Concealment and fabrication by experienced research subjects

Abstract

The use of deception threatens both participant safety and the integrity of research findings. Deception may be fueled in part by undue inducements, overly restrictive criteria for entry, and increased demand for healthy controls. Screening measures designed to detect deception among study subjects would aid in both protecting subjects and ensuring the quality of research findings.

Undue inducement: a case study in CAPRISA 008

“…Devine et al 8 hypothesise that compensation may influence willingness to tolerate risk, but that this is more likely in those who participate for financial reward (paid inducement) only. Macklin14 notes that whether an inducement is considered undue or not, is entirely subjective and based on the individual's value scheme.…”

“…The focus is often on financial payments12 13 15 16 and direct benefits from experimental treatment for the disease under investigation 8 10 11. A distinction is made between payment to healthy participants and those with the condition under investigation,8–10 12 as well as between research-naïve and research-experienced populations 7 8. However, research on inducement has been conducted primarily in high-income countries, including marginalised populations, with limited empirical work in low-and-middle-income countries (LMICs) 10…”

Ethics Dumping

“…One can assume that many of the ethical issues related to US "professional volunteers" are highly relevant to their counterparts in LMICs. Many have developed tactics to conceal their involvement in several studies at the same time and have become experts at manipulating screening tests for enrolment in clinical trials, for instance by concealing their participation in concomitant studies, medical conditions, concomitant medications or substance abuse (Edelblute and Fisher 2015;Devine et al 2013). These concealments expose the volunteers to medical risks (e.g.…”

“…This could be done by ensuring that documents are specifically designed for a population with low scientific literacy levels. Establishing compulsory national databases for healthy volunteers appears to be the best way to avoid some of the risks related with participation in multiple studies, detailed above (Devine et al 2013;Resnik and McCann 2015). Some countries (e.g.…”

Concealment and fabrication: The hidden price of payment for research participation?

“…Discussion in scholarly literature, in guidance and regulatory documents, and among investigators and institutional review board members has centered around concerns about impairing judgment, blinding subjects to risk, exploitation, commodification, or unjust distribution of research burden [1]. The article by Devine et al [2] in this issue addresses a different and largely understudied concern -the potential for paid research subjects to misrepresent themselves in order to gain entry into studies.…”