Hawthorn-based National Institute of Integrative Medicine faces scrutiny over clinical trials
“Where an in-house [blood test] has been used within a clinical trial and the results are reported to a clinician, then the Therapeutic Goods Administration usually mandates use of an accredited facility,” National Association of Testing Authorities general manager of compliance and governance Tony Vandenberg told The Age.
However, medical watchdog the Therapeutic Goods Administration had a different view, telling The Age that National Association of Testing Authorities’ accreditation was not a requirement for clinical trials.
David Hawkes, a University of Melbourne molecular virologist, said accreditation was important to show a laboratory had a “framework for quality”.
“Clinical tests being reported from non-accredited laboratories have no such assurances.”
By operating within a clinical trial, researchers are able to subject volunteers to drugs and devices that otherwise are banned for use on the public.
The Therapeutic Goods Administration has no oversight of a trial’s design, safety, or whether it is ethical; that is the purview of a human research ethics committee appointed by the institution running the trial.
David Vaux, a senior cancer researcher and member of the US-based Centre for Scientific Integrity, said a loophole had been exposed in Australia’s scientific research regulations.
“It must be corrected urgently,” Professor Vaux said. “An organisation could set up its own human research ethics committee and approve its own clinical trials with essentially no oversight.
“Currently, if a human research ethics committee chooses to do so, it can approve clinical trials that would be in breach of the Nuremberg Code and the Helsinki Declaration that were brought in in response to atrocities by Germany before the end of the Second World War.”
The National Health and Medical Research Council requires ethics committees to self-report their compliance with the National Statement on Ethical Conduct in Human Research.
In 2020, according to research council documents seen by The Age, NIIM told the regulator it did not have all the required members. But when research proposals were reviewed, it told the regulator it did have enough members.
The National Health and Medical Research Council said it did not have the power to investigate clinical trials.
Ken Harvey, president of industry association Friends of Science in Medicine, who backed Professor Vaux’s calls for a review of clinical trial regulation, said the lack of oversight was troubling.
“The regulators don’t look. That’s the problem,” Dr Harvey said.
NIIM did not respond to questions about its unaccredited laboratory or the make-up of its ethics committee.
“The results of the trial you asked about have been published and we have no further comment to add,” a spokesman for the institute said.
“Questions about activities undertaken by the regulatory authorities named in your questions should be directed to those authorities.”