Page 1024 - Week 03 - Thursday, 10 April 2014

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Mr Rattenbury (in reply to a question by Mr Coe on Wednesday, 19 March 2014): In response to your question, two databases are maintained by the ACT Government which include information on cyclist safety.

One database is maintained by Territory and Municipal Services Directorate and the other by the Health Directorate.

Both Directorates share this information and report annually on the number of reported cyclists crashes through the ‘Patterns of Road Traffic Crashes in the ACT’ report that is published on the Justice and Community Safety Directorate website. It should be noted that there is likely to be a high level of unreported crashes in the ACT involving cyclists.

Canberra Hospital—stem cell treatment

Ms Gallagher (in reply to a supplementary question by Mr Hanson on Wednesday, 19 March 2014): I am aware the ACT Health Human Research Ethics Committee (HREC) rejected an initial and an amended stem cell treatment research proposal on ethical grounds. Ordinarily, HREC proceedings are confidential and information about why research protocols are not approved is not released to the public and this would include the Legislative Assembly. However, in this case, in view of the recent publicity in the media and the Legislative Assembly discussion, I consider it reasonable to release general information that respects the researchers’ and the participants’ privacy and confidentiality.

In accordance with the National Statement on Ethical Conduct in Research Involving Humans (the Code), issued by the National Health and Medical Research Council (NHMRC), HREC will require an amendment of or reject a research proposal on ethical grounds when it is not satisfied that a research protocol gives adequate consideration to participants’ welfare, rights, beliefs, perceptions, customs and cultural heritage (both individual and collective).

HREC Review of the Initial Stem Cell Treatment Research Proposal

HREC concluded that the initial research proposal failed to satisfy the Code criteria in Research Merit and Integrity. Specifically:

Research Merit and Integrity

- Justifiable by its potential benefit: European study shows limited benefit and high toxicity. Figures report a fatality rate of one percent. HREC agreed the potential harm outweighed the benefit.

- Study design: Figures presented in the application showed the study to be under powered and lacking a sufficient scientific rationale. HREC agreed the study design, as presented, did not satisfy the requirements of Research Merit and Integrity.

Further (unspecified) concerns were raised with regard to Beneficence and Respect. HREC invited the researchers to meet with the committee before resubmitting an amended research proposal.

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