In 2006, the Indian Council of Medical Research (ICMR) published its ‘Ethical guidelines for Biomedical Research on human participants’. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the guidelines, there (...) are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India. (shrink)

The formal oversight of medical education in India occurred with the promulgation of the Indian Medical Degrees Act in 1916. Despite an awareness of the need to train ethical doctors and the formal discussion of this as early as 1955, the formal teaching of medical ethics has been restricted to a few colleges as it has not been part of a mandated requirement. In August, 2019, all medical colleges in India will adopt a new (...) class='Hi'>Medical Council of India mandated curriculum. An embedded AETCOM module across all years of training is a part of this curriculum and is the first attempt to introduce medical ethics uniformly in close to 500 medical colleges in the country. This paper traces the historical attempts to include medical ethics in medical education in India, and describes the current plan to implement ethics teaching in the undergraduate medical curriculum in India. (shrink)

Background The field of bioethics examines the moral and ethical dilemmas that arise in the biological sciences, healthcare, and medical practices. There has been a rise in medical negligence cases, complaints against healthcare workers, and public dissatisfaction with healthcare professionals, according to reports from the Indian Medical Council and other healthcare associations. We intend to assess the level of knowledge, attitude, and practice of bioethics among the registered healthcare professionals (HCPs) of Maharashtra, India. Methods A (...) State-level online survey was conducted among the registered HCPs (n = 2143) casing all five regions of the Maharashtra state using a pre-tested self-administered questionnaire. The responses were expressed as mean, and proportions with their standard deviation and 95% CI respectively. Binary logistic regression and a multivariate logistic model were used to determine factors associated with knowledge, attitude, and practice of bioethics. Results Of the 2143 registered HCPs in Maharashtra included in this study, most of them (65.2%) had adequate knowledge of bioethics. Adequate knowledge was associated with lower age, profession (nurses and dentists), employment in the private sector, HCPS at Marathwada and Pune, and higher educational attainment. About 3 in 5 HCPs (59.4%) had a favorable attitude towards the ethical practice of bioethics, and was associated with profession, place of work, region of practice, and work experience. The distribution of unethical bioethics practices among 10 items was proportionally high, and only 34.4% reported good/fair practice. The common unethical practices in the state were allowing patients to be examined by interns, and not informing them about professional misconduct to the regulatory bodies. Conclusion Most HCPs had adequate knowledge of bioethics, which is encouraging and would favor the laying foundation for forming a good bioethics framework. Only 3/5 HCPs demonstrated a favorable attitude, and the observed unethical practice is alarmingly common. A serious consideration to evaluate the compliance level of bioethics practice periodically and measures to educate, sensitize, and train bioethics among HCPs in Maharashtra is warranted. (shrink)

We write in response to the original article by Rennie and Rudland published in the April 2003 edition of this journal.1 Current and former Dundee Medical School students are concerned at the media misinterpretation of the study and the consequences that this branding of “dishonesty” will have on Dundee Medical School’s reputation and also on individuals embarking on their ….

This article featuring India constitutes one of five articles in a collection of essays on local capacity-building in research ethics by graduates from the University of Toronto’s Joint Centre for Bioethics MHSc in Bioethics, International Stream program funded by the Fogarty International Center for Advanced Study in the Health Sciences. Research ethics is a growing area of work and interest in India. Ethics review remains the weakest component in the mechanism of good clinical practice, and there is a severe dearth (...) of professionals trained in ethics who can provide leadership. Although the Indian Good Clinical Practice Guidelines, the Indian Medical Council Act, and the Drugs and Cosmetics Act require that the Indian Council of Medical Research’s ethical guidelines be followed as a mandatory requirement for physicians who conduct research, there is a pervasive lack of awareness of basic requirements guiding the ethical conduct of research. There is a great need to strengthen India’s research ethics capacity and regulatory framework for research. (shrink)

Presents the fundamental ideas of Indian thinkers that have shaped the mind of Indian from 1770 to the post-modern era in the middle of 20th century in India. Lists the most Indian influential figures in the field of philosophy, political theory, activicism such as Rabindranath Tagore, Ram Mohan Roy, Swami Vivekananda, and Mohandas Karamchand Gandhi.

