When science takes man as its subject, tensions arise between two values basic to Western society: freedom of scientific inquiry and protection of individual inviolability.... At the heart of this conflict lies an age-old question: When may a society, actively or by acquiescence, expose some of its members to harm in order to seek benefits for them, for others, or for society as a whole?

Few early debates in bioethics invigorated the field to the same extent as the one concerning whether or not young children could be used in nontherapeutic research. Though some of the issues in the debate were never fully settled, a consensus emerged, reflected in the Common Rule—that surrogates could consent to use children in such research, although once the level of risk rises above minimal, additional stipulations are required. Nontherapeutic research on cognitively impaired elderly people raises equally complex ethical issues, (...) but there has been a dearth of debate in the literature about whether such research is ethically permissible. Instead, there have been many published recommendations regarding the circumstances under which such research can occur. (shrink)

When science takes man as its subject, tensions arise between two values basic to Western society: freedom of scientific inquiry and protection of individual inviolability.... At the heart of this conflict lies an age-old question: When may a society, actively or by acquiescence, expose some of its members to harm in order to seek benefits for them, for others, or for society as a whole?

The voluntary and informed consent of subjects has been the central focus of concern in research reviews, overshadowing the importance of all other considerations. The Nuremberg Code, with its rights-based protection of the subject's autonomy above all else, made it difficult to justify research with no intended benefit when subjects are incompetent to make a valid informed choice to participate. Subsequent codes providing for research with incompetent subjects followed the lead of Nuremberg, substituting the informed authorization of a proxy for (...) the informed consent of the subject. (shrink)