Persons Jacqueline B, Osborne Travis L, Codd R Trent
Oakland Cognitive Behavior Therapy Center and University of California, Berkeley.
Evidence Based Treatment Centers of Seattle.
Behav Ther. 2021 Mar;52(2):313-323. doi: 10.1016/j.beth.2020.04.012. Epub 2020 Apr 26.
Mental health practitioners, even when they have research training, rarely contribute to the scientific literature. One reason for this may be that they need help addressing the ethical and legal issues they encounter as they contemplate undertaking research in a clinical practice setting. To address that need, we offer several types of guidance for conducting research in a private practice setting in a way that meets high ethical and legal standards. We describe the situations in which ethical review of a research proposal by a federally registered institutional review board (IRB) is legally required, and identify alternate mechanisms that practitioners can use to obtain an ethical review when a formal IRB review is not required by law. We discuss legal and ethical requirements of conducting single-case studies in a practice setting. We provide a rationale, and free and inexpensive options, for obtaining a formal certificate of training in human subjects research. And we offer guidance for obtaining informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from research participants. We conclude with a brief discussion of other legal and professional issues to consider when conducting research in private practice.
心理健康从业者，即使他们接受过研究培训，也很少为科学文献做出贡献。其中一个原因可能是，当他们考虑在临床实践环境中开展研究时，需要帮助来解决所遇到的伦理和法律问题。为满足这一需求，我们提供了几种类型的指导，以便在私人执业环境中开展研究时能够符合高伦理和法律标准。我们描述了在何种情况下，联邦注册机构审查委员会（IRB）对研究提案进行伦理审查在法律上是必需的，并确定了在法律不要求进行正式IRB审查时，从业者可用于获得伦理审查的替代机制。我们讨论了在实践环境中进行单病例研究的法律和伦理要求。我们提供了获得人类受试者研究正式培训证书的理由以及免费且低成本的选择。并且我们为从研究参与者处获得知情同意和《健康保险流通与责任法案》（HIPAA）授权提供指导。我们最后简要讨论了在私人执业中进行研究时要考虑的其他法律和专业问题。
