Liability and new drug studies. Informed consent and clinical trials at the National Institutes of Health.

The liability risk in carrying out clinical trials can be severely affected if the informed consent process is poorly carried out. A poorly informed patient could prematurely drop out of a costly study. Worse yet, if the patient discovers that information is withheld, the patient could sue the sponsor, physician investigator, or IRB and hold them liable, though this is unlikely for investigational drug studies. These costs can be avoided by making sure the clinical trial is properly carried out according to strict federal regulations. It is also critical that clinicians keep the research participant informed on an ongoing basis. The chain of command is vital: The monitor informs the sponsor, the sponsor in turn informs the investigator, and the investigator in turn informs the patient of any new treatment information that may affect his willingness to stay in the trial. Finally, wherever the clinical trial is conducted, it should conform with the ethical principles outlined in the Declaration of Helsinki or with the latest regulations of that country--whichever guidelines provide the greater protection for the patient.