Monitoring approved research protocols - A question of balance

Medicine and Law

Volumn 16, Issue 4, 1997, Pages 655-677

  Linden Laufer, Suzie ^a,b  

^a Department of Law ^*  (Australia)

^b BOND UNIVERSITY   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; AUSTRALIA; DRUG RESEARCH; ETHICS; HEALTH CARE SYSTEM; HUMAN RIGHTS; MEDICAL ETHICS; MEDICAL RESEARCH; MONITORING; PRACTICE GUIDELINE; PROFESSIONAL PRACTICE; PROFESSIONAL STANDARD;

EID: 0031545380     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (17)

1. A discussion paper prepared for the Australian Health Ethics Committee 1995 series of workshops for Institutional Ethics Committees. The author would like to acknowledge the contribution of ideas and assistance provided by all members of the Australian Health Ethics Committee.
2. Paragraph 8, Supplementary Note 1, NHMRC Statement on Human Experimentation.
3. S35(3) National Health and Medical Research Council Act 1992 (Cth).
4. Guidelines for the Monitoring of Research by Institutional Ethics Committees, National Health and Medical Research Council, 1992, Section A, paragraphs 1-4 inclusive.
5. Ibid, Section A, paragraph 5.
6. Ibid, Section C.
7. Ibid, Section B.
8. Ibid, Preamble.
9. IEC Annual Reports for the period 1 July 1993 to 30 June 1994. The information generated was based upon responses to Question 2 in the Annual Report which asked: "What procedures does your IEC have in place to monitor research projects approved by your IEC to their completion?" It should be noted that the degree of reliance to be placed on the answers in the Annual Report depends, to some extent, on the type of institution, the number and frequency of meetings of the IEC, the type of research conducted within the particular institution, and other local variations in procedure. In this respect there is no way in which the comments provided can be related back to the particular institutions from whence they came. Thus, for those institutions which already have in place structures for continuous scrutiny, these may have been taken for granted in their responses to the questions asked.
10. Review of the Clinical Trial Notification (CTN) Scheme, May 1993, Prof R Day (Chair), Recommendation 30 stating that "...further action is urgently required in developing monitoring systems at the local/institutional level".
11. Ibid.
12. See Medicare Agreements Act 1992 (Cth) and Accompanying Principles.
13. "Patient and Quality Assurance", Ian Siggins, Health Rights Commissioner, Qld, (1993) 1 HLB, 81.
14. "Stressors for the IRB: Handling Reports of Non-Compliance, Surviving Audits, and Adverse Reaction Reporting", Melody H Lin, Paper presented at PRIM&R conference entitled "Protecting Human Subjects; Challenges Presented by the New Research Environment", Boston, Massachusetts, October 22, 1993.
15. Data Safety Monitoring Boards are generally constituted by researchers, "ideally independent of a clinical trial". They monitor, on a regular basis, the data and have the capacity to prematurely stop a trial in the event of detected adverse effects on research subjects. See "Clinical Trial Monitoring: Hit or Miss?", Special News Report, Science Vol 264, 10 June 1994, 1534, 1535.
16. "The Institutional Review Board: The Ethical Gatekeeper", Richard L Cohen and Alexander J Ciocca, Research Fraud In The Behavioural and Biomedical Sciences, edited by David J Miller and Michael Hersen, 1992, John Wiley & Sons, Inc, p 219-220.
17. Supra note 3, at 1-15.