Preprints in times of COVID19: the time is ripe for agreeing on terminology and good practices.

Over recent years, the research community has been increasingly using preprint servers to share manuscripts that are not yet peer-reviewed. Even if it enables quick dissemination of research findings, this practice raises several challenges in publication ethics and integrity. In particular, preprints have become an important source of information for stakeholders interested in COVID19 research developments, including traditional media, social media, and policy makers. Despite caveats about their nature, many users can still confuse pre-prints with peer-reviewed manuscripts. If unconfirmed but already widely shared first-draft results later prove wrong or misinterpreted, it can be very difficult to "unlearn" what we thought was true. Complexity further increases if unconfirmed findings have been used to inform guidelines. To help achieve a balance between early access to research findings and its negative consequences, we formulated five recommendations: (a) consensus should be sought on a term clearer than 'pre-print', such as 'Unrefereed manuscript', "Manuscript awaiting peer review" or ''Non-reviewed manuscript"; (b) Caveats about unrefereed manuscripts should be prominent on their first page, and each page should include a red watermark stating 'Caution-Not Peer Reviewed'; (c) pre-print authors should certify that their manuscript will be submitted to a peer-review journal, and should regularly update the manuscript status; (d) high level consultations should be convened, to formulate clear principles and policies for the publication and dissemination of non-peer reviewed research results; (e) in the longer term, an international initiative to certify servers that comply with good practices could be envisaged.

Innovations in research ethics governance in humanitarian settings.

BACKGROUND: Médecins Sans Frontières (MSF) is one of the world's leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper. DISCUSSION: We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices: • A new framework to guide ethics review • The introduction of a policy exempting a posteriori analysis of routinely collected data • The preapproval of "emergency" protocols • General ethical approval of "routine surveys" • Evaluating the impact of approved studies. The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced. SUMMARY: We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out research in fragile contexts and for ethics committees reviewing such research.

Ethics regulation by National Medical Commission: No reason for hope.

Over the last three decades, medical councils in India have come under fire for rampant corruption and failure in the governance of medical education and practice. In fact, this journal itself grew out of the disquiet felt by a section of medical professionals at the barefaced corruption they witnessed in electoral practices, when contesting elections to the Maharashtra Medical Council in 1992 [1]. That experience triggered a movement of doctors and non-medical individuals for reform in the governance of healthcare, resulting in the birth of this journal in 1993. This also helped advance the disciplines of bioethics and healthcare ethics and humanities in India.

Scientific integrity tested by the Covid-19 pandemic.

In October 2020, the world's three top medical journals, The Lancet, The New England Journal of Medicine and Nature denounced, in their editorials, the United States' response to the Covid-19 pandemic, and appealed to US citizens to vote for change (1,2,3). Nature went to the extent of naming the candidate to vote for. The Lancet has a history of making comments and taking positions on political issues. However, what surprised many was the NEJM editorial, signed by several of its editors, taking a partisan political position for the first time since it was established in 1812, 208 years ago (4). These editorials express not only disappointment with the political leadership, but anger against its wilful disregard of science, undermining of services in the public sector and regulatory institutions, gross partisan political interference in science, and so on.

Centring patient autonomy in DNAR decisions.

The Response from the ICMR team of Dr Mani et al (1) to the IJME Editorial (2) on the ICMR DNAR Guidelines (3) provides some answers to the gaps and questions raised, and it is hoped that these will find a place in revised versions of the document. The document Disclaimer said "further revisions" were planned, based on perceptions and experiences of clinicians and the public; an early revision will allow for better acceptance of the Guidelines.

The crisis of ethics and integrity in Evidence Based Medicine and scientific practice.

This issue of IJME carries three essays and a letter on the current crisis in Cochrane, earlier known as the Cochrane Collaboration. Cochrane expelled one of its founder members, Peter Gotzsche, on September 13, 2018, and in protest, four other Governing Board Members resigned. The essays show that what happened was not merely a clash within an organisation, but involved some basic differences on approach to Evidence Based Medicine. While these issues had been simmering for a long time, the expulsion brought them sharply into focus in the public domain.

New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights.

The enactment of the New Drugs and Clinical Trials Rules, 2019 (hereafter New Rules), on March 19 by the Ministry of Health and Family Welfare (MoHFW), Government of India (1), is the use of power delegated to the political executive by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940. Has this power been used wisely? Whose interests do these rules represent?

How Civil Society Organisations Changed the Regulation of Clinical Trials in India.

In 2005 India changed its pharmaceutical and innovation policy that facilitated a dramatic increase in international clinical trials involving study sites in India. This policy shift was surrounded by controversies; civil society organisations (CSOs) criticised the Indian government for promoting the commercialisation of pharmaceutical research and development. Health social movements in India fought for social justice through collective action, and engaged in normative reasoning of the benefits, burdens and equality of research. They lobbied to protect trial participants from structural violence that occurred especially in the first 5-6 years of the new policy. CSOs played a major role in the introduction of new regulations in 2013, which accelerated a decline in the number of global trials carried out in India. This activism applied interpretations of global social justice as key ideas in mobilisation, eventually helping to institutionalise stricter ethical regulation on a national level. Like government and industry, activists believed in randomised controlled trials and comparison as key methods for scientific knowledge production. However, they had significant concerns about the global hierarchies of commercial pharmaceutical research, and their impact on the rights of participants and on benefits for India overall. Pointing to ethical malpractices and lobbying for stricter ethical regulations, they aimed to ensure justice for research participants, and developed effective strategies to increase controls over the business side of clinical research.

In the 25th year of bioethics publishing: new challenges of the post-truth era.

