72nd OREGON LEGISLATIVE ASSEMBLY--2003 Regular Session
NOTE: Matter within { + braces and plus signs + } in an
amended section is new. Matter within { - braces and minus
signs - } is existing law to be omitted. New sections are within
{ + braces and plus signs + } .
LC 2542
Senate Bill 618
Sponsored by COMMITTEE ON JUDICIARY
SUMMARY
The following summary is not prepared by the sponsors of the
measure and is not a part of the body thereof subject to
consideration by the Legislative Assembly. It is an editor's
brief statement of the essential features of the measure as
introduced.
Modifies laws relating to genetic privacy. Clarifies
requirements for genetic research.
Declares emergency, effective on passage.
A BILL FOR AN ACT
Relating to genetic privacy; creating new provisions; amending
ORS 192.531, 192.533, 192.535, 192.537, 192.547 and 192.549 and
section 8, chapter 588, Oregon Laws 2001; repealing section 8,
chapter 588, Oregon Laws 2001; and declaring an emergency.
Be It Enacted by the People of the State of Oregon:
SECTION 1. ORS 192.531 is amended to read:
192.531. As used in ORS 192.531 to 192.549:
(1) 'Anonymous research' means scientific or medical research
conducted in such a manner that { - the identity of an
individual who has provided a sample, or the identity of an
individual from whom genetic information has been obtained or the
identity of the individual's blood relatives, cannot be
determined. - } { + a DNA sample or genetic information used in
the research is unidentified. + }
(2) 'Blanket informed consent' means that the individual has
consented to the use of the individual's DNA sample or health
information for any future research, but has not been provided
with a description of or consented to the use of the sample in
genetic research or any specific genetic research project.
(3) 'Blood relative' means a person who is:
(a) Related by blood to an individual; and
(b) A parent, sibling, son, daughter, grandparent, grandchild,
aunt, uncle, first cousin, niece or nephew of the individual.
(4) 'Clinical' means relating to or obtained through the actual
observation, diagnosis or treatment of patients and not through
research.
{ + (5) 'Coded' means identifiable only through the use of a
system of encryption that links a DNA sample or genetic
information to an individual or the individual's blood relative.
A coded DNA sample or genetic information is supplied by a
repository to an investigator with a system of encryption, rather
than with identifiers, so that:
(a) The repository or an agent holding the encryption key under
security precautions retains the ability to link the DNA sample
or genetic information with individual identifiers; and
(b) The investigator cannot link the DNA sample or genetic
information with individual identifiers.
(6) 'Deidentified' means lacking, or having had removed, the
identifiers or system of encryption that would make it possible
for a person to link a DNA sample or genetic information to an
individual or the individual's blood relative, and neither the
investigator nor the repository can reconstruct the identity of
the individual from whom the sample or information was obtained.
Deidentified DNA samples and genetic information must meet the
standards provided in 45 C.F.R. 164.502(d) and 164.514(a) to
(c). + }
{ - (5) - } { + (7) + } 'Disclose' means to release,
publish or otherwise make known to a third party a DNA sample or
genetic information.
{ - (6) - } { + (8) + } 'DNA' means deoxyribonucleic acid.
{ - (7) - } { + (9) + } 'DNA sample' means any human
biological specimen that is obtained or retained for the purpose
of extracting and analyzing DNA to perform a genetic test. 'DNA
sample' includes DNA extracted from the specimen.
{ - (8) - } { + (10) + } 'Genetic characteristic' includes
a gene, chromosome or alteration thereof that may be tested to
determine the existence or risk of a disease, disorder, trait,
propensity or syndrome, or to identify an individual or a blood
relative. ' Genetic characteristic' does not include family
history or a genetically transmitted characteristic whose
existence or identity is determined other than through a genetic
test.
{ - (9) - } { + (11) + } 'Genetic information' means
information about an individual or the individual's blood
relatives obtained from a genetic test.
{ + (12) 'Genetic privacy statutes' means ORS 192.531 to
192.549, 659A.303 and 746.135 and the provisions of ORS 659A.300
relating to genetic testing. + }
{ - (10) - } { + (13) + } 'Genetic research' means research
using DNA samples, genetic testing or genetic information.
{ - (11) - } { + (14) + } 'Genetic test' means a test for
determining the presence or absence of genetic characteristics in
an individual or the individual's blood relatives, including
tests of nucleic acids such as DNA, RNA and mitochondrial DNA,
chromosomes or proteins in order to diagnose or determine a
genetic characteristic.
