I . OPENING RENARKS 
Dr. Walters called the meeting to order and said that the subcommittee would be 
considering a proposal by the Committee for Responsible Genetics to amend the 
National Institutes of Health (NIH) Guidelines for Research Involving Recombinant 
DMA Molecules, and would be reviewing the Points to Consider in the Design and 
Submission of Human Sanat-ic-Cell Gene Therapy Protocols. 
Cfc-. Walters noted that Cr . W. French Anderson of the NIH has resigned from the 
siixxmmittee. He welcomed Dr. William Kelley of the Uhiversity of Michigan as 
a new member of the subcommittee. He also noted that Dc. Elizabeth Milewski 
has left the NIH. 
Dr. Walters noted that the Institute of Medicine annual meeting on October 15, 
1986, will be devoted to "Human Somatic Cell Gene Therapy: Prospects for 
Treating Inherited Diseases." 
II. BIOMEDICAL ETHICS BOARD 
Dr. Charles MacKay updated the sJd commit tee on the status of the Biomedical 
Ethics Board and the appointment of a Biomedical Ethics Advisory Committee. 
III. REVIEW OF POINTS TO CONSIDER 
The subcommittee considered the September 23, 1985, version of the Points to 
Consider in the Design and Submission of Human Somatic-Cell Gene Therapy Proto- 
cols and letters of suggested changes fron Dr. Temin on March 4 and July 22, 
1986, and Dr. Kelley on March 3, 1986 (Attachment II), as well as other proposed 
changes. The subcommittee recommended that the following sentence be added 
after the first sentence in I-A-2 on page 8: 
"Wiat objective and/or Quantitative measures of disease activity are 
available?" 
The subcommittee recommended that the following new material be added as 
paragraphs (c) and (d) on page 10: 
"(c) If co-cultivation of virus-producing cells with target cells is 
used, how is the absence of contamination by donor cells or by sequen- 
ces packaqed into infectious particles by the donor (e.g., VL30 
sequences) demonstrated? Vhat is the sensitivity of these tests? 
Vhat cells were used for co>-cultivation? 
"(d) If methods other than those covered by a-c are used to introduce new 
genetic information into target cells, how is it demonstrated that 
the final target cells are free of contamination? Vhat are possible 
sources of contamination? What is the sensitivity of tests used to 
monitor contamination?" 
Recombinant DNA Research, Volume 1 1 
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