Document Detail


Liability and new drug studies. Informed consent and clinical trials at the National Institutes of Health.
MedLine Citation:
PMID:  10110213     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
J F Gallelli
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians     Volume:  7     ISSN:  8755-1225     ISO Abbreviation:  J Pharm Technol     Publication Date:    1991 Jan-Feb
Date Detail:
Created Date:  1991-05-31     Completed Date:  1991-05-31     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8504643     Medline TA:  J Pharm Technol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  9-12     Citation Subset:  H    
Affiliation:
National Institutes of Health, Bethesda, MD 20892.
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MeSH Terms
Descriptor/Qualifier:
Clinical Trials as Topic / legislation & jurisprudence*
Drug Evaluation / standards*
Drug Industry
Hospital Bed Capacity, 500 and over
Humans
Informed Consent / legislation & jurisprudence*
Liability, Legal*
Maryland
National Institutes of Health (U.S.)
Pharmacy Service, Hospital / legislation & jurisprudence*
Physician's Role
United States
United States Food and Drug Administration

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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