出版中的伦理问题

1临床研究1.1伦理审批与注册要求所有在人体中进行或涉及人体标本的研究应符合国际医学期刊的编辑委员会(ICMJE)的有关要求,严格遵守临床试验研究的所有伦理原则。文章中需提供批准此次研究的伦理委员会名称、伦理审查编号及审批日期,并且必须按照《赫尔辛基宣言》中的原则进行。要求前瞻性临床试验研究,需在招募受试者前,在国际认可(WHO Registry Network)的临床试验注册平台进行前瞻性注册,如北美临床试验注册中心(www.clinicaltrials.gov)、国际临床试验注册中心(ISRCTN)、中国临床试验注册中心(ChiCTR)等进行注册。文章投稿时需提供临床试验注册平台的名称、注册号及注册时间,并标记于文章中。     

重视医学研究中的伦理学问题

2004年2月在杭州举办了第一期“中美生物医学科研伦理研修班”。研修班是由美国纽约中华医学基金会资助、北京大学医学部医学伦理学教研室主办、中华医学会医学伦理学分会、卫生部医学伦理学专家委员会协办。涉及内容为：伦理学的基本理论、原则；医学科学家的行为与道德责任；医学科研中的利益冲突；人体实验中的知情同意；医学科研中的随机对照；人体实验中弱势人群的保护；     

人类胚胎干细胞在移植医学领域中的应用潜力

人类胚胎干细胞由于在移植医学领域中巨大的应用潜力而受到人们重视。若人类胚胎干细胞能成功应用于临床,将可为器官移植和基因治疗提供源源不断的供体。近来的研究进展为人类胚胎干细胞的应用打下了坚实的基础。     

异种移植中的免疫学问题及对策

随着临床同种异体移植的深入开展 ,人类供者器官来源与临床需求之间的缺口日益扩大 ,许多研究者逐渐把目标转向了利用动物器官的异种移植。因其具有诸多优点 ,猪成为了移植界公认的替代人类器官的最佳来源。本文将对近年来国外有关异种移植免疫学问题的可能机制及对策的文献作一综述以供参考。     

028 异种移植中的免疫学问题及对策

随着临床同种异体移植的深入开展，人类供者器官来源与临床需求之间的缺口日益扩大，许多研究者逐渐把目标转向了利用动物器官的异种移植。因其具有诸多优点，猪成为了移植界公认的替代人类器官的最佳来源。本文将对近年来国外有关异种移植免疫学问题的可能机制及对策的文献作一综述以供参考。     

临床医疗和临床科研中的知情同意问题

知情同意概念含有丰富的伦理内涵。该讲介绍了知情同意的伦理学基础,讨论了在临床医疗活动及研究工作中应如何理解知情同意,以及知情同意与保护性医疗制度的关系等问题。     

异种移植中的免疫学问题及对策

随着临床同种异体移植的深入开展，人类供者器官来源与临床需求之间的缺口日益扩大，许多研究者逐渐把目标转向了利用动物器官的异种移植。因其具有诸多优点，猪成为了移植界公认的替代人类器官的最佳来源。本文将对近年来国外有关异种移植免疫学问题的可能机制及对策的文献作一综述以供参考。     

骨折诊治中的伦理问题

医生成功地诊治一名患者 ,不仅需要掌握一定的医疗技术 ,还需要遵循针对某种疾病所需要的特殊伦理道德规范。据我科诊治骨折患者的经验 ,笔者认为诊治骨折患者过程中应该注意的伦理道德问题有以下几点 :1　骨折患者在诊疗过程中的几个特点1.1　首次诊疗往往为急诊　骨折往往在无任何思想准备的情况下突然发生 ,并伴有骨折部位剧烈疼痛 ,致使患者产生急切的求医心理 ,并对医生有极高的期望 ,希望获得快速有效的诊治。1.2　骨折创面较污秽　骨折时尤其是开放性骨折 ,创面出血、体液外渗 ,软组织损伤 ,往往令人在心理上无法接受。1.3　患者心理…     

携带人脑基因的恒河猴实验引发的伦理问题调研结果分析

目的 2019年,中国医学研究团队构建了人类MCPH1的转基因恒河猴模型,有必要了解科研人员对此类新型伦理问题的认知和行为倾向。方法 课题组自行编制了调查问卷,内容包括人口统计学信息、伦理情景题等,被调查者为申请2019年国家自然科学基金的医学科研人员。对所得数据进行了描述性统计分析。结果 70.9%的被调查者(n=11 164)称使用携带人类基因的转基因猴研究存在伦理问题;最突出的伦理问题是“不可接受的风险-受益比”(49.1%)和“对恒河猴的伤害”(33.7%);31.1%的被调查者称,此研究只要得到所在机构伦理委员会的批准就可以开展。结论 医学研究人员对此类转基因猴研究持谨慎态度。转基因猴实验应更加严格执行3R原则,人-恒河猴嵌合体研究应遵循伦理规范,严格审查。     

