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Stakeholders' Perspectives regarding Participation in Neuromodulation-Based Dementia Intervention Research. 利益相关者对参与基于神经调节的痴呆干预研究的看法
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2022-02-01 Epub Date: 2021-12-06 DOI: 10.1177/15562646211060997
Laura B Dunn, Jane P Kim, Maryam Rostami, Sangeeta Mondal, Katie Ryan, Asees Waraich, Laura Weiss Roberts, Barton W Palmer

This study evaluated stakeholders' perspectives regarding participation in two hypothetical neuromodulation trials focused on individuals with Alzheimer's disease and related disorders (ADRDs). Stakeholders (i.e., individuals at risk for ADRDs [n = 56], individuals with experience as a caregiver for someone with a cognitive disorder [n = 60], and comparison respondents [n = 124]) were recruited via MTurk. Primary outcomes were willingness to enroll (or enroll one's loved one), feeling lucky to have the opportunity to enroll, and feeling obligated to enroll in two protocols (transcranial magnetic stimulation, TMS; deep brain stimulation, DBS). Relative to the Comparison group, the At Risk group endorsed higher levels of "feeling lucky" regarding both research protocols, and higher willingness to participate in the TMS protocol. These findings provide tentative reassurance regarding the nature of decision making regarding neurotechnology-based research on ADRDs. Further work is needed to evaluate the full range of potential influences on research participation.

这项研究评估了利益相关者对参与两项假设的神经调控试验的看法,这两项试验侧重于阿尔茨海默病和相关疾病(ADRD)患者。利益相关者(即有ADR风险的个人[n = 56],有照顾认知障碍患者经验的人[n = 60],以及比较受访者[n = 124])通过MTurk招募。主要结果是愿意加入(或加入自己的爱人),有机会加入感到幸运,以及有义务加入两种方案(经颅磁刺激,TMS;深部脑刺激,DBS)。与对照组相比,风险组对两种研究方案的“幸运感”水平更高,参与TMS方案的意愿更高。这些发现为基于神经技术的ADR研究的决策性质提供了初步的保证。需要进一步的工作来评估对研究参与的所有潜在影响。
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引用次数: 2
A Study on the Characteristics of Healthy Volunteers who Participate in Phase I Clinical Trials in Korea. 韩国参加I期临床试验的健康志愿者的特征研究
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2022-02-01 Epub Date: 2021-08-20 DOI: 10.1177/15562646211034275
Ji-Hye Seo, Ock-Joo Kim, Sang-Ho Yoo, Eun Kyung Choi, Ji-Eun Park

The phase I trial is the first step in administering a drug to humans, but it has no therapeutic purpose. Under the absence of therapeutic purpose, healthy volunteers demonstrated different motivations, unlike the actual patients participating in trials. There were many reported motivations, such as financial motivation, contributing to the health science, accessing ancillary health care benefits, scientific interest or interest in the goals of the study, meeting people, and general curiosity. The aim of this study was to identify the motivation and characteristics of healthy volunteers participating in phase I trials in the Republic of Korea. We gave surveys to 121 healthy volunteers to study their demographic characteristics and the reasons of participation. We identified whether the decision to participate in the research was influenced by demographic factors and whether the perception and attitudes toward the research were influenced by the characteristics of the healthy volunteers. After completion of the first survey, 12 healthy volunteers who had participated in a phase I clinical trial were selected to answer the second interview. According to our survey, most healthy volunteers were unmarried men and economically dependent. Most of them participated in the study because of financial reward. The most important factor to measure financial reward was the research period. Also, 43% of the volunteers were university students, 42% answered "university graduation" and 55% were residing in family-owned houses. Many healthy volunteers were found to be living in family homes and to have a student status or lack of economic independence. Results of the survey showed that 64% of respondents indicated having more than one clinical trial participation. In-depth interviews showed that healthy volunteers had diverse motivation to participate in research and that healthy volunteer perceive the clinical trial positively. The main motivation for healthy volunteers' participation in research was "financial reward." Healthy volunteers also considered research schedules, processes, and safety, and had a positive perception of clinical trials, but they thought that the public has a negative perception.