The General Medical Council renewed its guidance on consent in 2020. In this essay, I argue that the 2020 guidance does not advance on the earlier, 2008 guidance in regard to treatments that doctors are obliged to offer to patients. In both, doctors are instructed to not provide treatments that are not in the overall benefit, or clinical interests, of the patient; although, patients are absolutely entitled to decline treatment. As such, consent has two aspects, and different standards (...) apply to each aspect. To explore this paradigm, I propose the reconceptualisation of consent as a person’s freedom to achieve treatment, using Amartya Sen’s approach. Sen explains that freedom has two aspects: process and opportunity. Accordingly, a patient’s freedom to achieve treatment would comprise a process for the identification of proper treatment, followed by an opportunity for the patient to accept or decline this treatment. As per Sen, the opportunity aspect is to be assessed by the standard of public reason, whereas the standard for the process aspect is variable and contingent on the task at hand. I then use this reconceptualised view of consent to analyse case law. I show that senior judges have conceived the patient’s opportunity to be encompassed in information, which is to be decided by public reason. On the other hand, the process aspect relies on the private reason of medical professionals. Given the nature of professionalism, this reliance is inescapable, and it is maintained in the case law that is cited in both guidances. (shrink)

The Council on Ethical and Judicial Affairs of the American Medical Association examines physicians’ professional ethical responsibility in the event that the security of patients’ electronic records is breached.

Many members of the public think of the General Medical Council (GMC) as the body which tries doctors: the doctors' law courts, as it were. And, except in the more sober of newspapers and news reports, the 'offences ' which receive the most publicity are those concerning alleged improper relations between doctors and patients. Professor Sir Denis Hill, in the following paper, which he read in the spring of this year to the annual conference of the London (...) class='Hi'>Medical Group devoted to a discussion of human sexuality, chose to examine the whole function of the General Medical Council as a frame of moral reference for doctors. Judging allegations of professional misconduct by doctors is the function of the Council's Disciplinary Committee. Judging sexual misconduct forms only a small part of their work. The GMC's responsibility covers the whole notion of morals and morality as it concerns doctors in their professional work. Sir Denis Hill stresses the modern thinking that morality must be learned and that attitudes are always shifting as society alters its norms of what is moral conduct. That is not to say that all that was previously considered not to be moral has now become acceptable but rather that other concepts have entered the field of moral debate. Therefore the GMC must constantly review the frame of reference it offers to doctors and the public may be surprised to learn that that process is never static. Sir Denis Hill in this paper is speaking personally and not as a member of the General Medical Council or of any of that body's special committees. (shrink)

Summary Principles Timely support for patients and people close to them, and effective, sensitive communication are essential. Decisions must be based on the individual patient's circumstances and reviewed regularly. Sensitive advance discussion should always be encouraged, but not forced. Information about CPR and the chances of a successful outcome needs to be realistic. Practical matters Information about CPR policies should be displayed for patients and staff. Leaflets should be available for patients and people close to them explaining about CPR, how (...) decisions are made and their involvement in decisions. Decisions about attempting CPR must be communicated effectively to relevant health professionals. In emergencies If no advance decision has been made or is known, CPR should be attempted unless: the patient has refused CPR; the patient is clearly in the terminal phase of illness; or the burdens of the treatment outweigh the benefits. Advance decision making Competent patients should be involved in discussions about attempting CPR unless they indicate that they do not want to be. Where patients lack competence to participate, people close to them can be helpful in reflecting their views. Legal issues Patients' rights under the Human Rights Act must be taken into account in decision making. Neither patients nor relatives can demand treatment which the health care team judges to be inappropriate, but all efforts will be made to accommodate wishes and preferences. In England, Wales and Northern Ireland relatives and people close to the patient are not entitled in law to take health care decisions for the patient. In Scotland, adults may appoint a health care proxy to give consent to medical treatment. Health professionals need to be aware of the law in relation to decision making for children and young people.IntroductionWhy policies are neededCardiopulmonary resuscitation can be attempted on any person whose cardiac or respiratory functions cease. Failure of these functions is part of dying and thus …. (shrink)

