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

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.</p

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 \u27pre-print\u27, such as \u27Unrefereed manuscript\u27, Manuscript awaiting peer review or \u27\u27Non-reviewed manuscript ; (b) Caveats about unrefereed manuscripts should be prominent on their first page, and each page should include a red watermark stating \u27Caution-Not Peer Reviewed\u27; (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

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

Research ethics governance in times of Ebola.

CAPRISA, 2017.Abstract available in pdf

Innovations in research ethics governance in humanitarian settings.

CAPRISA, 2015.Abstract available in pdf

Narco Analysis, Torture and Democratic Rights

Narco-analysis was started almost seven years back in India, and was also accompanied by the increased use of lie-detection testing used on criminals. It was not taken up by human-rights organisations until 2007 when radical activists were arrested and subjected to narco-analysis. There are four components in the human right or legal definition of torture: the first that torture produces physical/mental suffering and is a degrading treatment. The second that it is always intentionally inflicted; the third that it is inflicted for certain purposes such as getting information, confession, etc., and the fourth that it is inflicted by an official actor oran actor acting on behalf of an official. In arco-analysis, all those four components are satisfied. Narco-analysis produces torture as clearly as the lethal injection produces death. Narco-analysis is eroding the very ethical core of the medical profession. [22nd Ramanadhan Memorial Meeting-PUDR]police, torture, narco analysis, lie detection, lethal injection, sodium pentotjal, doctors and torture, confessions, information, medical ethical code

Bioethics—The Basics by Alastair V. Campbell (review)

10.1353/asb.2014.0015Asian Bioethics Review62197-20

Ethics in Health Research: A Social Science Perspective

Ethical codes of conduct cannot be effectively implemented in isolation and may be enforced in several different ways. One, is to conscientise the members of the profession to observe the rules, second, is to effectively police the system, and a third is to create links with associated disciplines or community of practitioners who together can form a network of conscience keepers. Thus consultations on ethical guidelines and the documentation of experiences in research were processes that have to be undertaken simultaneously. Simultaneously with the publication of the guidelines for health research in social sciences, a first attempt in India, in November 2005, a set of papers were commisioned on various related and relevant issues as bases for discussion. This volume of collected papers describe, enunciate or elaborate relevant principles in ethics in the social sciences. Some papers elaborate on practitioners’ experiences that illustrate these principles and enrich their discussion. Others discuss theoretical issues. [Pagination may not be as in original. Individual chapters are available for downloading independently.]ethics, social sciences, conscience-keepers, bioethics, guidelines for health research in social sciences, Sociology, Medicine, Health Studies