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

Medical Journal of Australia

Volumn 187, Issue 1, 2007, Pages 7-8

  Fraser, Helen E ^a   Martlew, Ainsley E ^a   Frew, Deborah J ^a  

^a New South Wales Government   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

AUSTRALIA; BUDGET; CLINICAL RESEARCH; CLINICAL STUDY; EDITORIAL; FINANCIAL MANAGEMENT; GOOD CLINICAL PRACTICE; HUMAN DIGNITY; HUMAN RIGHTS; LAW; MEDICAL ETHICS; PROFESSIONAL STANDARD; PUBLIC HEALTH; PUBLICATION; RESEARCH ETHICS; RESEARCH SUBJECT; STANDARDIZATION; WELFARE;

EID: 34447515208     PISSN: 0025729X     EISSN: None     Source Type: Journal    
DOI: 10.5694/j.1326-5377.2007.tb01106.x     Document Type: Editorial

References (10)

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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.
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6. Lowenthal RM. Outdated ethical review system impedes important research [letter]. Med J Aust 1999; 171: 51.
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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).