Stryjewski Tomasz P, Kalish Brian T, Silverman Benjamin, Lehmann Lisa Soleymani
Massachusetts Eye and Ear Infirmary, Boston, USA Harvard Medical School, Boston, MA, USA.
Harvard Medical School, Boston, MA, USA Boston Children's Hospital, MA, USA.
J Empir Res Hum Res Ethics. 2015 Dec;10(5):481-7. doi: 10.1177/1556264615614936.
We conducted a survey to assess the perspectives of principal investigators and Institutional Review Board (IRB) members on the impact of the IRB structure on the conduct of research and innovative therapy, defined as a nonstandard treatment intended to enhance the well-being of an individual patient. Although investigators and IRB members agreed that the IRB provides adequate protection to study subjects (97% vs. 100%) and an ethically insightful review (88% vs. 100%), a third of clinical investigators felt that the IRB review process limits clinical innovation, in comparison with only 4% of IRB representatives. Limitations of the current IRB review process were explored. We propose several measures to improve the IRB review process while maintaining the protection of human research subjects, including the use of centralized IRBs, the opening of IRB meetings to investigators, the development of metrics and outcome measures for the IRB, and the promotion of guidelines that distinguish research and innovative therapy.
我们开展了一项调查，以评估主要研究者和机构审查委员会（IRB）成员对IRB结构对研究及创新疗法实施的影响的看法。创新疗法被定义为旨在提高个体患者福祉的非标准治疗方法。尽管研究者和IRB成员一致认为IRB为研究对象提供了充分保护（97%对100%）以及具有伦理洞察力的审查（88%对100%），但三分之一的临床研究者认为IRB审查过程限制了临床创新，相比之下，只有4%的IRB代表持此观点。我们探讨了当前IRB审查过程的局限性。我们提出了若干措施，在维持对人体研究对象保护的同时改进IRB审查过程，包括采用集中式IRB、向研究者开放IRB会议、为IRB制定指标和结果衡量标准，以及推广区分研究和创新疗法的指南。
