Harmonizing regulations for biomedical research: A critical analysis of the us and venezuelan systems

Developing World Bioethics

Volumn 8, Issue 3, 2008, Pages 167-177

  Di Tillio Gonzalez, Dannie ^a   Fischbach, Ruth L ^a  

^a MC 161 ^*  (United States)

Author keywords

Biomedical research; Developing countries; Harmonizing regulations; Research; United States; Venezuela

Indexed keywords

ARTICLE; COMPARATIVE STUDY; COOPERATION; DEVELOPED COUNTRY; DEVELOPING COUNTRY; ETHICS; EUROPE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; GOVERNMENT REGULATION; HUMAN; HUMAN EXPERIMENT; INTERNATIONAL COOPERATION; JAPAN; LEGAL ASPECT; MEDICAL ETHICS; MEDICAL RESEARCH; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; RESEARCH ETHICS; RESEARCH SUBJECT; STANDARD; UNITED STATES; UNIVERSITY; VENEZUELA; WORLD HEALTH ORGANIZATION;

BIOMEDICAL RESEARCH; COOPERATIVE BEHAVIOR; DEVELOPED COUNTRIES; DEVELOPING COUNTRIES; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; EUROPE; FEDERAL GOVERNMENT; GOVERNMENT AGENCIES; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HELSINKI DECLARATION; HUMAN EXPERIMENTATION; HUMANS; INTERNATIONALITY; JAPAN; RESEARCH SUBJECTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; UNIVERSITIES; VENEZUELA; WORLD HEALTH ORGANIZATION;

EID: 57349178490     PISSN: 14718731     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1471-8847.2006.00174.x     Document Type: Article

References (67)

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3. Ibid.
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6. Ibid.
7. Council for International Organizations of Medical Sciences (CIOMS) & World Health Organization (WHO). 1982. Proposed International Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS in collaboration with WHO.
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9. Ibid: Guideline 2.
10. Ibid: Guideline 3.
11. Ibid.
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17. Ibid.
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19. Ibid.
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23. United States Department of Health and Human Services, op. cit. note 15, 45 CFR 46.101.
24. Ibid: 45 CFR 46.109.
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50. Ibid: Part III A. 1,5; A2, A3; The NGOs must register officially and work in the following areas: environment, animal welfare or human rights.
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58. Council for International Organizations of Medical Science & World Health Organization, op. cit. note 4, Guidelines 3 & 10.
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60. Council for International Organizations of Medical Science & World Health Organization, op. cit. note 4, Guideline 11.
61. World Medical Association, op. cit. note 3, paragraph 29.
62. Ministry of Science and Technology & National Funds for Science and Technology, op. cit. note 43, Annex 2.
63. United Nations Educational, Scientific and Cultural Organization (UNESCO). 1997. Universal Declaration of Human Rights and the Human Genome Paris: UNESCO. Available at: http://portal.unesco. org/en/ev.php-URL-ID=13177&URL-DO=DO-TOPIC&URL-SECTION=201.html [Accessed 29 August 2006].
64. Ministry of Science and Technology & National Funds for Science and Technology, op. cit. note 44, Part I. The Bioethics Code of FONACIT includes the principles of responsibility, autonomy, precaution, non-malfeasance, beneficence and justice.
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66. R. Macklin. 1999. Against Relativism: Cultural Diversity and the Search for Ethical Universals in Medicine. New York, NY: Oxford University Press: 1-25.
67. See The World Medical Association (WMA). op. cit. note 34.