12 
Dr. Rich said the language of item 8 of this section was difficult to interpret. 
That section reads as follcws: 
"If there are possible dangers fran gene therapy to patients, present cost- 
benefit considerations. As an example, with a lethal disease a slight 
but definite hazard of necplasia some years after gene therapy might be 
acceptable while such a hazard would be ccmpletely unacceptable in using 
a new vaccine on healthy people." 
The working group suggested alternative language be developed for item 8 and 
that Section 3-(a)-[3] of the section Research Methods be rephrased to ask 
"What harmful effects might you foresee." Mr. Capron suggested the working 
group should inquire whether the treatment is reversible. 
The working group agreed item 9 dealing with the qualifications of personnel 
and the adequacy of facilities should be divided into two separate itons; 
one section would deal with personnel, the second would deal with facilities. 
Dr. Walters called the attention of the working grcup to item 5 of the section 
Clinical and Public Health Considerations which reads as follows: "Describe 
tests that will be done to assess possible toxic or side effects of gene therapy." 
The working group agreed the information requested on tests to assess possible 
toxic or side effects of gene therapy should be incorporated with itan 4 into 
a section dealing with monitoring and follow-up studies. 
Dr. Walters then called the attention of the working group to the topic of 
Selection of Subjects (Attachment II). 
Mr. Capron preposed the addition cf a preamble to the section of the document 
entitled Selection of Subjects (Attachment II). Dr. Miller proposed adding 
criteria for inclusion and exclusion of patients in this section of the document. 
Mr. Capron suggested the last paragraph of this section which addresses problems 
of equity in selecting patients should either be moved to another section of 
the document or deleted. Dr. Rich suggested the section on selection of subjects 
should begin by stating the criteria used to select subjects. He suggested 
references to geographical distribution be deleted from this section of the 
document. 
Mr. Capron asked whether the points to consider document should ask how patients 
will be recruited. Dr. Rich said subjects may be selected from a recruitment 
pool which cculd introduce a bias. Dr. Miller said he did not think such 
considerations are relevant. 
Dr. Grobstein thought the first and last paragraphs of the preposed section 
entitled Selection of Subjects would be sufficient; he suggested the second 
paragraph be deleted. Dr. Goro/itz pointed out that the working group wants 
information on selection criteria and recruitment procedures. Mr. Capron 
suggested the language of the section be reworked into four questions: (1) how 
many patients will be in the proposed study; (2) what recruitment procedures 
will be employed; (3) what are the criteria for selection; and (4) what are 
the criteria for exclusion? 
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