Resnik David B
National Institute of Environmental Health Sciences, National Institutes of Health, Box 12233, Mail Drop CU03, Research Triangle Park, NC 27709, USA.
Philos Ethics Humanit Med. 2009 Dec 3;4:16. doi: 10.1186/1747-5341-4-16.
The nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.
In this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty to provide the patient/subject with clinical care can vary from one situation to the next, as a function of several factors, including: the research design, benefits and risks of the research; the subject's reasonable expectations, motivations, and vulnerabilities; the investigator's ability to benefit the subject; and the investigator's prior relationship with the subject. These and other factors need to be considered when determining the clinical investigator's obligations to provide clinical care to human research subjects. In some research contexts, the investigator has extensive clinical obligations to the patient/subject; in others, the investigator has minimal ones.
临床研究者与研究对象之间关系的本质引发了诸多争论，因为研究者扮演着两个截然不同的角色：临床医生和科学家。作为临床医生，研究者有责任为患者提供最佳治疗并全心全意地忠诚服务。作为科学家，研究者有责任遵循方案中描述的规则、程序和方法。
在本文中，我提出了一种针对研究者与研究对象关系的情境化方法。研究者为患者/研究对象提供临床治疗的责任程度会因多种因素而有所不同，这些因素包括：研究设计、研究的益处和风险；研究对象的合理期望、动机和脆弱性；研究者使研究对象受益的能力；以及研究者与研究对象之前的关系。在确定临床研究者对人类研究对象提供临床治疗的义务时，需要考虑这些及其他因素。在某些研究情境中，研究者对患者/研究对象负有广泛的临床义务；而在其他情境中，研究者的义务则微乎其微。
