Model for a single ethical and scientific review of multicentre research in New South Wales

Fraser, Helen E; Martlew, Ainsley E; Frew, Deborah J

doi:10.5694/j.1326-5377.2007.tb01106.x

Topics

A welcome alternative to the current cumbersome and inefficient system

Australia’s system of ethical review of human research is based on a National Health and Medical Research Council (NHMRC) publication, the National statement on ethical conduct in research involving humans.1 This statement requires all research involving humans to be reviewed by an appropriately constituted human research ethics committee (HREC), whose primary role is to protect the welfare, rights and dignity of human research participants. It is also a requirement of Australian therapeutic goods legislation that all clinical trials that use unapproved therapeutic goods obtain approval from an HREC.2

Health Research and Ethics Branch, NSW Health, Sydney, NSW.

Correspondence: hfras@doh.health.nsw.gov.au

1. National Health and Medical Reseach Council. National statement on ethical conduct in research involving humans. Canberra: NHMRC, 1999. http://www.nhmrc.gov.au/publications/synopses/_files/e35.pdf (accessed May 2007).
2. Therapeutic Goods Administration. Access to unapproved therapeutic goods — clinical trials in Australia. Canberra: TGA, 2004: 12. http://www.tga.gov.au/docs/pdf/unapproved/clintrials.pdf (accessed Jun 2007).
3. Roberts LM, Bowyer L, Homer CS, Brown MA. Multicentre research: negotiating the ethics approval obstacle course [letter]. Med J Aust 2004; 180: 139. <MJA full text>
4. Sarson-Lawrence M, Alt C, Mok MT, et al. Trust and confidence: towards mutual acceptance of ethics committee approval of multicentre studies. Intern Med J 2004; 34: 598-603.
5. Fox RM. Debate: should Australia move towards a centralized ethics committee system? The case for. Intern Med J 2005; 35: 247-248.
6. Lowenthal RM. Outdated ethical review system impedes important research [letter]. Med J Aust 1999; 171: 51.
7. Banscott Health Consulting Pty Ltd. Report of the review of access to unapproved therapeutic goods. Canberra: Therapeutic Goods Administration, 2005: 91. http://www.tga.gov.au/consult/2005/cltrialrevrep.pdf (accessed Jun 2007).
8. Directive 2001/20/EC of the European parliament and of the council on the approximation of the laws, regulations and administrative provisions of member states relating to the implementation of good clinical practice in the conduct of clinical trials on medical products for human use. OJEC 2001; L121: 34-44. http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf (accessed Jun 2007).
9. Pharmaceuticals Industry Council Research and Development Taskforce. Report on the 2007 forum: an update on a national approach to clinical trials. Canberra: Pharmaceuticals Industry Council, 2007: 13-16. http://www.ausbiotech.org/UserFiles/File/2007%20PIC%20RDTF%20Forum %20Report%2001%20March%202007Final.pdf (accessed Jun 2007).
10. Australian Government. Budget 2007–08. Health and medical research — streamlining human research ethics reviews. http://www.budget.gov.au/2007-08/bp2/html/expense-20.htm (accessed Jun 2007).

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