Johnson Matthew S, Gonzales Marcia N, Bizila Shelley
Department of Radiology, Indiana University School of Medicine, Indiana University Hospital, Room 0279, 550 N University Blvd, Indianapolis, IN 46202-5253, USA.
Radiology. 2005 Dec;237(3):757-64. doi: 10.1148/radiol.2373041148.
For the past 5 years, the regulatory environment for research involving humans has been turbulent, with criticism coming from the federal government, the academic community, and the press. The purpose of this series of articles is to explain the ethical and legal bases for responsible conduct of radiology research and the rules that an investigator must follow. The purpose of this fifth part of the series is to explain the requirements of the Privacy Rule, which is a component of the Health Insurance Portability and Accountability Act (HIPAA), as they relate to human research. Under the HIPAA Privacy Rule, researchers within covered entities must follow appropriate methods as they use or disclose protected health information (PHI). Investigators should know the conditions under which PHI may be accessed for research purposes (ie, with authorization or waiver of authorization, when only a limited data set is evaluated, if data have been de-identified, or in reviews preparatory to research). Furthermore, researchers should know which information, such as the Notice of Privacy Practices and the Accounting of Disclosures, must be provided to potential subjects, when appropriate. At the conclusion of this article, several scenarios related to various types of radiology research and related regulatory requirements are presented.
在过去的5年里，涉及人类的研究监管环境动荡不安，受到了联邦政府、学术界和媒体的批评。本系列文章的目的是解释放射学研究负责任开展的伦理和法律依据以及研究者必须遵循的规则。本系列第五部分的目的是解释《隐私规则》的要求，该规则是《健康保险流通与责任法案》（HIPAA）的一部分，与人体研究相关。根据HIPAA隐私规则，受保实体的研究人员在使用或披露受保护的健康信息（PHI）时必须遵循适当的方法。研究人员应该知道在哪些条件下可以出于研究目的访问PHI（即，获得授权或放弃授权、仅评估有限数据集、数据已去识别或在研究准备审查时）。此外，研究人员应该知道在适当的时候必须向潜在受试者提供哪些信息，如隐私惯例通知和披露记录。在本文结尾，给出了与各类放射学研究及相关监管要求相关的几种情形。
