Title
Post-Approval Monitoring and Oversight of U.S.-Initiated Human Subjects Research in Resource-Constrained Countries
Date Issued
01 June 2014
Access level
metadata only access
Resource Type
journal article
Author(s)
Publisher(s)
Springer Netherlands
Abstract
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.
Start page
119
End page
123
Volume
11
Issue
2
Language
English
OCDE Knowledge area
Ciencias socio biomédicas (planificación familiar, salud sexual, efectos políticos y sociales de la investigación biomédica) Ética
Scopus EID
2-s2.0-84957429021
PubMed ID
Source
Journal of Bioethical Inquiry
ISSN of the container
11767529
Sources of information: Directorio de Producción Científica Scopus