Editorials
Ethics Genetics
Volume 194 - Issue 8

Alerting genetic relatives to a risk of serious inherited disease without a patient’s consent

Authors:  Graeme K Suthers, Elizabeth A McCusker and Samantha A Wake

Med J Aust 2011; 194 (8): 385-386. || doi: 10.5694/j.1326-5377.2011.tb03026.x
Published online: 18 April 2011
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Guidelines for private sector practitioners implementing the new provisions in the Privacy Act

Every health care practitioner must respect confidentiality. Patients reasonably expect that private information offered or identified during an episode of care will not be divulged without their consent. The fundamental importance of confidentiality finds formal expression in the National Privacy Principles. Practitioners in the private sector must comply with the National Privacy Principles, which are embodied in the Privacy Act 1988 (Cwlth).1 Public sector employees are obliged to comply with the relevant legislation in each jurisdiction.

Knowledge of a history of disease in relatives can be crucial for making a diagnosis in a patient. Similarly, medical care of relatives may be affected by the patient’s diagnosis. For example, a family history of colorectal cancer may assist in identifying the cause of a patient’s abdominal pain, and the diagnosis of colorectal cancer in the patient would then place his or her close relatives at increased risk of the same condition.

In general, a practitioner is not obliged to inform relatives about the diagnosis of a familial disorder. There are some situations in which a practitioner may be required to advise a third party about a patient’s non-genetic diagnosis because of an immediate threat to the safety of others, as is the case with certain infections such as hepatitis A.2 These legally sanctioned breaches of confidentiality do not apply to the risk of a relative developing a familial disorder at some unspecified time in the future. Nonetheless, a practitioner cannot ignore the medical implications of a familial diagnosis for the patient’s relatives, and must inform the patient (or the patient’s authorised representative) of these implications and recommend that they seek medical advice in their own right.3

It is unusual for a patient to refuse to share such information with relatives,4 but such situations do arise and present the practitioner with a challenging dilemma.5 On the one hand, the patient has a right to make an autonomous decision about the use of personal information. On the other hand, this information has a direct bearing on the future health of relatives who may welcome the opportunity to make strategic decisions regarding their health. Whose rights should prevail?

Before 2006, the privacy legislation in Australia was unequivocal: in the absence of an immediate threat to the health or wellbeing of a third party, the patient’s right to privacy prevailed and relatives could not be informed without the patient’s consent. This situation has since changed. In response to a recommendation from the Australian Law Reform Commission,6 the federal government amended the Privacy Act in 2006 to make specific provision for this situation.7 The Privacy Legislation Amendment Act 2006 (Cwlth) allows for the disclosure and use of information without consent, provided that such disclosure is

necessary to lessen or prevent a serious threat to the life, health or safety (whether or not the threat is imminent) of an individual who is a genetic relative of the individual to whom the genetic information relates ...

The significant provision is that the threat need not be imminent and may occur at an unspecified time in the future.

There are some important features of this amendment that must be borne in mind. First, the amendment applies only in the setting of managing a familial disorder in a health care setting. A medical practitioner must authorise disclosure, and there must be consultation with appropriate colleagues.

Second, the amendment does not require the practitioner to notify relatives about a familial disorder. The amendment provides a potential legal mechanism for doing so but does not create an obligation.

Third, the amendment only applies to the disclosure and use of genetic information that is necessary to lessen the risk of a familial disorder for a genetic relative. There is no provision to release other information about the patient (including the patient’s identity), or to release information to a non-genetic relative (other than the authorised representative of a genetic relative).

Finally, the Privacy Act currently applies only to practitioners in the private sector. The amendment does not apply to health care practitioners in the public sector. It is anticipated that similar provisions and processes will be developed in the local legislation of the states and territories, which would apply to practitioners in the public sector.

