Comment: As I understand Carapetis et al's study, the researchers determine who has a group A streptococcal infection from the laboratory that performs the test (as this infection is not a notifiable disease,1 there is no central source of information). The laboratory may be independent or in a public or private hospital, and may be situated anywhere in Victoria. The laboratory tells them who requested the test and the patient's name and infection status. The researchers then seek assistance from the hospital or doctor requesting the test in obtaining "individual informed consent" from the patient to release clinical information to the researchers. Each institution has required that its own human research ethics committee approve the project, as well as the Department of Human Services (DHS) Ethics Committee, before the laboratory releases information. This accords with the law, but the additional bureaucracy and costs involved will deter much important public health research.
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- 1. Health (Infectious Diseases) Regulations 2001 (Vic) reg 6, scheds 3, 6.
- 2. Health Records Act 2001 (Vic) s 141(3)(g)(iii). Sched 1, Health Privacy Principle (HPP) 2.2(g).
- 3. National Health and Medical Research Council. Guidelines approved under Section 95A of the Privacy Act 1988. Canberra: NHMRC, 2001. Available at <http://www.nhmrc.gov.au/publications/synopses/e43syn.htm>
- 4. Health Records Act 2001 (Vic) s 22(1)(a)(5).
- 5. Tully J, Ninis N, Booy R, Viner R. The new system of review by multicentre research ethics committees: prospective study. BMJ 2000; 320: 1179-1182.