The present study was aimed at gaining a broad opinion regarding bioethical reasoning amongst student fraternity. These students had been admitted to medical schools after completion of their high school . Ethnically all the students were of Indian origin though they belonged to a diverse socio-economic-cultural background. The mean age of students was 18 years and a total of 125 first year medical students were questioned in 1998 , using the questionnaire designed by Macer with some modifications. (...) The observations revealed the fact that even though fair amount of awareness regarding the wide perspectives of bioethics did prevail amongst many, yet some sense of ignorance was reflected as well. However, the respondents were divided on various sensitive issues like cloning, in vitro fertilisation etc. The results suggest enforcement of both individual and collective efforts to arouse the consciousness of students regarding bioethics and application of bioethical decision making to dilemmas posed by science and technology. (shrink)

In September 1998 the Bundesrztekammer, i.e., the German Medical Association, published new principles concerning terminal medical care. Even before publication, a draft of these principles was very controversial, and prompted intense public debate in the mass media. Despite some of the critics' suspicions that the principles prepared the way for liberalization of active euthanasia, euthanasia is unequivocally rejected in the principles. Physician-assisted suicide is considered to violate professional medical rules. In leaving aside some of the notions customarily (...) used in the euthanasia debate, e.g., passive euthanasia, the principles emphasize the obligation of physicians to offer and the right of patients to receive palliative care. The principles explicitly list modalities of basic treatment that are indispensable in all cases, such as the obligation to satisfy hunger and thirst. This statement is meant to resolve the dispute on nutrition and hydration at the end of life, as it shifts the focus of care from maintaining physiological parameters to satisfying subjective needs. For patients in a persistent vegetative state, artificial feeding is held to be obligatory. Yet, the principles make reference to recent German jurisdiction which permit the stopping of artificial feeding if it is in accordance with the patient's presumed will. Additionally, the wording concerning this issue is found to remain unclear. Patients' autonomy is strengthened by explicitly welcoming advance directives as a means to ascertain patients' wills. The principles mark some changes compared to earlier documents. They deserve careful analysis and should be considered in the international debate on issues concerning the end of life. (shrink)

What do the terms sex and gender identity, or gender history, mean in a medical context? When does it matter to a healthcare professional whether a patient has male or female reproductive biology?...

As a neo-liberal economy, India has become one of the new health tourism destinations, with commercial gestational surrogacy as an expanding market. Yet the Indian Assisted Reproductive Technology Bill has been pending for five years, and the guidelines issued by the Indian Council of Medical Research are somewhat vague and contradictory, resulting in self-regulated practices of fertility clinics. This paper broadly looks at clinical ethics in reproduction in the practice of surrogacy and decision-making in various procedures. (...) Through empirical research in New Delhi, the capital of India, from December 2011 to November 2012, issues of decision-making on embryo transfer, fetal reduction, and mode of delivery were identified. Interviews were carried out with doctors in eighteen ART clinics, agents from four agencies, and fourteen surrogates. In aiming to fulfil the commissioning parents’ demands, doctors were willing to go to the greatest extent possible in their medical practice. Autonomy and decision-making regarding choice of the number of embryos to transfer and the mode of delivery lay neither with commissioning parents nor surrogate mothers but mostly with doctors. In order to ensure higher success rates, surrogates faced the risk of multiple pregnancy and fetal reduction with little information regarding the risks involved. In the globalized market of commercial surrogacy in India, and with clinics compromising on ethics, there is an urgent need for formulation of regulative law for the clinical practice and maintenance of principles of reproductive ethics in order to ensure that the interests of surrogate mothers are safeguarded. (shrink)