第一阶段试验是将药物用于人体的第一步,但它没有治疗目的。在没有治疗目的的情况下,健康志愿者表现出不同于实际参与试验的患者的动机。有许多报告的动机,如经济动机、为健康科学做出贡献、获得辅助医疗保健福利、科学兴趣或对研究目标的兴趣、与人交往和一般的好奇心。本研究的目的是确定参与大韩民国一期试验的健康志愿者的动机和特征。我们对121名健康志愿者进行调查,研究他们的人口学特征和参与的原因。我们确定参与研究的决定是否受到人口因素的影响,以及对研究的看法和态度是否受到健康志愿者特征的影响。在完成第一次调查后,12名参加过一期临床试验的健康志愿者被选中回答第二次访谈。根据我们的调查,大多数健康的志愿者都是未婚且有经济依赖的男性。他们中的大多数人参加这项研究是因为经济奖励。衡量经济报酬的最重要因素是研究期间。此外,43%的志愿者是大学生,42%的人回答“大学毕业”,55%的人居住在家庭拥有的房子里。调查发现,许多健康的志愿者住在家庭中,有学生身份或缺乏经济独立。调查结果显示,64%的受访者表示参加了不止一项临床试验。深度访谈显示,健康志愿者参与研究的动机是多样的,健康志愿者对临床试验的认知是积极的。健康志愿者参与研究的主要动机是“经济奖励”。健康志愿者也考虑了研究日程、过程和安全性,对临床试验有积极的看法,但他们认为公众有消极的看法。
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引用次数: 2
Human Research Ethics Committee Experiences and Views About Children's Participation in Research: Results From the MESSI Study. 人类研究伦理委员会关于儿童参与研究的经验和观点:来自梅西研究的结果。
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2022-02-01 Epub Date: 2021-10-12 DOI: 10.1177/15562646211048294
Stephanie Taplin, Jenny Chalmers, Judith Brown, Tim Moore, Anne Graham, Morag McArthur

As part of a larger study, Australian Human Research Ethics Committee (HREC) members and managers were surveyed about their decision-making and views about social research studies with child participants. Responses of 229 HREC members and 42 HREC managers are reported. While most HREC members had received ethical training, HREC training and guidelines specific to research involving children were rare. Most applications involving children had to go through a full ethical review, but few adverse events were reported to HRECs regarding the conduct of the studies. Revisions to study proposals requested by HRECs were mostly related to consent processes and age-appropriate language. One-third of HREC members said that they would approve research on any topic. Most were also concerned that the methodology was appropriate, and the risks and benefits were clearly articulated. Specific training and guidance are needed to increase HREC members' confidence to judge ethical research with children.

作为一项更大的研究的一部分,澳大利亚人类研究伦理委员会(HREC)的成员和管理人员接受了关于他们对儿童参与的社会研究的决策和看法的调查。报告了229名HREC成员和42名HREC管理者的反馈。虽然大多数HREC成员都接受过道德培训,但HREC针对涉及儿童的研究的培训和指导方针却很少。大多数涉及儿童的申请必须经过全面的伦理审查,但很少有不良事件报告给HRECs关于研究的进行。HRECs要求对研究提案进行修订,主要涉及同意程序和适合年龄的语言。三分之一的HREC成员表示,他们会批准任何主题的研究。大多数人还关心方法是否适当,风险和利益是否清楚地表达出来。需要具体的培训和指导,以增强HREC成员判断儿童伦理研究的信心。
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引用次数: 3
An Overview of King Hussein Cancer Center Institutional Review Board Over 12 Years (2009-2020), Successes and Challenges, Including Those Imposed by the COVID-19 Pandemic. 侯赛因国王癌症中心机构审查委员会12年来(2009-2020年)的概况,成功和挑战,包括COVID-19大流行带来的挑战。
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2022-02-01 Epub Date: 2021-11-22 DOI: 10.1177/15562646211053234
Linda Kateb, Sawsan El-Jayousi, Maysa Al-Hussaini

The problem: Running an efficient institutional review board (IRB) can be challenging. The research subjects: To ensure an efficient committee, our IRB adopted several operational metrics. Methods: Analysis of retrospective data from the IRB records, database, and annual reports over 12 years. Results: The IRB roster comprises 11 members. The average medical to nonmedical member ratio is 5:6, and the male to female ratio is 4:7, which has not been consistent over the years. One thousand three hundred and twenty-four proposals were reviewed including 1077 exempt (81.3%), 126 expedited (9.5%), and 121 full board (9.2%) with a median turnaround time to approval of 4.0, 35.0, and 68.0 days, respectively. Training of the IRB members was conducted to enhance their knowledge and skills. IRB at King Hussein Cancer Center has managed to stay abreast and efficient during the COVID-19 pandemic, by working remotely. Conclusion: Running an efficient IRB mandates implementing a number of operational metrics.

