best interests of childre n as a group through research while protecting the rights and welfare of in dividual research subjects. The Nuremberg Code forbids studies without cons ent, eliminating most children as subjects, and the Declaration of Helsinki disallows non-therapeutic research on non-consenting subjects. Both codes are unreasonably restrictive. Another approach is represented by the Counci l for the International Organizations of Medical Science, the U.S. Federal Research Guidelines, and many other national policies. They allow research ethics committees or institutional review boards to authorize studies with acceptable balances of likely benefits and harms, but neither clarify how t o balance them nor explain the meaning of pivotal concepts, like "minimal r isk." Paths to the improvement of balancing or consequentialist approaches include (1) improving standardizing of risk assessment, (2) rejecting crude utilitarianism, (3) identifying and justifying normative or moral judgment s, and (4) acknowledging extra-regulatory thresholds and deontological or n on-negotiable duties to children.