In this paper, I examine the rhetoric employed by court judgements, with a particular emphasis on the narrative construct of the ‘passive patient’. This construction advances and reinforces paternalistic values, which have scant regard for the patients’ preferences, values, or choices within the legal context. Further, I critique the rhetoric employed and argue that the use of this rhetoric is the basis for a precedent that limits the understanding and respect of patients. Through this paper, I present the contemporary use (...) of the ‘passive patient’ construct in the context of the Indian legal system and describe how such constructions have become a source of normative justification for legal reasoning that jeopardizes the patient’s agency. I argue for the primacy of ‘respect for persons’ within Indian law and the need to treat each patient as a person who has agency, preferences, and values during clinical interactions. I conclude by suggesting that laws that adopt narratives that acknowledging the significance of patient engagement and the relevance of effective communication during clinical encounters would help cultivate a culture of patient-centred care, by moving beyond the rhetoric of ‘passive patient’ and the ‘health/choice’ dichotomy. (shrink)

Over the past 6 months, coronavirus-induced disease has spread across 212 countries, affecting millions of people. As it has no known cure, social distancing is highly recommended for prevention of spread of the disease. Here, we have described the impact of the social distancing measures implemented by the Government of India on various sections of the society, especially the vulnerable sections. Furthermore, we have presented an analysis of these measures, according to the World Health Organization´s Guidance for Managing Ethical Issues (...) in Infectious Disease Outbreaks ; we have also applied principles, as applicable, from the Indian Council of Medical Research’s National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. Finally, we have presented several measures that should have been adopted before and in addition to implementing the lockdown to improve its effectiveness. (shrink)

In the early 1970s, a World Health Organization‐initiated and United States‐funded project released lab‐reared mosquitoes outside New Delhi in the first large‐scale field trials of the genetic control of mosquitoes. Despite partnering with the Indian Council of Medical Research and investing significantly in outreach to local communities at the release sites, the project was embroiled in controversy and became an object of vehement debate within the Indian parliament and diplomatic contretemps between the United States and India. (...) This early episode of genetic control research demonstrates how a scientific collaboration was entangled in geopolitics and shaped by the legacy of colonialism. This historical case study has implications for public deliberation in the present, pointing to the challenges of shared decision‐making in the context of structural inequality, the way that a backdrop of military interest in a technology can impede trust, and the long‐term consequences of projects that foster mistrust. (shrink)

Biobank-based research is not specifically addressed in Indian statutory law and therefore Indian Council for Medical Research guidelines are the primary regulators of biobank research in India. The guidelines allow for broad consent and for any level of identification of specimens. Although privacy is a fundamental right under the Indian Constitution, courts have limited this right when it conflicts with other rights or with the public interest. Furthermore, there is no established privacy test or actionable (...) privacy right in the common law of India. In order to facilitate biobank-based research, both of these lacunae should be addressed by statutory law specifically addressing biobanking and more directly addressing the accompanying privacy concerns. A biobank-specific law should be written with international guidelines in mind, but harmonization with other laws should not be attempted until after India has created a law addressing biobank research within the unique legal and cultural environment of India. (shrink)

Objective To evaluate the questions asked during the informed consent process by adult and adolescent participants as well as their parents in five interventional regulatory studies conducted at our center from 2018 to 2019. Methods The study protocol was approved by Institutional Ethics Committee [EC/OA-116/2019]. Consent narratives in the source documents for the studies were evaluated. Questions asked were classified as per Indian Council of Medical Research’s guidelines. We evaluated total number of questions, nature of questions and (...) whether there was an association between education, gender, phase of trials, physician taking consent and number questions being asked. Results A total of five studies that had N = 297 consent narratives were evaluated. Narratives of n = 284 adult participants/Guardians and of n = 13 children were analysed. A total of 374 questions were asked of which children asked only 10 questions. A total of 131/284 of the participants did not ask any question. Among the participants who asked questions, the majority132/171 participants asked about risks related to investigational products followed by questions related to study procedures 83/171. Participants/guardians with higher education and those who consented for Phase III studies asked significantly more questions. Conclusion A majority of the queries were related to the risks associated with the investigational products. Educational status and the Phase of the trial were found to be significantly associated with the number of questions being asked. (shrink)

