Excluded, not dismissed: enhancing benefit in clinical research

Abstract

Participation in clinical research projects may allow an opportunity for early detection of covert diseases and subclinical disorders in asymptomatic volunteers from study-specific screening process. Exclusion of a potential participant due to failure to meet inclusion criteria eliminates any possibility of potential for research related benefit, as may exist for those that are deemed eligible and allowed to proceed with participation in the specific research study. Although the institutional bodies overseeing conduct of clinical research strive to ensure an ongoing scrutiny and prioritization of participants' wellbeing, we perceive that these mechanisms fall short as regards the interests of those volunteers who are subsequently excluded from participation in clinical research of relevance. While provision of ancillary care to address health concerns that are unmasked during the screening process may be an optimal strategy, the likelihood of successfully implementing this latter concept in current times of fiscal constraints is slim to nonexistent. Through this submission, we hope to initiate a dialogue within the research community regarding whether the current paradigm of conduct of clinical research be modified to include some degree of consideration for the screened out. We herein propose that for those volunteering for disease/disorder specific clinical research, some added degree of benefit can be assured to the screened out population through the provision of targeted health education or counseling.

Trial registration: ClinicalTrials.gov NCT00743574.

Conflict of interest statement

Competing Interests: NONE

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