论医学伦理学的自主性原则

医学伦理学的自主性原则是对个人的自主和自由的尊重,其核心是对人权的尊重,包含有知情同意、保密、隐私等具体规则。自主性原则是根源于西方强调个性自由和选择的自由主义道德传统,我国古代哲人也提出过相近乃至相同的看法。     

健康医疗数据相关研究的伦理审查要点重构及其论证

健康医疗数据相关研究极大地拓展了传统生物医学研究的范畴,影响了医学研究的思路、方法和范式,也给伦理审查带来了新的挑战。从梳理国际伦理指南对健康医疗数据相关研究提出的要求出发,探讨此类研究当前的伦理审查现状及挑战,强调伦理审查不仅要关注风险获益比、知情同意程序、隐私保护措施这些核心问题,还需要以更加全面和深入的视角进行关注。同时,针对研究的科学价值和社会价值、研究目的的合理性和合法性、数据治理和数据管理要求、风险获益评估、知情同意模式创新以及研究团队资质等六个伦理审查要点进行重构和探讨。

     

Active SETI and the Problem of Research Ethics

This article argues that research involving active SETI, or sending messages toward possible extraterrestrial intelligence (METI), is not ethically justifiable. As a way of working some of the ethical problems associated with METI, I approach the sending of a message from the perspective that it represents a research endeavor involving sentient beings and therefore, should undergo review by a university institutional review board (IRB). As such, METI should be expected to meet several criteria expected by IRBs as being necessary components of ethically justifiable research. By considering issues of proportionality, justice, informed consent, the likely success of obtaining desired results, and necessity and considering risks and benefits to research subjects, as well as the mandate to do no harm, it is evident that METI does not meet the requirements for ethical research on human subjects and, thus, should not be considered ethical when it comes to nonhuman sentient beings.     

知情同意的风险决策能力评估探究

能力是知情同意的“守门人”概念,风险相关决策能力将患者的行为能力与具体决策风险结合起来,并充分考量其法律依据与医学特点。一般情况下,临床实践并不需要评估患者的决策能力。但是,当患者拒绝医生提出的最有利患者的建议,患者同意会伤害其本身利益的决策,以及患者前后决策相互矛盾且后期决策会伤害患者健康的情况下,需要评估。风险相关决策能力评估需要考察患者的沟通能力、信息理解能力、评估能力和道德推理能力。其道德合理性在于“行善”的价值辩护,在实践操作中需要借助个体的“实践智慧”。     

The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards (IRBs), to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation (REC) services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research.     

综合医院临床研究伦理初始审查常见问题及对策研究

为了探究综合医院临床研究的受试者权益是否得到有效保护,以某综合医院机构开展的临床研究项目伦理初始审查材料为例,进行了回顾性研究。选取2018年~2019年笔者所在医院开展的临床科研伦理审查项目存档资料进行评估。结果发现,在67项申请伦理审查的项目中,提出修改意见的项目占53.7%,其中知情同意书占47.8%;项目申请的主要问题集中于研究目的、研究内容和风险告知。研究方案设计的科学性、公平性、目的明确性、伦理合理性、风险告知充分等是研究者伦理意识和能力的关键。研究者和伦理委员会的工作能力仍需进一步提高以保护受试者的权益。     

ART伦理委员会构建与作用的探讨

辅助生殖技术(Assisted Reproduction Technique,ART)的飞速发展给社会带来了复杂的伦理难题。实践证明,只有发挥伦理委员会作为一个工作机构的职能,在医患人群中加强ART技术基本原理及相关伦理原则的宣传教育,才能促使医患人群都能够自觉遵守优良的医学伦理道德规范,保证人类辅助生殖技术的健康发展。     

Looking for Trouble: Preventive Genomic Sequencing in the General Population and the Role of Patient Choice

Advances in genomics have led to calls for developing population-based preventive genomic sequencing (PGS) programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control individuals should have over the generation, use, and handling of their genomic information. In this article we examine whether PGS programs should offer individuals the opportunity to selectively opt out of the sequencing or analysis of specific genomic conditions (the menu approach) or whether PGS should be implemented using an all-or-nothing panel approach. We conclude that any responsible scale-up of PGS will require a menu approach that may seem impractical to some, but that draws its justification from a rich mix of normative, legal, and practical considerations.     

新冠肺炎疫情期间心理热线服务的相关问题思考

通过系统分析心理咨询和心理热线服务的相关研究,探讨新冠肺炎疫情期间开展心理热线服务的优势与伦理问题。心理热线服务与传统的面对面咨询方式相比,具有受众范围广、保密性强、容易获得、来访者在咨询过程中注意力和控制感更强以及安全性更高等优势。疫情期间开展的心理热线服务的相关问题,主要包括四个方面:心理热线咨询师的资质认证;心理热线中的知情同意;心理热线的保密问题;心理热线的适用性。只有遵守伦理守则,才能更好地通过心理热线服务帮助他人。     

An Evaluation of the Reliability and Validity of the Self-Appraisal Questionnaire (SAQ) in South African Context

The Self-Appraisal Questionnaire (SAQ: Loza, 2005) is a self-report questionnaire designed to assist with the prediction of violent and nonviolent recidivism among correctional populations. Use of scale could help in the assessment of risk and the identification of factors that could be addressed by programming or other intervention to reduce recidivism risk. Evidence for use of the SAQ in South African settings is needed. The SAQ was administered at two separate occasions and a week apart to a total of 125 male offenders in South Africa to evaluate its psychometric properties. Scores from the SAQ were reliable with South African inmates.     

D-N认知评估系统在AD/HD儿童认知评估中的应用

研究采用基于PASS理论建构的D-N认知评估系统(CAS)作为主要评估工具, 以临床推介的18名AD/HD儿童和18名在性别、年龄及智力水平与临床样本相匹配的正常儿童为被试, 对其PASS认知过程特征开展比较研究, 探查临床组儿童潜在的认知过程异常, 研究结果表明:(1)临床AD/HD儿童在CAS总量表分上显著低于正常对照组儿童;(2)临床AD/HD儿童与正常对照组儿童在计划和注意过程分数上存在显著差异, 且临床AD/HD儿童的计划和注意分量表分数可很好地预测其在DSM-IV上的注意涣散评估分数;(3)临床AD/HD组儿童与正常对照组儿童在同时性加工和继时性加工水平上则没有显著差异。     

An exploration of the Self-Appraisal Questionnaire for assessing female recidivism in South Africa

This study profiled incarcerated female offenders’ criminogenic-oriented self-appraisals. Respondents were 77 female offenders between the ages of 20 and 56 years, serving custodial sentences within the South African Department of Correctional Services ranging from under a year to 25 years, and of whom 7 per cent were reoffenders. They completed the Self-Appraisal Questionnaire (SAQ: Loza, 2005 Loza, W. (2005). Self-Appraisal Questionnaire (SAQTM). Technical manual. Toronto: Multi-Health Systems. [Google Scholar]), which is a self-report measure for assessing violent and non-violent recidivism. Findings suggest offenders with a history of violence to be at risk for reoffending compared to non-violent offenders.