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机构审查委员会:临床研究人员须知

Institutional Review Boards: What Clinician Researchers Need to Know.

机构信息

Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN; Mayo Clinic Institutional Review Board, Mayo Clinic, Rochester, MN.

Department of Medicine, Division of Endocrinology, Mayo Clinic, Rochester, MN; Mayo Clinic Institutional Review Board, Mayo Clinic, Rochester, MN.

出版信息

Mayo Clin Proc. 2019 Mar;94(3):515-525. doi: 10.1016/j.mayocp.2019.01.020.

Abstract

The institutional review board (IRB) is a group federally mandated to review and monitor research involving humans to ensure protection of their rights and welfare as research participants. Clinicians engaged in research require IRB approval for all research involving human participants, whether living individuals, data, or specimens. The process for obtaining IRB approval may seem like a daunting task. However, it is critical for clinical researchers to conduct research in a manner that protects human participants, and it is the mission of the IRB to help researchers accomplish this task. The purpose of this article is to review the role and purpose of the IRB, highlight federal and regulatory standards in human research participants protection, and help clinical researchers have a broader understanding of IRB functions that will help them conduct high-quality research with human participants.

摘要

机构审查委员会(IRB)是一个联邦授权的小组,负责审查和监督涉及人类的研究,以确保保护他们作为研究参与者的权利和福利。从事研究的临床医生需要获得所有涉及人类参与者的研究的 IRB 批准,无论是活体个体、数据还是标本。获得 IRB 批准的过程似乎是一项艰巨的任务。然而,临床研究人员以保护人类参与者的方式进行研究至关重要,而 IRB 的使命是帮助研究人员完成这项任务。本文的目的是审查 IRB 的作用和目的,强调保护人类研究参与者的联邦和监管标准,并帮助临床研究人员更广泛地了解 IRB 功能,这将有助于他们进行高质量的人类参与者研究。

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