Adenovirus-Mediated Gene Transfer for Cystic Fibrosis: Safety of Single Administration in the Lung 
nebulizer selection and for the exclusion of hospital staff with respiratory disease from working with the 
patients. These requests will be complied with. The Harvard IBC also approved a more aggressive dosing 
schedule than the more conservative one we intend to follow. They will be advised of this revision. Copies of 
the approvals are included. 
2 The study has been unconditionally approved by the IRBs of both institutions. Copies of the approvals are 
included. 
E INFORMED CONSENT DOCUMENTS 
1. The IRB-approved consent forms for both institutions are included and text is identified as requested except 
for the following points. 
New England Medical Center 
Subsequent to IRB approval for the two New England Medical Center documents for lobar and aerosol delivery, 
some deficiencies were identified. They will be corrected as follows: 
• The last paragraph in the 'Risks and Side Effects' section discusses the need for patients to adopt a reliable 
form of contraception. In the last sentence we will change the first word from 'You' to 'All participants'. 
• Long-term follow-up for 10 years (as per the protocol) will be added to both consent forms. 
• A request for an autopsy will be added to both consent forms. 
The Principal Investigator has been made aware of the RAC's requirements for inclusion of these issues. 
Appropriate statements addressing the above points will be added to the informed consent documents and 
approved by the IRB prior to initiation of the study at the New England Medical Center. 
Massachusetts General Hospital 
Subsequent to IRB approval for the two Massachusetts General Hospital documents for lobar and aerosol 
delivery, a deficiency and a mistake were identified. They will be corrected as follows: 
• The 5th paragraph of the 'Risks and Discomforts' section discusses the need for patients to adopt a reliable 
form of contraception. In the last sentence we will change the first word from "You" to 'All participants'. 
• A request for an autopsy will be added to both consent forms. 
• The aerosol consent form indicates there will be 30 patients included in the study. There will be 40 patients 
included in this study as indicated in the protocol and their lobar consent form. The aerosol form will be 
changed to indicate the correct total number of patients planned for inclusion in the study. 
• The aerosol consent form indicates there will be a placebo group. This was part of our original plan, but we 
no longer intend to include a placebo arm for this study. Reference to it will be removed. 
The Principal Investigator has been made aware of the RAC's requirement for long term follow up and a 
statement addressing that point will be added to both consent forms. The aerosol consent form will be modified to 
reflect there are 40 patients planned for inclusion in this study and discussion of the placebo will be removed. The 
revised consent forms will be approved by the IRB prior to initiation of the study at Massachusetts General 
Hospital. 
F. ADDITIONAL INFORMATION 
1. The CVs for the principal investigators and key personnel are included. 
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