The purpose of the work was to produce a framework to guide the development of meritorious clinical trial proposals. The framework consists of essential features of rigourous methodology, ethical acceptability, and a component referred to as "community context". These three domains were woven together in a checklist format under the headings of general, scientific and ethical considerations. Since texts concerning clinical trial methodology do not integrate ethics criteria and ethics guidelines do not provide detailed scientific criteria in obvious and practical (...) ways, we outline a more contemporary and comprehensive set of guidelines. (shrink)

The book then discusses another group of issues ("whether it is, what it is, how and why it is"), which determined the argumentation, the axiomatic ordering of the sciences, and concludes with a demonstration on the basis of concrete ...

For nearly two decades, the process of reviewing the ethical merit of research involving human subjects has been based on the application of principles initially described in the U.S. National Commission's Belmont Report, and later articulated more fully by Beauchamp and Childress in their Principles of Biomedical Ethics. Recently, the use of ethical principles for deliberating about moral problems in medicine and research, referred to in the pejorative sense as “principlism”, has come under scrutiny. In this paper we argue that (...) these principles can provide a foundation for the source of ethical appraisal of human research, but are not themselves wholly adequate for this purpose. Therefore, we further propose that (1) principles should be understood as heuristics that can be “specified” as described by DeGrazia (1992), and (2) that the principle‐based approach should be supplemented by formally incorporating “sensitivity to context” into the evaluation of clinical trials. (shrink)

Cancer-related electronic support groups (ESGs) may be regarded as a complement to face-to-face groups when the latter are available, and as an alternative when they are not. Advantages over face-to-face groups include an absence of barriers imposed by geographic location, opportunities for anonymity that permit sensitive issues to be discussed, and opportunities to find peers online. ESGs can be especially valuable as navigation aids for those trying to find a way through the healthcare system and as a guide to the (...) cancer journey. Outcome indicators that could be used to evaluate the quality of ESGs as navigation aids need to be developed and tested. Conceptual models for the navigator role, such as the Facilitating Navigator Model, are appropriate for ESGs designed specifically for research purposes. A Shared or Tacit Model may be more appropriate for unmoderated ESGs. Both conceptual models raise issues in Internet research ethics that need to be address. (shrink)