Like nuclear energy, most technologies could have dual use—for health and well being and disaster and terror. Some research publications have brought to the forefront the tragic consequences of the latter potential through their possible use. Monitoring life science research and development (R&D) to prevent possible misuse is a challenging task globally, more so in developing economies like India, which are emerging as major biotech hubs. As a signatory to the Biological and Toxin Weapons Convention, India has put in motion (...) a process of evolving a series of measures to manage dual-use technology. The Indian Council of Medical Research (ICMR) has taken a lead in drafting model codes of conduct, ethics and practice for use by other S&T agencies to tailor them as per their requirements. Taking cue from the discussions held by the editors of the various medical and science journals in the developed world, the Indian Journal of Medical Research, the official publication of the ICMR, is working on policy and uniform practice of publication of dual-use research results. The Government of India too has promulgated legal provisions to minimize the risks of misuse of technology, like the Weapons of Mass Destruction Act. Clearly, no single agency would be able to manage the dual-use of technology effectively. Multiple agencies have to come together to work in tandem for effective implementation of various measure and also like Janus, ensure that they are neither too restrictive nor intrusive to discourage the development of science. (shrink)

Medical research aims to achieve a better scientific understanding of health and disease. It is firstly undertaken for the improvement of medical care in general, not excluding a potential direct benefit for participants undergoing such research. There is a traditional conflict between the fundamental rights and the dignity of those participating individuals and the interests of science, researchers and even the society. The Convention of Human Rights and Biomedicine of the Council of Europe is a new legally (...) binding instrument for the solution of these conflicts. (shrink)

The UK’s Medical Research Council (MRC) introduced a specific policy and procedure for inquiring into allegations of scientific misconduct in December 1997; previously cases had been considered under normal disciplinary procedures. The policy formally covers staff employed in MRC units, but those in receipt of MRC grants in universities and elsewhere are expected to operate under similar policies. The MRC’s approach is stepwise: preliminary action; assessment to establish prima facie evidence of misconduct; formal investigation; sanctions; and appeal. Strict (...) time limits apply at all stages. The procedure will be evaluated after two years. The indications so far are that the procedure is robust, and its clarity and transparency have been an asset to all parties. The MRC is also convinced that it is equally important to achieve a working culture that fosters integrity. Thus education and training in good research practices are fundamental to the prevention of research misconduct. (shrink)

The UK Medical Research Council, in order to further its mission of maintaining and improving human health, supports a substantial number of clinical trials on a wide variety of medical questions; some of these trials involve the use of placebos as controls or to maintain blinding. Before providing support, proposed trials are carefully reviewed to assess scientific quality, and to determine whether a placebo is required and is ethical — in addition to ethics review by independent Research (...) Ethics Committees. Some questions such as the choice of placebos in trials in developing countries, in surgical trials and those involving alternative medicine require consideration of additional, specific issues. Involvement of consumers in MRC work has been increasing and includes the establishment of a Consumer Liaison Group; members of this group comment on patient information leaflets for clinical trials, helping to improve patient understanding of trials and ensuring topics like placebo use are explained clearly. Views differ on the value of placebos in clinical care and on their mechanism of action; continuing research is helping to clarify the issues. (shrink)

As practicing clinicians, physicians are expected to uphold the ethical norms of their profession, including fidelity to patients and respect for patients’ self-determination. At the same time, as individuals, physicians are moral agents in their own right and, like their patients, are informed by and committed to diverse cultural, religious, and philosophical traditions and beliefs. In some circumstances, the expectation that physicians will put patients’ needs and preferences first may be in tension with the need to sustain the sense of (...) moral integrity and continuity that grounds a physician’s personal and professional life. This article examines the implications for patients, physicians, and the medical profession when tensions arise between a physician’s professional commitments and his or her deeply held personal moral beliefs. It offers guidance on when a physician’s professional commitments should outweigh personal beliefs as well as when physicians should have freedom to act according to the dictates of conscience while still protecting patients’ interests. (shrink)

