Existing regulation of genetic registers

22.8 Existing regulation of genetic registers is based on the NHMRC Guidelines for Genetic Registers.^[11] In 1990, the Human Genetics Society of Australasia (HGSA) issued guidelines dealing with DNA banking, including the storage of genetic samples in association with the operation of genetic registers.^[12] These guidelines may be supplemented by other, more specific, guidelines developed by clinical genetics services, and other organisations that operate genetic registers.

22.9 The collection, use and disclosure of genetic information on genetic registers may be subject to information and health privacy legislation, depending on where it is held. Privacy regulation of genetic registers differs according to the state or territory in which the register operates, whether the register is a public or private sector organisation, and the legal resolution of possible conflicts between federal, state and territory privacy laws.

22.10 Regulation of the handling of genetic information by genetic registers is primarily a state and territory matter. However, in the context of this federal Inquiry, this chapter focuses on federal privacy law and leaves it to the States and Territories to assess the implications of the Inquiry’s recommendations for genetic registers operating under state and territory privacy regimes, in accordance with Recommendations 7–1 and 7–2.^[13]

NHMRC Guidelines for Genetic Registers

22.11 The content of the NHMRC Guidelines for Genetic Registers was summarised in IP 26.^[14] In particular, the Guidelines deal in detail with consent to inclusion of genetic information on a register, and list information to be provided to a person before they choose to participate.^[15] There are detailed provisions relating to obtaining consent from people other than the initial registrant, such as children and other nominated relatives and in relation to deceased persons.^[16] The Guidelines also contain detailed confidentiality provisions^[17] and guidelines on contacting other family members.^[18]

22.12 The NHMRC Guidelines for Genetic Registers have no direct legal effect and do not provide any formal sanction for non-compliance. However, the Guidelines have a status similar to that of the NHMRC National Statement on Ethical Conduct in Research Involving Humans,^[19]as discussed in Chapter 14. Non-compliance may, therefore, influence National Health and Medical Research Council (NHMRC) advice and recommendations to government on any research funding related to the operation of a genetic register.^[20] In addition, the Guidelines may be used as a standard in assessing complaints about the conduct of health professionals responsible for genetic registers and are likely to positively influence professional behaviour. As is the case with clinical practice guidelines, courts may approach the guidelines as a form of evidence of accepted standards of practice.^[21]

Application of privacy legislation to genetic registers

22.13 The collection, use and disclosure of genetic information on genetic registers may be subject to information and health privacy legislation. The extent to which genetic registers are covered by existing legislation depends on whether they are maintained by federal or state public sector entities or by private sector organisations.

22.14 Genetic registers are most commonly hospital based or community based. Where registers are established and maintained as part of the services provided by a public hospital they may be covered by state privacy legislation such as the Health Records (Privacy and Access) Act 1997 (ACT), the Privacy and Personal Information Protection Act 1998 (NSW), Health Records and Information Privacy Act 2002 (NSW), or the Health Records Act 2001 (Vic).

22.15 Genetic registers maintained by community based organisations, such as disease support groups, are covered by the private sector amendments to the federal Privacy Act 1988 (Cth) (Privacy Act), as are registers maintained by private sector health professionals or organisations.

22.16 Some genetic registers are maintained by state and territory cancer councils. For example, the New South Wales Cancer Council maintains hereditary bowel cancer registers. Where such bodies are established for a public purpose under a law of a State they will not be covered by the Privacy Act^[22]but may be covered by state legislation.

22.17 In their submission, Professor Nick Saunders and Associate Professor Paul Komesaroff observed that a genetic register may take the form of a network of data sources that links information stored in a number of locations, such as hospital records, pathology laboratories and research institutes. They noted that

in such settings it is important that an individual is identified who assumes responsibility for ensuring security of the data and for discharging the other responsibilities normally associated with the conduct of a register.^[23]

22.18 This may also be important in order to establish which laws apply to the collection, use and disclosure of the information on the particular genetic register.