D. Local Committee Approvals 
1. The Johns Hopkins Institutional Biosafety Committee has approved the 
protocol without condition, and this approval is enclosed. 
2. The Phase I portion of the Phase I/ll study has been unconditionally 
approved by the Institutional Review Board. The study design of the Phase 
II portion is approved with the conditions of N.I.H. RAC, FDA, and IRB 
review of phase I data. Approval is enclosed. 
E. Informed Consent Document 
1. The "Informed Consent Document" is enclosed. Per the Johns Hopkins IRB 
(Joint Committee on Clinical Investigation), the page limitation for consent forms 
continues to be three pages, written at a six grade level of reading comprehension. Each 
patient, in addition to being requested to sign the "Informed Consent" is given a "Patient 
and Family Brochure" which has been coauthored by current cancer patients at Johns 
Hopkins for readability and is also approved by the IRB. Both of these are enclosed. 
Specific items in the "Informed Consent" document require the following documentation: 
(a) Women do not get prostate cancer; therefore, birth control is not an 
issue in the consent form. 
(e) The Johns Hopkins Oncology Center has strict policies on sharing 
information on ongoing clinical trials with the public or news media. 
There are no interactions with the press until after peer- reviewed 
papers have been published. 
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