73rd OREGON LEGISLATIVE ASSEMBLY--2005 Regular Session
Enrolled
Senate Bill 1025
Sponsored by COMMITTEE ON RULES
CHAPTER ................
AN ACT
Relating to genetic privacy; creating new provisions; amending
ORS 192.531, 192.535, 192.537 and 192.547; 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 genetic
research conducted in such a manner that any 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.
(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).
(7) 'Disclose' means to release, publish or otherwise make
known to a third party a DNA sample or genetic information.
(8) 'DNA' means deoxyribonucleic acid.
(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.
Enrolled Senate Bill 1025 (SB 1025-B) Page 1
(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.
(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.
(13) 'Genetic research' means research using DNA samples,
genetic testing or genetic information.
(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) 'Health care provider' has the meaning given that
term in ORS 192.519. + }
{ - (15) - } { + (16) + } '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) - } { + (17) + } '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) - } { + (18) + } '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.
{ + (19) 'Individually identifiable health information' has
the meaning given that term in ORS 192.519. + }
{ - (18) - } { + (20) + } 'Obtain genetic information'
means performing or getting the results of a genetic test.
{ - (19) - } { + (21) + } 'Person' has the meaning given in
ORS 433.045.
{ - (20) - } { + (22) + } 'Research' means a systematic
investigation, including research development, testing and
evaluation, designed to develop or contribute to generalized
knowledge.
{ - (21) - } { + (23) + } 'Retain a DNA sample' means the
act of storing the DNA sample.
{ - (22) - } { + (24) + } 'Retain genetic information'
means making a record of the genetic information.
{ - (23) - } { + (25) + } 'Unidentified' means deidentified
or not identifiable.
SECTION 2. 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:
Enrolled Senate Bill 1025 (SB 1025-B) Page 2
(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 { + or coded research + } conducted
{ - after notification or with consent pursuant to - }
{ + under conditions described in + } ORS 192.537 (2) { + ,
after notification pursuant to section 5 of this 2005 Act or
pursuant to ORS 192.547 (7)(b) + };
(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 3. 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 { + that is derived from a biological specimen or
clinical individually identifiable health information + } for
anonymous research { + or coded research + } only if the
individual:
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(A) Has granted informed consent for the specific anonymous
research { + or coded research + } project;
(B) Has granted consent for genetic research generally;
{ - or - }
(C) Was notified { + in accordance with section 5 of this 2005
Act that + }the { - sample or genetic information - }
{ + individual's biological specimen or clinical individually
identifiable health information + } may be used for anonymous
research { + or coded research + } and the individual did not,
at the time of notification, request that the { - sample - }
{ + biological specimen or clinical individually identifiable
health information + } not be used for anonymous research
{ - . - } { + or coded research; or
(D) Was not notified, due to emergency circumstances, in
accordance with section 5 of this 2005 Act that the individual's
biological specimen or clinical individually identifiable health
information may be used for anonymous research or coded research
and the individual died before receiving the notice.
(b) Paragraph (a) of this subsection does not apply to
biological specimens or clinical individually identifiable health
information obtained before the effective date of this 2005 Act
if an institutional review board operating under ORS 192.547
(1)(b) meets the requirements described in ORS 192.547
(7)(b). + }
{ - (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 { + or coded
research + } conducted after notification or with consent
pursuant to subsection (2) of this section { + or section 5 of
this 2005 Act + }.
(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
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(c) Retention is for anonymous research { + or coded
research + } conducted after notification or with consent
pursuant to subsection (2) of this section { + or section 5 of
this 2005 Act + }.
(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.
(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 apply only to a DNA
sample or genetic information that 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 4. { + Sections 5 and 8 of this 2005 Act are added to
and made a part of ORS 192.531 to 192.549. + }
SECTION 5. { + (1) A health care provider that is a covered
entity as defined in ORS 192.519 (2)(c) and that obtains an
individual's biological specimen or clinical individually
identifiable health information shall notify the individual that
the biological specimen or clinical individually identifiable
health information may be disclosed or retained by the provider
for anonymous research or coded research.
(2) A health care provider that is not a covered entity as
defined in ORS 192.519 (2)(c) and that obtains an individual's
biological specimen or clinical individually identifiable health
information may notify the individual that the biological
specimen or clinical individually identifiable health information
may be disclosed or retained by the provider for anonymous
research or coded research.
