Risk standards for pediatric research: Rethinking the Grimes ruling

Kennedy Institute of Ethics Journal

Volumn 14, Issue 2, 2004, Pages 187-198

  Wendler, David ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ZIDOVUDINE;

CLINICAL OBSERVATION; COMMUNITY CARE; COURT; FEASIBILITY STUDY; GOVERNMENT; HEALTH CARE NEED; HEALTH SURVEY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LAW; LONG TERM CARE; MEDICAL EXAMINATION; MEDICAL RESEARCH; MEDICOLEGAL ASPECT; METHODOLOGY; PARENT; POPULATION RESEARCH; PROSPECTIVE STUDY; REVIEW; RISK ASSESSMENT; SAMPLING; STANDARD;

EID: 3042522542     PISSN: 10546863     EISSN: None     Source Type: Journal    
DOI: 10.1353/ken.2004.0024     Document Type: Review

References (12)

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2. Brennan, Troyen A. 1999. Proposed Revisions to the Declaration of Helsinki - Will They Weaken the Ethical Principles Underlying Human Research? New England Journal of Medicine 341: 527-31.
3. Glantz, Leonard H. 2002. Nontherapeutic Research with Children: Grimes v. Kennedy Krieger Institute. American Journal of Public Health 92: 1070-73.
4. Jonsen, Albert R. 1998. The Birth of Bioethics. New York: Oxford University Press.
5. Lantos, John. 2004. Pediatric Research: What is Broken and What Needs to be Fixed? Journal of Pediatrics 144: 147-49.
6. Levine, Robert J. 1999. The Need to Revise the Declaration of Helsinki. New England Journal of Medicine 341: 531-34.
7. Nuremberg Code. 1996. JAMA 276: 1691.
8. Lurie, Peter, and Wolf, Sydney M. 1997. Unethical Trials of Methods to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries. New England Journal of Medicine 337: 853-56.
9. Mastroianni, Anna C., and Kahn, Jeffery P. 2002. Risk and Responsibility, Grimes v. Kennedy Krieger, and Public Health Research Involving Children. American Journal of Public Health 92: 1073-76.
10. NBAC. National Bioethics Advisory Commission. 2001. Ethical and Policy Issues in Research Involving Human Participants, Volume 1. Available at http:// www.ntis.gov. Accessed 12 February 2004.
11. Rothman, Kenneth J., and Michaels, Karin B. 1994. The Continuing Unethical Use of Placebos. New England Journal of Medicine 331: 394.
12. Wendler, David; Emanuel, Ezekiel; and Lie, Reidar. 2004. The Standard of Care Debate. American Journal of Public Health. In press.