,,ii #aadth ,,congress #b;d ,session ,s4 #bgdd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #e1 #bjaf ,ms4 ,warren 7for herself and ,mr4 ,enzi7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,public ,health ,service ,act to protect the privacy of individuals who are research subjects1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,genetic ,research ,privacy ,protection ,act4 #b4 ,protection of privacy of individuals who are research subjects 7a7 ,in general ,subsection 7d7 of section #cja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda7 is amended to read as follows3 7d7 ,protection of privacy of individuals who are research subjects 7#a7 ,issuance of certificate 7,a7 ,in general ,if a person is engaged in biomedical1 behavioral1 clinical1 or other research1 in which identifiable1 sensitive information is collected 7including research on mental health and research on the use and effect of alcohol and other psychoactive drugs71 the ,secretary1 in coordination with other ,departments1 as applicable-- 7i7 shall issue to such person a certificate of confidentiality to protect the privacy of individuals who are the subjects of such research if the research is funded wholly or in part by the ,federal ,government2 and 7ii7 may1 upon application by a person engaged in research1 issue to such person a certificate of confidentiality to protect the privacy of such individuals if the research is not so funded4 7,b7 ,result of certificate ,except as provided in subparagraph 7,c71 any person to whom a certificate is issued under subparagraph 7,a7 to protect the privacy of individuals described in such subparagraph shall not disclose or provide to any other person not connected with the research the name of such an individual or any information1 document1 or biospecimen that contains identifiable1 sensitive information about such an individual and that was created or compiled for purposes of the research4 7,c7 ,exceptions ,the disclosure prohibition in subparagraph 7,b7 shall not apply to disclosure or use that is-- 7i7 required by ,federal1 ,state1 or local laws1 excluding instances described in subparagraph 7,d72 7ii7 necessary for the medical treatment of the individual to whom the information1 document1 or biospecimen pertains2 7iii7 made with the consent of the individual to whom the information1 document1 or biospecimen pertains2 or 7iv7 made for the purposes of other scientific research that is in compliance with applicable ,federal regulations governing the protection of human subjects in research4 7,d7 ,prohibition on compelling disclosure ,any person to whom a certificate is issued under subparagraph 7,a7 to protect the privacy of an individual described in such subparagraph shall not1 in any ,federal1 ,state1 or local civil1 criminal1 administrative1 legislative1 or other proceeding1 disclose or provide the name of such individual or any such information1 document1 or biospecimen that contains identifiable1 sensitive information about the individual and that was created or compiled for purposes of the research4 7,e7 ,immunity ,identifiable1 sensitive information protected under subparagraph 7,a71 and all copies thereof1 shall be immune from the legal process1 and shall not1 without the consent of the individual to whom the information pertains1 be admissible as evidence or used for any purpose in any action1 suit1 or other judicial1 legislative1 or administrative proceeding4 7,f7 ,terms of protection ,identifiable1 sensitive information collected by a person to whom a certificate has been issued under subparagraph 7,a71 and all copies thereof1 shall be subject to the protections afforded by this section for perpetuity4 7,g7 ,minimizing administrative burden ,the ,secretary shall take steps to minimize the burden to researchers1 streamline the process1 and reduce the time it takes to comply with the requirements of this subsection4 7#b7 ,rule of construction ,nothing in this subsection shall be construed to limit the access of an individual who is a subject of research to information about himself or herself collected during such individual's participation in the research4 7#c7 ,definitions ,for purposes of this subsection1 the term identifiable1 sensitive information means information that is about an individual and that is gathered or used during the course of research described in paragraph 7#a77;,a7 and-- 7,a7 through which an individual is identified2 or 7,b7 for which there is a risk1 as determined by current scientific practices or statistical methods1 that some combination of the information1 the request1 and other available data sources could be used to deduce the identity of an individual4 4 7b7 ,applicability ,beginning on the date of enactment of this ,act1 all persons engaged in research and authorized by the ,secretary of ,health and ,human ,services to protect information under section #cja7;d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda7;d77 prior to the date of enactment of this ,act shall be subject to the requirements of such section 7as amended by this ,act74 #c4 ,protection of identifiable1 sensitive information ,section #cja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda7 is amended by adding at the end the following3 7f7 7#a7 ,the ,secretary may exempt from disclosure under section #eeb7;b77#c7 of title #e1 ,united ,states ,code1 biomedical information that is about an individual and that is gathered or used during the course of biomedical research if-- 7,a7 an individual is identified2 or 7,b7 there is a risk1 as determined by current scientific practices or statistical methods1 that some combination of the information1 the request1 and other available data sources could be used to deduce the identity of an individual4 7#b7 7,a7 ,each determination of the ,secretary under paragraph 7#a7 to exempt information from disclosure shall be made in writing and accompanied by a statement of the basis for the determination4 7,b7 ,each such determination and statement of basis shall be available to the public1 upon request1 through the ,office of the ,chief ,,foia ,officer of the ,department of ,health and ,human ,services4 7#c7 ,nothing in this subsection shall be construed to limit a research participant's access to information about such participant collected during the participant's participation in the research4 4