Rosemarie de laCruz Bernabe

As WHO and US and Dutch drug industry interests want to reduce barriers to drug development, postmarketing drug studies (phase IV drug trials) become curiously interesting (PROTECTION PARADIGM) to ethicists. Shifting the protection paradigm (important in all areas of humanitarian studies, the Internet, technological development, etc.) from a population perspective to the individual patient characterizes ethical reflection around Phase IV trials because of the more therapeutic nature of those trials, in which research and practice are intertwined. Are any fiduciary duties to the patient waivable IF (and only if) the therapeutic value of the research to enrolled research patients is not diminished by doing that?… (mais)