65.84 NPP 10 and NPP 2 allow the collection, use and disclosure of health information for research without consent where it is impracticable for the organisation to seek the individual’s consent before the collection, use or disclosure. The Macquarie Dictionary defines ‘impracticable’ as ‘not practicable; that cannot be put into practice with the available means’. The National Statement provides that ‘impracticable’ may include situations where the quantity, age or accessibility of the records makes it impracticable to obtain consent.
65.85 The Section 95 Guidelines allow the collection, use or disclosure of personal information by agencies without consent when it is reasonable for the research to proceed without this consent.
65.86 In its submission to the OPC Review, the NHMRC argued that the Privacy Act regime should allow the use and disclosure of health information in health and medical research where seeking consent may prejudice the scientific value of the research, or where the procedures necessary to obtain consent are likely to affect seriously and adversely the well being, including the psychological health, of the individual. A number of other submissions to the OPC Review stated that the circumstances in which the NPPs allow the collection, use and disclosure of health information without consent are too narrow.
65.87 In DP 72, the ALRC did not propose a change to the requirement that it be impracticable to seek the consent of individuals before collecting, using or disclosing their personal information for research purposes. This was on the basis that, although there is room for interpretation in regard to what amounts to ‘impracticable’ to seek consent, it appeared to be an appropriate element of the framework permitting the collection, use or disclosure of personal information without consent for research.
65.88 The ALRC did propose, however, that the Privacy Commissioner consult with relevant stakeholders in developing the rules to be issued under the research exceptions to ensure that the approach adopted in the rules and the National Statement were compatible. The ALRC anticipated that the Privacy Commissioner would include in those rules guidance on the meaning of ‘impracticable to seek consent’.
Submissions and consultations
65.89 In its submission, the OPC expressed the view that the framework contained in the NPPs for the use of health information in research without consent, including the requirement that it be ‘impracticable to seek consent’, is appropriate and effective and did not support amendments to the framework. The OPC noted that whether it is impracticable to seek consent depends on the particular circumstances of the case, and that the OPC has issued guidance on the matter. The OPC considered that organisations are required to take reasonable steps to seek consent and that there must be compelling justification to support the collection, use or disclosure of health information without consent. In the OPC’s view, this means concrete and substantial obstacles, as opposed to mere inconvenience.
65.90 The OPC provided the following examples of situations that might give rise to ‘impracticality’ for the purposes of the Privacy Act:
individuals may be uncontactable due to death or relocation (this particularly arises in relation to old records);
individuals may be part of a demographic group that is difficult to contact (for example, remote/indigenous groups);
the number of records involved may cause logistical problems; or
the objective of the investigation may need to be concealed from subjects in order to minimise various forms of bias (for example, having to obtain consent in blind trials could compromise the integrity of the research).
65.91 The Australian Privacy Foundation also expressed support for the existing framework providing for the use of personal information in research where obtaining consent is impracticable. The Australian Nursing Federation stated that the framework was appropriate, but that further guidance was needed as to the meaning of ‘impracticable’. A number of stakeholders expressed support for the proposition that the Privacy Act and the National Statement should be consistent.
65.92 On the other hand, some stakeholders raised concerns about the use of the term ‘impracticable’. The Alfred Hospital Ethics Committee stated that researchers and HRECs find the term confusing and suggested that ‘unduly burdensome’ or ‘unreasonably onerous’ would be clearer. The Committee noted that guidance was necessary on when the cost of obtaining consent would make it ‘impracticable’. The NHMRC, in particular, expressed concern, stating that:
It is not clear to us whether it would be considered impracticable to seek consent in circumstances where research subjects are contactable but the process of seeking consent would damage the scientific integrity of the proposed research. In addition, if a research participant previously has given consent in general terms for their health information to be used in a future similar research study, even though it may not be ‘impracticable’ to seek specific consent for the second study it may be quite unnecessary and inefficient to do so.
65.93 The OPC Review noted evidence that requiring consent to participate in some research projects significantly reduces the participation rate—and therefore the scientific value and integrity of the research. The AIC stated that in criminal justice research, consent can raise complex bias issues:
For example, a study that attempts to understand the correlates of delinquent behaviour amongst a sample of primary school children requires the permission of parents for their children to answer the questionnaire. However, parents whose children are less likely to be engaged in delinquent activity might be more likely to give consent, consequently biasing the sample. This would affect the validity of the results resulting in poor, and possible harmful, policy and practitioner responses.
