Alert
Recommended Alerts
New SACHRP Recommendations on Interactions among Sponsors, Clinical Trial Sites, and Study Subjects
The U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (“SACHRP”) recently issued recommendations on interactions between clinical trial sponsors (which could be either industry or academic entities) and clinical trial subjects. Increased interactions between sponsors and patient populations have begun to blur the traditional division of roles between sponsors and investigators. SACHRP’s recommendations contemplate such changes in the clinical trial enterprise, examine the key legal and ethical concerns in this area, and offer specific solutions for addressing these challenges.