INFORMED CONSENT - PROTECTION OR OBSTACLE - SOME EMERGING ISSUES

There is widespread consensus on the need for informed consent procedu res in medical research. Nevertheless, aspects of the informed consent process remain controversial, and innovative approaches to research m ay raise new issues and concerns. The randomized consent design for cl inical trials, proposed by Zelen (N Engl J Med 1979; 300:1242-1245), p ermitted physicians to randomize patients without consent, then obtain informed consent from only those patients randomized to the experimen tal (as opposed to the standard treatment) arm. More recently, the pro posal has been made to allow waiver of informed consent for study of p atients in emergency circumstances who may be temporarily incapable of providing such consent, and for whom no family member is immediately available to give a ''proxy'' consent (Biros M.H. et al. JAMA 1995; 27 3:1283-1287). The medical community and federal regulatory policy have responded differently to these proposals. Published by Elsevier Scien ce Inc. 1997.