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
fDate :
6/1/1988 12:00:00 AM
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;
Journal_Title :
Engineering in Medicine and Biology Magazine, IEEE
