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Addressing exploitation of poor clinical trial participants in North America and the European Union

      One of the cornerstones of ethical research is to protect participants from exploitation [
      • Emanuel E.J.
      • Wendler D.
      • Grady C.
      What makes clinical research ethical?.
      ]. Exploitation occurs when investigators, sponsors or others take unfair advantage of participants by failing to provide them with sufficient benefits given the burdens and risks they face (Table 1). For example, one of the paradigm cases of exploitation occurs when a pharmaceutical company earns billions in profit from a new drug that was tested in poor individuals who receive no benefits as a result of their participation.
      Table 1Conception of exploitation in clinical research
      • Dal-Re R.
      • Rid A.
      • Emanuel E.
      • Wendler D.
      The potential exploitation of research participants in high income countries who lack access to health care.
      .
      Following Wertheimer
      • Wertheimer A.
      Exploitation in clinical research.
      , we are concerned with the potential for exploitation of research participants understood as “A exploits B when A takes ‘unfair advantage’ of B”. Exploitation in this sense is transaction specific and concerns the outcome of individual transactions. This account allows for the possibility that a person may be exploited even though she consents to the transaction and also benefits from it. Vulnerability, is neither necessary nor sufficient for exploitation.

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