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Indian Journal of Medical Ethics

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https://www.readbyqxmd.com/read/28661403/accelerated-approval-of-drugs-ethics-versus-efficacy
#1
Krishnan V Chary, Kumaresh Pandian
OBJECTIVE: To analyse the post-marketing status of molecules approved through the expedited review process in the last quintile. METHODS: This observational study was carried out between January 2016 and June 2016. The details of the time taken to approve drugs were collected from the official website of United States Food and Drug Administration (FDA). The average time taken to review drugs and take a decision following the review were ascertained from the FDA's annual release of novel drugs from 2011 to 2015...
June 27, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28661402/cioms-guidelines-remain-conservative-about-vulnerability-and-social-justice
#2
Calvin Wai-Loon Ho
This paper begins by considering how the revised CIOMS guidelines have progressed beyond a mere labelling approach in the handling of vulnerability. However, progress is limited as the guidelines remain fixated on voluntariness and harm reduction or prevention. Although these are important considerations, vulnerability could also serve as a robust analytic for the evaluation of situational and pathogenic (or structural) contributions to susceptibilities to harm. They could also provide better guidance on how to differentiate among varying types and degrees of harm, rather than merely noting their presence...
June 13, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28630031/response-to-david-s-article-on-the-use-of-pellet-guns-in-kashmir
#3
Ratna Magotra
I am distressed by the political inclination of the journal reflected in publishing the article by Siddarth David in a recent issue of Indian Journal of Medical Ethics. The journal has tried to redeem its image by publishing a counterview by Ravindra Ghooi. I feel more voices need to be heard on the utter unsuitability of David's comments on the use of pellet guns by security forces in Kashmir in a medical ethics journal.
June 13, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28592392/code-krishna-an-innovative-practice-respecting-death-dying-and-beyond
#4
Bhalendu Vaishnav, Somashekhar Nimbalkar, Sandeep Desai, Smruti Vaishnav
In moments of grief, human beings seek solace and attempt to discover the meaning of life and death by reaching out to wider and deeper dimensions of existence that stem from their religious, cultural and spiritual beliefs. Conventional patient care fails to consider this vital aspect of our lives. Many hold the view that life and its experiences do not end with death; the body is but a sheath which holds the soul that inhabits it. The use of a protocol-based practice to create a solemn atmosphere around the departed individual can bridge the gap between the materialistic and non-materialistic perceptions of the dimensions of care...
June 6, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28592393/enhancing-the-autonomy-of-indian-nurses
#5
Meena Putturaj, N S Prashanth
With additional training and qualification, nurses in several countries are recognised as independent professionals. Evidence from several countries shows that capacitating nurses to practise independently could contribute to better health outcomes. Recently, the idea of nurses practising independently has been gaining momentum in Indian health policy circles as well, and the Ministry of Health and Family Welfare is contemplating the introduction of nurse practitioners (NPs) in primary healthcare. We briefly assess the policy environment for the role of NPs in India...
May 30, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28537222/the-revision-of-the-ich-good-clinical-practice-guidelines-a-missed-opportunity
#6
Raffaella Ravinetto
The Guideline for Good Clinical Practice (GCP) of the International Conference of Harmonisation (ICH) is an international standard for the ethical and scientific quality of the designing, conducting, recording and reporting of trials that involve the participation of human subjects. Today, most regulators and funding agencies follow the ICH guidelines. These were drawn up by a small number of regulatory agencies and drug companies from high-income countries and do not pay sufficient heed to the problematic aspects of clinical trials in the low- and middle-income countries...
May 23, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28537221/ethical-stumbling-blocks-in-uncovering-folate-deficiency-as-a-preventable-cause-of-spina-bifida
#7
Lars H Breimer, Torbjörn K Nilsson
The year 2016 witnessed the anniversaries of several key events related to the prevention of neural tube defects (NTD) with folate supplementation. However, the road leading up to this achievement was full of stumbling blocks, both in terms of research ethics and researcher ethics. First, the decisions of ethics review boards differed with respect to allowing placebo groups in folate trials, thus reducing the level of evidence obtained from the earliest studies. Second, statisticians insisted on analysing the outcome of a trial by intention-to-treat - which turned out to be non-significant - rather than by treatment received, which was statistically significant...
