Part E: Human Genetic Databases

Part E deals with the regulation of genetic samples and information in databases created specifically for use in research (human genetic research databases) and in collections formed for other purposes that may have research uses (human tissue collections). Part E also considers regulatory issues related to the law of property and the Human Tissue Acts.

Chapter 18 is concerned with genetic samples and information collected primarily for use in research and held in collections by hospitals, public and private research organisations, and in the archives of pathology laboratories. Researchers increasingly are compiling such collections to aid studies into the causes of disease, drug reactions, and the interaction between genetics and the environment. The Inquiry recommends that the NHMRC amend the National Statement to provide ethical guidance on the establishment, governance and operation of human genetic databases—and, in parti-cular, to offer specific guidance on obtaining consent to unspecified future research.

As part of these changes to the National Statement, the Inquiry recommends that the NHMRC establish and administer a public register of human genetic research databases, develop conditions of registration, and include provisions so that no genetic research under the National Statement can be conducted using information from a database unless it is duly registered. The Inquiry also recommends that the National Statement be amended to provide guidance on the use of a ‘gene trustee’ system, where appropriate, as an additional privacy protection.

Finally, Chapter 18 recommends that the Australian Health Ministers’ Advisory Council (AHMAC) 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 be based upon the principle that such disclosure is permissible only with the consent of the person sampled or pursuant to a court order.

Chapter 19 is concerned with genetic samples and information held in tissue collections maintained chiefly by hospitals or pathology laboratories, which have not been collected primarily for use in research. For example, archived collections of preserved human tissue and collections of newborn screening cards (also known as ‘Guthrie cards’) are invaluable research resources for studies into the genetic causes of disease. Genetic testing of stored tissue samples has potential uses in other contexts, including criminal or police investigations, as evidence in court proceedings and for parentage or other kinship testing. These secondary uses raise important issues of ethics, privacy and consent. The Inquiry recommends that AHMAC also develop nationally consistent rules in relation to the handling of newborn screening cards and other human tissue collections. Disclosure for law enforcement purposes should be permissible only with the consent of the person sampled (or a person authorised to consent on his or her behalf) or pursuant to a court order.

Chapter 20 considers whether privacy interests in genetic information might be protected more effectively by recognising increased property rights over genetic samples. The Inquiry concludes there should be no change to the current position whereby hospitals and pathology laboratories have a proprietary right to preserved samples, but full property rights in genetic samples are not recognised.

Each Australian State and Territory has enacted legislation that regulates the donation of human tissues and organs for transplantation and research (the Human Tissue Acts). In Chapter 20, the Inquiry examines whether amending the Human Tissue Acts to cover the handling of genetic samples might be an effective means of protecting pri-vacy interests. Until such a review is conducted, the Inquiry believes that the regulation of the handling of genetic samples should not rely primarily on amendments to the Human Tissue Acts.