References
- Amdur , R. 2003 . Institutional Review Board Member Handbook , Boston : Jones and Bartlett .
- American Cancer Society. (2004). How to Fight Teenage Smoking. Accessed on August 17, 2004 http://www.cancer.org/docroot/PED/content/PED_10_14_How_to_Fight_ Teen_ Smoking.asp (http://www.cancer.org/docroot/PED/content/PED_10_14_How_to_Fight_ Teen_ Smoking.asp)
- Angell , M. and Kassirer , D. 1998 . Alternative Medicine—The Risks of Untested and Unregulated Remedies . New England Journal of Medicine , 339 : 839 – 841 . [PUBMED] [INFOTRIEVE] [CSA]
- 1999 . Black’s Law Dictionary , 7th , St. Paul, MN : West Group .
- Brandon , R. 1995 . Adaptation and Environment , Princeton, NJ : Princeton University Press .
- Collins , F. 2004 . The Case for a US Prospective Cohort Study of Genes and Environment . Nature , 429 : 475 – 477 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- Collins , F. and McKusick , V. 2001 . Implications of the Human Genome Project for Medical Science . Journal of the American Medical Association , 285 : 540 – 44 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- Council of International Organization of Medical Sciences (CIOMS). (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Accessed on August 25, 2005 http://www.cioms.ch/frame_guidelines_nov_2002.htm (http://www.cioms.ch/frame_guidelines_nov_2002.htm)
- Dresser , R. 2001 . When Science Offers Salvation: Patient Advocacy and Research Ethics , New York : Oxford University Press .
- Eisenberg , D. , Davis , R. , Ettner , S. , Appel , S. , Wilkey , S. , Van Rompay , M. and Kessler , R. 1998 . Trends in Alternative Medicine Use in the United States, 1990–1997 . Journal of the American Medical Association , 280 : 1569 – 1575 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- Eldredge , N. 1985 . Unfinished Synthesis: Biological Hierarchies and Modern Evolutionary Thought , Oxford : Oxford University Press .
- Emanuel , E. and Miller , F. 2001 . The Ethics of Placebo-Controlled Trials—A Middle Ground . New England Journal of Medicine , 345 : 915 – 919 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
- Emanuel , E. , Wendler , D. and Grady , C. 2000 . Journal of the American Medical Association , 283 : 2701 – 2711 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- Freedman , B. 1987 . Equipoise and the Ethics of Clinical Research . New England Journal of Medicine , 317 : 382 – 383 .
- Greenberg v. Miami Children's Hospital. 264 F.Supp.2d 1064 (S.D. Fla. 2003)
- Grimes vs. Kennedy Krieger Institute, Inc. 782 A.2d 807 (Md. 2001) http://www.courts.state.md.us/coa/2001/128a00.pdf (http://www.courts.state.md.us/coa/2001/128a00.pdf)
- Health Insurance Portability and Accountability Act. (1996). Pub. Law 104–191.
- Hoffman , D. and Rothenberg , K. 2002 . Whose Duty Is It Anyway? The Kennedy Krieger Opinion and Its Implications for Public Health Research . Journal of Health Care Law Policy , 6 : 109 – 147 . [CSA]
- Hrobjartsson , A. and Gotzsche , P. 2001 . Is the Placebo Effect Powerless? An Analysis of Clinical Trials Comparing Placebo with No Treatment . New England Journal of Medicine , 344 : 1594 – 1602 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
- International Society For the Study of Environmental Epidemiology (ISEE). (1996). Ethical Guidelines for Environmental Epidemiologists. Accessed on February 24, 2005 http//:www.iseepi.org/ethguide.htm (http//:www.iseepi.org/ethguide.htm)
- Kionka , E. 1999 . Torts , 3rd St. Paul, MN
- Kopelman , L. 2000 . Children as Research Subjects: A Dilemma . Journal of Medicine and Philosophy , 25 : 745 – 674 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
- Kopelman , L. 2002 . Pediatric Research Regulations Under Legal Scrutiny: Grimes Narrows Their Interpretation . Journal of Law, Medicine, and Ethics , 38 : 30 – 48 . [CSA]
- Lavery , J. , Upshur , R. , Sharp , R. and Hofman , K. 2003 . Ethical Issues in International Environmental Health Research . International Journal of Hygiene and Environmental Health , 206 ( 4–5 ) : 453 – 463 . [PUBMED] [INFOTRIEVE] [CSA]
- Levine , R. 1988 . Ethics and Regulation of Clinical Research , 2nd , New Haven, CT : Yale University Press .
- Lurie , P. and Wolfe , S. 1997 . Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries . New England Journal of Medicine , 337 : 853 – 856 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
- Macklin , R. 2003 . Bioethics, Vulnerability, and Protection . Bioethics , 17 : 472 – 486 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- Mannino, D., Homa, D., Akinbami, L., Moorman, J., Gwynn, C., and Redd, S. (2002). Centers for Disease Control. Surveillance for Asthma---United States, 1980–1999. Accessed on August 19, 2004 http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5101a1.htm (http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5101a1.htm)
- McCarthy , C. 1998 . “ The Evolving Story of Justice in Federal Research Policy ” . In Beyond Consent: Seeking Justice in Research , Edited by: Kahn , J , Mastroianni , A and Sugarman , J. 11 – 32 . New York : Oxford University Press .
