CONSORT-EHEALTH has the potential to improve reporting and provides a basis for evaluating the validity and applicability of e Health trials.
Subitems describing how the intervention should be reported can also be used for non-RCT evaluation reports.
While the CONSORT statement can be applied to provide broad guidance on how e Health and m Health trials should be reported, RCTs of web-based interventions pose very specific issues and challenges, in particular related to reporting sufficient details of the intervention to allow replication and theory-building.
To develop a checklist, dubbed CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and on Line Tele Health), as an extension of the CONSORT statement that provides guidance for authors of e Health and m Health interventions.
CIOMS serves the scientific interests of the international biomedical community in general and has been active in promulgating guidelines for the ethical conduct of research, among other activities.
CIOMS promulgated guidelines in 1993 entitled International Ethical Guidelines for Biomedical Research Involving Human Subjects.
Although it was recognized that several conditions affected this picture, among them economic and social contexts, the context of justification, as distinct from the context of discovery, emphasized the production of value-free, culturally neutral and context-insensitive data.
In point of fact, the professionalization of research activity was modelled on the notion that the scientific method was such a powerful conceptual device that it precluded any spurious influence upon the products of research activities.
Levine and Samuel Gorovitz with James Gallagher CIOMS Geneva 2000 Commentary on Informed Consent in International Health research: (1) Cultural Influences on Communication Fernando Lolas Director, Regional Program on Bioethics, Pan American Health Organization (PAHO/WHO), Santiago, Chile.
It is a privilege and a pleasure to offer my comments on transcultural aspects of informed consent presented in the paper of Patricia Marshall, whose contributions to health anthropology are both substantive and inspiring.
In order to stay within my own limits in perspective I shall restrict my remarks to medicine, although it should be understood that I employ the word medicine to refer to all social practices related to health (1).
We tend to forget that research-based medicine is a rather recent development in historical time.
Experiment is not the ancient experience, and the ideal experiment is one in which most, if not all, conditions are carefully controlled or at least monitored, phenomena are provoked or induced, and the personal biases and views of the experimenter do not interfere with the data-gathering process.