Gene database study backs 'privacy guardians'

A new class of "privacy guardians" for genetic research databases and new laws requiring private sector researchers to conform to public sector ethical guidelines are two likely outcomes of a major Australian inquiry into the protection of genetic information.

The 18-month inquiry, headed by the Australian Law Reform Commission, has released 105 proposals which give a strong indication of its final report due next March.

The recommendations cover ethical guidance and scrutiny for medical researchers, privacy and anti-discrimination laws, education and counselling services, risk-rating in insurance, the use of genetic information by employers, DNA profiling by law enforcement authorities, and DNA testing to determine kinship relations, including parentage and Aboriginality.

In particular, they foreshadow new rules governing researchers' access to genetic databases and tissue banks.

The inquiry sees the need for privacy guardians controlling some types of access to institutional databases, said Dr Kerry Breen, chairman of the Australian Health Ethics Committee of the National Health and Medical Research Council (NHMRC), which is jointly running the inquiry.

Such guardians - who would be independent of both internal ethics committees and researchers - would rule on situations involving the linkage of specific individuals with data being used for research purposes.

An example might be a case in which anonymous tissue is found to contain previously undetected abnormalities by researchers. A request to identify the individual who provided the tissue sample would be routed through the independent privacy guardian.

Australian Genomic Information Centre CEO Mike Poidinger said he saw a growing need for such guardians because of research database trends.

"There is a move toward robust federated databases which hold information on both scientific results and human clinical trials," Poidinger said. "One of the holy grails [of life science researchers] is biological data integration in which all this information is brought together."

The inquiry also recommends patching holes in current ethical guidelines for genetics researchers. At the moment, national guidelines only apply to institutions receiving funding from the NHMRC, Breen said. Private foundations using their own resources "can theoretically work outside these guidelines.

"There is no evidence it is happening but the possibility is there so our feeling is to get it tightened up," Breen said.

A second hole the inquiry wants filled relates to tissue banks holding material that may have been stored for some time. Contacting donors to obtain consent is often difficult and ethics committees can grant waivers to researchers.

The inquiry is proposing that ethics committees be required to provide statistics in future on how often consent is waived.

"There are those who are sceptical of the value of ethics committees and believe they may be waiving consent left, right and centre," Breen said.

There is no data to prove or disprove that belief at present but the inquiry recommendation would solve that problem.

Besides strengthening ethical oversight of all human genetic research and tightening reporting requirements, the inquiry wants transparent disclosure to research participants of the commercialisation potential flowing from their work.

As previously flagged, the inquiry strongly believes in setting up a broad-based, independent body - similar to the UK's Human Genetics Commission - to provide high-level advice to governments and industry about human genetics, and to assist in developing and harmonising the existing "patchwork" of laws, guidelines and practices. The interim report is meant to prompt feedback on its proposals so they can be fine-tuned before final recommendations are released.

There is no "one-size-fits-all" solution to the issue of protecting people's privacy and rights from misuse of genetic information, according to Breen: "For example, the way we deal with genetic material for research should be different from regulating its use by insurers or employers."

The inquiry has found Australia requires a careful mix of strategies that embrace stronger ethical oversight, stiffer regulations, industry codes, education campaigns, an independent expert advisory body, revised privacy and discrimination laws, and perhaps even new criminal laws.