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)

Background and rationaleWhen deception is used, a conflict ensues between the need to use it to answer a research question scientifically whilst protecting the participants’ autonomy simultaneously...

Background and rationale Several factors that motivate individuals to participate in non-therapeutic studies have been identified. This study was conducted as limited data is available regarding these motivations from developing countries. Methods This was a single-centre study conducted over 4 months in which a questionnaire was administered to 102 healthy participants and 16 patient participants who had earlier taken part in non-therapeutic studies at our centre. Descriptive statistics and univariate analysis were used to analyse data. Results The most common motivation (...) among healthy participants was financial reward (65%) followed by altruism, free medical check up, curiosity and personal health benefit. Patient participants, however, most commonly said they consented to take part in the trial as they were ‘invited to participate by the treating physician’ (88%). In comparison with the patient participants, healthy participants were more likely to be satisfied with the financial reward (p=0.02), and recommend participation in studies to friends or relatives (p=0.0013). Conclusions The most common motivating factor to participate in non-therapeutic studies appears to be different for healthy participants (financial reward) and patient participants (invitation to participate by the physician). Participants also felt that adequate information and care was given to them during the trial, and that they would participate in future clinical studies, and would also recommend such studies to their friends. (shrink)

We recently described a novel form of stress‐associated bidirectional plasticity at GABA synapses onto hypothalamic parvocellular neuroendocrine cells (PNCs), the apex of the hypothalamus‐pituitary‐adrenal axis. This plasticity may contribute to neuroendocrine adaptation. However, this GABA synapse plasticity likely does not translate into a simple more and less of inhibition because the ionic driving force for Cl−, the primary charge carrier for GABAA receptors, is dynamic. Specifically, stress impairs a Cl− extrusion mechanism in PNCs. This not only renders the steady‐state GABA (...) response less hyperpolarizing but also makes PNCs susceptible to the activity‐dependent accumulation of Cl−. Accordingly, GABA synapse plasticity impacts both the robustness of GABA voltage response and dynamic Cl− loading, imposing nonlinear influences on PNC excitability during circuit activities. This theoretical consideration predicts roles for GABA transmission far more versatile than canonical inhibition. We propose potential impacts of GABA synapse plasticity on the experience‐dependent fine‐tuning of neuroendocrine stress responses. (shrink)

Do hard budget constraints work in favour or against truth telling in double auctions? McAfee constructed a simple double auction mechanism, which is strategyproof and minimally inefficient, but may resort to dual prices, where the difference between prices is channelled as a surplus to the market maker, preventing MDA from achieving a balanced budget. We construct a variant of MDA in which no-loss constraints play a major positive role. Our variant of MDA is also strategyproof, as efficient as MDA but (...) improves on it by achieving a balanced budget via always having a uniform price. (shrink)

We use the multiple price list method and a recursive expected utility theory of smooth ambiguity to separate out attitude towards risk from that towards ambiguity. Based on this separation, we investigate if there are differences in agent behaviour under uncertainty over gain amounts vis-a-vis uncertainty over loss amounts. On an aggregate level, we find that (i) subjects are risk averse over gains and risk seeking over losses, displaying a “reflection effect” and (ii) they are ambiguity neutral over gains and (...) are mildly ambiguity seeking over losses. Further analysis shows that on an individual level, and with respect to both risky and ambiguous prospects, there is limited incidence of a reflection effect where subjects are risk/ambiguity averse (seeking) in gains and seeking (averse) in losses, though this incidence is higher for ambiguous prospects. A very high proportion of such cases of reflection exhibit risk (ambiguity) aversion in gains and risk (ambiguity) seeking in losses, with the reverse effect being significantly present in the case of risk but almost absent in case of ambiguity. Our results suggest that reflection across gains and losses is not a stable individual characteristic, but depends upon whether the form of uncertainty is precise or ambiguous, since we rarely find an individual who exhibits reflection in both risky and ambiguous prospects. We also find that correlations between attitudes towards risk and ambiguity were domain dependent. (shrink)

This study investigates the connection of moral reasoning to demographic and performance variables in business education, especially business and technical writing. The moral reasoning construct serves as the foundation for one''s decision making when confronted with moral dilemmas. Significant relationships are reported between subjects'' writing skill and their moral reasoning scores. This research serves as a foundation for questions about writers'' moral reasoning and the ethical decisions each writer makes in written communication. In addition, this study supports further research into (...) the connection between moral reasoning and written communication, given the significant relationships reported and the noticeable shortage of related, data-based research. (shrink)

Background Informed consent confers upon participants the right to decline or accept participation in a study in equal measure. Consent declines can be used as a potential metric to assess the adequacy of the informed consent process. Limited literature is available on the reporting of consent declines in Clinical Research. We evaluated randomized controlled trials published in three high-impact factor journals for consent declines to assess the extent of exertion of autonomy by research participants. Methods CONSORT flow charts in RCTs (...) published in New England Journal of Medicine, The Lancet and Journal of the American Medical Association between 2012 and 2015 were evaluated. The total and per journal proportion of RCTs reporting consent declines was calculated. Percentage of consent declines was also compared based on number of centers and type of setting. Between-groups analysis was done using Chi Square, Chi Square for trend and a Crude odds ratio [95% C.I] were calculated. Results Only 3.7% of the published articles were RCTs. Of the 1103 RCTs, only 532 reported consent declines. JAMA had the highest RCTs reporting consent declines, the Lancet [129,150/781,924, 16.5%] had the most participants declining consent. Difference was significant using Chi square for linear trend [ p < 0.00001]. Consent decline rate was higher in developed countries relative to developing countries [cOR: 2.27, p < 0.000001] and in single centric versus multicentric studies [cOR : 3.63, p < 0.0000001]. Conclusion Both authors and journal editors need to ensure better reporting of consent declines. (shrink)

Misleading information pervades marketing communications, and is a long-standing issue in business ethics. Regulators place a heavy burden on consumers to detect misleading information, and a number of studies have shown training can improve their ability to do so. However, the possible side effects have largely gone unexamined. We provide evidence for one such side-effect, whereby training consumers to detect a specific tactic (illegitimate endorsers), leaves them more vulnerable to a second tactic included in the same ad (a restrictive qualifying (...) footnote), relative to untrained controls. We update standard notions of persuasion knowledge using a goal systems approach that allows for multiple vigilance goals to explain such side-effects in terms of goal shielding, which is a generally adaptive process by which activation and/or fulfillment of a low-level goal inhibits alternative detection goals. Furthermore, the same goal systems logic is used to develop a more general form of training that activates a higher-level goal (general skepticism). This more general training improved detection of a broader set of tactics without the negative goal shielding side effect. (shrink)

Providing efficient and clean power is a challenge for devices that range from the micro to macro in scale. Although there has been significant progress in the development of micro-, meso-, and macro-scale power supplies and technologies, realization of many devices is limited by the inability of power supplies to scale with the diminishing sizes of CMOS-based technology. Here, the authors provide an overview of piezoelectric energy harvesting technology along with a discussion of proof of concept devices, relevant governing equations, (...) and figures of merit. They present two case studies: (a) energy capture from the operation of a novel shear and elastic modulus indentation device subjected to applied voltage and (b) energy capture from vibrating commercial bimorph piezoelectric structures mounted on household appliances. Lastly, areas of development needed for realization of commercial energy harvesting devices are suggested. (shrink)