{ + (15) 'Identifiable' means capable of being linked to the
individual or a blood relative of the individual from whom the
DNA sample or genetic information was obtained.
(16) 'Identified' means having an identifier that links, or
that could readily allow the recipient to link, a DNA sample or
genetic information directly to the individual or a blood
relative of the individual from whom the sample or information
was obtained.
(17) 'Identifier' means data elements that directly link a DNA
sample or genetic information to the individual or a blood
relative of the individual from whom the sample or information
was obtained. Identifiers include, but are not limited to, names,
telephone numbers, electronic mail addresses, Social Security
numbers, driver license numbers and fingerprints. + }
{ - (12) - } { + (18) + } 'Obtain genetic information'
means performing or getting the results of a genetic test.
{ - (13) - } { + (19) + } 'Person' has the meaning given in
ORS 433.045.
{ - (14) - } { + (20) + } 'Research' means a systematic
investigation, including research development, testing and
evaluation, designed to develop or contribute to generalized
knowledge.
{ - (15) - } { + (21) + } 'Retain a DNA sample' means the
act of storing the DNA sample.
{ - (16) - } { + (22) + } 'Retain genetic information'
means making a record of the genetic information.
{ + (23) 'Unidentified' means deidentified or not
identified. + }
SECTION 2. ORS 192.533 is amended to read:
192.533. (1) The Legislative Assembly finds that:
(a) The DNA molecule contains information about the probable
medical future of an individual and the individual's blood
relatives. This information is written in a code that is rapidly
being broken.
(b) Genetic information is uniquely private and personal
information that generally should not be collected, retained or
disclosed without the individual's authorization.
(c) The improper collection, retention or disclosure of genetic
information can lead to significant harm to an individual and the
individual's blood relatives, including stigmatization and
discrimination in areas such as employment, education, health
care and insurance.
(d) An analysis of an individual's DNA provides information not
only about the individual, but also about blood relatives of the
individual, with the potential for impacting family privacy,
including reproductive decisions.
(e) Current legal protections for medical information, tissue
samples and DNA samples are inadequate to protect genetic
privacy.
(f) Laws for the collection, storage and use of identifiable
DNA samples and private genetic information obtained from those
samples are needed both to protect individual and family privacy
and to permit and encourage legitimate scientific and medical
research.
(2) The purposes of { - ORS 192.531 to 192.549 and 746.135
and the provisions of ORS 659A.300, 659A.303 and 746.015 relating
to genetic characteristics, information and testing - } { + the
genetic privacy statutes + } are as follows:
(a) To define the rights of individuals whose genetic
information is collected, retained or disclosed and the rights of
the individuals' blood relatives.
(b) To define the circumstances under which an individual may
be subjected to genetic testing.
(c) To define the circumstances under which an individual's
genetic information may be collected, retained or disclosed.
(d) To protect against discrimination by an insurer or employer
based upon an individual's genetic characteristics.
(e) To define the circumstances under which a DNA sample or
genetic information may be used for research.
SECTION 3. ORS 192.535 is amended to read:
192.535. (1) A person may not obtain genetic information from
an individual, or from an individual's DNA sample, without first
obtaining informed consent of the individual or the individual's
representative, except:
(a) As authorized by ORS 181.085 or comparable provisions of
federal criminal law relating to the identification of persons,
or for the purpose of establishing the identity of a person in
the course of an investigation conducted by a law enforcement
agency, a district attorney, a medical examiner or the Criminal
Justice Division of the Department of Justice;
(b) For anonymous research conducted after notification { + or
with consent + } pursuant to ORS 192.537 (2);
(c) As permitted by rules of the Department of Human Services
for identification of deceased individuals;
(d) As permitted by rules of the Department of Human Services
for newborn screening procedures;
(e) As authorized by statute for the purpose of establishing
paternity; or
(f) For the purpose of furnishing genetic information relating
to a decedent for medical diagnosis of blood relatives of the
decedent.
(2) Except as provided in subsection (3) of this section, a
physician licensed under ORS chapter 677 shall seek the informed
consent of the individual or the individual's representative for
the purposes of subsection (1) of this section in the manner
provided by ORS 677.097. Except as provided in subsection (3) of
this section, any other licensed health care provider or facility
must seek the informed consent of the individual or the
individual's representative for the purposes of subsection (1) of
this section in a manner substantially similar to that provided
by ORS 677.097 for physicians.
