13 
; Ms. Witherby questioned whether renumeration of patients has been considered. 
Mr. Capron assumed renumeration questions are included under the section dealing 
with relative advantages and disadvantages of alternative therapies. Dr. Walters 
said this issue should be stated explicitly under the section dealing with 
alternative therapies. Dr. Miller thought it reasonable for the document to 
ask investigators whether patients will pay. Dr. Mahoney said sane reimbursement 
to the patient might be reasonable. Mr. Capron suggested this issue should be 
considered in the informed consent document. Dr. Miller said it will be difficult 
to estimate the cost of new procedures such as human gene therapy. Dr. Grobstein 
asked whether a question dealing with reimbursement serves a purpose in the 
! context of the points to consider document. Dr. Miller suggested the document 
i should not pose this question; he said these kinds of questions invite speculation 
and polemics. Dr. Walters said explicit mention of alternative therapies and 
consideration of the costs of gene therapy and alternative treatments might be 
added to the section on Informed Consent (Attachment II). The working group 
agreed that information on costs would only be requested under informed consent 
issues dealing with alternative therapies. 
Dr. Walters called the attention of the working group to the preposed language 
for Informed Consent . Dr. Grobstein questioned whether human gene therapy 
presents special issues in reversibility of the procedure that are not present 
with other therapies. He pointed out that removal of a lint) is irreversible 
under most circumstances. Dr. Mahoney said nonreversible therapies are often 
used in medicine and may be part of human gene therapy protocols; he suggested 
seme mention be made of this in the informed consent portion of the document. 
Mr. Capron suggested the working group document highlight options for patient 
withdrawal fran therapy and potential reversibility of therapy. Dr. Miller felt 
the patients' right to withdraw from follow-up should be stated in the working 
group document. 
The working group agreed that language dealing with reversibility and financial 
costs should be added to this section. 
Dr. Rich asked if parental or guardian consent alone is sufficient in obtaining 
informed consent for children. Ms. Areen said DHHS regulations also require 
assent by the children. 
The working group generally agreed that the following issues should be treated 
in the section of the document dealing with informed consent: financial costs 
to the patient and family; right of the patient to withdraw frcm the protocol; 
and discussion of whether the therapy could lead to adverse or unknown 
consequences . 
Dr. Rich asked whether the section on Data Monitoring (Attachment II) of the 
points to consider document should require inspection of laboratories. 
Dr. Mahoney said he did not see any reason for inspecting laboratories or 
clinics. Dr. Miller said FDA has data-keeping requirements involving data 
monitoring in protocols. The working group after some discussion agreed the 
section on Data Monitoring would be emitted from the points to consider 
document. 
[227] 
