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Undue inducement: a case study in CAPRISA 008.

Kathryn T Mngadi1,2, Jerome A Singh1,3, Leila E Mansoor1

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Summary
This summary is machine-generated.

Undue inducement in HIV prevention trials may arise from participant benefits in middle-income countries. A case study highlights risks from deception to access unlicensed HIV prevention during pregnancy.

Keywords:
AutonomyClinical EthicsHIV Infection and AIDSResearch Ethics

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Area of Science:

  • Clinical Research Ethics
  • Public Health
  • Infectious Diseases

Background:

  • Participant safety and data integrity are paramount in investigational drug trials.
  • Post-trial access studies for HIV prevention in middle-income countries offer significant benefits, including access to unlicensed technologies and enhanced care.
  • Economic challenges in these regions may create conditions for undue inducement.

Observation:

  • A case study involving 382 participants in an HIV prevention post-trial access study is presented.
  • One participant employed concealment, fabrication, and deception to gain eligibility for an unlicensed HIV prevention technology.
  • The participant's motivation stemmed from an unplanned pregnancy and concerns about her partner's fidelity.

Findings:

  • The combination of benefits in post-trial access studies can potentially constitute undue inducement for some participants.
  • Deception to access HIV prevention technology posed risks to the participant and her fetus.
  • Root cause analysis identified the participant's desire for HIV prevention during a high-risk pregnancy as the primary driver.

Implications:

  • Researchers must develop systems to identify potential undue inducement without burdening the majority of participants.
  • Ethical considerations for clinical trials in resource-limited settings require careful evaluation of benefit packages.
  • Ensuring genuine informed consent and preventing participant risk are critical in HIV prevention research.