问题是:管理一个高效的机构审查委员会(IRB)可能具有挑战性。研究主题:为了确保委员会的效率,我们的内部审查委员会采用了几个操作指标。方法:回顾性分析来自IRB记录、数据库和年度报告的12年数据。结果:IRB名册包括11名成员。医务人员与非医务人员的平均比例为5:6,男女比例为4:7,多年来一直不一致。审查了1324份提案,包括1077份豁免(81.3%),126份加速(9.5%)和121份全员(9.2%),批准的平均周转时间分别为4.0,35.0和68.0天。为聘审局成员提供培训,以提高他们的知识和技能。侯赛因国王癌症中心的IRB通过远程工作,在COVID-19大流行期间保持了及时和高效。结论:运行一个有效的IRB要求实现一些操作指标。
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引用次数: 0
Perceptions of HIV Research Participation Among Gay, Bisexual, and Other Men who Have Sex with Men and Transgender and Nonbinary Adults: Results From a Midwest Pride Event. 同性恋、双性恋和其他男男性行为者、变性人和非二元性成年人对艾滋病研究参与的看法:来自中西部骄傲事件的结果。
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2022-02-01 Epub Date: 2021-12-06 DOI: 10.1177/15562646211062707
Andrea R Kaniuka, Meagan Zarwell, Robert J Cramer, Katherine Quinn, Michelle Broaddus, Alexandra Patton, Jennifer L Walsh

Human immunodeficiency virus (HIV) continues to disproportionately affect gay, bisexual, and other men who have sex with men (GBM) and transgender and nonbinary (trans/NB) individuals. This study investigated attitudes toward participation in HIV survey research, guided by Emanuel's framework for ethical clinical research (e.g., risk-benefit ratio, fair participant selection, respect for participants, social value, and collaborative partnership). GBM (n = 294) and trans/NB (n = 86) persons recruited at a Pride event in Milwaukee completed a survey assessing risks and benefits of participation in, and comfort responding to, sexual health surveys. Participants reported few ethical concerns (e.g., privacy and confidentiality), with notable differences by race, sexual orientation and gender identity, and prior research experiences. Implications for HIV research with GBM and trans/NB individuals are discussed.

人类免疫缺陷病毒(HIV)继续不成比例地影响同性恋、双性恋和其他男男性行为者(GBM)以及跨性别和非二元性(trans/NB)个体。本研究以Emanuel的伦理临床研究框架(如风险收益比、公平参与者选择、尊重参与者、社会价值和合作伙伴关系)为指导,调查了参与HIV调查研究的态度。在密尔沃基的骄傲活动中招募的GBM (n = 294)和跨性别/NB (n = 86)完成了一项调查,评估参与性健康调查的风险和益处,以及对性健康调查的回应。参与者报告的伦理问题(如隐私和保密)很少,在种族、性取向和性别认同以及之前的研究经历方面存在显著差异。讨论了GBM和跨性别/NB个体HIV研究的意义。
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引用次数: 0
Social Researchers' Approaches to Research Ethics During the COVID-19 Pandemic: An Exploratory Study. COVID-19大流行期间社会研究者的研究伦理途径:一项探索性研究
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2022-02-01 Epub Date: 2021-11-15 DOI: 10.1177/15562646211055056
Adrianna Surmiak, Beata Bielska, Katarzyna Kalinowska

The global COVID-19 pandemic and quarantine/distancing measures have forced researchers to cope with a new situation. This paper aimed to analyze how the pandemic and its associated constraints have affected social researchers' approach to research ethics. Drawing on an online qualitative survey with 193 Polish social researchers conducted in April and May 2020, we distinguished three approaches: nothing has changed, opportunity-oriented, and precautionary. According to the first, the pandemic was not regarded as a situation that required additional reflection on ethical issues or changes in research approaches. By contrast, the other two were based on the assumption that the pandemic affected research project ethics. The difference was in the assessment of changes in the area of ethics. The pandemic presented an opportunity and a threat to the ethicality of research, respectively. We discuss the implications of all three approaches for research and education.

