Four forward-looking guidance points

Developing World Bioethics

Volumn 1, Issue 2, 2001, Pages 121-134

  Macklin, Ruth ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE; PLACEBO;

ADVISORY COMMITTEE; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL TRIAL; COMPARATIVE STUDY; COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES; DEVELOPING COUNTRY; ETHICS; HUMAN; HUMAN EXPERIMENT; INTERNATIONAL COOPERATION; INTERNATIONAL ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS; MEDICAL ETHICS; METHODOLOGY; NATIONAL BIOETHICS ADVISORY COMMISSION; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; SOCIAL BEHAVIOR; STANDARD; UNAIDS;

BIOMEDICAL AND BEHAVIORAL RESEARCH; COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES; INTERNATIONAL ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS; NATIONAL BIOETHICS ADVISORY COMMISSION; UNAIDS;

ADVISORY COMMITTEES; AIDS VACCINES; CLINICAL TRIALS; DEVELOPING COUNTRIES; ETHICS COMMITTEES, RESEARCH; GUIDELINES; HELSINKI DECLARATION; HUMAN EXPERIMENTATION; HUMANS; INTERNATIONALITY; PLACEBOS; RESEARCH DESIGN; SOCIAL RESPONSIBILITY;

EID: 0037778766     PISSN: 14718731     EISSN: None     Source Type: Journal    
DOI: 10.1111/1471-8847.00017     Document Type: Article

References (16)

1. World Medical Association. 1964. As amended by the WMA 52nd General Assembly, Edinburgh, Scotland, October 2000. Declaration of Helsinki.
2. US National Bioethics Advisory Commission. 2000. Ethical and Policy Issues in International Research. Bethesda, MD.
3. Council for International Organizations of Medical Sciences (CIOMS). 1993. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva. CIOMS. The draft revision is currently available only on the CIOMS website: www.cioms.ch.
4. For a discussion of this issue, see R. Macklin. After Helsinki: Unresolved Issues in International Research. Kennedy Institute of Ethics Journal 2001; 11: 17-36.
5. National Bioethics Advisory Commission. Chapter 4. See also A. Page. Prior Agreements in International Clinical Trials: Ensuring the Provision of Drugs and Other Research Benefits to Developing Countries. Background paper prepared for the National Bioethics Advisory Commission. 2000. Unpublished.
6. See, e.g., T.A. Brennan. Proposed Revisions to the Declaration of Helsinki Will They Weaken the Ethical Principles Underlying Human Research? New England Journal of Medicine 1999; 341: 527-531;
7. R.J. Levine. The 'Best Proven Therapeutic Method' Standard in Clinical Trials in Technologically Developing Countries. IRB: A Review of Human Subjects Research 1998; 20: 5-9;
8. R.J. Levine. The Need to Revise the Declaration of Helsinki. New England Journal of Medicine 1999; 341: 531-534;
9. R.K. Lie. Ethics of Placebo-controlled Trials in Developing Nations. Bioethics 1998; 12: 307-311;
10. S. Okie. Health Officials Debate Ethics of Placebo Use. Washington Post, November 24, 2000: A03.
11. H. Varmus and D. Satcher. Ethical Complexities of Conducting Research in Developing Countries. NEJM 1997; 337: 1003-1005;
12. R.J. Levine. The Need to Revise the Declaration of Helsinki. New England Journal of Medicine 1999; 341: 531-534.
13. P. Lurie and S. Wolfe. Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries. NEJM 1997; 337: 853-856.
14. E.K. Mbidde. 1997. Letter to NIH. Dr. Mbidde's letter, dated May 8, 1997, was sent to Dr. Harold Varmus, then Director of the NIH, in response to the Public Citizen News Release of April 22, 1997. Public Citizen faxed copies of Dr. Mbidde's letter to individuals on their mailing list.
15. S.R. Benatar and P.A. Singer. A New Look at International Research Ethics. BMJ 2000; 321: 824-26;
16. D.B. Resnik. The Ethics of HIV Research in Developing Nations. Bioethics 1998; 12: 286-306.