Department of Psychiatry, Columbia University Medical Center, New York, NY, United States.
Int J Law Psychiatry. 2012 Sep-Dec;35(5-6):380-6. doi: 10.1016/j.ijlp.2012.09.003. Epub 2012 Sep 27.
Clinician-researchers have responsibilities both to seek the best interests of the people they treat and to advance scientific knowledge. The purpose of this study was to examine researchers' beliefs and behaviors regarding areas of tension between their clinical and scientific roles. We conducted and analyzed 19 in-depth interviews with psychiatric clinical researchers to explore these issues. Responses usually indicated that researchers recognize limits on their abilities to be helpful to patients, since they cannot know in advance whether a specific research intervention will help and whether participation is in the patient's best interest. Hence, most researchers did not make special efforts to recruit patients doing poorly in standard care, although they occasionally tolerated minor deviations from recruitment and treatment protocols when they might be in participants' interests. Often respondents asked the IRB to approve these deviations or change the protocol for all subjects, though it was unclear how often they may have acted without this approval. Despite researchers' high regard for following the research protocol, clinical judgment remained the ultimate guide if patients were not doing well and needed alternative care. Hence, respondents expressed a strong commitment both to protecting patients' interests and to advancing science. In cases of direct conflict between the two, many of the researchers tended to promote patients' best interests even at some cost to scientific research.
临床研究人员有责任寻求他们所治疗的人群的最佳利益,并推进科学知识。本研究的目的是考察研究人员在其临床和科学角色之间存在紧张关系的领域的信念和行为。我们对 19 名精神科临床研究人员进行了深入访谈,并对这些问题进行了分析。受访者的回答通常表明,研究人员认识到他们对患者提供帮助的能力有限,因为他们无法事先知道特定的研究干预是否会有帮助,以及参与是否符合患者的最佳利益。因此,尽管他们偶尔会容忍参与者的利益允许对招募和治疗方案进行微小偏离,但大多数研究人员并没有特别努力招募在标准护理中表现不佳的患者。受访者经常要求 IRB 批准这些偏离或更改所有受试者的方案,尽管尚不清楚他们在没有这种批准的情况下可能会采取多少次行动。尽管研究人员非常重视遵守研究方案,但如果患者情况不佳且需要替代治疗,临床判断仍然是最终的指导。因此,受访者表示强烈致力于保护患者的利益和推进科学。在两者直接冲突的情况下,许多研究人员往往倾向于促进患者的最佳利益,即使这对科学研究造成了一定的损失。