Recombinant DNA Advisory Committee - 3/3-4/94 
contrary to the regulations. The institution is required to disclose such policy to any 
potential participant. 
Drs. Parkman and Straus agreed that the RAC should not dwell on this issue during the 
dehberation of each protocol, citing unfairness to investigators. Dr. Straus stated that 
although the RAC has the persuasive power to change policy, the committee does not 
have the legal authority to demand local IRBs to incorporate such changes in their 
Informed Consent documents. 
Investigators' Responses-Drs. Seeger and Rosenblatt 
In response to Dr. Zallen's questions about HLA typing. Dr. Seeger responded that 140 
cryopreserved tumor cell lines are currently in the process of being HLA typed. From 
this cell bank, a panel of common HLA types will be identified, e.g., HLA-A2. 
Approximately 40% of all individuals are HLA-A2 positive. An HLA matched cell line 
is anticipated for most allogeneic patients. The protocol and the Informed Consent 
document will be revised to reflect a modified eligibility criterion such that subjects with 
no available autologous tumor cells will receive a single HLA matched allogeneic cell 
line. If an HLA matched cell line is unavailable, the subject will be ineligible to 
participate in the study. 
In response to Dr. Zallen's concerns about patient responsibility for research-related 
costs. Dr. Rosenblatt stated that all of the costs for research will be the responsibility of 
the institution. Dr. Rosenblatt agreed to revise the assent form in language that is more 
understandable to children; however, the average age of patients entered on this protocol 
will be 3 to 4 years old, which is below the age at which a subject can give assent. Most 
children are diagnosed with neuroblastoma before 7 years of age. 
Dr. Walters asked how a determination will be made regarding the assignment of 
patients to a particular institution. He said that the language regarding compensation for 
research related injury in the Informed Consent documents differs between the 
University of California at Los Angeles and Children's Hospital of Los Angeles. Dr. 
Seeger responded that most patients will choose the institution where they will receive 
their care but others will be referred from outside institutions. 
Committee Motion 
The RAC approved a motion made by Dr. Smith and seconded by Dr. Post to accept the 
protocol submitted by Dr. Joseph Rosenblatt of the University of California, Los 
Angeles, California, and Robert Seeger of the Children's Hospital, Los Angeles, 
Cahfomia, by a vote of 1 1 in favor, 1 opposed, and 1 abstention. RAC approval is 
contingent on the review and approval by the primary RAC reviewers of: (1) a revised 
protocol that includes an indication of when HLA typing will be performed on subjects 
considering participation in the allogeneic study, (2) modification of the eligibility criteria 
to exclude subjects that do not demonstrate a match at any HLA locus, (3) a revised 
Informed Consent document that includes a statement notifying subjects that they will 
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Recombinant DNA Research, Volume 19 
