Recombinant DNA Advisory Committee - 03/1-2/93 
demonstrates that irradiated tumor cells are equally effective as non-irradiated cells at 
evoking an anti-tumor response. 
In response to Ms. Meyers' concerns about the informed consent document, Dr. Simons 
explained that the Johns Hopkins IRB will not approve an informed consent document 
similar to those approved by the RAC, because the reading level is too high. Johns 
Hopkins requires the document be worded at a sixth grade reading level. An attempt 
will be made to incorporate statements about confidentiality, contraception, and request 
for autopsy at the sixth grade reading level; however, there is no guarantee that the IRB 
will approve these additions. 
Ms. Meyers said the informed consent document that was approved by the Johns 
Hopkins IRB is outrageous. The language is not written at the sixth grade level. The 
sentence that explains that the patient will receive an "injection of cancer" is not an 
accurate description of the procedure that will be performed. Dr. Simons explained that 
the IRB has very strict standards as to length of the document and the reading level. It 
is unlikely that the IRB will accept any major revisions or additions to the document. 
Dr. Simons explained that the informed consent document is the product of "field 
testing." The Johns Hopkins IRB asked that the document be distributed to outpatients 
for comments and suggestions regarding the clarity of the document. The current 
document has been improved over the original version. Ms. Meyers suggested that the 
investigators ask the IRB if the document could be expanded to provide a more detailed 
description of the gene therapy procedures. This protocol is not a drug study but a novel 
approach which requires further explanation. 
Dr. Wivel reminded the members of the RAC that recommendations about IRB 
informed consent documents are not binding. The IRB has the authority to accept or 
deny any changes to the document; therefore, the RAC should not include any such 
contingencies in a motion for approval. Ms. Meyers stated that if a contingency is not 
included as part of the formal motion for approval of this protocol, she will not vote for 
approval based on the opinion that patients will be misinformed. Dr. Parkman suggested 
that changes to the informed consent document should be recommended to the IRB; 
however, it is inappropriate to disapprove a scientifically sound protocol because the 
RAC does not approve of the IRB's standards. Dr. Simons stated that he would 
incorporate the changes suggested by Ms. Meyers, submit these changes to the IRB for 
approval, and modify the current document to the extent that the Johns Hopkins IRB 
will allow. 
Committee Motion 
A motion was made by Dr. Brinckerhoff and seconded by Dr. Carmen to approve the 
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