May 18, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28501793/ethical-issues-in-death-dying-and-palliation-the-ijme-sixth-national-bioethics-conference
#8
Rakhi Ghoshal, V Deepa, Sunita Simon Kurpad
The IJME Sixth National Bioethics Conference (6th NBC), on the theme "Healing and dying with dignity: ethical issues in palliative care, end-of-life care and euthanasia", was held in Pune, Maharashtra from January 12-15, 2017. Palliative care (PC) and end-of-life care (EOLC) are closely related areas of concern, yet they have been neglected so far. There is an urgent need to discuss these issues in India due to the changing demographics, socioeconomic and work profiles of the population, people's living conditions and health status, and the contexts of the country's population...
May 10, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28501792/healing-ministry-and-palliative-care-in-christianity
#9
S Stephen Jayard, Nishant A Irudayadason, J Charles Davis
Death is inevitable, but that does not mean it can be planned or imposed. It is an ethical imperative that we attend to the unbearable pain and suffering of patients with incurable and terminal illnesses. This is where palliative care plays a vital role. Palliative care has been growing faster in the world of medicine since its emergence as a specialty in the last decade. Palliative care helps to reduce physical pain while affirming the aspect of human suffering and dying as a normal process. The goal of palliative care is to improve the quality of life both of the patient and the family...
May 3, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28501791/the-jurisprudence-of-emergency-medical-care-in-india-an-ethics-perspective
#10
Edward Premdas Pinto
This paper, which is part of a primary interdisciplinary doctoral research work with a qualitative research design, seeks to understand the ethical principles that intersect healthcare jurisprudence in litigations where citizens, who have encountered death or violations in the provision of critical care, have had to take recourse to the courts to get justice.
April 25, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28433962/ten-minute-snapshots-a-team-approach-to-teaching-postgraduates-about-professional-dilemmas
#11
Prabha S Chandra, G Ragesh, Santosh K Chaturvedi
As medical professionals, most of us face professional dilemmas that catch us unawares and are not discussed in medical training. One often learns about these dilemmas on one's own and deals with them with a common sense approach, rather than reflection. The professional dilemmas may concern receiving gifts from patients, handling issues of confidentiality or dealing with personal questions. There is seldom any formal instruction in competencies related to professionalism, especially in India. We adopted a team approach to provide training in these issues to postgraduate trainees in mental health and to engage them in discussion, using team feedback on snapshots of real-life professional situations, which were simulated through role play...
April 12, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28433965/national-health-policy-2017-a-cautious-welcome
#12
T Sundararaman
On March 15, 2017 the union cabinet approved the new National Health Policy. The next day a 28-page policy text and an accompanying 13-page situational analysis were placed in Parliament and in the public domain. To have, at all times, a health policy in place that shows a road map on how a nation would show "progressive realization" of health as a basic human right is an obligation under the International Covenant on Economic, Social and Cultural Rights. This is an international treaty adopted in 1976, to which India became a signatory in 1979, and this was one of the catalysts for the adoption of the first National Health Policy in 1 983...
April 4, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28433964/ethical-management-of-substance-use-disorders-the-indian-scenario
#13
Arpit Parmar, Vaibhav Patil, Siddharth Sarkar
Substance use disorders are among the most prevalent and emergent public health problems in India. The treatment of individuals with these disorders is associated with many ethical dilemmas. Due to the pervasiveness of substance use disorders, the majority of mental health professionals working in the area of addiction medicine face several ethical dilemmas. When discussing substance use disorders, it must be borne in mind that there are important differences between India and the western countries in terms of the social and cultural aspects, as well as the legislative framework and healthcare delivery system...
April 4, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28512078/is-mci-over-emphasising-publication-for-promotion-of-medical-teachers
#14
Shobhit Jain, Harjeet Jain, Ashok Kumar Jain
Over the past year, there has been constant debate in various journals on the circular issued by the Medical Council of India (MCI) in September 2015, regarding the requirements for promotion of teaching faculty. The lack of a time-bound promotion system of medical faculty results in higher stress, dissatisfaction, lower productivity and quality of life and work. The critics have highlighted several issues in assessment of publication for teacher's promotion, eg the exclusion of publications in "electronic-only" journals, awarding points only to "original research" papers and first or second authors, listing of indexing databases for journals, categorising journals as national or international...
