The Ethics of Opt-Out Provider-Initiated HIV Testing in the Emergency Department

急诊科选择退出医疗服务提供者发起的艾滋病毒检测的道德规范

• 批准号: 8417613
• 负责人: Ethan Adrian Cowan
• 金额: $ 13.51万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-01-20 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8417613
• 关键词: Accident and Emergency department; Adoption; Adult; Attitude; Belief; Bioethics; Centers for Disease Control and Prevention (U.S.); Clinic; Clinical; Clinical Research; Clinical Trials; Counseling; Data; Development; Educational Curriculum; Elements; Emergency Medicine; Empirical Research; Environment; Epidemic; Ethicists; Ethics; Exercise; Faculty; Goals; Guidelines; HIV; Happiness; Head; Healthcare; Human immunodeficiency virus test; Individual; Informed Consent; International; K-Series Research Career Programs; Knowledge; Language; Lead; Medical; Medical center; Medicine; Mentors; Methods; Monitor; Patient Care; Patients; Population; Prevention Guidelines; Primary Health Care; Procedures; Process; Provider; Public Health; Public Health Practice; Recommendation; Research; Research Methodology; Research Personnel; Rights; Science; Site; Testing; Training; Uninsured; United States; United States National Institutes of Health; Universities; base; clinical care; college; disorder prevention; experience; instrument; professor; programs; safety net; scale up; treatment center

DESCRIPTION (provided by applicant): Dr. Ethan Cowan is an Assistant Professor in the Department of Emergency Medicine at the Albert Einstein College of Medicine. With a background in research on informed consent for clinical procedures, Dr. Cowan is now seeking to develop expertise in empirical research in bioethics. Dr. Cowan is planning to study the intersection of bioethics as it applies to the individual and the health of the public. Emergency Departments (EDs) are a unique environment for this type of research because they provide individual clinical care and serve as a "safety net" for the population by treating the uninsured and underserved making it difficult to separate clinical and public health practice. The proposed study examines the ethical implications of a new public health initiative, opt-out provider-initiated HIV testing (hereby referred to as opt-out testing) in the ED. A mixture of qualitative and quantitative methods will be used to explore ED patients' and providers' beliefs, attitudes and acceptability toward opt-out testing. Ethical aspects of opt-out HIV testing will be examined including, 1) the ability of patients to understand that they have the right to decline the HIV test and that testing will be performed unless they exercise that right, 2) patients' understanding of HIV pretest information prior to undergoing testing, and 3) the impact of language on the understanding of opt-out testing and HIV pretest information. The research will be conducted in the urban ED of the Jacobi Medical Center, serving over 70,000 adult patients annually and staffed by faculty experienced in conducting NIH clinical trials. Dr. Cowan's training plan includes formal coursework, direct mentoring, specialized seminars, and practical experience in project planning and execution. Courses have been selected from the sociomedical sciences curriculum of Columbia University and the ethics program at Union Graduate College. Headed by a world renowned ethicist, Dr. Ruth Macklin, a committee of experts in clinical research methods will serve as mentors for this project. The proposed research has direct impact on public health. The instruments developed in this study may be adapted for use in evaluating and monitoring the ethical aspects of national and international opt-out testing programs. Furthermore, if this study demonstrates that opt-out testing is acceptable and can be ethically implemented this will lend support for adoption of ED based opt-out testing programs on a national scale.

描述（由申请人提供）：伊森科万博士是爱因斯坦医学院急诊医学系的助理教授。科万博士具有临床程序知情同意研究的背景，现在正在寻求发展生物伦理学经验研究的专业知识。科万博士正计划研究生物伦理学的交叉点，因为它适用于个人和公众的健康。急诊科（ED）是这类研究的独特环境，因为它们提供个人临床护理，并通过治疗未投保和服务不足的人群为人群提供“安全网”，从而难以将临床和公共卫生实践分开。拟议的研究探讨了一个新的公共卫生倡议，选择退出提供者发起的艾滋病毒检测（以下简称为选择退出测试）在ED的伦理影响。定性和定量的方法的混合物将被用来探索艾德患者和提供者的信念，态度和接受选择退出测试。将检查选择退出HIV检测的伦理方面，包括：1）患者理解他们有权拒绝HIV检测以及除非他们行使该权利否则将进行检测的能力，2）患者在接受检测前对HIV预检测信息的理解，以及3）语言对选择退出检测和HIV预检测信息理解的影响。该研究将在Jacobi医学中心的城市艾德进行，每年为70，000多名成年患者提供服务，并由具有进行NIH临床试验经验的教师组成。科万博士的培训计划包括正式课程、直接指导、专业研讨会以及项目规划和执行方面的实践经验。课程选自哥伦比亚大学的社会医学科学课程和联合研究生院的伦理学课程。由世界著名伦理学家Ruth Macklin博士领导的临床研究方法专家委员会将担任该项目的导师。这项研究对公众健康有直接影响。本研究中开发的工具可能适用于评估和监测国家和国际选择退出测试计划的伦理方面。此外，如果本研究证明选择退出测试是可接受的，并且可以在伦理上实施，这将支持在全国范围内采用基于艾德的选择退出测试项目。

项目成果

A qualitative assessment of emergency department patients' knowledge, beliefs, attitudes, and acceptance toward revised HIV testing strategies.

对急诊科患者的知识、信念、态度以及对修订后的艾滋病毒检测策略的接受程度进行定性评估。

• DOI: 10.1111/acem.12090
• 发表时间: 2013
• 期刊: Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
• 作者: Cowan,Ethan;Leider,Jason;Velastegui,Lorena;Wexler,Juliana;Velloza,Jennifer;Calderon,Yvette
• 通讯作者: Calderon,Yvette

Orbital fracture clinical decision rule development: burden of disease and use of a mandatory electronic survey instrument.

眼眶骨折临床决策规则的制定：疾病负担和强制性电子调查仪器的使用。

• DOI: 10.1111/j.1553-2712.2011.01017.x
• 发表时间: 2011
• 期刊: Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
• 作者: Yadav,Kabir;Cowan,Ethan;Wall,Stephen;Gennis,Paul
• 通讯作者: Gennis,Paul

Capacity to Consent to Research in Patients with Acute Pain: A Pilot Study.

同意急性疼痛患者研究的能力：一项试点研究。

• 发表时间: 2015
• 期刊: IRB
• 作者: Cowan,Ethan;Klerman,Hadassa;Ma,Jeffrey
• 通讯作者: Ma,Jeffrey

Unconsented HIV testing in cases of occupational exposure: ethics, law, and policy.

职业暴露情况下未经同意的艾滋病毒检测：道德、法律和政策。

• DOI: 10.1111/j.1553-2712.2012.01453.x
• 发表时间: 2012
• 期刊: Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
• 作者: Cowan,Ethan;Macklin,Ruth
• 通讯作者: Macklin,Ruth

Is preexposure prophylaxis ready for prime time use in HIV prevention research?

暴露前预防是否已准备好在艾滋病毒预防研究的黄金时段使用？

• DOI: 10.1097/qad.0000000000000055
• 发表时间: 2014
• 期刊: AIDS (London, England)
• 作者: Cowan,EthanA;Macklin,Ruth
• 通讯作者: Macklin,Ruth