(3) A person conducting research shall seek the informed
consent of the individual or the individual's representative for
the purposes of subsection (1) of this section in the manner
provided by ORS 192.547.
(4) Except as provided in ORS 746.135 (1), any person not
described in subsection (2) or (3) of this section must seek the
informed consent of the individual or the individual's
representative for the purposes of subsection (1) of this section
in the manner provided by rules adopted by the Department of
Human Services.
(5) The Department of Human Services may not adopt rules under
subsection (1)(d) of this section that would require the
providing of a DNA sample for the purpose of obtaining complete
genetic information used to screen all newborns.
SECTION 4. ORS 192.537 is amended to read:
192.537. (1) Subject to the provisions of ORS 192.531 to
192.549, 659A.303 and 746.135, an individual's genetic
information and DNA sample are private and must be protected, and
an individual has a right to the protection of that privacy. Any
person authorized by law or by an individual or an individual's
representative to obtain, retain or use an individual's genetic
information or any DNA sample must maintain the confidentiality
of the information or sample and protect the information or
sample from unauthorized disclosure or misuse.
(2)(a) A person may use an individual's DNA sample or genetic
information for anonymous research only if the individual { + :
(A) Has granted informed consent for the specific anonymous
research project;
(B) Has granted consent for genetic research generally; or
(C) + } Was notified the sample or genetic information may be
used for anonymous research and the individual did not, at the
time of notification, request that the sample not be used for
anonymous research.
(b) The Department of Human Services shall adopt rules to
implement paragraph (a) of this subsection after considering
similar federal regulations.
(3) A person may not retain another individual's genetic
information or DNA sample without first obtaining authorization
from the individual or the individual's representative, unless:
(a) Retention is authorized by ORS 181.085 or comparable
provisions of federal criminal law relating to identification of
persons, or is necessary for the purpose of a criminal or death
investigation, a criminal or juvenile proceeding, an inquest or a
child fatality review by a multidisciplinary child abuse team;
(b) Retention is authorized by specific court order pursuant to
rules adopted by the Chief Justice of the Supreme Court for civil
actions;
(c) Retention is permitted by rules of the Department of Human
Services for identification of, or testing to benefit blood
relatives of, deceased individuals;
(d) Retention is permitted by rules of the Department of Human
Services for newborn screening procedures; or
(e) Retention is for anonymous research conducted after
notification { + or with consent + } pursuant to subsection (2)
of this section.
(4) The DNA sample of an individual from which genetic
information has been obtained shall be destroyed promptly upon
the specific request of that individual or the individual's
representative, unless:
(a) Retention is authorized by ORS 181.085 or comparable
provisions of federal criminal law relating to identification of
persons, or is necessary for the purpose of a criminal or death
investigation, a criminal or juvenile proceeding, an inquest or a
child fatality review by a multidisciplinary child abuse team;
(b) Retention is authorized by specific court order pursuant to
rules adopted by the Chief Justice of the Supreme Court for civil
actions; or
(c) Retention is for anonymous research conducted after
notification { + or with consent + } pursuant to subsection (2)
of this section.
(5) A DNA sample from an individual that is the subject of a
research project, other than an anonymous research project, shall
be destroyed promptly upon completion of the project or
withdrawal of the individual from the project, whichever occurs
first, unless the individual or the individual's representative
directs otherwise by informed consent.
(6) A DNA sample from an individual for insurance or employment
purposes shall be destroyed promptly after the purpose for which
the sample was obtained has been accomplished unless retention is
authorized by specific court order pursuant to rules adopted by
the Chief Justice of the Supreme Court for civil, criminal and
juvenile proceedings.
(7) An individual or an individual's representative, promptly
upon request, may inspect, request correction of and obtain
genetic information from the records of the individual { - ,
unless the genetic information has been made anonymous by
destruction of all information that could allow disclosure of the
identity of the individual who provided the sample or the
identity of the individual's blood relatives - } .
(8) Subject to the provisions of ORS 192.531 to 192.549, and to
policies adopted by the person in possession of a DNA sample, an
individual or the individual's representative may request that
the individual's DNA sample be made available for additional
genetic testing for medical diagnostic purposes. If the
individual is deceased and has not designated a representative to
act on behalf of the individual after death, a request under this
subsection may be made by the closest surviving blood relative of
the decedent or, if there is more than one surviving blood
relative of the same degree of relationship to the decedent, by
the majority of the surviving closest blood relatives of the
decedent.
