Human Gene Therapy Subcommittee - 11/21-22/91 
Dr. Leventhal said that the HGTS still needs to discuss the mechanics of how the 
incoming data will be reviewed; confidentiality is an issue that needs to be addressed. 
Patient confidentiality should obviously be preserved. In addition, to what degree 
unpublished data should be kept confidential. Reporting should not interfere with 
publication of the data. If data were presented more along the lines of an abstract for a 
meeting, then nothing should preclude publication of research results in a peer-reviewed 
journal. 
Dr. Walters suggested that the HGTS make a formal motion to recommend the revised 
reporting requirements form to the RAC. 
Subcommittee Motion 
A motion was made by Ms. Meyers and seconded by Dr. Mclvor that the HGTS 
recommend adoption of the reporting requirements document submitted by the Working 
Group on Data Management, having incorporating the HGTS members' suggested 
changes. The motion passed by a vote of 9 in favor, 0 opposed, and no abstentions. Dr. 
Walters suggested that a question should be added to the reporting form which says, 
"Have you reported any adverse reactions?" Dr. Walters added that this would be an 
appropriate question to include since the question appears in the Points to Consider. 
Dr. Leventhal stated that although the Points to Consider requires data reporting every 
six months, yearly reporting is probably enough since patient accrual from gene therapy 
has been relatively slow. This reporting period is completely in line with how the IRBs 
function. If an investigator fails to renew a protocol with a yearly update, the protocol 
expires. Dr. Neiman said that if an investigator is required to file a report with his/her 
IRB once a year, then perhaps a copy of that report should be forwarded to the RAC in 
place of the reporting form that has been submitted by the Working Group on Data 
Management. Dr. Erickson noted that the IRB probably does not require the 
investigators to answer as many questions as the reporting requirements form. Dr. 
Neiman suggested that the HGTS should inform the local IRBs of the NIH reporting 
requirements if approved by the RAC, so that the efforts of both groups might be more 
closely coordinated. 
FUTURE DISCUSSION ITEMS 
Dr. Walters noted that in response to earlier discussions, Dr. Zallen and Ms. Meyers 
have submitted a statement regarding the establishment of uniform standards for 
payment of medically related costs for injuries arising out of non-therapeutic biomedical 
research. Dr. Walters suggested that this statement should be included as an agenda 
item for discussion at the next HGTS meeting. Since this issue was not placed on the 
agenda for discussion at today's meeting, it would be appropriate that it be placed on the 
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