Justifying research risks in a clinical trial for treatment of multidrug-resistant tuberculosis

IRB Ethics and Human Research

Volumn 33, Issue 4, 2011, Pages 10-17

  Heilig, Charles M ^a   Chia, David ^b   El Sadr, Wafaa M ^c   Hlrsch Moverman, Yael ^c   MacKenzie, Wllliam R ^a   Saukkonen, Jussi ^d   Villarino, Margarita E ^a   Padayatchi, Nesri ^e  

^a CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^b YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c Department of Medicine   (United States)

^d BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF KWAZULU NATAL   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

ACETAMIDE DERIVATIVE; LINEZOLID; OXAZOLIDINONE DERIVATIVE; PLACEBO; TUBERCULOSTATIC AGENT;

ARTICLE; ETHICS; HUMAN; MULTIDRUG RESISTANT TUBERCULOSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT;

ACETAMIDES; ANTITUBERCULAR AGENTS; HUMANS; OXAZOLIDINONES; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; TUBERCULOSIS, MULTIDRUG-RESISTANT;

EID: 80054112907     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (15)

1. 45 CFR 46.111(a)(1,1); 21 CFR 56.m(a)(1,2); International Conference on Harmonisation. Guideline for Good Clinical Practice E6(R1), 1996-06-10, principle 2.2.
2. Weijer C, Miller PB. When are research risks reasonable in relation to anticipated benefits? Nature Medicine 2004;10(6):570-573; (Pubitemid 38796840)
3. Miller PB, Weijer C. The trust-based obligations of the state and physician-research to patient-subjects. Journal of Medical Ethics 2006;32(9):542-547. (Pubitemid 44390342)
4. One such example is in Miller PB, Weijer C. Evaluating benefits and harms in research on healthy children. In: Kodish E. Ethics and Research with Children: A Case-Based Approach. New York: Oxford University Press, 2005, pp. 29-45.
5. Centers for Disease Control and Prevention. TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB (LiMiT), February 2011, http://www.clinicaltrials.gov/ct2/sh0w/NCT00664313.
6. The WHO/IUATLD Global Project on Anti-Tuberculosis Drug Resistance Surveillance, 2002-2007. Anti-Tuberculosis Drug Resistance in the World, Fourth Global Report. WHO/HTM/TB/2008.394, http://www.who.int/tb/publications/2008/drs- report4-26feb08.pdf.
7. Glynn JR, Murray J, Bester A, et al. Effects of duration of HIV infection and secondary tuberculosis transmission on tuberculosis incidence in the South African gold mines. AIDS 2008;22(14):1859-1867;
8. Gandhi NR, Shah NS, Andrews JR, et al. HIV coinfection in multidrug- and extensively drug-resistant tuberculosis results in high early mortality. American Journal of Respiratory and Critical Care Medicine 2010;181(1):80-86.
9. Karim SSA, Churchyard GJ, Karim QA, et al. HIV infection and tuberculosis in South Africa: An urgent need to escalate the public health response. Lancet 2009;374(9693):921-933.
10. Gandhi NR, Moll A, Sturm AW, et al. Extensively drug-resistant tuberculosis as a cause of death in patients co-infected with tuberculosis and HIV in a rural area of South Africa. Lancet 2006;368(9547):1575-1580. (Pubitemid 44780738)
11. Pfizer Inc. ZYVOX label information, LAB-0139-20.0, February 2011, http://media.pfizer.com/files/products/uspi-zyvox.pdf.
12. Vinh, DC, Rubinstein E. Linezolid: A review of safety and tolerability. Journal of Infection 2009;59:559-574.
13. World Health Organization. Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis. WHO/HTM/TB/2006.361, http://whqlibdoc.who.int/ publications/2006/9241546956-eng.pdf.
14. Restrepo BI. Convergence of the tuberculosis and diabetes epidemics: Renewal of old acquaintances. Clinical Infectious Diseases 2007;45:436-438. (Pubitemid 47204458)
15. Freedman B. Equipoise and the ethics of clinical research. NEJM 317(3):141-145.