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press will easily be able to ascertain the name of the investigator from the 
name of the institution. He reminded the ccmmittee that in same cases the 
patient and the family may seek publicity. Dr. Motulsky thought the preanble 
to this section should state that RAC and its working groups will do as much as 
possible to protect the identity of the patient and the family but will not be 
able to guarantee their identities will be protected. 
Dr. McCarthy felt protecting the identities of the first patients participating 
in human gene therapy protocols will be difficult. Dr. Gorcvitz agreed that the 
warking group document should alert the family to this situation. 
Mr. Capron said the working group would like to knew if the investigator intends 
to "parade" the patient. Dr. Gorovitz said he would like to know if the 
investigator will respect the option of the family to either go public or to 
protect the patient's identity; he said this was another example of the warking 
group's desire to knew in attempting to formulate public policy. 
Dr. Mahoney asked vhether there may be a lawsuit over the attempt to implement 
human gene therapy. Dr. McCarthy said freedom of information lawsuits are the 
mare likely type of suit. Mr. Capron said the possibility of a suit such as 
those brought against EHHS, NIH, and USDA by the Foundation on Eaoncmic Trends 
cannot be ruled out. Dr. Mahoney suggested the warking group document might 
indicate that individuals seeking therapy may have to sue or countersue in 
order to obtain treatment. 
Dr. Walters called the attention of the working group to Part II, General Social 
Issues not Covered by the DHHS Regulations for Research Involving Human Subjects , 
of the document. 
Mr. Mitchell felt Part II of the draft document should be further developed. 
He suggested this part of the document might ask vhat legal and religious 
concepts might be challenged by human gene therapy. Part II might also ask 
the economic consequences of implementing this therapy. Mr. Mitchell suggested 
Part II of the document should also consider questions of parental rights. 
Dr. Gottesman asked why Section II-A, Financial Support , asks vhich public and 
private sources funded the study. Dr. Goro/itz said this question addresses 
social policy issues and refers to patentability; it asks who pays and who 
gains . 
Mr. Capron said this consideration bears on equity issues; if a process is 
patented, access to the treatment may be dispensed on the basis of financial 
ability. 
Dr. Gottesman suggested the working group document could ask vh ether the fruits 
of the research will be in the public domain. She said this concept is implied 
in Section II-D, Implications . She suggested language requesting information on 
whether the public will have access to this therapy regardless of ability to 
pay be included in Section II-D. If the therapy will not be generally available 
to the public, this should be known. Dr. Gottesman said the working group 
would discuss patent issues in the absence of this information; it might, 
therefore, be to the advantage of the investigator to provide such information 
[104] 
