转化医学研究中生命伦理学辩护的现况分析与前瞻思考

转化医学作为一门新兴学科,运用多学科交叉策略来推动医学发展,从临床实践中发现问题,将其凝练成科学问题进行基础医学研究,再将基础研究成果应用到临床疾病的诊断、治疗和预防过程中,使其真正发挥作用,是一个从基础医学到临床应用的双向进程。转化医学已逐步融人各个学科,并在干细胞研究、生物标志物、细胞信号转导、药物及器具研发及个体化医学等各个领域发挥着重要的作用。随着转化医学研究的深入,一些临床试验势必对人体存在一定伤害和潜在危险,存在各种伦理问题。虽说科学研究与伦理道德是一对相互冲击的矛盾,但两者在总体上又是一致的,共同决定着社会前进的步伐。科研的重大进步必然会对伦理道德提出更高要求,而伦理道德的高标准又规范、引导、促进科学研究朝着正确方向迈进,两者相辅相成。鉴于伦理辩护对于转化医学研究的强有力支撑,建议在转化医学研究中能进一步完善伦理监管体系、发挥机构伦理委员会的功效、持续加大伦理培训的力度、强化研究人员的伦理道德修养,从而为转化医学的发展夯实人文基础。     

临床医生在转化医学发展中的关键角色

临床医生是转化医学发展中的关键角色,是临床问题的发现者、科学问题的凝炼者、基础研究与临床研究的合作者,及研究成果的实践者,发挥临床医生在转化医学发展中的角色作用,有利于促进转化医学的发展和人民健康水平的提高.     

医学检验中若干理论问题及对策探讨

医学检验在医学领域中对于疾病的诊断和及时、有效地治疗发挥着至关重要的作用,鉴于当前在医学检验的过程当中存在着一些制约其发展的伦理性问题,需要相关医院部门及时进行工作的调整和改善,重视医院的医学检验伦理教育工作,坚持为患者服务和保密的工作态度,以人文关怀的理念创造温馨的医院环境。本文主要论述医学检验中的伦理性问题,分析伦理原则,最后探讨应对医学检验中存在的伦理问题的应对策略。     

美国国立卫生院临床与转化科学基金分析

转化医学能够提高生物医学研究的投资效益,促进生物医学研究向提高人类健康水平的原始目的回归,解决基础研究与临床需求脱节的问题.为促进转化医学发展,NIH实施了临床与转化科学基金专项计划.     

转化医学在预防医学领域相关学科中的应用

转化医学是近年来在国内外科研领域兴起的一个新概念,其意在促使基础研究成果向实际医学应用的快速转换.本文简述了转化医学的概念及在其国内外的研究现状,并介绍转化医学在公共卫生领域相关学科中应用的初步进展,旨在推动相关研究的发展.     

医学科技发展对我国八年制医学教育的影响

医学科技的快速发展给高等医学教育,尤其是承担培养高层次临床医学人才任务的八年制医学教育带来新的挑战.本文通过分析当代医学科技发展趋势的主要特征,及其对医学教育提出的新要求,提出了八年制医学教育应加强医学与其他学科的交叉融合、加强整合式医学课程体系建设、开展转化医学研究、探索多机构合作办学等方面的改革建议.     

医院转化医学发展的实践与思考

医院通过构建三联体临床医学研究平台、转化医学中心、医疗卫生服务共同体等转化医学平台,以及着眼转化医学源头、树立转化医学思维、促进转化医学人才培养等途径促进转化医学的发展.努力将基础医学研究成果转化为临床实践和健康策略.     

转化医学科研项目的管理策略探讨

本文探讨了转化医学科研项目管理的几个重要方面：科学规划、研究平台建设、攻关团队组建、项目过程管理、成果推广运用、知识产权保护及科研伦理监督、单位内部的转化医学项目资助体系的探索.     

