Access to Medications and Medical Care After Participation in HIV Clinical Trials: A Systematic Review of Trial Protocols and Informed Consent Documents

REFERENCES

• Pace C, Grady C, Wendler D, Bebchuk JD, Tavel JA, McNay LA, et al. Post-trial access to tested interventions: The views of IRB/REC chair, investigators, and research participants in a multinational HIV/AIDS study. AIDS Res Hum Retro viruses. 2006;22:837–841.
   PubMed Web of Science ®Google Scholar
• Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries. Moral standards for res-earch in developing countries: From "reasonable availability" to "fair benefits." Hastings Center Report. 2004;34:17–27.
   Google Scholar
• Emanuel EJ. Undue inducement: Nonsense on stilts? Am J Bioethics. 2005;5:9-13.
   Google Scholar
• GlaxoSmithKline. Clinical trials in the developing world. 2005. Available at: http://www.gsk.com/corporate_respon-sibiIity/Downloads/clinical_trials_in_the_developing_world.pdf. Accessed December 15,2005.
   Google Scholar
• Macklin R. After Helsinki: Unresolved issues in interna-tional research. Kennedy lnst Ethics J. 200111: 17–36.
   Google Scholar
• Weijer C, LeBlanc G. The Balm of Gilead: Is the provision of treatment to those who seroconvert in HIV prevention trials a matter of moral obligation or moral negotiation? J Law Med Ethics. 2006;34:793–808.
   Google Scholar
• Slack C, Stobie M, Milford C, Lindegger G, Wassenaar D, Strode A, Ijsselmuiden C. Provision of HIV treatment in HIV preventive vaccine trials: A developing country perspec-tive. Soc Sci Med. 2005;60:1197–1208.
   PubMed Web of Science ®Google Scholar
• McMillan JR, Conlon C. The ethics of research related to health care in developing countries. J Med Ethics. 2004;30:204–206.
   PubMed Web of Science ®Google Scholar
• Ananworanich J, Cheunyam T, Teeratakulpisarn S, Boyd MA, Ruxrungtham K, Lange J, et al. Creation of a drug fund for post-clinical trial access to antiretrovirals. Lancet. 2004;364:101–102.
   PubMed Web of Science ®Google Scholar
• Shaffer DN, Yebei VN, Ballidawa JB, Sidle JE, Greene JY, Meslin EM, et al. Equitable treatment for HIV/AIDS clinical trial participants: A focus group study of patients, clinician researchers, and administrators in Western Kenya. J Med Ethics. 2006;32:55–60.
   PubMed Web of Science ®Google Scholar
• El-Sadr WM, Lundgren JD, Neaton JD, Gordin F, Abrams D, Arduino RC, et al. CD4+ count-guided inter-ruption of antiretroviral treatment. N Engl J Med. 2006;355: 2283–2296.
   PubMed Web of Science ®Google Scholar
• Lundgren JD, Babiker A, El-Sadr W, Emery S, Grund B, Neaton JD, et al. Inferior clinical outcome of the CD4+ cell count-guided antiretroviral treatment interruption strategy in the SMART study: Role of CD4+ cell counts and HIV RNA levels during follow-up. J Infect Dis. 2008;197:1145–1155.
   PubMed Web of Science ®Google Scholar
• Department of Health and Human Services. Panel on Antiretroviral Guidelines for Adults and Adolescents: Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. 2008. Available at: http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf. Accessed September 15, 2008.
   Google Scholar
• World Medical Association. Declaration of Helsinki. 2004. Available at: http://www.wma.net/e/policy/b3.htm. Accessed October 15, 2006.
   Google Scholar
• National Institutes of Health. Guidance for addressing the provision of antiretroviral treatment for trial participants following their completion of NIH-funded HIV antiretro-viral treatment trials in developing countries: March 16, 2005. Available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-038.html. Accessed December 28, 2006.
   Google Scholar
• Council for International Organizations of Medical Sci-ences. International ethical guidelines for biomedical research involving human subjects (revised, 2002). 1993. Available at: http://www.fhi.org/training/fr/Retc/pdf_files/cioms.pdf. Accessed January 4, 2007.
   Google Scholar
• Joint United Nations Programme on HIV/AIDS (UNAIDS). Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS Guidance Document. Geneva: UNAIDS; 2001.
   Google Scholar
• Nuffield Council on Bioethics. The Ethics of Research Related to Healthcare in Developing Countries. London: Nuffield Council on Bioethics; 2002. Available at: http://www.nuffieldbioethics.org/fileLibrary/pdf/errhdc_fullreport001.pdf
   Google Scholar
• National Bioethics Advisory Commission. When research is concluded-access to the benefits of research by participants, communities, and countries. In: Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Washington, DC: US Government Printing Office; 2001.
   Google Scholar
• United States Department of Health and Human Serv-ices. Common Rule: 45 Code of Federal Regulations (CFR) 46. 2005. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed January 4, 2007.
   Google Scholar
• United States Public Health Service. Consultation on inter-national collaborative HIV research. Law Med Health Care. 1991;259:3–4.
   Google Scholar
• US Food and Drug Administration. CDER Handbook. 2008. Available at: http://www.fda.gov/cder/handbook/. Accessed September 15, 2008.
   Google Scholar
• US Food and Drug Administration. Center for Drug Evalu-ation and Research: Drugs used in the treatment of HIV infection. 2006. Available at: http://www.fda.gov/oashi/aids/virals.html. Accessed December 15, 2006.
   Google Scholar
• National Institutes of Health. Clinicaltrials.gov. 2008. Avail-able at: http://www.clinicaltrials.gov. Accessed December 15, 2006.
   Google Scholar
• Adult AIDS Clinical Trials Group. Protocol Specific Web Pages. Available at: http://www.aactg.com/members/reports/aactprot.htm. Accessed December 15, 2006.
   Google Scholar
• Merritt M, Grady C. Reciprocity and post-trial access for participants in antiretroviral therapy trials. AIDS. 2006;20:1791–1794.
   PubMed Web of Science ®Google Scholar
• Hutt LE. Freebies for subject 641: A discussion of the ethical prospect of providing drug trial subjects with post-trial access to the drug tested-a Canadian perspective. Health Law J. 1998;6(Spec No):169–187.
   PubMedGoogle Scholar
• Grady C. The challenge of assuring continued post-trial access to beneficial treatment. Yale J Health Policy Law Ethics. 2005;5:425–435.
   PubMedGoogle Scholar
• US Department of Health and Human Services. Office for Human Research Protections (OHRP): Assurances. 2006. Available at: http://www.hhs.gov/ohrp/assurances/assurances_index.html. Accessed August 14, 2008.
   Google Scholar
• US Food and Drug Administration. Information Sheets (Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update). A Guide to Informed Con-sent. 1998. Available at: http://www.fda.gov/oc/ohrt/IRBs/informedconsent.html. Accessed August 13, 2008.
   Google Scholar
• Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283:2701–2711.
   Google Scholar