[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2744 Introduced in Senate (IS)]
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114th CONGRESS
2d Session
S. 2744
To amend the Public Health Service Act to protect the privacy of
individuals who are research subjects, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 5, 2016
Ms. Warren (for herself and Mr. Enzi) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to protect the privacy of
individuals who are research subjects, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Genetic Research Privacy Protection
Act''.
SEC. 2. PROTECTION OF PRIVACY OF INDIVIDUALS WHO ARE RESEARCH SUBJECTS.
(a) In General.--Subsection (d) of section 301 of the Public Health
Service Act (42 U.S.C. 241) is amended to read as follows:
``(d) Protection of Privacy of Individuals Who Are Research
Subjects.--
``(1) Issuance of certificate.--
``(A) In general.--If a person is engaged in
biomedical, behavioral, clinical, or other research, in
which identifiable, sensitive information is collected
(including research on mental health and research on
the use and effect of alcohol and other psychoactive
drugs), the Secretary, in coordination with other
Departments, as applicable--
``(i) 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 Government; and
``(ii) may, upon application by a person
engaged in research, issue to such person a
certificate of confidentiality to protect the
privacy of such individuals if the research is
not so funded.
``(B) Result of certificate.--Except as provided in
subparagraph (C), any person to whom a certificate is
issued under subparagraph (A) 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
information, document, or biospecimen that contains
identifiable, sensitive information about such an
individual and that was created or compiled for
purposes of the research.
``(C) Exceptions.--The disclosure prohibition in
subparagraph (B) shall not apply to disclosure or use
that is--
``(i) required by Federal, State, or local
laws, excluding instances described in
subparagraph (D);
``(ii) necessary for the medical treatment
of the individual to whom the information,
document, or biospecimen pertains;
``(iii) made with the consent of the
individual to whom the information, document,
or biospecimen pertains; or
``(iv) made for the purposes of other
scientific research that is in compliance with
applicable Federal regulations governing the
protection of human subjects in research.
``(D) Prohibition on compelling disclosure.--Any
person to whom a certificate is issued under
subparagraph (A) to protect the privacy of an
individual described in such subparagraph shall not, in
any Federal, State, or local civil, criminal,
administrative, legislative, or other proceeding,
disclose or provide the name of such individual or any
such information, document, or biospecimen that
contains identifiable, sensitive information about the
individual and that was created or compiled for
purposes of the research.
``(E) Immunity.--Identifiable, sensitive
information protected under subparagraph (A), and all
copies thereof, shall be immune from the legal process,
and shall not, without the consent of the individual to
whom the information pertains, be admissible as
evidence or used for any purpose in any action, suit,
or other judicial, legislative, or administrative
proceeding.
``(F) Terms of protection.--Identifiable, sensitive
information collected by a person to whom a certificate
has been issued under subparagraph (A), and all copies
thereof, shall be subject to the protections afforded
by this section for perpetuity.
``(G) Minimizing administrative burden.--The
Secretary shall take steps to minimize the burden to
researchers, streamline the process, and reduce the
time it takes to comply with the requirements of this
subsection.
``(2) 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
research.
``(3) Definitions.--For purposes of this subsection, the
term `identifiable, sensitive information' means information
that is about an individual and that is gathered or used during
the course of research described in paragraph (1)(A) and--
``(A) through which an individual is identified; or
``(B) for which there is a risk, as determined by
current scientific practices or statistical methods,
that some combination of the information, the request,
and other available data sources could be used to
deduce the identity of an individual.''.
(b) Applicability.--Beginning on the date of enactment of this Act,
all persons engaged in research and authorized by the Secretary of
Health and Human Services to protect information under section 301(d)
of the Public Health Service Act (42 U.S.C. 241(d)) prior to the date
of enactment of this Act shall be subject to the requirements of such
section (as amended by this Act).
SEC. 3. PROTECTION OF IDENTIFIABLE, SENSITIVE INFORMATION.
Section 301 of the Public Health Service Act (42 U.S.C. 241) is
amended by adding at the end the following:
``(f)(1) The Secretary may exempt from disclosure under section
552(b)(3) of title 5, United States Code, biomedical information that
is about an individual and that is gathered or used during the course
of biomedical research if--
``(A) an individual is identified; or
``(B) there is a risk, as determined by current scientific
practices or statistical methods, that some combination of the
information, the request, and other available data sources
could be used to deduce the identity of an individual.
``(2)(A) Each determination of the Secretary under paragraph (1) to
exempt information from disclosure shall be made in writing and
accompanied by a statement of the basis for the determination.
``(B) Each such determination and statement of basis shall be
available to the public, upon request, through the Office of the Chief
FOIA Officer of the Department of Health and Human Services.
``(3) 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 research.''.
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