Chapter 333 Oregon Laws 2003

 

AN ACT

 

SB 618

 

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 genetic 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.] 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).

          [(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 identifiable.

 

          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 research project or has consented to genetic research generally.

          (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.

          (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) 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 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 or individuals promoting public education about 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. (1) Except as provided in subsection (2) of this section, 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 before, on or after the effective date of this 2003 Act.

          (2) The amendments to ORS 192.547 (5) by section 5 of this 2003 Act requiring that a subject grant informed consent for a specific research project or consent to genetic research generally for genetic research in which the DNA sample or genetic information is coded applies to DNA samples or genetic information obtained on or after the effective date of this 2003 Act.

 

          SECTION 10. Notwithstanding ORS 192.537 (2)(a)(C), a person may use an individual’s DNA sample or genetic information for anonymous research if the DNA sample or genetic information was obtained prior to the effective date of this 2003 Act and the individual was not notified the sample or genetic information may be used for anonymous research.

 

          SECTION 11. 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.

 

Approved by the Governor June 12, 2003

 

Filed in the office of Secretary of State June 12, 2003

 

Effective date June 12, 2003

__________