Undue inducement: a case study in CAPRISA 008

Journal of Medical Ethics 43 (12):824-828 (2017)

Abstract
Participant safety and data integrity, critical in trials of new investigational drugs, are achieved through honest participant report and precision in the conduct of procedures. HIV prevention post-trial access studies in middle-income countries potentially offer participants many benefits including access to proven efficacious but unlicensed technologies, ancillary care that often exceeds local standards-of-care, financial reimbursement for participation and possibly unintended benefits if participants choose to share or sell investigational drugs. This case study examines the possibility that this combination of benefits may constitute an undue inducement for some participants in middle-income countries, where economic challenges are prevalent. A case study is presented of a single participant in a cohort of 382 participants who used concealment, fabrication and deception to ensure eligibility for a post-trial access study of an unlicensed HIV prevention technology at potential risk to her health and that of her fetus. A root cause analysis revealed her desire to access HIV prevention during an unplanned pregnancy with a partner whose faithfulness was in question. Researchers should consider implementation of systems to efficiently identify similar cases without inconveniencing the majority of participants Trial registration number NCT01691768.
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1136/medethics-2016-103414
Options
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

Our Archive


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 46,223
Through your library

References found in this work BETA

Defining and Describing Benefit Appropriately in Clinical Trials.Nancy M. P. King - 2000 - Journal of Law, Medicine and Ethics 28 (4):332-343.
Undue Inducement: Nonsense on Stilts?Ezekiel J. Emanuel - 2005 - American Journal of Bioethics 5 (5):9-13.
Ending Concerns About Undue Inducement.Ezekiel J. Emanuel - 2004 - Journal of Law, Medicine and Ethics 32 (1):100-105.
Ending Concerns About Undue Inducement.Ezekiel J. Emanuel - 2004 - Journal of Law, Medicine and Ethics 32 (1):100-105.

View all 8 references / Add more references

Citations of this work BETA

Add more citations

Similar books and articles

Analytics

Added to PP index
2017-11-24

Total views
17 ( #532,097 of 2,285,714 )

Recent downloads (6 months)
1 ( #835,767 of 2,285,714 )

How can I increase my downloads?

Downloads

My notes

Sign in to use this feature