8 
Dr. Walters said Section I-D-5 has also been modified to inquire "hew" 
patients and/or their guardians will be informed that some procedures may 
be irreversible, that it may not be medically advisable to withdraw frem 
the study, that patients will be required to participate in long-term 
follow-up, and that an autopsy would be required. 
Dr. Walters said the fourteenth modification was introduced in Section 
II-A in recognition of the tension between providing the greatest possible 
information to the public while protecting the privacy of patients and 
families. Section II-A. has been modified to read as follows: 
"What steps will be taken, consistent with point I-E above, bo ensure 
that accurate information is made available to the public with 
respect to such public concerns as may arise from the proposed 
study?" 
Dr. Walters said Mr. Edward Lee Rogers for the Foundation on Economic 
Trends had ccmrented (tab 1244) that the working group should begin 
immediately to develop cooperative efforts with other groups to evaluate 
long-term implications of human gene therapy. Dr. Walters said working 
group members have already collaborated with the Office of Technology 
Assessment in the preparation of the 1984 background paper. Human Gene 
Therapy . Working group members have also expressed their willingness to 
cooperate with organizations planning meetings or studies on human gene 
therapy. 
Dr. Walters said Mr. Rogers had also questioned whether the working group 
has sufficiently broad expertise to deal with all of the dimensions of 
human gene therapy. Dr. Walters said it is difficult for a group the size 
of the Working Group on Human Gene Therapy to cover all the possible bases, 
but the working group is committed to enlisting the help and comments of 
consultants to try and obtain the broadest spectrum of opinion. 
Dr. Walters said Mr. Rogers had also suggested the working group, utilizing 
an interdisciplinary approach, should begin the difficult task of addressing 
"risk -benefit and value-resolution issues." Dr. Walters said the working 
group agreed with this suggestion. The points to consider document attempts 
to indicate specific concerns. The working group expects to learn a great 
deal from investigator responses to these specific points, and as experience 
is gained it will be possible not only to ask questions but to indicate 
the expectations of the working group and the RAC. 
Dr. Walters asked RAC to approve these points to consider as a guidance 
document for researchers considering the application of gene therapy to 
patients. Dr. Gottesman emphasized that the points to consider document 
is a working document vhich will change as the technology develops. The 
points to consider are not intended for inclusion in the NIH Guidelines. 
