Post-Approval Monitoring and Oversight of U.S.-Initiated Human Subjects Research in Resource-Constrained Countries

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• 作者：Brandon Brown (1)
  Janni Kinsler (2)
  Morenike O. Folayan (3)
  Karen Allen (4)
  Carlos F. Cáceres (5)
  
• 关键词：Ethics ; Oversight ; Post ; approval monitoring ; Developing countries ; REC
• 刊名：Journal of Bioethical Inquiry
• 出版年：2014
• 出版时间：June 2014
• 年：2014
• 卷：11
• 期：2
• 页码：119-123
• 全文大小：
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• 作者单位：Brandon Brown (1)
  Janni Kinsler (2)
  Morenike O. Folayan (3)
  Karen Allen (4)
  Carlos F. Cáceres (5)
  
  1. Program in Public Health, Department of Population Health & Disease Prevention, University of California, Irvine, 653 E. Peltason Drive, 2024 AIRB, Irvine, CA, 92697-3957, USA
  2. Department of Community Health Sciences UCLA School of Public Health, Los Angeles, CA, 90095-1772, USA
  3. Institute of Public Health and Department of Child Dental Health, Obafemi Awolowo University, Ile-Ife, 22005, Nigeria
  4. UC Irvine Office of Research, 5171 California Avenue, Ste. 150, Irvine, CA, 92697-7600, USA
  5. Unit of Health, Sexuality and Human Development, Cayetano Heredia, University School of Public Health, Lima, Peru. Av. Armendariz 445, Lima 18, Peru
  
• ISSN：1872-4353

文摘

The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study’s investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research regulatory structures, arranging a site visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide.