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Challenges in obtaining informed consent for health research from dependent older persons in the Indian socio-cultural context. 在印度社会文化背景下,获得受抚养老年人健康研究知情同意方面的挑战。
Pub Date : 2025-10-01 DOI: 10.20529/IJME.2025.048
Vijayaprasad Gopichandran, Sudharshini Subramaniam, Priyadarshini Chidambaram, Balasubramanian Palanisamy

In this brief commentary, we share our experience of obtaining informed consent from older persons living in the community, dependent on their sons, daughters or in-laws. We present a scenario in which for our community-based cluster randomised controlled trial on diabetes peer support groups for diabetes self-management, we attempted to obtain informed consent from an older person living in a dependent state with her daughter. While the older woman herself was interested in participating in the study initially, later she declined to consent, probably influenced by her daughter and son-in-law with whom she was living. In this article, we reflect on this unique social dynamic in India where many older persons are in a dependent relationship with their primary caregivers; and what this relationship means to autonomy in research participation. We propose that engaging with primary care givers of older persons before approaching them for research participation may be a crucial step in this social context.

在这篇简短的评论中,我们分享了我们从生活在社区、依靠儿子、女儿或姻亲的老年人那里获得知情同意的经验。我们提出了一个基于社区的糖尿病同伴支持小组糖尿病自我管理的随机对照试验方案,我们试图获得一位与女儿生活在依赖状态的老年人的知情同意。虽然这位年长的妇女本人最初对参与这项研究很感兴趣,但后来她拒绝了,可能是受到与她住在一起的女儿和女婿的影响。在这篇文章中,我们反思了印度这种独特的社会动态,许多老年人与他们的主要照顾者处于依赖关系;以及这种关系对自主参与研究意味着什么。我们建议,在接近老年人的初级护理人员参与研究之前,与他们接触可能是这种社会背景下的关键一步。
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引用次数: 0
Silicosis: A public health emergency in India. 矽肺病:印度的突发公共卫生事件。
Pub Date : 2025-07-01 DOI: 10.20529/IJME.2025.051
Jagdish Patel

Occupational health is a public health emergency, long ignored in India, primarily as it is considered more of a class issue than a public health problem. The economic impact of mortality and morbidity associated with occupational diseases (OD) and accidents at work is nowhere a priority, resulting in the absence of reliable estimates and credible data on ODs. There are no laws for the protection and preservation of health at work for over 90% of workers in the unorganised sector. These should be a priority across economic sectors, along with laws to compensate workers and citizens for environmental contamination. In spite of the Employees' State Insurance Act, 1948 for the workers in the organised sector, and the Employees' Compensation Act, 1923 for both, organised and unorganised sectors, most of the victims have to depend upon doles paid by the State schemes for financial assistance in case of silicosis.

职业健康是一个公共卫生紧急事件,在印度长期被忽视,主要是因为它被认为是一个阶级问题,而不是公共卫生问题。与职业病和工伤事故有关的死亡率和发病率的经济影响在任何地方都不是一个优先事项,因此缺乏关于职业病的可靠估计和可信数据。没有法律保护和维护无组织部门90%以上工人的工作健康。这些应该成为各经济部门的优先事项,同时还要制定法律,对工人和公民的环境污染进行补偿。尽管1948年为有组织部门的工人制定了《雇员国家保险法》,1923年为有组织和无组织部门的工人制定了《雇员赔偿法》,但大多数矽肺病受害者必须依靠国家计划支付的补助金。
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引用次数: 0
Junior researchers and the authorship dilemma. 初级研究人员和作者困境。
Pub Date : 2025-07-01 DOI: 10.20529/IJME.2025.039
Umashri Sundararaju, Hamrish Kumar Rajakumar

Medical students face authorship issues as they are increasingly involved in research. Senior researchers often claim undue credit, while students lack support and awareness of their rights. The fear of retaliation and power imbalance worsens the issue. Solutions such as ethics training, student representation on research committees, and mandatory formal authorship agreements have been proposed. These can create a more ethical research environment for future medical professionals.

随着医学生越来越多地参与研究,他们面临着作者问题。高级研究人员经常声称不应有的荣誉,而学生缺乏支持和对自己权利的认识。对报复和权力不平衡的恐惧使问题恶化。解决方案,如伦理培训,学生在研究委员会的代表,和强制性的正式作者协议已经提出。这些可以为未来的医学专业人员创造一个更合乎道德的研究环境。
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引用次数: 0
Response to critique by Indira Chakravarthi. 对英迪拉·查克拉瓦希批评的回应。
Pub Date : 2025-07-01 DOI: 10.20529/IJME.2025.047
Indraneel Mittra, Gauravi Mishra, Rajendra Badwe, Rajesh Dikshit

Indira Chakravarthi's critique relates to our paper published in the British Medical Journal in 2021 titled "Effect of screening by clinical breast examination on breast cancer incidence and mortality after 20 years: prospective, cluster randomised controlled trial in Mumbai". The study addressed the unanswered questions as to whether clinical breast examination (CBE) conducted by female health workers would lead to a reduction in mortality from breast cancer. Chakravarthi raises multiple issues relating to our study and we provide in this paper point-by-point responses to these issues. The results of our study show that two-yearly CBE screening can reduce death rate from breast cancer by 30% in women above the age of 50 and to a lesser extent to those below this age. CBE screening if implemented in low- and middle-income countries can save thousands of lives globally each year.

Indira Chakravarthi的批评涉及我们在2021年发表在《英国医学杂志》上的论文,题为“临床乳房检查对20年后乳腺癌发病率和死亡率的影响:孟买前瞻性、随机对照试验”。该研究解决了由女性保健工作者进行的临床乳房检查是否会降低乳腺癌死亡率这一悬而未决的问题。Chakravarthi提出了与我们的研究相关的多个问题,我们在本文中对这些问题提供了逐点的回应。我们的研究结果表明,两年一次的CBE筛查可以将50岁以上妇女的乳腺癌死亡率降低30%,而对50岁以下妇女的影响较小。如果在低收入和中等收入国家实施CBE筛查,每年可在全球挽救数千人的生命。
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引用次数: 0
Cause, Effect, and Adverse Events: Evident-Based Medicine or Evidence-Based Medicine? 原因、影响和不良事件:循证医学还是循证医学?
Pub Date : 2025-07-01 Epub Date: 2025-02-14 DOI: 10.20529/IJME.2025.011
David Healy

From the late 1940s to 1991, the adverse effects of prescription drugs were primarily established through the publication of detailed case studies by doctors in medical journals. Subsequently, pharmaceutical companies would change the labels of medicines accordingly. This will be called "evident-based medicine" in this paper. After 1991, what is now called "evidence-based medicine" offers a markedly different view on establishing the adverse effects of a treatment, with randomised controlled trials (RCTs) held up as the gold standard. The differences between evidence- and evidence-based medicine are often framed in terms of the differences between specific and general causation. This article outlines the origins of these distinctions and the confusions they generate among both clinicians and the general public.

从20世纪40年代末到1991年,处方药的不良影响主要是通过医生在医学杂志上发表详细的案例研究来确定的。随后,制药公司会相应地改变药品的标签。本文将其称为“循证医学”。1991年后,现在所谓的“循证医学”在确定治疗的不良反应方面提供了一种明显不同的观点,随机对照试验(rct)被奉为黄金标准。循证医学和循证医学之间的差异通常是根据具体因果关系和一般因果关系之间的差异来界定的。本文概述了这些区别的起源,以及它们在临床医生和公众中产生的混淆。
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引用次数: 0
Applying the non-maleficence principle to basic research in Alzheimer's disease. 无害原则在阿尔茨海默病基础研究中的应用。
Pub Date : 2025-07-01 DOI: 10.20529/IJME.2025.024
Bor Luen Tang

Despite the urgency for new leads towards Alzheimer's disease (AD) interventions, the impact of such basic research on patient welfare and potential socioeconomic repercussions are considered remote. Nonetheless, basic science research in AD must adhere to the highest level of ethical stringency. Even preliminary advances in AD basic research offer hope that percolates along the line from researchers to patients. A promising basic research result that is subsequently proven unreliable due to irreproducibility or research misconduct would not only dash hopes but might also misdirect downstream efforts. Furthermore, such misadventures could quash promising research directions that, if otherwise carefully and meticulously interrogated, could yield useful leads. Stringency and reproducibility in biomedical research should thus be framed in accordance with the principle of non-maleficence, which I posit should take priority over loose attempts at beneficence that offer more hype than hope.

尽管阿尔茨海默病(AD)干预措施迫切需要新的线索,但这种基础研究对患者福利和潜在的社会经济影响的影响被认为是遥远的。尽管如此,AD的基础科学研究必须坚持最高水平的伦理严格性。即使是阿尔茨海默病基础研究的初步进展也提供了从研究人员到患者的一线希望。一个有希望的基础研究成果,由于不可复制性或研究不当而被证明是不可靠的,这不仅会使希望破灭,而且可能会误导下游的努力。此外,这样的不幸事件可能会使有希望的研究方向落空,而这些研究方向如果得到仔细细致的调查,可能会产生有用的线索。因此,生物医学研究的严格性和可重复性应该根据非恶意原则来制定,我认为,这应该优先于对慈善的松散尝试,这些尝试提供的是更多的炒作而不是希望。
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引用次数: 0
Ethics in processing research participants' payments: navigating institutes' finance and administrative mandate. 处理研究参与者付款的伦理:引导研究机构的财务和行政授权。
Pub Date : 2025-07-01 DOI: 10.20529/IJME.2025.035
Salik Ansari, Harikeerthan Raghuram, Gauri Mahajan, Anant Bhan

Processing payments (reimbursements or honoraria) to study participants by researchers working in institutional setups can raise ethical concerns, as the institute's administration and finance departments control the procedural mandate of this issue. This commentary discusses this critical and often ignored aspect and provides suggestions that could help minimise the risk of violating research participants' anonymity.

