9 
Dr. Walters called the attention of the subworking group to the comments sub- 
mitted by Mr. Timothy J. McDermott of Mount Auburn Hospital of Cambridge, 
Massachusetts . Mr. McDermott suggested the danger to the phiebotcmist frcm 
accidental needxe puncture ( seif-innocuiation) should be dealt with in a straight- 
forward rranner and health care workers should be closely monitored. He also 
suggested human gene therapy subjects should be prevented frcm ever donating 
blood. 
Dr. Anderson thought these issues are public health considerations and adequately 
covered in the points to consider document. He said the vector to be used in 
human gene therapy is a very debilitated retrovirus which is not infectious and 
should not present a potential danger to health care personnel. The subworking 
group agreed a specific prohibition against gene therapy recipients donating 
blood might stigmatize these individuals. 
Dr . Waiters then called the attention of the subworking group to Dr. McKinney's 
cement on Section I-B-5-a of the document. Cr . McKinney had suggested this 
section should reference Section III-D. The subworking group agreed Section 
I-B-5-a should reference Section III-D. 
Dr. Walters noted that Dr. McKinney had also suggested Section I-B-5-b be 
amended to request information on all facilities in which either primary and/or 
follow-up studies will be performed since these care facilities may not be 
the treatment facility. 
Dr. Anderson agreed this might be a reasonable information request since the 
patient could be transferred to a nurrsing home for follcw-up care. The sub- 
working group agreed to include this specification in the points to consider 
document. 
Dr. Waiters said Dr. Leon Hass of the National Humanities Center in Research 
Triangle Park, North Carolina, had commented (Attachment V) that the words 
"equity consideration" of Section I-C are too abstract and renote. Dr. Kass 
suggested the sentence might read: "How will patients fairly be chosen, if 
there are more who need treatment than can be treated?" 
The subworking group noted that many people think there wall be a scarcity 
of patients for initial human gene therapy protocols but agreed the language 
proposed by Dr. Kass was clearer than the language currently in the points to 
consider document. They agreed to substitute Cr . Kass* proposed language in 
Section I-C. 
Dr. Walters then asked the subworking group to consider Dr. Miller's comments 
concerning .Section I-D. Dr. Miller wrote that points 1 through 5 are only a 
partial listing of informed consent requirenents and are thus misleading and 
should be deleted. If a listing of informed consent requirements is deemed 
necessary, it should include all the elements of informed consent contained in 
the regulations. Dr. Miller suggested the initial paragraph under "informed 
consent" alone would provide sufficient guiidance if the following language 
were added to the paragraph: 
[ 9 ] 