As IJME enters its 25th year of publication, all of us closely associated with the journal look back on this journey with a degree of satisfaction. Not only has the only bioethics journal published from India survived for 24 years, it has also produced some extraordinary successes. As you read this issue, we will be celebrating the 12th year of the biennial National Bioethics Conferences - the sixth NBC will take place in Pune from January 13 to 15, 2017.

Ethical and legal challenges of vaccines and vaccination: Reflections.

Vaccines and vaccination have emerged as key medical scientific tools for prevention of certain diseases. Documentation of the history of vaccination shows that the initial popular resistance to universal vaccination was based on false assumptions and eventually gave way to acceptance of vaccines and trust in their ability to save lives. The successes of the global eradication of smallpox, and now of polio, have only strengthened the premier position occupied by vaccines in disease prevention. However, the success of vaccines and public trust in their ability to eradicate disease are now under challenge, as increasing numbers of people refuse vaccination, questioning the effectiveness of vaccines and the need to vaccinate.

Vaccine delivery to disease control: a paradigm shift in health policy.

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?

Research Ethics Governance in Times of Ebola.

The Médecins Sans Frontières (MSF) ethics review board (ERB) has been solicited in an unprecedented way to provide advice and review research protocols in an 'emergency' mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at (very) early development stages. This article examines the MSF ERB's experience addressing issues related to both the process of review and substantive ethical issues in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees (ECs), we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the 'optimal' ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process.

The absent discourse of communication: understanding ethics of provider-patient relationship in six hospitals in urban India.

Understanding the complexities of a provider-patient relationship is considered to be of critical importance especially in medical ethics. It is important to understand this relation from the perspectives of all stakeholders. This article derives from a qualitative study conducted across six obstetric care providing institutions in the cities of Mumbai and Navi Mumbai, India, over a period of 10 months. Thirty obstetricians were interviewed in-depth to understand what they perceived as the most important aspect in developing a good provider-patient relationship. The study found that while most providers highlighted the point of communication as the most critical part of the provider-patient relationship, they admitted that they could not engage in communication with the patients for various reasons. Obstetric consultants and residents said that they were too overburdened to spend time communicating with patients; providers working in public hospitals added that the lack of education of their patients posed a hindrance in effective communication. However, providers practicing in private institutions explained that they faced a challenge in communicating with patients because their patients came from educated families who tended to trust the provider less and were generally more critical of the provider's clinical judgement. The article shows how provider-patient communication exists as an idea among medical providers but is absent in daily clinical practice. This gives rise to a discourse shaped around an absence. The authors conclude by decoding the term 'communication' - they read the word against the context of its use in the interviews, and argue that for the providers 'communication' was not intended to be a trope towards setting up a dialogue-based, egalitarian provider-patient relationship. Providers used the word in lieu of 'counselling', 'guiding', 'talking to'. It concludes that, despite the providers' insisting on the significance of communication and complaining about its absence, what they desired in reality was not the possibility of a dialogue with the patient or a chance to be able to share decision-making power with the patient, but to be able to provide better instructions and chart out what was best for them in a more detailed way.

Influencing policy change: the experience of health think tanks in low- and middle-income countries.

In recent years there has been a growth in the number of independent health policy analysis institutes in low- and middle-income countries which has occurred in response to the limitation of government analytical capacity and pressures associated with democratization. This study aimed to: (i) investigate the contribution made by health policy analysis institutes in low- and middle-income countries to health policy agenda setting, formulation, implementation and monitoring and evaluation; and (ii) assess which factors, including organizational form and structure, support the role of health policy analysis institutes in low- and middle-income countries in terms of positively contributing to health policy. Six case studies of health policy analysis institutes in Bangladesh, Ghana, India, South Africa, Uganda and Vietnam were conducted including two NGOs, two university and two government-owned policy analysis institutes. Case studies drew on document review, analysis of financial information, semi-structured interviews with staff and other stakeholders, and iterative feedback of draft findings. Some of the institutes had made major contributions to policy development in their respective countries. All of the institutes were actively engaged in providing policy advice and most undertook policy-relevant research. Relatively few were engaged in conducting policy dialogues, or systematic reviews, or commissioning research. Much of the work undertaken by institutes was driven by requests from government or donors, and the primary outputs for most institutes were research reports, frequently combined with verbal briefings. Several factors were critical in supporting effective policy engagement. These included a supportive policy environment, some degree of independence in governance and financing, and strong links to policy makers that facilitate trust and influence. While the formal relationship of the institute to government was not found to be critical, units within government faced considerable difficulties.

Impact of ethics and economics on end-of-life decisions in an Indian neonatal unit.

OBJECTIVE: The aim of this article was to describe how providers in an Indian NICU reach life-or-death treatment decisions. METHODS: Qualitative in-depth interviews, field observations, and document analysis were conducted at an Indian nonprofit private tertiary institution that provided advanced neonatal care under conditions of resource scarcity. RESULTS: Compared with American and European units with similar technical capabilities, the unit studied maintained a much higher threshold for treatment initiation and continuation (range: 28-32 completed gestational weeks). We observed that complex, interrelated socioeconomic reasons influenced specific treatment decisions. Providers desired to protect families and avoid a broad range of perceived harms: they were reluctant to risk outcomes with chronic disability; they openly factored scarcity of institutional resources; they were sensitive to local, culturally entrenched intrafamilial dynamics; they placed higher regard for "precious" infants; and they felt relatively powerless to prevent gender discrimination. Formal or regulatory guidelines were either lacking or not controlling. CONCLUSIONS: In a tertiary-level academic Indian NICU, multiple factors external to predicted clinical survival of a preterm newborn influence treatment decisions. Providers adjust their decisions about withdrawing or withholding treatment on the basis of pragmatic considerations. Numerous issues related to resource scarcity are relevant, and providers prioritize outcomes that affect stakeholders other than the newborn. These findings may have implications for initiatives that seek to improve global neonatal health.