Assessing Social Risks Prior to Commencement of a Clinical Trial: Due Diligence or Ethical Inflation?

REFERENCES

• Adams , B. 2003 . Thailand's crackdown: Drug ‘war’ kills democracy too . International Herald Tribune , 6 April 24
   Google Scholar
• Biddulph , S. 2003 . The production of legal norms: A case study of administrative detention in China . University of California Los Angeles Pacific Basin Law Journal , 20 ( 2 ) : 217 – 277 .
   Google Scholar
• Burris , S. 1998 . Law and the social risk of health care: Lessons from HIV testing . Albany Law Review , 61 : 831 – 895 .
   Google Scholar
• Burris , S. 2008 . Regulatory innovation in the governance of human subjects research: A cautionary tale and some modest proposals . Regulation and Governance , 2 : 1 – 20 .
   Web of Science ®Google Scholar
• Burris , S. , Blankenship , K. M. , Donoghoe , M. , Sherman , S. , Vernick , J. S. Case , P. 2004 . Addressing the “risk environment” for injection drug users: The mysterious case of the missing cop . Milbank Quarterly , 82 : 125 – 56 .
   PubMed Web of Science ®Google Scholar
• Burris , S. C. , Davis , C. S. , Fu , X. , Pandey , I. , Wang , Z. Zhang , Y. 2007 . HIV Protection Trial Network (HPTN) 058: Rapid Policy Assessment for China and Thailand , Durham, NC : Family Health International .
   Google Scholar
• Burris , S. and Moss , K. 2006 . United States health researchers review their ethics review boards: A qualitative study . Journal of Empirical Research on Human Research Ethics , 1 ( 2 ) : 39 – 58 .
   PubMed Web of Science ®Google Scholar
• Burris , S. and Welsh , J. 2006 . Regulatory paradox in the protection of human research subjects: A review of office for human research protections (OHRP) enforcement letters . Northwestern University Law Review , 101 ( 2 ) : 643 – 85 .
   Web of Science ®Google Scholar
• Carpenter , D. 2007 . Institutional review boards, regulatory incentives, and some modest proposals for reform . Northwestern University Law Review , 101 ( 2 ) : 687 – 705 .
   Web of Science ®Google Scholar
• Ceci , S. J. , Peters , D. and Plotkin , J. 1985 . Human subjects review, personal values, and the regulation of social science research . American Psychologist , 40 : 994
   Web of Science ®Google Scholar
• Chua , A. , Ford , N. , Wilson , D. and Cawthorne , P. 2005 . The tenofovir pre-exposure prophylaxis trial in Thailand: Researchers should show more openness in their engagement with the community . PLoS Medicine , 2 ( 10 ) : e346
   PubMed Web of Science ®Google Scholar
• Curtis , M. , ed. 2006 . Delivering HIV Care and Treatment for People Who Use Drugs: Lessons from Research and Practice , New York, NY : Open Society Institute International Harm Reduction Development Program .
   Google Scholar
• Dawson , L. and Kass , N. E. 2005 . Views of United States researchers about informed consent in international collaborative research . Social Science & Medicine , 61 : 1211 – 1222 .
   PubMed Web of Science ®Google Scholar
• Dean , J. C. and Rud , F. 1984 . The drug addict and the stigma of addiction . International Journal of the Addictions , 19 ( 8 ) : 859 – 869 .
   PubMed Web of Science ®Google Scholar
• Gill , B. and Okie , S. 2007 . China and HIV—A window of opportunity . New England Journal of Medicine , 356 ( 18 ) : 1801 – 1805 .
   PubMed Web of Science ®Google Scholar
• Gray , J. 1995 . Operating needle exchange programs in the hills of Thailand . AIDS Care , 7 ( 4 ) : 489 – 499 .
   PubMed Web of Science ®Google Scholar
• Gray , J. 1998 . Harm reduction in the hills of northern Thailand . Substance Use & Misuse , 33 ( 5 ) : 1075 – 1091 .
   PubMed Web of Science ®Google Scholar
• Gunsalus , K. C. 2004 . The nanny state meets the inner lawyer: Over regulating while under protecting human participants in research . Ethics & Behavior , 14 ( 4 ) : 369 – 382 .
   PubMed Web of Science ®Google Scholar
• Gunsalus , C. K. , Bruner , E. M. , Burbules , N. C. , Dash , L. , Finkin , M. Goldberg , J. P. 2006 . Mission creep in the institutional review board (IRB) world . Science , 312 ( 5779 ) : 1441
   PubMed Web of Science ®Google Scholar
• Hammett , T. , Bartlett , N. , Chen , Y. , Ngu , D. , Cuong , D. D. Phuong , N. M. 2005 . Law enforcement influences on HIV prevention for injection drug users: Observations from a cross-border project in China and Vietnam . International Journal of Drug Policy , 16 : 235 – 245 .
   Web of Science ®Google Scholar
• Hirshon , J. M. , Krugman , S. D. , Witting , M. D. , Furuno , J. P. , Limcangco , M. R. Perisse , A. R. 2002 . Variability in institutional review board assessment of minimal-risk research . Academic Emergency Medicine , 9 ( 12 ) : 1417 – 1420 .
   PubMed Web of Science ®Google Scholar
• Human Rights Watch . 2003 . Locked Doors: The Human Rights of People Living with HIV/AIDS in China , New York, NY : Human Rights Watch .
