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Review flags national indemnity program for clinical trials

Insurance and indemnity arrangements for clinical trials could be streamlined to provide more national consistency, a new report has found.

“There are variations between the states and territories, between the public and private sectors and across the private sector, in relation to indemnity and insurance arrangements and practices for clinical trials,” the paper by Rallis Legal says.

“However, more significantly, the review has identified that there are also many fundamental similarities.”

The report was commissioned by the National Health and Medical Research Council, which aims to improve the competitiveness of Australia’s clinical research sector.

States and territories have their own procedures for ethical reviews and governance of clinical trials in the public health sector, but the report says they are increasingly similar and there do not appear to be laws preventing a national approach.

An existing national mutual acceptance arrangement for scientific and ethical reviews of trials held in multiple centres provides a public sector model that works across jurisdictions, according to the review.

“Many stakeholders, including commercial sponsors and commercial insurers, are supportive of, and would welcome, processes that standardise indemnity and insurance requirements across the public and private sectors.”

The report suggests it “may not be exceedingly difficult” to establish a baseline level of insurance that would qualify a private sector entity for unrestricted participation in a national system.