Yale School of Medicine, New Haven, CT 06510, USA.
Contemp Clin Trials. 2013 Jan;34(1):70-3. doi: 10.1016/j.cct.2012.08.013. Epub 2012 Sep 7.
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.
参与临床研究项目可能为研究特定筛选过程中的无症状志愿者提供早期发现隐匿性疾病和亚临床疾病的机会。由于不符合纳入标准而排除潜在参与者，就消除了那些被认为符合条件并被允许参与特定研究的人所存在的潜在研究相关获益的可能性。尽管监督临床研究实施的机构机构努力确保对参与者的福祉进行持续审查和优先排序，但我们认为，这些机制在那些随后被排除在相关临床研究之外的志愿者的利益方面存在不足。虽然提供辅助护理以解决筛选过程中暴露的健康问题可能是一种最佳策略，但在当前财政拮据的情况下成功实施这一概念的可能性微乎其微。通过本提交，我们希望在研究界发起一场关于是否修改当前临床研究实施模式以纳入一定程度对被筛选出的人的考虑的对话。我们在此建议，对于那些自愿参与疾病/障碍特定临床研究的人，可以通过提供有针对性的健康教育或咨询，为被筛选出的人群提供一定程度的额外获益。
