15 
Dr. Motulsky asked what type of information would be sought in an autcpsy. 
Dr. Temin said the investigator would wish to knew if the introduced DNA was 
indeed where it should have been. The autcpsy would also pinpoint the cause 
of death. Dr. Grobstein said an autopsy should be performed should the patient 
die in order to gain information which might help other patients. 
Dr. Walters said an autopsy might be against some people's scruples. 
Dr. Mahoney said all consent forms have an escape clause for withdrawing from 
the experiment. The patient, however, should not be pari: of this experimental 
procedure if the parents and patient are not willing to permit an autcpsy. 
Dr. Mahoney said these types of experimental procedures are a true partnership 
between the patient and the investigator; individuals not willing to participate 
fully in the procedure should not volunteer as subjects. In the initial phases 
of a research project, the investigator can require patients consent to proce- 
dures which might not be required in later stages of a project. After the 
initial trial protocol phase has been passed, individuals whose scruples prevent 
than frem participating in the earliest studies might be considered as subjects. 
Mr. Capron said the points to consider document should explicitly require the 
investigator be willing to speak to the parents or guardians about this aspect 
of the protocol. This issue must be on the table before the consent form is 
signed. The parents must have a moral understanding with the investigator. 
Dr. Anderson said even though the consent form indicates a patient can withdraw 
frem an experimental protocol, in some cases public health considerations 
prevent the patient frem withdrawing from the protocol. 
Dr. Mot ul sky asked whether state powers could be invoked to prevent a patient 
frem withdrawing from the protocol. Mr. Capron felt they could be invoked 
since in some cases the patient cannot be permitted to withdraw. 
Dr. McCarthy said he saw no problem in including an autcpsy requirement in the 
points to consider document since it is not an absolute right to participate in 
research protocols. He said the working group could include language indicating 
this section might be changed at a later (fete. 
Dr. Lee asked whether the working group will set a time limit for an autcpsy. 
Would the working group require an autopsy on an individual who has lived 20 
or 30 years after treatment? Dr. Walters thought the points to consider document 
would probably be modified within such a long time frame. 
Ms. Areen and Dr. Temin agreed to develop language for this section of the 
document. They would focus on what special studies will be performed as part 
of the autopsy. 
[Jr. Walters then called the attention of the working group to the alternative 
language ccmposed by Dr. Grobstein (Attachment V) for the Section, Public health 
considerations . Dr. Grobstein said he particularly washed to ask whether any 
public health considerations associated with human gene therapy differ frem 
[100] 
