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Ethical Challenges

12. References

Appelbaum, P. S., Lidz, C. W., & Grisso, T. (2004). Therapeutic misconception in clinical research: Frequency and risk factors. IRB: Ethics and Human Research, 26(2), 1-8

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Association for the Accreditation of Human Research Protection Programs, Inc. (2011). AAHRPP - Web Site. Retrieved from http://www.aahrpp.org/

Association of American Medical Colleges (2011). Alternative IRB Models. 

Public Responsibility in Medicine and Research - The Center for Advanced Study (2007). The Illinois White Paper - Improving the System for Protecting Human Subjects: Counteracting the IRB “Mission Creep”. Retrieved from http://qix.sagepub.com/content/13/5/617.short   

Cico, S. J., Vogeley, E., & Doyle, W. J. (2011). Informed consent language and parents’ willingness to enroll their children in research. IRB: Ethics and Human Research, 33(2), 6-13

The Council for International Organizations of Medical Sciences & the World Health Organization (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Retrieved from http://www.cioms.ch/publications/layout_guide2002.pdf 

The Council for International Organizations of Medical Sciences & the World Health Organization (2011). Updates. Retrieved from http://www.cioms.ch/publications/layout_guide2002.pdf 

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International Committee of Medical Journal Editors (2009). Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research: Authorship and Contributorship. 

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2011). Good Clinical Practice. Retrieved from http://ichgcp.net/

IRB Forum (2011). The Institutional Review Board – Discussion and News Forum. Retrieved from  www.irbforum.org/

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Krugman, S. (1986). The Willowbrook hepatitis studies revisited: Ethical aspects. Reviews of Infectious Diseases, 8(1), 157-162

Office of Extramural Research – National Institutes of Health (2011, August 3). Office of Laboratory Animal Welfare. Retrieved from http://grants.nih.gov/grants/olaw/olaw.htm

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Paasche-Orlow, M. K., Taylor, H. A., & Brancati, F. L. (2003). Readability standards for informed-consent forms as compared with actual readability. New England Journal of Medicine, 348(8), 721-726

Pace, C., Emanuel, E. J., Chuenyam, T., Duncombe, C., Bebchuk, J. D., Wendler, D., … Grady, C. (2005). The quality of informed consent in a clinical research study in Thailand. IRB: Ethics and Human Research, 27(1), 9-17 

Reverby, S. M. (2011). “Normal exposure” and inoculation syphilis: A PHS “Tuskegee” doctor in Guatemala, 1946-1948. The Journal of Policy History, 23(1), 2011.

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US. Department of Health & Human Services (2009, January 15). Code of Federal Regulations – 46.110. Retrieved from http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.110

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US Department of Health & Human Services – National Institutes of Health (2007, February 2). HIPPA Privacy Rule Information for Researchers. Retrieved from http://privacyruleandresearch.nih.gov/

US Department of Health & Human Services – Office of Extramural Research (2007, April 13). Inclusion of Women and Minorities as Participants in Research Involving Human Subjects – Policy Implementation Page. Retrieved from http://grants.nih.gov/grants/funding/women_min/women_min.htm

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US Department of Health & Human Services – Office of Research Integrity (2010, April 12). Handling Misconduct: Introduction. Retrieved from http://ori.hhs.gov/misconduct/

The University of Alabama (2007). Research Compliance. Retrieved from http://osp.ua.edu/site/PRCO_History.html

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World Medical Association (2011). WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Retrieved from http://www.wma.net/en/30publications/10policies/b3/