(9) The Department of Human Services shall coordinate the
implementation of this section.
(10) { + Subsections (3) to (8) of + } this section
{ - applies - } { + apply + } only to { + a DNA sample or + }
genetic information that { - can be identified as belonging to
an individual or the individual's blood relative - } { + is
coded, identified or identifiable + }.
{ + (11) + } This section does not apply to any law, contract
or other arrangement that determines a person's rights to
compensation relating to substances or information derived from
an individual's DNA sample.
SECTION 5. ORS 192.547 is amended to read:
192.547. (1)(a) The Department of Human Services shall adopt
rules for conducting research using DNA samples, genetic testing
and genetic information. Rules establishing minimum research
standards shall conform to the Federal Policy for the Protection
of Human Subjects, 45 C.F.R. 46, that is current at the time the
rules are adopted. The rules may be changed from time to time as
may be necessary.
(b) The rules adopted by the Department of Human Services shall
address the operation and appointment of institutional review
boards. The rules shall conform to the compositional and
operational standards for such boards contained in the Federal
Policy for the Protection of Human Subjects that is current at
the time the rules are adopted. The rules must require that
research conducted under paragraph (a) of this subsection be
conducted with the approval of the institutional review board.
(c) Persons proposing to conduct anonymous research or genetic
research that is otherwise thought to be exempt from review must
obtain from an institutional review board prior to conducting
such research a determination that the proposed research is
exempt from review.
(2) A person proposing to conduct research under subsection (1)
of this section, including anonymous research, must disclose to
the institutional review board the proposed use of DNA samples,
genetic testing or genetic information.
(3) The Department of Human Services shall adopt rules
requiring that all institutional review boards operating under
subsection (1)(b) of this section register with the department.
{ + The Advisory Committee on Genetic Privacy and Research
shall use the registry to educate institutional review boards
about the purposes and requirements of the genetic privacy
statutes and administrative rules relating to genetic
research. + }
(4) The Department of Human Services shall consult with the
Advisory Committee on Genetic Privacy and Research before
adopting the rules required under subsections (1) and (3) of this
section, including rules identifying those parts of the Federal
Policy for the Protection of Human Subjects that are applicable
to this section.
(5) { - In consultation with the Advisory Committee on
Genetic Privacy and Research, the Department of Human Services
shall promulgate guidelines for - } Genetic research in which
the { - identity of the individual providing a - } DNA sample
{ + or genetic information is coded + } { - is protected by an
encryption or coding system. The department shall base the
guidelines on recommendations of credible national and state
organizations. - } { + shall satisfy the following
requirements:
(a) The subject has granted informed consent for the specific
anonymous research project or has consented to genetic research
generally.
(b) The research has been approved by an appropriate
institutional review board after disclosure by the investigator
to the board of risks associated with the coding.
(c) The code is:
(A) Not derived from individual identifiers;
(B) Kept securely and separately from the DNA samples and
genetic information; and
(C) Not accessible to the investigator unless specifically
approved by the institutional review board.
(d) Data is stored securely in password protected electronic
files or by other means with access limited to necessary
personnel.
(e) The data is limited to elements required for analysis and
meets the criteria in 45 C.F.R 164.514(e) for a limited data set.
(f) The investigator is a party to the data use agreement as
provided by 45 C.F.R. 164.514(e) for limited data set
recipients. + }
(6) Research conducted in accordance with this section is
rebuttably presumed to comply with ORS 192.535 and 192.539.
(7) In cases in which informed consent is required by either
ORS 192.535 or the Federal Policy for the Protection of Human
Subjects, samples collected before June 25, 2001, with blanket
informed consent for research may be used for genetic research
without specific informed consent, but samples obtained after
June 25, 2001, must have specific informed consent from the
individual for genetic research.
(8) Except as otherwise allowed by rule of the Department of
Human Services, if DNA samples or genetic information obtained
for either clinical or research purposes is used in research, a
person may not recontact the individual or the individual's
physician by using research information { - with personal
identifiers - } { + that is identifiable or coded + }. The
Department of Human Services shall adopt by rule criteria for
recontacting an individual or an individual's physician. In
adopting the criteria, the department shall consider the
recommendations of national organizations such as those created
by executive order by the President of the United States and the
recommendations of the Advisory Committee on Genetic Privacy and
Research.