65.94 The ALRC has considered the arguments put forward in relation to ‘impracticable to seek consent’ and acknowledges that ‘impracticable’ may not be the clearest and most appropriate test in some circumstances. For example, it may be practicable to obtain consent from individuals to use their personal information for the purposes of research in the sense that it is logistically possible, but obtaining their consent may have an unacceptable adverse impact on the integrity and validity of the research. The term ‘impracticable’, as defined above, does place a certain emphasis on the means of obtaining consent, rather than the impact of obtaining consent.
65.95 The Section 95 Guidelines incorporate a reasonableness test in relation to agencies—that is, research may proceed without consent when it is reasonable to do so. While it might be practicable to seek the consent of research participants in a particular case, it would not be reasonable to do so if this would have an unacceptable adverse impact on the integrity and validity of the research.
65.96 Both these tests should be picked up and incorporated in the model UPP research exceptions. The ALRC recommends, therefore, that agencies and organisations should be able to collect, use or disclose personal information for the purposes of research without consent where it is ‘unreasonable or impracticable’ to seek that consent.
65.97 This test is mirrored in the ‘Collection’ principle, which requires that where it is ‘reasonable and practicable’ personal information about an individual must be collected from that individual.
65.98 It is important to note that ‘unreasonable or impracticable to seek consent’ is only one element of the research exceptions. All of the other safeguards set out in the exceptions would apply, including the requirement that an HREC be satisfied that the public interest in the research outweighs the public interest in maintaining the level of privacy protection provided by the Privacy Act. In addition, the research would have to be conducted in accordance with the Research Rules issued by the Privacy Commissioner.
Recommendation 65-5 The research exceptions to the ‘Collection’ principle and the ‘Use and Disclosure’ principle should include a provision stating that it must be ‘unreasonable or impracticable’ to seek consent from individuals to the collection, use or disclosure of their personal information before that information may be used without consent for the purposes of research.
Macquarie Dictionary (online ed, 2007).
 National Health and Medical Research Council, Australian Research Council and Australian Vice Chancellors’ Committee, National Statement on Ethical Conduct in Human Research (2007), [2.3.6(c)].
 National Health and Medical Research Council, Guidelines under Section 95 of the Privacy Act 1988 (2000), [3.2(a)].
 National Health and Medical Research Council, Submission to the Office of the Privacy Commissioner Review of the Private Sector Provisions of the Privacy Act 1988, 10 December 2004.
 Australian Compliance Institute Inc, Submission to the Office of the Privacy Commissioner Review of the Private Sector Provisions of the Privacy Act 1988, 1 December 2004; University of Adelaide, Submission to the Office of the Privacy Commissioner Review of the Private Sector Provisions of the Privacy Act 1988, 21 December 2004; Australasian Epidemiology Association, Submission to the Office of the Privacy Commissioner Review of the Private Sector Provisions of the Privacy Act 1988, 1 December 2004.
 Australian Law Reform Commission, Review of Australian Privacy Law, DP 72 (2007), Proposal 58–5.
 Office of the Federal Privacy Commissioner, Handling Health Information for Research and Management, Information Sheet 9 (2001).
 Office of the Privacy Commissioner, Submission PR 215, 28 February 2007.
 Australian Privacy Foundation, Submission PR 167, 2 February 2007.
 Australian Nursing Federation, Submission PR 205, 22 February 2007.
 Australian Privacy Foundation, Submission PR 553, 2 January 2008; Australasian Epidemiological Association, Submission PR 473, 14 December 2007; Australian Nursing Federation, Submission PR 205, 22 February 2007; Office of the Health Services Commissioner (Victoria), Submission PR 153, 30 January 2007; Centre for Law and Genetics, Submission PR 127, 16 January 2007.
General Ethical Issues Sub-Committee—Alfred Hospital Ethics Committee, Submission PR 531, 21 December 2007.
 National Health and Medical Research Council, Submission PR 397, 7 December 2007.
 Office of the Privacy Commissioner, Getting in on the Act: The Review of the Private Sector Provisions of the Privacy Act 1988 (2005), 211.
 Australian Institute of Criminology, Submission PR 461, 12 December 2007.