The potential to disclose a patient’s confidential information to a relative against the patient’s wishes represents a major departure from longstanding views on confidentiality in health care. It is appropriate that such an action be taken rarely and with great circumspection. Furthermore, the process for disclosure must recognise that many relatives do not use the genetic information provided to them.8

The National Health and Medical Research Council (NHMRC) has developed guidelines for practitioners who might use this amendment;1 the principles that form the heart of the document are summarised in the Box. Readers should refer to the full guidelines for details, and to a more general NHMRC discussion paper on genetic testing in health care.9

It is important to note that the guidelines1 are not simply recommendations regarding best practice — they are the formal mechanism for implementation of this federal legislation, and practitioners who wish to use the provisions of the Privacy Legislation Amendment Act must comply with the guidelines and requirements of the Privacy Commissioner.10

There is another important sense in which the guidelines do not reflect “best practice”. With careful and considerate communication, especially before embarking on genetic tests that might diagnose a familial disorder, it is usually possible to resolve issues of concern that a patient may have about sharing this personal, confronting, and potentially useful information with relatives. Best practice is represented by striving to avoid the need to use the provisions of this amendment. With a combination of professionalism and patience, most apparent conflicts can be resolved without recourse to disclosing private information without consent.

NHMRC guidelines for the use or disclosure of genetic information to a patient’s genetic relatives1

The guidelines developed by the NHMRC* for implementing the new provisions of the Privacy Act 1988 (Cwlth) are as follows:

1. Use or disclosure of genetic information without consent may proceed only when the authorising medical practitioner has a reasonable belief that this is necessary to lessen or prevent a serious threat to the life, health or safety of a genetic relative.

2. Specific ethical considerations must be taken into account when making a decision about whether or not to use or disclose genetic information without consent.

3. Reasonable steps must be taken to obtain the consent of the patient or his or her authorised representative to use or disclose genetic information.

4. The authorising medical practitioner should have a significant role in the care of the patient and sufficient knowledge of the patient’s condition and its genetic basis to take responsibility for decision making about use or disclosure.

5. Prior to any decision concerning use or disclosure, the authorising medical practitioner must discuss the case with other health practitioners with appropriate expertise to fully assess the specific situation.

6. Where practicable, the identity of the patient should not be apparent or readily ascertainable in the course of interprofessional communication.

7. Disclosure to genetic relatives should be limited to genetic information that is necessary for communicating the increased risk and should avoid identifying the patient or conveying that there was no consent for the disclosure.

8. Disclosure of genetic information without consent should generally be limited to relatives no further removed than third-degree relatives.

9. All stages of the process must be fully documented, including how the decision to use or disclose without consent was made.

NHMRC = National Health and Medical Research Council.
* NHMRC’s Working Committee (Dr Sandra Hacker, Ms Sharon Caris, Dr Elizabeth McCusker, Dr Graeme Suthers and Dr Samantha Wake) developed the guidelines in collaboration with the NHMRC’s Australian Health Ethics Committee and Human Genetics Advisory Committee.

Authors

  • Graeme K Suthers PhD, FRACP, FRCPA1,2
  • Elizabeth A McCusker MB BS, FRACP3
  • Samantha A Wake BSc(Hons), PhD, FHGSA4,5
  • 1. SA Clinical Genetics Service, SA Pathology, Women’s & Children’s Hospital, Adelaide, SA.
  • 2. Department of Paediatrics, University of Adelaide, Adelaide, SA.
  • 3. Huntington Disease Service, Department of Neurology, Westmead Hospital, Sydney, NSW.
  • 4. Genetic Health Services Victoria, Murdoch Childrens Research Institute, Melbourne, VIC.
  • 5. Department of Paediatrics, University of Melbourne, Melbourne, VIC.

Correspondence: graeme.suthers@health.sa.gov.au

Competing interests

We were on the NHMRC committee that drafted the guidelines for practitioners about using the provisions of the Privacy Act 1988 (Cwlth) to disclose genetic information without consent, and received travel support from the NHMRC to attend committee meetings; Samantha Wake also received a sitting fee.

References

Provenance: Not commissioned; externally peer reviewed.

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