ARTICLE;
CHILD;
CHILD HEALTH CARE;
CLINICAL RESEARCH;
DECISION MAKING;
GOVERNMENT;
HEALTH CARE POLICY;
HEALTH CARE QUALITY;
HUMAN;
INFORMED CONSENT;
LAW;
MEDICAL ETHICS;
PROTECTION;
QUALITY OF LIFE;
REIMBURSEMENT;
RESPONSIBILITY;
RISK ASSESSMENT;
BIOMEDICAL AND BEHAVIORAL RESEARCH;
ECONOMICS;
HUMAN EXPERIMENT;
LEGAL ASPECT;
PEDIATRICS;
PROFESSIONAL STANDARD;
RESEARCH ETHICS;
SOCIAL BEHAVIOR;
UNITED STATES;
BIOMEDICAL AND BEHAVIORAL RESEARCH;
CHILD;
ETHICS, RESEARCH;
HUMANS;
INFORMED CONSENT;
PEDIATRICS;
PROFESSIONAL ROLE;
SOCIAL RESPONSIBILITY;
THERAPEUTIC HUMAN EXPERIMENTATION;
UNITED STATES;
Possible barriers to the availability of medical devices intended to treat or diagnose diseases and conditions that affect children; Request for comments
US Food and Drug Administration
US Food and Drug Administration. Possible barriers to the availability of medical devices intended to treat or diagnose diseases and conditions that affect children; Request for comments. Fed Reg. 2004;69:34374-34375.
Institute of Medicine Committee on Clinical Research Involving Children. Field MJ, Behrman RE, eds. Washington, DC: National Academy Press
Institute of Medicine Committee on Clinical Research Involving Children. Ethical Conduct of Clinical Research Involving Children. Field MJ, Behrman RE, eds. Washington, DC: National Academy Press; 2004.
Institute of Medicine Committee on Assessing the System for Protecting Human Research Participants. Federman DD, Hanna KE, Rodriguez LL, eds. Washington, DC: National Academy Press
Institute of Medicine Committee on Assessing the System for Protecting Human Research Participants. Responsible Research: A Systems Approach to Protecting Research Participants. Federman DD, Hanna KE, Rodriguez LL, eds. Washington, DC: National Academy Press; 2003.
National Bioethics Advisory Commission. Bethesda, Md: National Bioethics Advisory Commission
National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants. Bethesda, Md: National Bioethics Advisory Commission; 2001.
A case study in adolescent participation in clinical research: Eleven clinical sites, one common protocol, and eleven IRBs
Adolescent Medicine HIV/AIDS Research Network
Rogers AS, Schwartz DF, Weissman G, English A, Adolescent Medicine HIV/AIDS Research Network. A case study in adolescent participation in clinical research: eleven clinical sites, one common protocol, and eleven IRBs. Instit Rev Board. 1999; 21:6-10.
Presented to the Committee on Clinical Research Involving Children, Institute of Medicine; January 9, Washington, DC
Wendler D. The ethics of pediatric research. Presented to the Committee on Clinical Research Involving Children, Institute of Medicine; January 9, 2003; Washington, DC.
How do institutional review boards apply the federal risk and benefit standards for pediatric research?
Shah S, Whittle A, Wilfond B, et al. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA. 2004;291:476-482.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Washington, DC: US Government Printing Office
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelinesfor the Protection of Human Subjects of Research Washington, DC: US Government Printing Office; 1978.
