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

ABSTRACT

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.     

The capacity for selective concentration on color versus form of consonants

The concept of active exclusion or inhibition of some stimuli while focusing on others has been largely ignored or rejected in recent work in the field of attention. As part of an ongoing series of studies involving five posthypnotically cued levels of mental concentration, it was possible to test the capacity for active blurring of one stimulus attribute (form) while simultaneously perceiving another attribute (color) accurately. In lowered concentration conditions three highly trained hypnotic Ss were dramatically successful in blurring the form and thereby impairing identification of colored consonants flashed tachistoscopically at speeds ranging from 300 msec down to 50 msec—without any concomitant loss in accuracy of identification of the color in which the letter was printed. Among a supplemental series of control experiments, it was further demonstrated that the active inhibitory process can be reversed so as to act upon color but not form; and that the Ss were unable to duplicate these feats in the waking state without benefit of posthypnotic programming. A theoretical interpretation of the findings, in terms of a conceptual model of the mind, is offered.