Do We Need Lie Detector Tests for Research Participants?

“Misconduct by research participants is a serious problem” (DB Resnick, DJ McCann. NEJM 2015; 373: 1192-3).

While research deception by investigators receives a great deal of attention, apparently research participants often fabricate or falsify information.  Key points in this commentary:

  • Research participant deception does not violate federal rules or institutional policies.
  • Among a group of 100 participants who had participated in at least two studies, a recent study found that 25% admitted to exaggerating their symptoms in order to qualify and 14% pretended to have a health problem that they did not have
  • Other deceptions: concealing other health problems, enrollment in other studies, prescription drug use, and recreational drug use

Why lie?

  • Economic motives
  • Embarrassment re: sexual history, mental health, or illegal activities

Are there consequences to this deception?

  • By including patients who may be ‘destined to succeed,’ it creates a significant bias and reduces the statistical power and effect size of a research study.
  • Deception could lead to a false conclusion that a drug was not very effective.
  • By including patients who do not have a condition, the true safety of the medication in the target population cannot be determined precisely.
  • Participants may place themselves at risk for complications by withholding important information.  (Example: Bernadette Gillcrist. Hastings Cent Rep 1980: 10: 5-6).

Potential ways to discourage deception?

  • Better screening with exams and blood tests (e.g. assays for non-study medications).
  • Require participants to be listed in a clinical trial patient registry.  The U.S. does not currently have a national registry.

Perhaps, a good first step is to let research candidates understand how their deception can be harmful.  I suspect that many are interested in the inducements to participate without considering the consequences of exaggerating their health problems.

My take: Given the enormous expense involved in most research studies, assuring that the research subjects are appropriate is crucial.  How to achieve this goal is not so clear.

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