Page:United States Statutes at Large Volume 114 Part 2.djvu/248

 114 STAT. 1130 PUBLIC LAW 106-310—OCT. 17, 2000 42 USC 285g note. Establishment. (1) the appropriateness of the regulations for children of differing ages and maturity levels, including legal status; (2) the definition of "minimal risk" for a healthy child or for a child with an illness; (3) the definitions of "assent" and "permission" for child clinical research participants and their parents or guardians and of "adequate provisions" for soliciting assent or permission in research as such definitions relate to the process of obtaining the agreement of children participating in research and the parents or guardians of such children; (4) the definitions of "direct benefit to the individual subjects" and "generalizable knowledge about the subject's disorder or condition"; (5) whether payment (financial or otherwise) may be provided to a child or his or her parent or guardian for the participation of the child in research, and if so, the amount and type given; (6) the expectations of child research participants and their parent or guardian for the direct benefits of the child's research involvement; (7) safeguards for research involving children conducted in emergency situations with a waiver of informed assent; (8) parent and child notification in instances in which the regulations have not been complied with; (9) compliance with the regulations in effect on the date of the enactment of this Act, the monitoring of such compliance, and enforcement actions for violations of such regulations; and (10) the appropriateness of current practices for recruiting children for participation in research. (c) CONSULTATION.—In conducting the review under subsection (a), the Secretary of Health and Human Services shall consult broadly with experts in the field, including pediatric pharmacologists, pediatricians, pediatric professional societies, bioethics experts, clinical investigators, institutional review boards, industry experts, appropriate Federal agencies, and children who have participated in research studies and the parents, guardians, or families of such children. (d) CONSIDERATION OF ADDITIONAL PROVISIONS.—In conducting the review under subsection (a), the Secretary of Health and Human Services shall consider and, not later than 6 months after the date of the enactment of this Act, report to Congress concerning— (1) whether the Secretary should establish data and safety monitoring boards or other mechanisms to review adverse events associated with research involving children; and (2) whether the institutional review board oversight of clinical trials involving children is adequate to protect children. SEC. 1004. LONG-TERM CHILD DEVELOPMENT STUDY. (a) PURPOSE. — It is the purpose of this section to authorize the National Institute of Child Health and Human Development to conduct a national longitudinal study of environmental influences (including physical, chemical, biological, and psychosocial) on children's health and development. (b) IN GENERAL. — The Director of the National Institute of Child Health and Human Development shall establish a consortium of representatives from appropriate Federal agencies (including the

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