全球COVID-19大流行和隔离/距离措施迫使研究人员应对新形势。本文旨在分析大流行及其相关限制因素如何影响社会研究者的研究伦理方法。根据2020年4月和5月对193名波兰社会研究人员进行的在线定性调查,我们区分了三种方法:没有改变,机会导向和预防。根据第一种说法,人们不认为这种大流行病的情况需要对伦理问题或研究方法的改变进行额外的思考。相比之下,另外两个是基于疫情影响研究项目伦理的假设。不同之处在于对道德领域变化的评估。这一流行病对研究的伦理性分别构成了机遇和威胁。我们将讨论这三种方法对研究和教育的影响。
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引用次数: 9
Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials. 了解在临床试验中使用最佳格式和简单的语言来呈现关键信息。
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2022-02-01 Epub Date: 2021-08-19 DOI: 10.1177/15562646211037546
Erin D Solomon, Jessica Mozersky, Matthew P Wroblewski, Kari Baldwin, Meredith V Parsons, Melody Goodman, James M DuBois

Recent revisions to the Common Rule require that consent documents begin with a focused presentation of the study's key information that is organized to facilitate understanding. We surveyed 1,284 researchers working with older adults or individuals with Alzheimer's disease, supplemented with 60 qualitative interviews, to understand current use and barriers to using evidence-based formatting and plain language in key information. Researchers reported using formatting in 42% of their key information sections, and plain language in 63% of their key information sections. Perceived barriers included lack of knowledge, Institutional Review Board, other members of their team, and the burden associated with implementation. Education and training are required to increase adoption of the practices.

最近对《共同规则》的修订要求同意书文件从重点介绍研究的关键信息开始,这些信息的组织有助于理解。我们调查了1284名研究老年人或阿尔茨海默病患者的研究人员,并辅以60次定性访谈,以了解目前在关键信息中使用循证格式和简明语言的情况和障碍。研究人员报告称,42%的关键信息部分使用了格式,63%的关键信息章节使用了简明语言。感知到的障碍包括缺乏知识、机构审查委员会、其团队的其他成员以及与实施相关的负担。需要进行教育和培训,以增加对这些做法的采用。
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引用次数: 9
Biobank Participants' Attitudes Toward Data Sharing and Privacy: The Role of Trust in Reducing Perceived Risks. 生物银行参与者对数据共享和隐私的态度:信任在降低感知风险中的作用。
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2022-02-01 Epub Date: 2021-11-15 DOI: 10.1177/15562646211055282
T J Kasperbauer, Colin Halverson, Abby Garcia, Peter H Schwartz

Biobank participants are often unaware of possible uses of their genetic and health information, despite explicit descriptions of those uses in consent forms. To explore why this misunderstanding persists, we conducted semi-structured interviews and knowledge tests with 22 participants who had recently enrolled in a research biobank. Results indicated that participants lacked understanding of privacy and data-sharing topics but were mostly unconcerned about associated risks. Participants described their answers on the knowledge test as largely driven by their trust in the healthcare system, not by a close reading of the information presented to them. This finding may help explain the difficulties in increasing participant understanding of privacy-related topics, even when such information is clearly presented in biobank consent forms.