本刊2020年征订启事

《中华流行病学杂志》创刊于1981年,是由中华医学会主办、中国疾病预防控制中心传染病预防控制所承办的流行病学及其相关学科的专业学术期刊,以从事预防医学与公共卫生、基础医学、临床医学的广大工作者为读者对象。报道内容涵盖流行病学及其各分支学科的科研成果,疾病预防控制热点、重点和难点问题,循证和转化医学、健康大数据分析应用,大型队列研究成果、现场流行病学调查、监测、临床流行病学研究成果、分子流行病学、相关实验室研究成果、教育教学方法与实践等。     

伦理视域下的医学科研之解读

伦理道德问题是医学科研中无法回避的问题.文章从医学科研中出现的伦理问题入手,在分析问题出现的原因及危害的基础上,提出增强医学科研人员的伦理意识,强化医学科研人员遵守伦理道德的责任感,发挥伦理审查的监督作用,完善科研管理制度和体制建设等伦理对策,以期实现其全心全意为人民身心健康服务的医学宗旨.     

Competing interests in healthcare: a conflict of quality. Part I: definition, background, and evidence

This policy paper investigates whether physician conflicts of interest have an effect on physicians' quality of care and whether implementation of conflict-of-interest policies will ameliorate any negative effects of divergent interests. Some government regulations are discussed in a policymaking perspective. We also suggest that healthcare organizations establish specific policies guarding against potential negative outcomes related to conflicts of interest. At the pinnacle of the conflict-of-interest debate resides the patient. One of the most important effects of disclosure is providing patients with the opportunity to make informed decisions regarding their healthcare. Research supports that conflicts of interest are inherent and oftentimes unavoidable in the healthcare setting.     

Implementation of financial disclosure policies to manage conflicts of interest

Amid concerns that clinical and basic research is increasingly vulnerable to pressure from industry sponsors, many federal agencies and professional organizations are recommending new or revised policies regardingfinancial disclosure and conflicts of interest. Despite pressure for greater external regulation and common professional standards, little is known about how existing policies are implemented. We analyze the implementation of conflict-of-interest policies within the multicampus University of California system. We show that there is variation among campuses in defining problematic relationships and in determining appropriate remedies to mitigate conflicts of interest. Our study suggests the importance of local culture and context for institutional decision making.     

Competing interests in healthcare: a conflict of quality. Part II: regulations, transparency, and policy implications

This research explores the association of physician conflicts of interest with quality of care. Specifically, we discuss the role of some government regulations as policy alternatives. The need for further regulation has become more apparent as improprieties in the healthcare industry have come to light. The dominating theme in current and proposed legislation, as well as institutional policies, is the idea of ensuring that conflicts of interest are transparent, thereby increasing the likelihood that appropriate relationships will be maintained between healthcare providers and industry representatives. Much of the difficulty that organizations are going to have in implementing effective policies is the resistance that will be initiated by physicians. In order to decrease the frequency of negative effects from conflicts of interest, we suggest that each organization establish a committee to create and oversee strict policies governing expectations regarding conflicts of interest.     

Enrolling Pregnant Women: Issues in Clinical Research

BackgroundDespite the fact that many pregnant women are affected by a range of serious health conditions and take medications for these conditions, there is widespread reticence to include them in clinical intervention research. Hence, their clinical care is typically not informed by evidence derived from pregnant populations.MethodIn October 2010, the National Institutes of Health Office of Research on Women's Health convened a workshop to address ethical, regulatory, and scientific issues raised by the enrollment of pregnant women in clinical research. This report summarizes three areas that emerged from that meeting as important next steps to be taken to promote ethically responsible and scientifically sound research during pregnancy.FindingsThe three areas are: 1) Reclassify pregnant women from their current status in regulations as a “vulnerable” population to a scientifically “complex” population and change the presumption of exclusion to one of inclusion; 2) examine the institutional review boards' (IRB) gatekeeper role in interpreting regulations governing pregnancy research and identify steps to facilitate IRB approval of ethically informed pregnancy research; and 3) develop a pregnancy-focused research agenda that addresses pressing clinical needs, identifies opportunities to gather information from existing resources and studies, and encourages important new research areas.ConclusionResearch is needed to address the therapeutic needs of pregnant women and to study pregnancy as it may shed light on a pregnant woman's later health and the health of her child.     

