“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
- 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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