在机构中工作的研究人员向研究参与者支付的款项(报销或酬金)可能会引起伦理问题,因为机构的行政和财务部门控制着这一问题的程序授权。这篇评论讨论了这个关键的、经常被忽视的方面,并提供了一些建议,可以帮助最大限度地降低违反研究参与者匿名权的风险。
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引用次数: 0
Ending nuclear weapons, before they end us. 在核武器终结我们之前终结它们。
Pub Date : 2025-07-01 DOI: 10.20529/IJME.2025.040
Kamran Abbasi, Parveen Ali, Virginia Barbour, Marion Birch, Inga Blum, Peter Doherty, Andy Haines, Ira Helfand, Richard Horton, Kati Juva, Jose F Lapena, Robert Mash, Olga Mironova, Arun Mitra, Carlos Monteiro, Elena N Naumova, David Onazi, Tilman Ruff, Peush Sahni, James Tumwine, Carlos Umaña, Paul Yonga, Chris Zielinski

This May, the World Health Assembly (WHA) will vote on re-establishing a mandate for the World Health Organization (WHO) to address the health consequences of nuclear weapons and war [1]. Health professionals and their associations should urge their governments to support such a mandate and support the new United Nations (UN) comprehensive study on the effects of nuclear war.

今年5月,世界卫生大会将就重新确立世界卫生组织(世卫组织)处理核武器和战争后果的任务进行表决。卫生专业人员及其协会应敦促本国政府支持这一任务,并支持新的联合国关于核战争影响的全面研究。
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引用次数: 0
Indian Stem Cell Research Governance after dissolution of the National Apex Committee. 国家顶点委员会解散后的印度干细胞研究治理。
Pub Date : 2025-07-01 DOI: 10.20529/IJME.2025.025
Ketan Thorat

The Government of India recently disbanded the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT). This decision followed expert and public consultations held last year and will significantly alter the review processes for human stem cell research in India. The NAC-SCRT played a crucial role in crafting and updating regulatory guidelines, fostering research and national discourse in human stem cell research, and defining safety and quality standards. The Institutional Ethics Committees are now being tasked to review stem cell research at the organisation level after due inclusion of two stem cell experts. The decision to merge regulatory frameworks is a welcome step, reflecting a dynamic regulatory landscape that is responsive to scientific advancements and aims to reduce the compliance burden. The effective implementation of the revised mechanism, however, necessitates further clarity on which agency will now be responsible for tasks earlier mandated to NAC-SCRT.

印度政府最近解散了国家干细胞研究和治疗最高委员会(NAC-SCRT)。这一决定是在去年举行的专家和公众磋商之后作出的,它将大大改变印度人类干细胞研究的审查程序。NAC-SCRT在制定和更新监管指南,促进人类干细胞研究和国家话语,以及确定安全和质量标准方面发挥了关键作用。在两名干细胞专家加入后,机构伦理委员会现在被要求在组织层面审查干细胞研究。合并监管框架的决定是一个受欢迎的步骤,反映了一个动态的监管环境,对科学进步作出反应,旨在减轻合规负担。然而,要有效执行订正的机制,就必须进一步明确现在由哪个机构负责以前授权给咨委会的任务。
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引用次数: 0
The intrinsic tension between articulating one's medical condition and explaining it: A commentary on An Unquiet Mind. 阐明一个人的医疗状况和解释它之间的内在张力:《不安的心灵》评论。
Pub Date : 2025-07-01 DOI: 10.20529/IJME.2025.021
Sushma Shetty

Kay Redfield Jamison, an author, clinical psychologist, and professor at Johns Hopkins University School of Medicine, grapples with bipolar disorder - shaping her professional focus. She dealt with manic-depressive disorder as a professor of psychiatry and a successful medical professional. What was that experience like? In her memoir, An Unquiet Mind: A Memoir of Moods and Madness, she navigates the inherent conflict of explaining her own condition while delving into the discomfort of taking, as well as being on different, "sides". Through a close reading of select chapters, this paper explores the nuanced approach needed to understand the complexity of human experiences and perspectives amidst the challenges of mental illness.

凯·雷德菲尔德·贾米森是一位作家、临床心理学家,也是约翰·霍普金斯大学医学院的教授,她与双相情感障碍作斗争,塑造了她的职业重点。作为一名精神病学教授和一名成功的医学专业人士,她处理过躁狂抑郁症。那是什么样的经历?在她的回忆录《不安的心灵:情绪与疯狂的回忆录》中,她在解释自己状况的同时,深入研究了采取不同“立场”的不适,以及站在不同“立场”上的内在冲突。通过对精选章节的仔细阅读,本文探讨了在精神疾病挑战中理解人类经历和观点复杂性所需的细致入微的方法。
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引用次数: 0
期刊
Indian journal of medical ethics
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