Recombinant DMA Advisory Committee - 2/10-11/92 
influence the number of RAC meetings and whether the HGTS will continue to meet this 
year to perform its transition tasks. 
Dr. R. Murray suggested in paragraph two that the phrase "realignment should be achieved 
by appointing to full membership of the RAC to read "realignment should be achieved by 
recommending full membership of the RAC.” Dr. Gellert suggested in paragraph 1 that 
the phrase "the membership of the RAC should be realigned so that it includes a greater 
expertise in human gene transfer" to read "the membership of the RAC should emphasize 
expertise in human gene transfer." 
Dr. Geiduschek raised a concern about the HGTS members voting in the interim period 
before they become full RAC members. Dr. Wivel stated that in order to implement that 
procedural change, the HHS Secretary would have to amend the RAC Charter. 
Dr. Walters gave some historical perspective to the idea of merging the HGTS with the 
RAC. The RAC was correct in creating a working group and then the HGTS to review 
human gene therapy protocols. In the meantime, RAC has dismissed some of its other 
spheres of responsibility and began focusing on gene therapy. There has been difficulty in 
communication between the two bodies which were reviewing the protocols. Therefore, it 
is a logical step to merge the two. Members of the HGTS would like to continue to 
contribute. Possibly, the HGTS could look at future issues, i.e., planning issues relating to 
germ line issues and streamlining the review process. 
Dr. H. Miller stated that changing the 15-day notification of RAC meetings would provide 
greater flexibility in reviewing protocols. Dr. Wivel added that changing the wording does 
not preclude giving more than 15 days notice. 
Dr. Brinckerhoff discussed setting guidelines for investigator presentations, especially 
concerning length. Dr. R. Murray stated that the RAC should allow the investigator more 
flexibility to present his/her material without time constraints. 
Dr. R. Murray suggested language to the motion under paragraph 4, the transition section: 
"During the transition year, the members of the HGTS should continue to contribute to 
the work of the RAC." This modification in language allows the RAC to recall the HGTS 
or just a few members to contribute to special issues. 
Dr. Anderson responded to Ms. Buc's earlier concerns about germ line gene therapy. The 
Points to Consider clearly states that germ line proposals will not be considered at this 
time. These early discussions about scientific, ethical, and social issues are merely a 
prelude. No one will even be contemplating this type of approach for several years. 
Recombinant DNA Research, Volume 15 
[351] 
