How payment for research participation can be coercive

The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consent- undermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. By contrast, coercion as subjection indicates a way in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment

A developing country response to Lavery et al. "In global health research, is it legitimate to stop clinical trials early on account of their opportunity costs?"

<p>Abstract</p> <p>Background</p> <p>A recent paper presents an argument and mechanism for the possible stopping of clinical trials early based on opportunity costs.</p> <p>Discussion</p> <p>Although we agree that the costs and opportunity costs of clinical trials need to be reduced wherever possible, we raise concerns about the motivation and mechanism for stopping clinical trials early raised by Lavery <it>et al</it>.</p> <p>Summary</p> <p>We argue that there are already enough acceptable criteria and actors in the clinical trials arena to justify early stoppage of clinical trials, and argue that factors other than efficacy need to be carefully considered, especially in developing country contexts.</p

Bridging consent: from toll bridges to lift bridges?

<p>Abstract</p> <p>Background</p> <p>The ability to share human biological samples, associated data and results across disease-specific and population-based human research biobanks is becoming increasingly important for research into disease development and translation. Although informed consent often does not anticipate such cross-domain sharing, it is important to examine its plausibility. The purpose of this study was to explore the feasibility of bridging consent between disease-specific and population-based research. Comparative analyses of 1) current ethical and legal frameworks governing consent and 2) informed consent models found in disease-specific and population-based research were conducted.</p> <p>Discussion</p> <p>Ethical and legal frameworks governing consent dissuade cross-domain data sharing. Paradoxically, analysis of consent models for disease-specific and population-based research reveals such a high degree of similarity that bridging consent could be possible if additional information regarding bridging was incorporated into consent forms. We submit that bridging of consent could be supported if current trends endorsing a new interpretation of consent are adopted. To illustrate this we sketch potential bridging consent scenarios.</p> <p>Summary</p> <p>A bridging consent, respectful of the spirit of initial consent, is feasible and would require only small changes to the content of consents currently being used. Under a bridging consent approach, the initial data and samples collection can serve an identified research project as well as contribute to the creation of a resource for a range of other projects.</p

Surveillance of a recently switched non-prescription medicine (diclofenac) using a pharmacy-based approach

Purpose - Postmarketing surveillance of prescription medicines is a routine practice, yet similar evaluation of non-prescription medicines, including those recently switched from prescription status, is uncommon. This study presents the methodologic issues and limitations of the use of pharmacies in the 'post-reclassification' surveillance of oral diclofenac potassium 25 mg which had been recently switched from physician prescription to non-prescription sale. Methods - Consenting user-purchasers were recruited from 175 New Zealand pharmacies over 4 months. Purchasers were mailed a questionnaire for completion 7 days post-purchase. Those purchasers who met criteria for being potentially 'at risk' of adverse events were re-surveyed 30 days post-purchase. A descriptive analysis was carried out using t-test and chi-square as appropriate. These results were compared to those from other types of studies in this area. Results - The 1240 recruited purchasers returned 990 valid questionnaires (80% response). Of these 557 (56%) met 'at risk' criteria and received the second questionnaire with 480 valid returns (86.2% response). Conclusions - Useful data was gathered on the 'real-life' usage of a medicine recently reclassified from prescription to non-prescription sale. The use of community pharmacies as recruiting centres was found to be effective. Copyright (C) 2000 John Wiley and Sons, Ltd