(3) A health care provider described in subsection (1) of this
section shall provide a notice to the individual describing how
the biological specimen or clinical individually identifiable
health information may be used and allowing the individual to
Enrolled Senate Bill 1025 (SB 1025-B) Page 5
request that the specimen or information not be disclosed or
retained for anonymous research or coded research. The notice
must contain a place where the individual may mark the
individual's request that the specimen or information not be
disclosed or retained for anonymous research or coded research
before returning the notice to the health care provider.
(4) The notice described in subsection (3) of this section:
(a) Must be given no later than when the provider obtains an
individual's biological specimen or clinical individually
identifiable health information; and
(b) May be given at the same time and in the same manner as the
notice of privacy practices required under the federal Health
Insurance Portability and Accountability Act privacy regulations,
45 C.F.R. parts 160 and 164. + }
SECTION 6. 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 { + , coded
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 { + or coded
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) Genetic research in which the DNA sample or genetic
information is coded shall satisfy the following requirements:
(a) { + (A) + } The subject has granted informed consent for
the specific research project { + ; + } { - or - }
{ + (B) The subject + }has consented to genetic research
generally { - . - } { + ; or
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(C) The DNA sample or genetic information is derived from a
biological specimen or from clinical individually identifiable
health information that was obtained or retained in compliance
with ORS 192.537 (2). + }
(b) The research has been approved by an 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. - }
{ + (7)(a) Notwithstanding ORS 192.535, a person may use a
DNA sample or genetic information obtained, with blanket informed
consent, before June 25, 2001, for genetic research.
(b) Notwithstanding ORS 192.535, a person may use a DNA sample
or genetic information obtained without specific informed consent
and derived from a biological specimen or clinical individually
identifiable health information for anonymous research or coded
research if an institutional review board operating under
subsection (1)(b) of this section:
(A) Waives or alters the consent requirements pursuant to the
Federal Policy for the Protection of Human Subjects; and
(B) Waives authorization pursuant to the federal Health
Insurance Portability and Accountability Act privacy regulations,
45 C.F.R. parts 160 and 164.
(c) Except as provided in subsection (5)(a) of this section or
paragraph (b) of this subsection, a person must have specific
informed consent from an individual to use a DNA sample or
genetic information of the individual obtained on or after June
25, 2001, 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 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.
Enrolled Senate Bill 1025 (SB 1025-B) Page 7
(9) The requirements for consent to, or notification of,
obtaining a DNA sample or genetic information for genetic
research are 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 institutional review board's most recent approval of
the study.
SECTION 7. { + No later than January 1, 2006, the Department
of Human Services shall adopt rules to implement section 5 of
this 2005 Act after considering the federal Health Insurance
Portability and Accountability Act privacy regulations, 45 C.F.R.
parts 160 and 164. The rules shall include but need not be
limited to the form, readability and content of the notice
required under section 5 of this 2005 Act. + }
SECTION 8. { + Notwithstanding ORS 192.535 and 192.537 (2), a
person may use an individual's DNA sample or genetic information
that is derived from a biological specimen or clinical
individually identifiable health information for anonymous
research or coded research if the individual was deceased when
the individual's biological specimen or clinical individually
identifiable health information was obtained. + }
SECTION 9. { + Section 5 of this 2005 Act and the amendments
to ORS 192.531, 192.535, 192.537 and 192.547 by sections 1, 2, 3
and 6 of this 2005 Act become operative on July 1, 2006. + }
SECTION 10. { + This 2005 Act being necessary for the
immediate preservation of the public peace, health and safety, an
emergency is declared to exist, and this 2005 Act takes effect on
its passage. + }
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Passed by Senate June 16, 2005
Repassed by Senate July 19, 2005
...........................................................
Secretary of Senate
...........................................................
President of Senate
Passed by House July 11, 2005
...........................................................
Speaker of House
Enrolled Senate Bill 1025 (SB 1025-B) Page 8
Received by Governor:
......M.,............., 2005
Approved:
......M.,............., 2005
...........................................................
Governor
Filed in Office of Secretary of State:
......M.,............., 2005
...........................................................
Secretary of State
Enrolled Senate Bill 1025 (SB 1025-B) Page 9