The Medical Research Council National Survey of Health and Development (NSHD) is Britain’s longest-running birth cohort study. From their birth in 1946 until the present day, its research participants, or study members, have filled out questionnaires and completed cognitive or physical examinations every few years. Among other outcomes, the findings of these studies have framed how we understand health inequalities. Throughout the decades and multiple follow-up studies, each year the study members have received a birthday card from the (...) survey staff. Although the birthday cards were originally produced in 1962 as a method to record changes of address at a time when the adolescent study members were potentially leaving school and home, they have become more than that with time. The cards mark, and have helped create, an ongoing evolving relationship between the NSHD and the surveyed study members, eventually coming to represent a relationship between the study members themselves. This article uses the birthday cards alongside archival material from the NSHD and oral history interviews with survey staff to trace the history of the growing awareness of importance of emotion within British social science research communities over the course of the 20th and early 21st centuries. It documents changing attitudes to science’s dependence on research participants, their well-being, and the collaborative nature of scientific research. The article deploys an intertextual approach to reading these texts alongside an attention to emotional communities drawing on the work of Barbara Rosenwein. (shrink)

Aim: The aim of this paper is to present the development and evaluation of an art psychotherapy brief treatment method for complex depression for patients referred to mental health services.Background: Art Psychotherapy literature describes a range of processes of relational change through the use of arts focused and relationship focused interventions. Complex depression has a prevalence of 3% of the population in the West and it is recorded that in 2016 only 28% of that population were receiving psychological treatment. This (...) study was developed to test the hypothesis of whether an accessible and acceptable approach to the treatment of complex depression could be developed in relation to existing evidence-based practice within mental health services.Method: The United Kingdom Medical Research Council phased guidance for complex intervention development was used to develop the intervention. The process included producing a literature overview, systematic description of clinical practice, including a logic model and a clinical protocol. The art psychotherapy protocol described an arts-based dynamic interpersonal therapy approach, offered 1:1 over 24 sessions. Further to this the intervention was tested for referrer acceptability. The intervention is in the early stages of evaluation, using changes to the patient's depression and anxiety measured pre- and post-treatment with a follow-up measure at 3 months following completion of treatment.Results: Phase I of the study provided a good basis for developing a logic model and protocol. The authors found that there was good clinical consensus about the use of a structured clinical art psychotherapy method and the literature overview was used to support specific examples of good practice. The verification of clinical coherence was represented by a logic model and clinical protocol for delivering the intervention. The acceptability study demonstrated very high levels of acceptability for referrers reporting that ADIT was acceptable for patients with complex/major depression, that they were likely to refer to ADIT in the future that the use of arts was likely to improve accessibility the use of arts was likely to improve outcomes and that offering ADIT was an effective use of mental health resources.Discussion: Phase I of this intervention development study demonstrated theoretical and practice coherence resulting in a clinical protocol and logic model. Whilst Phase II of this study showed promising results, Phase II would need to be sufficiently scaled up to a full trial to further test the intervention and protocol. (shrink)

The General Medical Council’s Outcome for Graduates, published in 2018,1 is the latest guidance for medical schools on the GMC’s expectations of the undergraduate medical curriculum. One of its three top level outcomes—Professional Values and Behaviours—refers to medical ethics and law, professionalism and patient safety competencies. Furthermore, the recent proliferation of patient safety inquiries in the UK2–4 has elevated the emphasis on ethical medical practice5 and critical medical ethics and law competencies for future (...) doctors. In response to these developments and to ensure an up to date offering, the Institute of Medical Ethics Education Committee has updated the consensus statement on the core curriculum for medical ethics and law for doctors of tomorrow.6 This refined curriculum is the result of a national consultation process. We asked for the views of all lead teachers of medical ethics and law in all UK medical schools, the UK’s chief medical officers, the GMC, and delegates at our annual education conference in 2017 who …. (shrink)