Ethical considerations for enzyme replacement therapy in neuronopathic Gaucher disease

Elstein D, Abrahamov A, Zimran A. Ethical considerations for enzyme replacement therapy in neuronopathic Gaucher disease. Clin Genet 1998: 54: 179–184. 0 Munksgaard, 1998
Enzyme replacement therapy for Gaucher diseases, the most prevalent lysosmal storage disease, was originally approved by the FDA for type I patients and has proven to be both safe and effective in reducing hepatosplenomegaly and improving the hematological parameters. However, the use of enzyme treatment in both neuronopathic forms has heretofore been on an investigational or trial basis, with reports of progression of neurological deterioration even at very high doses. To date, there are no guidelines for clinicians with regard to enzyme replacement therapy in the neuronopathic forms of metabolic diseases. Herein, we discuss strategies derived from the literature ub-his treatment of very premature babies and from the Jewish Halachic point of view. In conclusion, we describe recommendations for the ethical treatment and/or withdrawal of treatment. as well as practical guidelines for dosage regimens, in children with neuronopathic Gaucher disease.     

北京市实施大规模流感疫苗接种政策的伦理学讨论

北京市自2007年,对全市中小学生和老年人开展了大规模流感疫苗接种的减免政策,至2009年已实现对全市中小学生和老年人的全部免费接种。至今已累计接种了约800万人次,取得了良好的社会效果和卫生经济学效果。然而与此同时,知情同意、个人信息保密、疫苗接种事故、群体免疫屏障以及医疗废弃物等伦理学问题也日益凸显。     

Ethical and Policy Issues Surrounding the Donation of Cryopreserved and Fresh Embryos for Human Embryonic Stem Cell Research

The use of human embryos in human embryonic stem cell (hESC) research raises significant ethical and policy issues associated with their donation. Recent research conducted in several countries assesses the percent of persons with cryopreserved and fresh supernumerary embryos willing to donate them for research, their reasons for considering this option, and the concerns they raise about its personal import. Such research provides new insights into rising ethical and policy questions associated with embryo donation for hESC research that should be addressed. In response to such questions, it is argued here that consent to the donation of supernumerary embryos for hESC research should be sought in two or three stages, depending on whether fresh or frozen embryos are at issue, in order to provide patients and their partners with sufficient time and information before they make a final decision. In addition, steps should be taken to support the voluntariness of their decisions by having personnel other than the treating reproductive specialist or stem cell investigators solicit their consent. Prospective embryo donors should also be given a choice about the uses to which hESCs derived from their donated embryos will be put in order to honor their ethical convictions and ensure that there are sufficient embryos for this research. The well-being and rights of those who donate embryos for this research require the sort of support and protection that can be provided by an ethical and policy framework that allows hESC investigations to move forward according to standards that are transparent and that resound with public values.     

Legal and ethical issues in the use of anonymous images in pathology teaching and research

The privacy of patients' health information is of paramount importance. However, it is equally important that medical staff and students have access to photographs and video recordings of real patients for training purposes. Where the patient can be identified from such images, his or her consent is clearly required to both obtain the image and to use it in this way. However, the need for consent, both legally and ethically, is much less convincing where the patient cannot, by the very nature of the image, be identified from it. This is the case for many images used in the teaching of clinical medicine, such as videos taken of laparoscopies, images of internal organs and unlabelled X-rays.     

An independent audit of electroconvulsive therapy patient information leaflets in Northern Ireland,Scotland and Wales

Objectives

To evaluate the accuracy of patient information leaflets about electroconvulsive therapy (ECT) used in Northern Ireland, Scotland and Wales, and their compliance with the principle of informed consent.

Design and Methods

To replicate an audit in England, Freedom of Information Act requests were sent to the 26 providers of ECT for their ECT patient information leaflet. These were scored, by two independent raters, on the same 40-item accuracy measure used in the England audit.

Results

The number of accurate statements (out of a possible 29) ranged from seven to 20, with a mean of 16.9. The most frequently omitted statements included: cardiovascular risks (mentioned by five leaflets), that it is not known how ECT works (3), risk of mortality (2), risks from multiple general anaesthetic procedures (2), how to access a legal advocate (2) and that that there is no evidence of long-term benefits (1). The leaflets made between six and nine inaccurate statements (out of 11) with a mean of 7.0. Nineteen minimised memory loss, blamed the memory loss on depression, claimed that ECT is the ‘most effective treatment’ and asserted it has very high response rates without mentioning similar placebo response rates. All 23 leaflets wrongly told patients that ECT saves lives.