医方保护性医疗与患者知情同意权冲突的制衡研究

保护性医疗与患者知情同意权间的矛盾已经浮出水面.虽然两者在理论和实践中存在一系列冲突,但这并不意味着其完全没有相容之处,其相容之处正在于它们的伦理一致性.文章在正确认识两者冲突的基础上,通过采取完善立法、区分各自适用情况等方法寻求制衡点,以期在保护下医疗制度下兼顾医患双方的权益.     

Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice

Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.     

Medicine: conflicts of interest in research

A conflict of interest is a set of conditions in which professional judgment concerning a primary interest (patient's welfare, research integrity, ethics, education) tends to be influenced by a secondary interest. Among secondary interests are intellectual conflicts of interest that include the desire for faculty advancement, competition for sponsored research funding, to win prestigious research prizes, as well as financial conflicts of interest that arise when medical investigators own equity in a company that sponsors the study they conduct or when they serve as consultants to companies or are members of the company's advisory boards. Ethical conflicts of interest predominate in undeveloped countries. Known consequences of conflicts of interests include compromising health, death, minimization of adverse reactions, lower research quality, the probability to favor the sponsor's product, and delayed publication when results obtained are not the expected. Medical consciousness should be corrected to avoid moral duality that could harm both patients and medical ethics.     

Can We Trust Positive Findings of Intervention Research? The Role of Conflict of Interest

In recent years, there has been increased attention to the issue of conflict of interest within prevention research. The aims of this paper are to discuss these developments and to relate them to discussions of conflict of interest in the broader scientific literature. Although there has been concern expressed about the extent to which conflicts of interest can be defined and measured, empirical research suggests that financial conflicts can be easily identified and assessed in meta-analyses focused on their effects on research quality. Research evidence also shows that conflict of interest is associated with use of flexible data analysis practices and the reporting of chance positive findings, both within prevention research and related disciplines such as public health and psychology. However, the overwhelming majority of published studies report positive results, and there are a number of other influences within academia (such as pressure to publish) that account for this and for the use of flexible data analysis practices. Accordingly, introducing measures to improve research quality in general, rather than just focusing on problems specific to research in which there is a clearly identifiable conflict of interest, may prove more effective and less controversial. Most such efforts focus on introducing greater transparency into research design, practice, and reporting. These both curtail employment of flexible data analysis practices and make their use transparent to investigators seeking to assess their effects on research quality. Also, requiring detailed disclosures of conflicts be reported by all investigators (not just senior authors) would improve current disclosure practices.     

Towards understanding the nature of conflict of interest and its application to the discipline of nursing

Most incidences of dishonesty in research, financial investments that promote personal financial gain, and kickback scandals begin as conflicts of interest (COI). Research indicates that healthcare professionals who maintain COI relationships make less optimal and more expensive patient care choices. The discovery of COI relationships also negatively impact patient and public trust. Many disciplines are addressing this professional issue, but little work has been done towards understanding and applying this moral category within a nursing context. Do COIs occur in nursing and are they problematic? What are the morally appropriate responses to COI for our discipline and for individual practicing nurses? In this paper I examine the nature of ‘conflict of interest’ as a general ethical category, its characteristics and its application to our discipline. Conflict of interest is an odd moral category that may actually or potentially result in immoral decisions. The moral justification for COI is grounded prime facie by the moral value of respect for persons and principle of fidelity from which trust is developed and maintained. In review of the historical development, there appears to be consensus on some qualities of COI that are presented. I conclude that making judgements about COI are challenging and often difficult to determine from a nursing perspective. Improving nurses' and professional organizations' awareness of COI and sharpening our ability to respond appropriately when COI arise can reduce potential harm and promote trust in those whom we serve.