Human Gene Therapy Subcommittee - 11/21-22/91 
committees, a member must be off of the advisory committee for at least one year 
before he/she is eligible to be renominated. 
Dr. Walters called on Dr. Erickson to restate the original motion. Dr. Erickson said that 
the HGTS will be merged into the RAC, that the number of meetings will be increased 
from 3 to 4 per year, and that there will be a transition year in which the HGTS will 
meet solely to develop strategies for simplifying the protocol review process. The motion 
passed by a vote of 11 in favor, 2 opposed, and 0 abstentions. 
REPORT FROM THE WORKING GROUP ON DATA MANAGEMENT: 
Dr. Walters called on Dr. Leventhal to report on the Working Group on Data 
Management. Dr. Leventhal noted that the Points to Consider- -Reporting Requirements 
would be a good starting point for being the discussion on data management. She read 
the following sections of the document: 
TV-A - Serious adverse effects of treatment should be reported immediately to 
both the Institutional Review Board (IRB) and the NIH Office for Protection 
from Research Risks (OPRR), and the written report should be filed with both 
groups. A copy of the report should be forwarded to the Office of Recombinant 
DNA Activities (ORDA). 
'TV-B - Reports regarding the general progress of patients should be filed with 
both your local IRB and ORDA within 6 months of the commencement of the 
experiment and at six-month intervals thereafter. These twice yearly reports 
should continue for a sufficient period of time to allow observation of all major 
effects. In the event of a patient's death, a summary of the special post mortem 
should be submitted to the IRB and ORDA, if available." 
Ms. Meyers asked if the required reports have been submitted by principal investigators 
who have received RAC and NIH approval to initiate human gene transfer/therapy 
trials. Dr. Anderson responded that he has provided verbal six-month reports to the 
HGTS regarding the status of his ADA protocol; he has not yet provided postmortem 
reports. Dr. Anderson stated that he would provide postmortems as soon as they are 
available. 
Dr. Leventhal said that the time has come for the HGTS to establish a procedure for 
ensuring that pertinent information regarding the status of approved protocols is 
obtained. The Working Group on Data Management met and devised a draft reporting 
form that could be distributed to investigators. The working group suggests that the 
reporting forms should be submitted yearly beginning on the date that the protocol was 
approved by the NIH Director. 
Recombinant DNA Research, Volume 15 
[289] 