- Miller , F. and Brody , H. 2002 . American Journal of Bioethics , 2 ( 2 ) : 3 – 9 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
- Miller , P. and Weijer , C. 2003 . Rehabilitating Equipoise . Kennedy Institute of Ethics Journal , 13 : 93 – 118 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
- Minkler , M. , Blackwell , A. , Thompson , M. and Tamir , H. 2003 . Community-Based Participatory Research: Implications for Public Health Funding . American Journal of Public Health , 93 : 1210 – 1213 . [PUBMED] [INFOTRIEVE] [CSA]
- Moore v. Regents of the University of California. 51 Cal.3d 120 (1990)
- Morgan , W. , Crain , E. , Gruchalla , R. , O'Connor , G. , Kattan , M. , Evans , R. , Stout , J. , Malindzak , G. , Smartt , E. , Plaut , M. , Walter , M. , Vaughn , B. and Mitchell , H. 2004 . Results of a Home-Based Environmental Intervention Among Urban Children with Asthma . New England Journal of Medicine , 351 : 1068 – 1080 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- Morin , K. , Rakatansky , H. , Riddick , F. , Morse , L. , O'Bannon , J. , Goldrich , M. , Ray , P. , Weiss , M. , Sade , R. and Spillman , M. 2002 . Managing Conflicts of Interest in the Conduct of Clinical Trials . Journal of the American Medical Association , 287 : 78 – 84 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. (1979). The Belmont Report. Accessed on August 20, 2004 http://ohsr.od.nih.gov/guidelines/belmont.html (http://ohsr.od.nih.gov/guidelines/belmont.html)
- National Institute of Environmental Health Sciences. (1996). How Do You Study Environmental Health?. Accessed on August 17, 2004 http://www.niehs.nih.gov/oc/factsheets/fshow.htm (http://www.niehs.nih.gov/oc/factsheets/fshow.htm)
- Nelson , R. 1998 . “ Children as Research Subjects ” . In Beyond Consent: Seeking Justice in Research , Edited by: Kahn , J. , Mastroianni , A. and Sugarman , J. 47 – 67 . New York : Oxford University Press .
- Nelson , R. 2002 . Appropriate risk exposure in environmental health research: the Kennedy Krieger lead abatement study . Neurotoxicity and Teratology , 24 : 445 – 49 . [CROSSREF]
- Porter , R. 1999 . The Greatest Benefit to Mankind , New York : W.W. Norton .
- Resnik , D. 1998 . The Ethics of HIV Research in Developing Nations . Bioethics , 12 : 286 – 06 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- Resnik , D. 2001 . Financial Interests and Research Bias . Perspectives on Science , 8 : 255 – 85 . [CROSSREF]
- Resnik , D. 2004a . Disclosing Conflicts of Interest to Research Subjects: An Ethical and Legal Analysis . Accountability in Research , 11 : 141 – 159 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
- Resnik , D. 2004b . Liability for Institutional Review Boards: From Regulation to Litigation . Journal of Legal Medicine , 25 : 131 – 184 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
- Resnik , D. and Shamoo , A. 2003 . Conflict of Interest and the University . Accountability in Research , 9 : 45 – 61 . [CROSSREF] [CSA]
- Ross , L. 2002 . In Defense of the Hopkins Lead Abatement Study . Journal of Law, Medicine and Ethics , 30 : 50 – 55 . [CSA]
- Sackett , D. , Straus , S. , Richardson , S. , Rosenberg , W. and Haynes , R. 2000 . Evidence-Based Medicine: How to Practice and Teach EBM , 2nd , London : Churchill Livingstone .
- Schaffner , K. 2003 . “ Research Methodology: Conceptual Issues ” . In Encyclopedia of Bioethics , 2nd , Edited by: Reich , W. 2270 – 2277 . New York : Simon and Schuster .
- Shamoo , A. and Resnik , D. 2003 . Responsible Conduct of Research , New York : Oxford University Press .
- Sharp , R. 2003 . Ethical Issues in Environmental Health Research . Environmental Health Perspectives , 111 : 786 – 788 .
- Sharp , R. and Foster , M. 2000 . Involving Study Populations in the Review of Genetic Research . Journal of Law, Medicine and Ethics , 28 : 41 – 51 . [CSA]
- Sober , E. 2000 . Philosophy of Biology , 2nd , Boulder, CO : Westview Press .
- Soskolne , C. and Light , A. 1996 . Toward Ethical Guidelines for Environmental Epidemiologists . The Science of the Total Environment , 184 : 137 – 147 . [CROSSREF]
- Tauer , C. 1999 . Testing Drugs in Pediatric Populations: The FDA Mandate . Accountability in Research , 7 : 37 – 58 . [PUBMED] [INFOTRIEVE] [CSA]
- The Common Rule . 56 Fed Reg 28012 . Codified in 45 C.F.R. 46 and 21 C.F.R. 50 and 56 . 2001 .
- Varmus , H. and Satcher , D. 1997 . Ethical Complexities of Conducting Research in Developing Countries . New England Journal of Medicine , 337 : 1000 – 10005 . [CROSSREF] [CSA]
- Veatch , R. 1987 . The Patient as Partner: A Theory of Human Experimentation Ethics , Bloomington : Indiana University Free Press .
- Woodruff , P. and Fahy , J. 2001 . Asthma: Prevalence, Pathogenesis, and Prospects for Novel Therapies . Journal of the American Medical Association , 286 : 395 – 398 . [PUBMED] [INFOTRIEVE] [CROSSREF]
- World Medical Association . 2000 . Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects . Journal of the American Medical Association , 284 : 3043 – 3045 . [CROSSREF]
- Wynia , M. , Latham , S. , Kao , A. , Berg , J. and Emanuel , L. 1999 . Medical Professionalism in Society . New England Journal of Medicine , 341 : 1612 – 1616 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]