DocumentCode
861707
Title
Clinical trials of medical devices and implants: ethical concerns
Author
Saha, P.S. ; Saha, Simanto
Author_Institution
Dept. of Orthopaedic Surgery, Louisiana State Univ. Med. Center, Shreveport, LA, USA
Volume
7
Issue
2
fYear
1988
fDate
6/1/1988 12:00:00 AM
Firstpage
85
Lastpage
87
Abstract
Various ethical concerns that are essential elements in the critical trial of any new treatment modality are examined. Problems surrounding the issue of informed consent are considered. Conflicts between therapeutic and research considerations are discussed. The role of double-blind studies is examined.<>
Keywords
biomedical equipment; prosthetics; clinical trials; double-blind studies; ethical concerns; informed consent; medical devices; research considerations; therapeutic considerations; treatment modality; Artificial heart; Biomedical engineering; Clinical trials; Humans; Implants; Manufacturing; Orthopedic surgery; Prosthetics; Technological innovation; Uncertainty;
fLanguage
English
Journal_Title
Engineering in Medicine and Biology Magazine, IEEE
Publisher
ieee
ISSN
0739-5175
Type
jour
DOI
10.1109/51.1982
Filename
1982
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