Chapter 4: Human Experimentation: Conflicts and Confluences
4. Human experimentation: conﬂicts and conﬂuences INTRODUCTION Medical research has been central to America’s vision of a good society— for, through its use, biological knowledge is enhanced which, in turn, allows for its application to the development of various technologies to cure disease.1 Indeed, the abiding goal of medicine has always been to relieve pain and suﬀering; and medical research aims to implement that very goal2 by not only promoting health, but, whenever possible, preventing disease in the ﬁrst instance from ever occurring.3 The size and complexity of contemporary medical research is seen dramatically when it is realized that approximately 16 000 to 20 000 investigations are conducted annually. It is estimated, further, that more than 19 million individuals have enrolled in medical experiments—with more than 2 million participating each year.4 Within each investigation undertaken, a signiﬁcant risk of pain, disability and death is ever present for the experimental subjects.5 This proliferation of biomedical research studies has led to signiﬁcant concerns regarding the adequacy of present federal regulatory schemes to ensure safety for study participants.6 Recent litigation against institutional review boards (IRBs) and IRB members as defendants may indicate new levels of responsibility will be imposed in order to safeguard those who participate.7 Fundamental to the whole research process and the human experimentation component of it is the need to assure that subject-participants have a level of information which, in turn, allows them to understand fully both the level of potential beneﬁts and...
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