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Chapter 6: References
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Chapter 6: References
Advisory Committee on Human Radiation Experiments (ACHRE). 1995. Final Report. Washington, D.C.: U.S. Government Printing Office.
Alberti, K.G.G.M. 2000. 'Multicentre Research Ethics Committees: Has the Cure Been Worse Than the Disease?' British Medical Journal 320:1157 - 1158.
Al-Shahi, R., and C.P. Warlow. 1999. 'Ethical Review of a Multicentre Study in Scotland: A Weighty Problem.' Journal of the Royal College of Physicians of London 33(6):549 - 552.
Bergen, R.P. 1967. 'Insurance Coverage for Clinical Investigation.' Journal of the American Medical Association 201:305 - 306.
Committee on Research Involving Human Subjects. 1998.
Guidelines on Ethical Review of Medical Research. China: Ministry of Public Health.
Cooke, R.A., and A.S. Tannenbaum. 1978. A Survey of Institutional Review Boards and Research Involving Human Subjects. In Appendix to Report and Recommendations: Institutional Review Boards, 1-1 - 1-310. Washington, D.C.: Department of Health, Education, and Welfare.
Council for International Organizations of Medical Sciences (CIOMS). 1991. International Guidelines for Ethical Review of Epidemiological Studies. Geneva: CIOMS.
... 1993. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS.
Council of Europe. 1997. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine. France: Council of Europe.
DeMets, D.L., S.J. Pocock, and D.G. Julian. 1999. 'The Agonizing Negative Trend in Monitoring of Clinical Trials.' The Lancet 354(9194):1983 - 1988.
Department of Health and Human Services (DHHS). 2000.
'Secretary Shalala Bolsters Protections for Human Research Subjects.' [Press Release.] 23 May.
Department of Health, Education, and Welfare (DHEW). Secretary's Task Force on the Compensation of Injured Research Subjects. 1977. Final Report. Pub. OS-77-003. Bethesda, MD: DHEW.
Ellis, G. 1994. 'Perspectives from OPRR.' In Changes and Choices for Institutional Review Boards: The Inclusion of Women and Minorities, and Other Emerging Issues in Research, 31 - 32. Boston: Public Responsibility in Medicine and Research.
Food and Drug Administration (FDA). 1998. Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators. Available at
http://www.fda.gov/oc/ohrt/irbs/default.htm
. Last accessed December 8, 2000.
General Accounting Office (GAO). 1996. Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. GAO/HEHS-96-72. Washington, D.C.: GAO.
Gordon, V.M., J. Sugarman, and N. Kass. 1998. 'Toward a More Comprehensive Approach to Protecting Human Subjects.' IRB: A Review of Human Subjects Research 20(1):1 - 5.
Health Research Council of New Zealand. 1997. HRC Guidelines on Ethics in Health Research. Auckland, New Zealand: Health Research Council of New Zealand.
Human Radiation Interagency Working Group. 1997. Building Public Trust: Actions to Respond to the Report of the Advisory Committee on Human Radiation Experiments. Washington, D.C.: U.S. Government Printing Office.
Indian Council of Medical Research. 2000. Ethical Guidelines on Biomedical Research Involving Human Subjects. New Delhi: Indian Council of Medical Research.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). 1996. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice. Geneva: ICH Secretariat, International Federation for Pharmaceutical Manufacturers Association.
Joint United Nations Programme on HIV/AIDS (UNAIDS). 2000.
Guidance Document: Ethical Considerations in HIV Preventive Vaccine Research. Geneva: UNAIDS.
Kolata, G., and K. Eichenwald. 1999. 'Stopgap Medicine: A Special Report for the Uninsured, Drug Trials Are Health Care.' New York Times, 22 June, A-1.
Ladimer, I. 1963. 'Clinical Research Insurance.' Journal of Chronic Diseases 16:1229, 1233.
Lux, A.L., S.W. Edwards, and J.P. Osborne. 2000. 'Responses of Local Research Ethics Committees to a Study with Approval from a Multicentre Research Ethics Committee.' British Medical Journal 320(7243):1182 - 1183.
Marwick, C. 1998. 'Compensation for Injured Research Subjects.'
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Medical Research Council (MRC). 1998. Guidelines for Good Clinical Practice in Clinical Trials. London: MRC.
Medical Research Council of South Africa. 1993. Guidelines on Ethics for Medical Research. South Africa: Medical Research Council of South Africa.
National Bioethics Advisory Commission (NBAC). 2001. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. 2 vols. Bethesda, MD: U.S. Government Printing Office.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission). 1978.
Report and Recommendations: Institutional Review Boards. Washington, D.C.: U.S. Government Printing Office.
National Consensus Conference on Bioethics and Health Research in Uganda. 1997. Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda. Kampala, Uganda.
National Health and Medical Research Council (NHMRC). 1999.
National Statement on Ethical Conduct in Research Involving Humans. Australia: NHMRC.
National Health Council (NHC). 1996. Resolution No. 196/96 on Research Involving Human Subjects. Brazil: NHC. Addition: 1997. Resolution No. 251. Addition: 1999. Resolution No. 292. Brazil: NHC.
Norton, I.M., and S.M. Manson. 1996. 'Research in American Indian and Alaska Native Communities Navigating the Cultural Universe of Values and Process.' Journal of Consulting and Clinical Psychology 64(5):856 - 860.
National Bioethics Advisory Commission
Office of Inspector General (OIG), DHHS. 1998a. Institutional Review Boards: A Time for Reform. OEI-01-97-00193. Washington, D.C.: DHHS.
... 1998b. Institutional Review Boards: The Emergence of Independent Boards. OEI-01-97-00192.Washington, D.C.: DHHS.
... 1998c. Institutional Review Boards: Their Role in Reviewing Approved Research. OEI-01-97-00190. Washington, D.C.: DHHS.
Prentice, E.D., and B. Gordon. 1997. 'IRB Review of Adverse Events in Investigational Drug Studies.' IRB: A Review of Human Subjects Research 19(6):1 - 4.
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission). 1981. Protecting Human Subjects. Washington, D.C.: U.S. Government Printing Office.
... 1982. Compensating for Research Injuries: The Ethical and Legal Implications of Programs to Redress Injured Subjects. Washington, D.C.: U.S. Government Printing Office.
Sharp, R.R., and M.W. Foster. 2000. 'Involving Study Populations in the Review of Genetic Research.' Journal of Law, Medicine, and Ethics 28(1):41 - 51.
Tully, J., N. Ninis, R. Booy, and R. Viner. 2000. 'The New System of Review by Multicentre Research Ethics Committees: Prospective Study.' British Medical Journal 320:1179 - 1182.
Tuskegee Syphilis Study Ad Hoc Advisory Panel. 1973. Final Report. Washington, D.C.: DHEW.
Vasgird, D.R., M. Hensleigh, A. Berkman, E. Schachne, and C. Trinh. 2000. 'Protecting the Uninsured Human Research Subject.' Journal of Public Health Management Practice 6(6):37 - 47.
Cite this page:
"Chapter 6: References"
Online Ethics Center for Engineering
7/25/2006
National Academy of Engineering
Accessed: Wednesday, February 08, 2012
<www.onlineethics.org/Topics/RespResearch/ResResources/nbacindex/nbachindex/h6ref.aspx>
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