Kodish E, Stocking C, Ratain M J, Kohrman A, Siegler M
Department of Pediatrics, University of Chicago Pritzker School of Medicine, IL.
J Clin Oncol. 1992 Nov;10(11):1810-6. doi: 10.1200/JCO.1992.10.11.1810.
Phase I research trials assess the safety of agents never before administered to humans. In the field of oncology, this practice raises several important ethical questions. We examined the ethics of these trials by surveying phase I oncology investigators and institutional review board (IRB) chairpersons at major cancer research centers around the country.
Questionnaires were mailed to 78 investigators and 47 chairpersons to obtain their views on the ethical propriety of conducting phase I oncology research, and on institutional practice regarding these trials. The response rate was 68% in each group.
The majority of each group reported that phase I oncology trials face no more scrutiny or resistance in their institution's IRB process than other research protocols. Nevertheless, IRB chairpersons were more likely than investigators to favor special procedural safeguards to protect subjects in phase I oncology trials. Nearly all respondents agreed that although actual medical benefit was very uncommon, most patients entered for a chance at a therapeutic effect. Investigators were more likely than chairpersons to report that patients obtained psychologic benefit from participation in phase I trials.
Although individual IRB chairpersons and oncology investigators may have important differences of opinion concerning the ethics of phase I trials, these disagreements do not represent a widespread area of ethical conflict in clinical research.
I期研究试验评估此前从未用于人类的药物的安全性。在肿瘤学领域，这种做法引发了几个重要的伦理问题。我们通过对全国主要癌症研究中心的I期肿瘤学研究人员和机构审查委员会（IRB）主席进行调查，研究了这些试验的伦理问题。
向78名研究人员和47名主席邮寄了调查问卷，以了解他们对开展I期肿瘤学研究的伦理适当性以及关于这些试验的机构实践的看法。每组的回复率均为68%。
每组中的大多数人报告称，I期肿瘤学试验在其机构的IRB流程中面临的审查或阻力并不比其他研究方案更多。然而，IRB主席比研究人员更倾向于采取特殊程序保障措施来保护I期肿瘤学试验中的受试者。几乎所有受访者都同意，尽管实际医疗益处非常罕见，但大多数患者参加试验是为了获得治疗效果的机会。研究人员比主席更倾向于报告患者从参与I期试验中获得心理益处。
尽管个别IRB主席和肿瘤学研究人员在I期试验的伦理问题上可能存在重要的意见分歧，但这些分歧并不代表临床研究中广泛存在的伦理冲突领域。