{ + (9) Genetic research approved by an institutional review
board is governed by the provisions of ORS 192.531 to 192.549 and
the administrative rules that were in effect on the effective
date of the board's most recent approval of the study. + }
SECTION 6. ORS 192.549 is amended to read:
192.549. (1) The Advisory Committee on Genetic Privacy and
Research is established consisting of { - 14 - } { + 15 + }
members. The President of the Senate and the Speaker of the House
of Representatives shall each appoint one member and one
alternate. The Director of Human Services shall appoint one
representative and one alternate from each of the following
categories:
(a) Academic institutions involved in genetic research;
(b) Physicians licensed under ORS chapter 677;
(c) Voluntary organizations involved in the development of
public policy on issues related to genetic privacy;
(d) Hospitals;
(e) The Department of Human Services;
(f) The Department of Consumer and Business Services;
(g) Health care service contractors involved in genetic and
health services research;
(h) The biosciences industry;
(i) The pharmaceutical industry;
(j) Health care consumers;
(k) Organizations advocating for privacy of medical
information; { - and - }
(L) Public members of institutional review boards { - . - }
{ + ; and
(m) Organizations promoting public awareness of genetic
research and genetic privacy and public involvement in
policymaking related to genetic research and genetic privacy. + }
(2) Organizations and individuals representing the categories
listed in subsection (1) of this section may recommend nominees
for membership on the advisory committee to the President, the
Speaker and the director.
(3) Members and alternate members of the advisory committee
serve two-year terms and may be reappointed.
(4) Members and alternate members of the advisory committee
serve at the pleasure of the appointing entity.
(5) The Department of Human Services shall provide staff for
the advisory committee.
(6) The advisory committee shall report biennially to the
Legislative Assembly in the manner provided by ORS 192.245. The
report shall include the activities and the results of any
studies conducted by the advisory committee. The advisory
committee may make any recommendations for legislative changes
deemed necessary by the advisory committee.
(7) The advisory committee shall study the use and disclosure
of genetic information and shall develop and refine a legal
framework that defines the rights of individuals whose DNA
samples and genetic information are collected, stored, analyzed
and disclosed.
(8) The advisory committee shall create opportunities for
public education on the scientific, legal and ethical development
within the fields of genetic privacy and research. The advisory
committee shall also elicit public input on these matters. The
advisory committee shall make reasonable efforts to obtain public
input that is representative of the diversity of opinion on this
subject. The advisory committee's recommendations to the
Legislative Assembly shall take into consideration public
concerns and values related to these matters.
SECTION 7. Section 8, chapter 588, Oregon Laws 2001, is amended
to read:
{ + Sec. 8. + } (1) The Advisory Committee on Genetic Privacy
and Research shall report to the Seventy-second Legislative
Assembly. The report shall include recommendations relating to:
(a) Patenting of human genes;
(b) Standards for recontacting patients who have provided
samples for genetic research;
(c) Privacy of information about genetic conditions obtained
other than through a genetic test;
(d) Privacy of persons who seek genetic counseling or genetic
testing;
(e) Whether to modify or expand current statutory provisions
requiring informed consent for genetic research; and
(f) Whether to modify the notification { + or consent + }
requirement of ORS { - 659.715 (2) - } { + 192.537 (2) + }
for anonymous research.
(2) The advisory committee shall report and make
recommendations to the Seventy-third Legislative Assembly
on { + :
(a) Patenting of human genes;
(b) + } Genetic testing { + ;
(c) + } { - and - } Use of genetic information by insurers
{ - . - } { + ;
(d) Informed consent as applied to DNA samples and genetic
information;
(e) Whether the genetic privacy statutes can be simplified in
light of federal health information privacy law;
(f) Procedures for protecting subjects of genetic research;
(g) Whether to include family history, clinical diagnosis of a
genetic condition or somatic changes in the definition of genetic
information; and
(h) Discrimination involving an individual seeking genetic
counseling, genetic testing or a clinical genetics
evaluation. + }
SECTION 8. { + Section 8, chapter 588, Oregon Laws 2001, is
repealed on January 2, 2006. + }
SECTION 9. { + The amendments to ORS 192.531, 192.533,
192.535, 192.537, 192.547 and 192.549 by sections 1 to 6 of this
2003 Act apply to DNA samples or genetic information obtained on
or after the effective date of this 2003 Act. + }
SECTION 10. { + This 2003 Act being necessary for the
immediate preservation of the public peace, health and safety, an
emergency is declared to exist, and this 2003 Act takes effect on
its passage. + }
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