Note: Where available, the PDF/Word icon below is provided to view the complete and fully formatted document
Genetic Privacy and Non-discrimination Bill 1998 [2008]

Part 5 Research

20   Research involving genetic analysis

             (1)  A DNA sample may be analysed as part of a research project only if the researcher has determined that:

                     (a)  use of DNA samples is essential to the research project; and

                     (b)  the potential benefit of the research project to society outweighs the potential risks to the research subjects, including psychosocial risks and intrusion into the privacy of the subjects that would result from genetic analysis of DNA samples; and

                     (c)  the research protocol:

                              (i)  contains adequate safeguards to protect against disclosure of genetic information that is generated by the research; and

                             (ii)  satisfies the requirements of section 12; and

                            (iii)  describes the intended uses of the DNA samples; and

                            (iv)  prohibits inclusion of specific molecular genetic genotype information in records unless the subjects authorise such inclusion in writing; and

                             (v)  with respect to protocols involving the use of DNA samples from subjects deceased prior to the commencement of this Act:

                                        (A)  provides a reasonable method for disclosing to the family members of a subject, the risks that are associated with genetic information of the subject that is generated by the research, and in reasonable medical judgment, can be effectively ameliorated, prevented or treated; and

                                        (B)  takes into account the right of family members to refuse to be informed about the genetic information; and

                            (vi)  describes the availability, or lack of availability, of genetic counselling related to the research project.

             (2)  For purposes of subparagraph (1)(c)(i), adequate safeguards against disclosure of genetic information, at a minimum, include:

                     (a)  satisfying any guidelines issued by the National Health and Medical Research Council and approved by the Privacy Commissioner under section 95 of the Privacy Act 1988 ; and

                     (b)  ensuring that research subjects will not be identifiable in any report or publication that results from the research without their authorisation; and

                     (c)  having procedures to remove or destroy any individual identifiers at the earliest opportunity, consistent with the purposes of the project and the terms of the authorisation of the subjects involved.

             (3)  If the DNA sample of a subject is collected, stored or analysed in connection with a research project, the researcher must ensure the destruction of the DNA sample on the date of completion of the project or withdrawal of the subject from the project, whichever occurs first, unless the researcher obtains a specific authorisation of the subject according to the provisions of this Act, to store the sample after such date.

             (4)  If a research project includes genetic analysis of the family members of a subject for pedigree analysis or linkage analysis:

                     (a)  the genotype records must be stored in strict confidentiality; and

                     (b)  the process for obtaining the authorisation of the subject must include information about:

                              (i)  the possibility that family members of the subject may learn genetic information about the subject as a result of a project; and

                             (ii)  the possibility that the project may determine that some family members are not genetic relatives; and

                            (iii)  the disposition of records and data generated during the project; and

                     (c)  the genetic information must only be disclosed according to the requirements of this Act.

21   Disclosure of genetic information for research purposes

             (1)  Any person who stores genetic information of a subject may allow access to such information only with the written authorisation of the subject according to the provisions of this Act, and such information must be provided with individual identifiers, or codes, or no identifiers, according to the written authorisation of the subject.

             (2)  Notwithstanding subsection (1), a person who stores genetic information may grant access to such information solely for the purpose of inspection or review of the records containing the information if:

                     (a)  the inspection or review is for the purpose of compiling data for statistical or epidemiological studies and genetic information that contains personal identifiers is not copied, removed from the records, or redisclosed in any way; and

                     (b)  the person conducting the inspection or review certifies in writing:

                              (i)  that the limitations in paragraph (a) will be complied with; and

                             (ii)  that the person has complied with this Act; and

                            (iii)  that the person has knowledge of liability for breaches of this Act.

22   DNA samples collected prior to the commencement date

             (1)  A DNA sample collected before the commencement of this Act may be analysed as part of a research project, unless the individual involved, within 3 years of the commencement of this Act, submits a written request that such sample be withdrawn or destroyed.

             (2)  Except as provided by this Act, genetic information collected as part of a research project described in this section may be disclosed only with the authorisation of the individual involved or the individual’s legal representative.