Videorecording in clinical research - Mapping the ethical terrain

Videorecording in clinical research - Mapping the ethical terrain
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DOI:
10.1097/01.nnr.0000280658.81136.e4
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发表时间:
2008-01-01
期刊:
影响因子:
2.5
通讯作者:
Happ, Mary Beth
Happ, Mary Beth
中科院分区:
医学4区
文献类型:
--
作者:
Broyles, Lauren M.;Tate, Judith A.;Happ, Mary Beth

文献摘要

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背景:录像越来越多地用于临床研究的数据收集;然而,解决相关的伦理问题和获得机构审查委员会批准使用录像往往是重大和艰巨的挑战。在文献中,指导方针和具体策略极为有限。为了保护被录像的患者和临床医生研究参与者的利益,几个伦理问题值得深思熟虑和规划:知情同意、保密和隐私、参与者负担和安全。方法:通过辅助沟通策略对患者-护士有效性的研究来说明如何在临床试验中管理这些伦理问题。包括知情同意文件的摘录,并特别关注重症监护环境,弱势患者群体和临床医生作为参与者。结果:在急症护理医院环境中,与使用录像技术进行以病人为导向的研究相关的伦理问题得到澄清,并提供了如何解决这些问题的具体例子。讨论:当伦理问题的确切性质被明确定义时,与在急性护理研究中使用录像有关的伦理问题可以通过现有的普遍人类受试者保护策略充分解决。
Background: Videography is used increasingly for data collection in clinical research; however, addressing related ethical issues and obtaining institutional review board approval to use videography are often significant and daunting challenges for investigators. Guidelines and specific strategies are extremely limited in the literature. To protect the interests of videorecorded patient and clinician research participants, several ethical issues deserve thoughtful consideration and planning: informed consent, confidentiality and privacy, and participant burden and safety.Approach: The Study of Patient-Nurse Effectiveness with Assisted Communication Strategies is used to illustrate how these ethical issues can be managed in a clinical trial. Excerpts from informed consent documents are included, and special attention is given to the critical care environment, vulnerable patient populations, and clinicians as participants.Results: Ethical issues related to the use of videography for patient-oriented research in the acute care hospital setting are clarified, and specific examples of how these issues can be addressed are provided.Discussion: Ethical issues related to using videorecording in acute care research can be adequately addressed through existing universal human subjects protection strategies when the precise nature of the ethical issues is defined clearly.