Skip to main content

Table 3 Conditions for federal approval of research that is not IRB-approvable according to any other regulatory standards

From: Overcoming burdens in the regulation of clinical research in children. Proceedings of a consensus conference, in historical context

45 CFR 46.407 (FDA 21 CFR 50.54 analogous). "Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. HHS will conduct or fund research that the IRB does not believe meets the requirements of §46.404, §46.405, or §46.406 only if:
   (a) the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and
   (b) the Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either:
  (1) that the research in fact satisfies the conditions of §46.404, §46.405, or §46.406, as applicable, or
  (2) the following:
   (i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
   (ii) the research will be conducted in accordance with sound ethical principles; and
   (iii) adequate provisions are made for soliciting the assent of children and the
permission of their parents or guardians, as set forth in §46.408."