Page:United States Statutes at Large Volume 115 Part 2.djvu/433

 PUBLIC LAW 107-109-^AN. 4, 2002 115 STAT. 1417 (1) The written and oral process of obtaining and defining "assent", "permission" and "informed consent" with respect to child clinical research participants and the parents, guardians, and the individuals who may serve as the legally authorized representatives of such children (as defined in subpart A of part 46 of title 45, Code of Federal Regulations). (2) The expectations and comprehension of child research participants and the parents, guardians, or legally authorized representatives of such children, for the direct benefits and risks of the child's research involvement, particularly in terms of research versus therapeutic treatment. (3) The definition of "minimal risk" with respect to a healthy child or a child with an illness. (4) The appropriateness of the regulations applicable to children of differing ages and maturity levels, including regulations relating to legal status. (5) Whether payment (financial or otherwise) may be provided to a child or his or her parent, guardian, or legally authorized representative for the participation of the child in research, and if so, the amount and type of payment that may be made. (6) Compliance with the regulations referred to in subsection (a)(1)(A), the monitoring of such compliance (including the role of institutional review boards), and the enforcement actions taken for violations of such regulations. (7) The unique roles and responsibilities of institutional review boards in reviewing research involving children, including composition of membership on institutional review boards. (c) REQUIREMENTS OF EXPERTISE.— The Institute of Medicine shall conduct the review under subsection (a)(1) and make recommendations under subsection (a)(2) in conjunction with experts in pediatric medicine, pediatric research, and the ethical conduct of research involving children. SEC. 13. FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH. Section 499 of the Public Health Service Act (42 U.S.C. 290b) is amended— (1) in subsection (b), by inserting "(including collection of funds for pediatric pharmacologic research)" after "mission"; (2) in subsection (c)(1)— (A) by redesignating subparagraph (C) as subparagraph (D); and (B) by inserting after subparagraph (B) the following: "(C) A program to collect funds for pediatric pharmacologic research and studies listed by the Secretary pursuant to section 4091(a)(1)(A) of this Act and referred under section 505A(d)(4)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)(4)(C))."; (3) in subsection (d)— (A) in paragraph (1)— (i) in subparagraph (B)— (I) in clause (ii), by striking "and" at the end; (II) in clause (iii), by striking the period and inserting "; and"; and (III) by adding at the end the following: "(iv) the Commissioner of Food and Drugs."; and

