Clinical trial information access: ‘Beyond Ageing Project’

In Raven v The University of Sydney [2015] NSWCATAD 104 the applicant, an academic,sought access information due to her concerns about a clinical trial which the University approved and, in particular, her concerns about the use of the antidepressant, sertraline, in the trial.

The Tribunal considered the public interest issues and noted at [40]:

The University acknowledged that there is a public interest in disclosing information that facilitates public scrutiny of research proposals and promotes transparency in University decision making. It submitted, however, that researchers are already required to provide detailed evidence-based justifications of their research to the HREC and that the appropriate time for debate about research is following the publication of peer-reviewed research results, not at the clinical trial phase.

At [131] the Tribunal concluded:

On balance, the public interest considerations against disclosure outweigh those in favour of disclosure, including the personal factors of the application, even though the considerations in favour of disclosure are not insubstantial. There is a strong public interest in preserving the confidentiality of ethics applications and of the University’s processes for considering such applications, so as to ensure that researchers continue to provide full and frank information when seeking ethics approval, that they continue to seek such approval at public institutions, that reviewers are prepared to conduct reviews and do so candidly and that HREC members are not inhibited in what they say about ethics applications in meetings. The prejudice to the supply of confidential information, and the effective exercise of the functions the University exercises through the HREC, could reasonably be expected to be significant.

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