12 
should determine appropriate monitoring. Dr. Gorovitz suggested a two or three 
year data monitoring follcw-up requiranent be part of the approval. 
Ms. Areen felt the working group document should state that the investigator 
must bear resorting responsibilities. Mr. Capron said reporting responsibilities 
could be assigned on a case-by-case basis. Dr. Gottesman suggested the preamble 
to the working group document could state that a reporting requirement may be 
specified by the working group or by the RAC. 
Ms. Areen asked whether the document would state when the reporting requiranent 
would be filled; would this be after the experiment is completed or would it 
be an ongoing requiranent. Mr. Capron said language describing an ongoing data 
feedback requirement could be included in Section I-D, Data Monitoring , of the 
working group document (Attachment II) . 
Dr. Walters asked if any pertinent public health requirements had been emitted 
frcm Section I-A-2-c, Clinical and public health considerations . Dr. Mot ul sky 
asked if language specifically referring to the potential for spread of retroviral 
vectors should be included in this section. Dr. Gottesman said the probability 
of vector spread could be calculated from the data requirements of Sections I-A- 
2-a and I-A-2-b of the document, but that answer might be restated in the 
context of public health. Mr. Capron suggested a separate section specifically 
addressing this important issue might be more useful. 
Dr. Grobstein said this type of concern is not a new problem in patient care, 
and the language of the section should be couched in this context. 
Dr. Varmus asked if the document should discuss whether a patient who has 
received a preparation containing no live virus should be kept in isolation. 
Dr. Gottesman suggested language addressing this type of concern might be included 
in the preamble to the section on public health. 
Dr. Varmus said the working group document should ask whether the experiment 
presents any risk to individuals other than the patient, such as family members 
or health care personnel. If no such risk is perceived, the investigator 
should explain why there is no such risk. If there is a risk the investigator 
should describe what will be done to protect individuals who might be exposed. 
Dr. Grobstein felt such an informational request should not be part of pctolic 
health consideration as these concerns would include such considerations as 
disposal of contaminated materials. 
Dr. Gottesman asked if any issues in Section I-A-2-c are specific to human gene 
therapy. Dr. Murray said the shedding of viruses might be a public health 
issue specific to human gene therapy. 
Dr. Gottesman asked why the language of this section mentions autopsy. Several 
mentoers of the working group replied that in seme cases the right to obtain 
information through an autopsy might be an important consideration; in such 
cases, the investigator might not choose a subject who is unlikely to permit an 
autopsy. Dr. Gottesman suggested this explanation be included in a preamble to 
the section. 
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