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Breach of ethics: Researchers conclude voluntary consent guidelines "suboptimal"

A team of Dutch researchers warns that "Current guideline approaches to protect voluntary informed consent within a dependent relationship are suboptimal"

That pharmaceutical firm- and university-sponsored medical researchers have for decades cut corners instead of taking appropriate care to protect vulnerable populations during drug trials is not exactly a secret. However, despite the many clinical trial registries and attempts at transparency that have sprung up over the past several years, the voluntary consent processes in use are likely not protecting participants as well as one might hope.

In an article published this month in BMC Medicine, a team of Dutch scientists headed by Sara Dekking warns that "Current guideline approaches to protect voluntary informed consent within a dependent relationship are suboptimal." Specifically, Dekker and her colleagues warn,

  1. Research nurses involved in clinical trials are not always independent.
  2. Physicians who also serve as clinical trial investigators are necessarily kept informed about the decisions their patients make regarding clinical trial involvement.
  3. It is not always practical to involve a counselor for potential trial participants.
  4. When the trial investigator is a trial participant's physician, the participant may not have true freedom to withdraw from the trial.

Dekker and colleagues describe these challenges in detail, pointing out the ways in which the guidelines fall short of ensuring truly informed consent. One example is the fact that although at least one review indicates that 75 percent of research participants are "generally aware of their right to withdraw" from a clinical trial, studies regarding the specifics of participants' beliefs indicate that many participants' consent is actually involuntary. Dekker cites a study involving Haitian participants in which 11 percent of the participants agreed with statements such as "a 'volunteer' is someone who makes an irreversible commitment to remain in the study." Such a belief is a clear indication that consent to continue participation is not truly voluntary.

Perhaps most troubling, Dekker and colleagues "believe that quick and easy solutions to the problem of compromised voluntariness do not exist." Among the actions that should be taken, the researchers write, are informing participants that withdrawing from a study will not have negative consequences for the patient and declaring honestly and transparently any research-related interests of the physician and the research nurse. Dekker and colleagues also advocate further research into voluntary consent procedures.

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