28.07.2010
18. Human Genetic Research Databases
18–1 The National Health and Medical Research Council (NHMRC), as part of its review of the National Statement on Ethical Conduct in Research Involving Humans (the National Statement) in the 2003–2005 triennium, should amend the National Statement to provide ethical guidance on the establishment, governance and operation of human genetic research databases. The amendments (whether by means of a new chapter or otherwise) should include specific guidance on obtaining consent to unspecified future research. (See also Recommendation 15–4.)
18–2 The NHMRC should establish and administer a public register of human genetic research databases. The National Statement, as revised in accordance with Recommendation 18–1, should establish conditions of registration and provide that no genetic research under the National Statement can be conducted using information from a database unless it is duly registered.
18–3 The NHMRC, in revising the National Statement in accordance with Recommendation 18–1, should provide guidance on the circumstances in which the use of an independent intermediary is to be a condition of: (a) registration of a human genetic research database; or (b) approval by an Human Research Ethics Committee of research involving a human genetic research database.
18–4 The Australian Health Ministers’ Advisory Council, in consultation with state and territory Attorney-General’s Departments and police services, the Human Genetics Commission of Australia and the NHMRC, should develop nationally consistent rules governing the disclosure, for law enforcement purposes, of genetic samples and information held in human genetic research databases. These rules should provide for disclosure only: (a) with the consent of the sampled person or a person authorised to consent on his or her behalf; or (b) pursuant to a court order.
19. Human Tissue Collections
19–1 The Australian Health Ministers’ Advisory Council (AHMAC), in consultation with the Human Genetics Commission of Australia (HGCA), the National Health and Medical Research Council (NHMRC) and key professional bodies, should develop nationally consistent rules in relation to the collection, storage, use and disclosure of, and access to, newborn screening cards. In particular, and in consultation with state and territory Attorney-General’s Departments and police services, AHMAC should develop nationally consistent rules governing disclosure of newborn screening cards for law enforcement purposes. These rules should provide for disclosure only: (a) with the consent of the person sampled or a person authorised to consent on his or her behalf; or (b) pursuant to a court order.
19–2 AHMAC, in consultation with the HGCA, the NHMRC and key professional bodies, should review the need for nationally consistent rules in relation to the collection, storage, use and disclosure of, and access to, other human tissue collections—including collections of pathology samples and banked tissue.
20. Ownership of Samples and the Human Tissue Acts
20–1 The proprietary rights in preserved samples, which are currently enjoyed by hospitals and others under the common law, should continue to be upheld on a case-by-case basis. Legislation should not be enacted to confer full proprietary rights in human genetic samples.
20–2 Pending any comprehensive review of relevant laws, the regulation of the collection, storage, access to, or use of genetic samples (whether for the purposes of human genetic research or otherwise) should rely primarily on the Privacy Act 1988 (Cth) as amended in accordance with the Recommendations in Chapter 8, rather than on amendment of the Human Tissue Acts.