   Google Scholar
• Human Rights Watch . 2004 . Not Enough Graves: The War on Drugs, HIV/AIDS, and Violations of Human Rights , New York, NY : Human Rights Watch .
   Google Scholar
• Hyder , A. A. , Wali , S. A. , Khan , A. N. , Teoh , N. B. , Kass , N. E. and Dawson , L. 2004 . Ethical review of health research: A perspective from developing country researchers . Journal of Medical Ethics , 30 ( 1 ) : 68 – 72 .
   PubMed Web of Science ®Google Scholar
• Hyman , D. A. 2006 . Institutional review board system (IRBS): Is this the least worst we can do? . Northwestern University Law Review , 101 ( 2 ) : 749 – 773 .
   Web of Science ®Google Scholar
• Kahnemann , D. , Slovic , P. and Tversky , A. , eds. 1982 . Judgment Under Uncertainty: Heuristics and Biases , Cambridge, UK : Cambridge University Press .
   Google Scholar
• Kerr , T. , Small , W. and Wood , E. 2005 . The public health and social impacts of drug market enforcement: A review of the evidence . International Journal of Drug Policy , 16 : 210 – 220 .
   Web of Science ®Google Scholar
• Luebbert , R. , Tait , R. C. , Chibnall , J. T. and Deshields , T. L. 2008 . IRB member judgments of decisional capacity, coercion, and risk in medical and psychiatric studies . Journal of Empirical Research on Human Research Ethics , 3 ( 1 ) : 1524
   Web of Science ®Google Scholar
• McWilliams , R. , Hoover-Fong , J. , Hamosh , A. , Beck , S. , Beaty , T. and Cutting , G. 2003 . Problematic variation in local institutional review of a multi-center genetic epidemiology study . Journal of American Medical Association , 290 ( 3 ) : 360 – 366 .
   Web of Science ®Google Scholar
• National People's Congress Standing Committee . 1990 . Decision of the Standing Committee of the National People's Congress on the Prohibition Against Narcotic Drugs Beijing, , China
   Google Scholar
• Pandey , I. 2006 . ‘Law on the Books’ and High Risk Populations in Thailand , Philadelphia, PA : Temple University Beasley School of Law .
   Google Scholar
• Parker , R. and Aggleton , P. 2003 . HIV and AIDS-related stigma and discrimination: A conceptual framework and implications for action . Social Science & Medicine , 57 ( 1 ) : 13 – 24 .
   PubMed Web of Science ®Google Scholar
• Reid , G. and Costigan , G. 2002 . Revisiting ‘The Hidden Epidemic’: A Situation Assessment of Drug Use in Asia in the Context of HIV/AIDS , Fairfield, , Australia : Macfarlane Burnet Institute for Medical Research and Public Health, Centre for Harm Reduction .
   Google Scholar
• Rogers , A. S. , Schwartz , D. F. , Weissman , G. , English , A. and H.I.V. Aids Research Network Adolescent Medicine . 1999 . A case study in adolescent participation in clinical research: Eleven clinical sites, one common protocol, and eleven institution review boards (IRB) . IRB: A Review of Human Subjects Research , 21 ( 1 ) : 6 – 10 .
   Google Scholar
• Shah , S. , Whittle , A. , Wilfond , B. , Gensler , G. and Wendler , D. 2004 . How do institutional review boards apply the federal risk and benefit standards for pediatric research? . Journal of American Medical Association , 291 ( 4 ) : 476 – 482 .
   PubMed Web of Science ®Google Scholar
• Shinawatra , T. 2003 . Order of the Prime Minister's Office No. 29/B.E. 2546. Bangkok, Thailand
   Google Scholar
• Singh , J. A. and Mills , E. J. 2005 . The abandoned trials of pre-exposure prophylaxis for HIV: What went wrong? . PLoS Medicine , 2 ( 9 ) : e234
   PubMed Web of Science ®Google Scholar
• United States Department of State, Bureau of Democracy, Human Rights and Labor . 2007 . Country Reports on Human Rights Practices: Thailand Available at: http://www.state.gov/g/drl/rls/hrrpt/2006/78792.htm(acessed September 8, 2009)
   Google Scholar
• Vongchak , T. , Kawichai , S. , Sherman , S. , Celentano , D. D. Sirisanthana , T. 2005 . The influence of Thailand's 2003 ‘war on drugs’ policy on self-reported drug use among injection drug users in Chiang Mai, Thailand . International Journal of Drug Policy , 16 ( 2 ) : 115
   Web of Science ®Google Scholar
• Wilson , D. , Ford , N. , Ngammee , V. , Chua , A. and Kyaw , M. K. 2007 . HIV prevention, care, and treatment in two prisons in Thailand . PLoS Medicine , 4 ( 6 ) : e204
   Web of Science ®Google Scholar
• Wu , Z. , Sullivan , S. G. , Wang , Y. , Rotheram-Borus , M. J. and Detels , R. 2007 . Evolution of China's response to HIV/AIDS . Lancet , 369 ( 9562 ) : 679 – 690 .
   PubMed Web of Science ®Google Scholar
• Zou , K. 2002 . The “re-education through labour” system in China's legal reform . Criminal Law Forum , 12 : 459 – 485 .
   Google Scholar
• Zywicki , T. J. 2007 . Institutional review boards as academic bureaucracies: An economic and experiential analysis . Northwestern University Law Review , 101 ( 2 ) : 861 – 895 .
   Web of Science ®Google Scholar