April 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28512077/vaccine-delivery-to-disease-control-a-paradigm-shift-in-health-policy
#15
T Jacob John, Yogesh Jain, Sarojini Nadimpally, Amar Jesani
India's Universal Immunisation Programme (UIP) has resulted in the creation of infrastructure, human resources and systems for the procurement and delivery of vaccines. Recently, new vaccines have been added and there are plans for the introduction of more. However, the outcomes in terms of reduction of the diseases for which the vaccines are being administered remain ambiguous. This is evident from the persistent health issues that children continue to experience, despite immunisation. This situation raises a fundamental ethical question for public health: vaccinations are one of the tools of disease control, but are they properly aligned to the control of disease so as to produce the expected public health utility or benefit?...
April 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28512076/considering-the-public-in-public-health-popular-resistance-to-the-smallpox-eradication-programme-in-india
#16
Luke Juran, Jennifer Trivedi, Korine N Kolivras
Public health initiatives, including large-scale vaccination and disease eradication programmes, regularly pit the rights of the individual against broader benefits to society. At times, the public resists such initiatives, with the World Health Organisation's Smallpox Eradication Programme (SEP) in India being a case in point. Here, we critically investigate resistance to smallpox vaccines in India and argue that while the SEP successfully eradicated a global killer; individuals were stripped of human rights through coercion, forcible vaccination and quarantine...
April 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28512075/public-trust-in-vaccination-an-analytical-framework
#17
Vijayaprasad Gopichandran
While vaccination is one of the most successful public health interventions, there has always been a parallel movement against vaccines. Apart from scientific factors, the uptake of vaccinations is influenced by historical, political, sociocultural and economic factors. In India, the health system is struggling with logistical weaknesses in taking vaccination to the remotest corners; while on the other hand, some people in places where vaccination is available resist it. Unwillingness to be vaccinated is a growing problem in the developed world...
April 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28512074/an-idea-whose-time-has-come-compensation-for-vaccine-related-injuries-and-death-in-india
#18
Sarojini Nadimpally, Sneha Banerjee, Deepa Venkatachalam, Divya Bhagianadh
This paper emphasises the urgent need for a compensation policy for those affected by adverse events following immunisation in India. In the absence of such a mechanism in the country, people claim compensation by taking recourse to tort law and have to face the ensuing uncertainty and challenges with regard to the award of compensation. The paper argues that people should be provided compensation in the event of death and serious adverse events following compulsory immunisation, irrespective of whether there is a causal association between the adverse event and the vaccine, on the basis of no fault compensation...
April 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28512073/identifying-ethical-issues-in-the-development-of-vaccines-and-in-vaccination
#19
Veena Johari
Vaccines are a widely accepted public health intervention. They are also a profitable tool for pharmaceutical companies manufacturing vaccines. There are many vaccines in the pipeline, for various diseases, or as combination vaccines for several diseases. However, there is also a growing concern about vaccines and the manner in which they are developed and approved by the authorities. Approvals are fast tracked and adverse events and serious adverse events following vaccination are seldom reported once the vaccine gets its marketing approval...
April 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28512072/lessons-learnt-in-japan-from-adverse-reactions-to-the-hpv-vaccine-a-medical-ethics-perspective
#20
Hirokuni Beppu, Masumi Minaguchi, Kiyoshi Uchide, Kunihiko Kumamoto, Masato Sekiguchi, Yukari Yaju
The human papillomavirus (HPV) vaccine has been linked to a number of serious adverse reactions. The range of symptoms is diverse and they develop in a multi-layered manner over an extended period of time. The argument for the safety and effectiveness of the HPV vaccine overlooks the following flaws: (i) no consideration is given to the genetic basis of autoimmune diseases, and arguments that do not take this into account cannot assure the safety of the vaccine; (ii) the immune evasion mechanisms of HPV, which require the HPV vaccine to maintain an extraordinarily high antibody level for a long period of time for it to be effective, are disregarded; and (iii) the limitations of effectiveness of the vaccine...
April 2017: Indian Journal of Medical Ethics
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