ABSTRACT
The active patient participation in clinical trials is key for a competitive clinical research. Given this, the Health Industry Physicians and Actors Association (AMIPS) has set up a working group to make communication recommendations towards patients. The group was made of patients, investigators and industry sponsors representatives. Efficacious communication is rarely obtained because it is not clear what is possible to do ethically and regulatory and because of technical and financial constraints. After having identified the expectations and limitations for every actor category, the group has summarized all types of communication, in a sort of tool box, before and during the whole of a study. The benefits and regulatory prerequisites such as the submission to the Ethical Committee and to the National Data Information and Freedom Commission (CNIL) as well as the practical feasibility are described for each tool.
Subject(s)
Clinical Trials as Topic/standards , Communication , Patient Selection , Clinical Trials as Topic/ethics , Consensus Development Conferences as Topic , Humans , Patient Education as Topic/standards , Patient Selection/ethics , Physician-Patient Relations/ethicsABSTRACT
The active patient participation in clinical trials is key for a competitive clinical research. Given this, the Health Industry Physicians and Actors Association (AMIPS) has set up a working group to make communication recommendations towards patients. The group was made of patients, investigators and industry sponsors representatives. Efficacious communication is rarely obtained because it is not clear what is possible to do ethically and regulatory and because of technical and financial constraints. After having identified the expectations and limitations for every actor category, the group has summarized all types of communication, in a sort of tool box, before and during the whole of a study. The benefits and regulatory prerequisites such as the submission to the Ethical Committee and to the National Data Information and Freedom Commission (CNIL) as well as the practical feasibility are described for each tool.
ABSTRACT
Web 2.0 sites are considered to be hosting providers and not publishers of user-generated content. The liability of hosting providers' liability is defined by the law enacted on June 21, 2004, on confidence in the digital economy. Hosting providers must promptly remove the information they host or make its access impossible once they are informed of its illegality. They are required to obtain and retain data to enable identification of any person who has contributed to content hosted by them. The liability of hosting providers has arisen in numerous disputes about user-produced content in various situations (discussion lists, blogs, etc.). The National Board of Physicians has developed specific ethical guidelines for web sites devoted to health issues and specifically for physician-authored content. The National Board of Physicians acknowledges that physicians can present themselves, their office, and their specific practice on their web site, notwithstanding any restrictions otherwise applicable to advertising.