Conclusions

Electroconvulsive therapy information leaflets in these three nations are barely more accurate than those in England and do not comply with the ethical principle of informed consent. Patients and families across the UK are systematically being misled about the risks they are taking and the limited nature of ECT's benefits.     

Biobank research and ethics: the problem of informed consent in Polish biobanks

Introduction

The dynamic development of biobanks causes some ethical, social, and legal problems. The most discussed problems are obtaining informed consent, especially for future research, from minors and from deceased people. The aim of this article is to present the current standards held by Polish biobanks concerning obtaining a participant''s informed consent in some aspects.

Material and methods

Survey was carried out by anonymous questionnaire among 59 institutions which deal with the collecting and storage of human cells and tissues in the year 2008. Twenty four filled-in copies of the questionnaires were sent back (return=41%).

Results

Almost every institution (92%) obtains written consent, but a third of the surveyed institutions (29%) do not obtain consent for the future use of the samples. The majority of the respondents (83%) support the idea of using biological materials for research purposes of a donor who died if he did not leave any written objection to such practices and 46% of respondents stated that biobanks should obtain the consent from the already mature donor who gave their samples as a child.

Conclusions

The practice and rules for obtaining informed consent for the scientific research require improvement. The possibility to use the human materials in the future, conditions for getting access to the data, the possibility of their withdrawal from the database and using the materials and data after the death of the donor should be clearly determined when the informed consent to collect the material is obtained.     

Research in human genetics: the tension between doing no harm and personal autonomy

The physician-patient relationship was governed for centuries by the ethical principle of beneficence and the physician's dedication to the principle of doing no harm. This structure shifted, however, to the principle of personal autonomy as medical and surgical knowledge expanded and patients, rather than physicians, became the locus of decision-making authority. In biomedical research in the United States, however, beneficence of the research professional remained dominant until a spectrum of doubtful research practices was made public in the 1970s and thereafter. Over the past three decades, state and federal governments have instituted regulations that provide increased protections for human research subjects, although research results are rarely shared with subjects because of the provisional nature of unconfirmed laboratory results. Now, however, genetics researchers and others suggest that subjects may well have an interest in present and future results, even though provisional. These issues are presently under discussion and may eventually open new possibilities for sharing research information with subjects who wish to be informed.     

Conducting clinical genomics research during the COVID-19 pandemic: Lessons learned from the CSER consortium experience

Clinical research studies have navigated many changes throughout the COVID-19 pandemic. We sought to describe the pandemic′s impact on research operations in the context of a clinical genomics research consortium that aimed to enroll a majority of participants from underrepresented populations. We interviewed (July to November 2020) and surveyed (May to August 2021) representatives of six projects in the Clinical Sequencing Evidence-Generating Research (CSER) consortium, which studies the implementation of genome sequencing in the clinical care of patients from populations that are underrepresented in genomics research or are medically underserved. Questions focused on COVID′s impact on participant recruitment, enrollment, and engagement, and the transition to teleresearch. Responses were combined and thematically analyzed. Projects described factors at the project, institutional, and community levels that affected their experiences. Project factors included the project′s progress at the pandemic′s onset, the urgency of in-person clinical care for the disease being studied, and the degree to which teleresearch procedures were already incorporated. Institutional and community factors included institutional guidance for research and clinical care and the burden of COVID on the local community. Overall, being responsive to community experiences and values was essential to how CSER navigated evolving challenges during the COVID-19 pandemic.     

Allogeneic haematopoietic stem cell transplantation in patients with human immunodeficiency virus: the experiences of more than 25 years

For treatment of several malignancies, transplantation of allogeneic haematopoietic stem cells (HSCT) derived from bone marrow or peripheral blood has been used as a therapeutic procedure for decades. In the past, HSCT has been suggested as a treatment option for infection with the human immunodeficiency virus type 1 (HIV-1), but these attempts were mostly unsuccessful. Today, after the introduction of an active anti-retroviral therapy, the lifetime expectancy of HIV-infected patients has improved substantially, but nevertheless the incidence rate of malignancies in these patients has increased considerably. Therefore, it can be assumed that there will be a rising necessity for HIV-1-infected patients with malignancies for allogeneic HSCT. At the same time, there is increasing interest in treatment methods which might target the HIV-1 reservoir more effectively, and the question has been raised as to whether allogeneic HSCT could be linked to such strategies. In this paper the data of more than 25 years experience with allogeneic HSCT in patients with HIV-1 are reviewed and analysed.