Use and disclosure of genetic information to a patient's genetic relatives: Guidelines for organisations in NSW
This publication reproduces parts of the National Health and Medical Research Council (NHMRC) publication Use and disclosure of genetic information to a patient’s genetic relatives under section 95AA of the Privacy Act 1988 (Cth) with the permission of NHMRC.
National Health and Medical Research Council and Office of the NSW Privacy Commissioner (2009). Use and disclosure of genetic information to a patient’s genetic relatives under section 95AA of the Privacy Act 1988 (Cth), National Health and Medical Research Council, Canberra.
Amendments to this publication have also been made where appropriate to reflect the March 2014 revision of the above Commonwealth Guidelines.
This publication takes effect when the Health Legislation Amendment Act 2012 is proclaimed on 1 November 2014.
The sequencing of the human genome has led to identification of the genetic basis of an ever-increasing number of conditions. Currently, the genetic basis of almost 2,000 different familial conditions has been determined (Forrest et al 2007). As a result, health practitioners are now aware of the genetic basis of a number of familial diseases and disorders. Some of these conditions pose a serious threat to life, health or safety, and many are associated with dementia and impaired decision-making ability.
Genetic information resulting from assessment of an individual may be relevant not only to that person but also to genetic relatives, due to the shared genetic heritage within families. Depending on the nature and penetrance of the genetic condition, genetic information from one person can have consequences for the health of entire extended families. Because information gained through genetic testing can be seen as being relevant to a family rather than an individual alone (Davey et al 2006), people generally either notify family members themselves or give consent for health practitioners to do so. When this consent is not given, health practitioners may recognise the potential benefits of providing information to genetic relatives.
In 2012, the New South Wales (NSW) Parliament passed the Health Legislation Amendment Act 2012 (NSW) (Amending Act). Once commenced, the Amending Act will make amendments to include new Health Privacy Principles (HPP) 10(1)(c1) and 11(1)(c1) in the Health Records and Information Privacy Act 2002 (NSW) (HRIP Act) to allow genetic information to be used or disclosed without consent for a secondary purpose other than for the purpose for which it was collected. HPP 10(1)(c1) will allow genetic information to be used by an organisation in circumstances where there is a reasonable belief that doing so would be necessary to lessen or prevent a serious threat to life, health or safety (whether or not the threat is imminent) of genetic relatives, and in accordance with guidelines issued by the NSW Privacy Commissioner, if any. HPP 11(1) (c1) will allow disclosure of genetic information to genetic relatives where there is a reasonable belief that disclosure is necessary to lessen or prevent a serious threat to life, health or safety of genetic relatives. This genetic information must also be disclosed in accordance with guidelines issued by the NSW Privacy Commissioner, if any.
The amendments to the HRIP Act provide for guidelines that clarify circumstances in which genetic information may be used or disclosed without consent. The amendments do not oblige disclosure of information but provide the framework for this to occur in appropriate circumstances.
Breaches of the Guidelines may be pursued under the procedures for inquiries and investigations conducted by the NSW Privacy Commissioner.
The Guidelines specify the requirements that must be met by an organisation if they choose to use or disclosegenetic informationwithout patient consent under HPP 10(1)(c1) or 11(1)(c1). Use or disclosure of genetic information without consent must be in accordance with HPP 10 or 11 and these Guidelines. These Guidelines have been issued by the NSW Privacy Commissioner with the approval of the Minister for Health.
These Guidelines apply to every organisation in NSW that is a health service provider or that collects, holds or uses genetic information in the course of providing health services to individuals (for example, medical specialists and general practitioners). The term organisation means public sector agencies, including public health organisations, or a private sector person.
A private sector person can be a natural person, body corporate, partnership or trust or any other unincorporated association or body, but does not include a small business operator within the meaning of the Commonwealth Privacy Act 1988, or an agency within the meaning of that Act (Section 4 of the HRIP Act).
Although small business operators are generally excluded, all health service providers are bound by the Guidelines irrespective of their size.
Organisations should take their own legal advice if they are in doubt about whether they are an organisation for the purposes of the HRIP Act, and these Guidelines.
As well as reflecting the amendments to the HRIP Act, the Guidelines give general guidance that can be adapted to specific situations. These situations will differ depending on a range of factors including the genetic condition involved, relationships within the family, and the health care setting.
The scope of the Guidelines does not include:
- the disclosure of genetic information to anyone other than the patient and genetic relatives, as this is outside the scope of HPP 10(1)(c1) and 11(1)(c1);
- situations in which consent to use or disclosegenetic information to relatives has been given — in these cases, the provisions under HPP 10(1)(c1) and 11(1)(c1) are not applicable as HPP 10(1)(c1) and 11(1)(c1) are concerned with disclosure without consent. However, the HPPs and the duty of confidentiality will still need to be considered before disclosing information even with the consent of the patient;
- situations concerning genetic information that present a serious threat to an unborn child, as these fall outside the intended scope of HPP 10(1)(c1) and 11(1)(c1). The patient’s consent to disclose his or her genetic information to a pregnant mother would be required if there was a serious threat to the unborn child;
- general information about genetic assessment, clinical information to support diagnosis, use of medical records, stored genetic samples or general consent issues;
- the health practitioner’s professional obligation to seek, record, interpret and act on the patient’s family history;
- more general issues relating to the application of the HRIP Act and the duty of confidentiality in health;
- genetic screening;
- genetic information that is stored in databases or registers maintained by the Commonwealth and other State or Territory agencies, as this is outside the scope of HPP 10(1)(c1) and 11(1)(c1); or
- the use of genetic information in human research (as discussed in Chapter 3.5 of the National Statement on Ethical Conduct in Human Research).
 Scenarios 1, 2 and 3 deal with circumstances where consent has been provided or the patient chooses to contact relatives. These are included to demonstrate good practice in these more usual circumstances.
Structure of the guidelines
The guidance in this document is intended to satisfy the purpose of HPP 10(1)(c1) and 11(1)(c1). The document comprises four parts:
- Part A lists the nine Guidelines that specify the requirements that must be met for disclosure to take place and provides an explanation of the terms used in the Guidelines;
- Part B provides a summary of the Guidelines and key points for good practice;
- Part C includes discussion of:
- the amendments to the HRIP Act introduced in the Amending Act (Chapter 1);
- ethical considerations, including factors involved in understanding specific situations (Chapter 2); and
- requirements for use or disclosure without consent in accordance with HPP 10(1)(c1) or 11(1)(c1) and good practice throughout the process of decision-making and, potentially, disclosure (Chapter 3); and
- Part D includes a number of scenarios, which provide general guidance on how authorising medical practitioners and disclosing health practitioners may meet the requirements under HPP 10(1)(c1) or 11(1)(c1) and act in accordance with the Guidelines. However, it should be noted that the scenarios are to assist organisations tocomply with HPP 10(1)(c1) and 11(1)(c1) and the nine Guidelines. Acting in accordance with the scenarios does not necessarily protect against a breach of the HPPs or a breach of the duty of confidentiality (common law) (see Appendix 1).
The appendices provide:
- excerpts from the HRIP Act, including the HPPs (Appendix 1);
- sample materials that can be adapted for local use (Appendix 2); and
- answers to frequently asked questions (Appendix 3).
The Guidelines were adopted (with appropriate amendments) from the NHMRC’s “Use and disclosure of genetic information to a patient’s genetic relatives under s95AA of the Privacy Act 1988 (Cth)” to ensure consistency with the applicable Commonwealth standards. The Commonwealth Guidelines were approved by the Commonwealth Privacy Commissioner.