52 
mitted to or otherwise obtained by such member is information re- 
lated to a facility affiliated with such committee. 
“(e) ( 1 ) Any person who maintain s a health record which contains 
individually identifiable personal data (hereinafter in this subection 
referred to as 'personal doled) and which receives a request from any 
governmental authority for such record for purposes of this part shall 
not disclose or transfer any such data to a governmental, authority un- 
less the individual whose personal data is to be so disclosed or trans- 
ferred gives an informed consent for such discloure or tranfer and 
such consent is evidenced by a document containing the signature of 
such individual and the signature of the person who explained the 
provisions of paragraph (if). 
“ (2) Notwithstanding any provision of law , personal data received 
or maintained by a governmental authority fen n purposes of this title , 
may not be disclosed or made available by a governmental authority 
to any person other than the individual who is the subject of such 
data. Such personal, data may not be required to be disclosed by any 
Federal , State , or local civil , criminal , administrative , legislative , or 
ocher proceeding . 
“( 3 ) For ^purposes of this subsection, the te r rm '■governmental au- 
thority' means any Federal agency , including the Commission , any 
Stole or local gove'mmental authority , its employees , contractors , 
grantees , or agents. 
“(i) For purposes of this subsection. Informed consent ’ includes a 
complete explanation of risks and benefits to the individual whose 
personal data is to be disclosed or transferred of such disclosure or 
transfer , mcl/uding — 
U (A) a statement informing such individual of whether he is 
legally required, or may refuse, to consent to such disclosure or 
transfer , and informing him of any specific consequences of con- 
senting or not consenting to such disclosure or transfer; 
U (B) a statement informing such individual that he may review 
the dala a r nd any other information which is proposed to be dis- 
closed or transferred, prior to such consent; 
“ ( C) a statement informing such individual of the use to be 
made of such data and other information and of the identity of 
persons and governmental autho'rilies which will use the dala and 
other information and their relationship to the recombinant DNA 
activities. 
“registration or recombinant dna projects 
“Sec. 1818. (a) The owner or operator of a facility licensed under 
section 1803 shall, after appropriale review and approval, file with 
the Com/mission a Project Registration. Statement for each recombinant 
DNA p'roject conducted in such facility. 
“(b) A Project Registration Statement shall be fled, in such form 
and manner as the Commission may require by rule, prior to the com- 
mencement of the project or, in the cose of projects in progress on the 
date of enactment of this part, as part of the initial licensing appli- 
cation.. The statement shall contain all information regarding the 
p'roject thal the Commission, by rule, has determined is necessa r ry fo'r 
an informed assessment of the precautions to be taken for assuring its 
safety and, complwnce with the requirements of this title. 
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