Attachment II - Page 5 
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public not only on the technical aspects of the proposals but also on the 
meaning and significance of the research. 
(5) The clinical application of recombinant DNA techniques to human gene therapy 
raises two general kinds of questions: (1) the questions usually discussed 
by IRBs in their review of any proposed research involving human subjects; 
and (2) broader social issues. The first type of question is addressed 
principally in Part I of this document. Several of the broader social 
issues surrounding human gene therapy are discussed later in this Introduction 
and in Part II below. 
(6) Fo Hewing the Introduction, this document is divided into four parts. 
Part I deals with the short-term risks and benefits of the proposed 
research to the patient^ and to other people, as well as with issues of 
fairness in the selection of patients, informed consent, and privacy and 
confidentiality. In Part II, investigators are requested to address 
special issues pertaining to the free flow of information about clinical 
trials of gene therapy. These issues lie outside the usual purview of 
IRBs and reflect general public concerns about biomedical research. 
Part III summarizes other requested documentation that will assist the 
RAC and its working group in their review of gene therapy proposals . 
Part IV specifies reporting requirements. 
(7) A distinction should be drawn between making genetic changes in somatic 
cells and in germ line cells. The purpose of somatic cell gene therapy 
is to treat an individual patient, e.g. , by inserting a properly functioning 
^The term "patient" and its variants are used in the text as a shorthand 
designation for "patient -subject . " 
[424] 