生物样本库的参与者往往不知道他们的遗传和健康信息可能被用于何种用途,尽管在同意书中明确说明了这些用途。为了探究这种误解持续存在的原因,我们对22名最近加入研究生物银行的参与者进行了半结构化访谈和知识测试。结果表明,参与者缺乏对隐私和数据共享主题的理解,但大多不关心相关风险。参与者描述他们在知识测试中的答案主要是由他们对医疗保健系统的信任驱动的,而不是通过仔细阅读提供给他们的信息。这一发现可能有助于解释在增加参与者对隐私相关主题的理解方面存在的困难,即使这些信息已在生物库同意书中清楚地呈现出来。
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引用次数: 5
Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes. 与参与生物库的不同患者沟通:比较电子和面对面知情同意程序的随机多站点研究。
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2022-02-01 Epub Date: 2021-08-19 DOI: 10.1177/15562646211038819
Christian M Simon, Kai Wang, Laura A Shinkunas, Daniel T Stein, Paul Meissner, Maureen Smith, Rebecca Pentz, David W Klein

Some individuals' understanding of informed consent (IC) information may improve with electronic delivery, but others may benefit from face-to-face (F2F). This randomized, multisite study explores how individuals from diverse backgrounds understand electronic IC documents versus F2F, their confidence in understanding, and enrollment in research. A total of 501 patients at two U.S. biobanks with diverse populations participated. There were no overall differences between electronic and F2F understanding, but F2F predicted higher confidence in understanding and enrollment. Ethnicity and a higher educational level predicted higher understanding and confidence. Study findings suggest that electronic consent may lead to better understanding for non-Hispanic patients of higher socioeconomic status. F2F processes may lead to better understanding and higher enrollment of patients from Hispanic and lower socioeconomic levels. Researchers should carefully consider how they implement electronic IC processes and whether to maintain an F2F process to better address the needs and limitations of some populations.

一些人对知情同意(IC)信息的理解可能会随着电子文件的提供而得到改善,但另一些人可能会从面对面(F2F)中受益。这项随机、多地点研究探讨了来自不同背景的个人如何理解电子 IC 文件与面对面文件、他们对理解的信心以及研究注册情况。共有 501 名来自美国两个不同人群的生物库的患者参与了这项研究。对电子文件和面对面文件的理解总体上没有差异,但面对面文件会使理解和注册的信心更高。种族和教育水平越高,对电子同意书的理解和信心越高。研究结果表明,对于社会经济地位较高的非西班牙裔患者来说,电子同意书可能会让他们更好地理解。F2F流程可能会让西班牙裔和社会经济地位较低的患者更好地理解,注册率也会更高。研究人员应仔细考虑如何实施电子 IC 流程,以及是否保留 F2F 流程,以更好地满足某些人群的需求和局限性。
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引用次数: 0
A Systematic Literature Review of Ethical Challenges Related to Medical and Public Health Data Sharing in China. 中国医疗和公共卫生数据共享相关伦理挑战的系统文献综述
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2021-12-01 Epub Date: 2021-09-13 DOI: 10.1177/15562646211040299
Xiaojie Li, Yali Cong

Although stakeholders in China have begun promoting medical and public health data sharing, a large portion of data cannot flow freely across research teams and borders and be converted into "big data." To identify the ethical challenges that are considered to hinder medical and public health data sharing, we performed a systematic literature review pertaining to medical and health data sharing in China. A total of 2959 unique records were retrieved through the database search, 61 of which were included in the final synthesis after full-text screening. This review provides an overview of the current ethical challenges and barriers involved in data sharing for healthcare purposes in China. Through the systematic review of evidence from peer-reviewed literature and dissertations, we identified barriers and ethical challenges grouped in a taxonomy of capacity building needs, balancing different stakeholders' interests, scientific and social value, and the data subjects' rights, public trust and engagement. Best practices and educational implications were suggested based on our findings.

虽然中国的利益相关者已经开始推动医疗和公共卫生数据共享,但很大一部分数据无法在研究团队和边界之间自由流动,无法转化为“大数据”。为了确定被认为阻碍医疗和公共卫生数据共享的伦理挑战,我们进行了与中国医疗和卫生数据共享有关的系统文献综述。通过数据库检索,共检索到2959条unique record,其中61条经过全文筛选后纳入最终的合成。这篇综述概述了目前中国医疗保健数据共享的伦理挑战和障碍。通过对同行评议文献和论文证据的系统回顾,我们确定了能力建设需求分类中的障碍和伦理挑战,平衡了不同利益相关者的利益、科学和社会价值,以及数据主体的权利、公众信任和参与。根据我们的研究结果,提出了最佳实践和教育意义。
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引用次数: 2
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Journal of Empirical Research on Human Research Ethics
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