BreastScreen SA Apologizes for Conducting Studies Without Ethics Approval or Consent
South Australia's public breast cancer screening service, BreastScreen SA, has issued an unreserved apology after an ombudsman investigation revealed it conducted research on nearly 100 patients without proper ethics approval or informed consent. The investigation, led by SA Ombudsman Emily Strickland, focused on two studies involving repeat needle biopsies performed between 2019 and 2021. In one study, women with benign lumps were subjected to additional assessments without being told they were part of a research project. In another, patients with abnormal cell growth were misled about the purpose of repeat biopsies, with officials withholding specific diagnosis details. Although the ombudsman characterized these actions as administrative errors made in good faith to improve public health services, the findings have drawn sharp criticism. Bernadette Mulholland of the SA Salaried Medical Officers' Association described the report as damning, suggesting a lack of transparency that would appall clinicians. The Central Adelaide Local Health Network acknowledged that the activities were later determined to be research rather than quality improvement, prompting retrospective efforts to inform participants and seek consent for data use.
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BreastScreen SA Apologizes for Conducting Studies Without Ethics Approval or Consent
South Australia's public breast cancer screening service, BreastScreen SA, has issued an unreserved apology after an ombudsman investigation revealed it conducted research on nearly 100 patients without proper ethics approval or informed consent. The investigation, led by SA Ombudsman Emily Strickland, focused on two studies involving repeat needle biopsies performed between 2019 and 2021. In one study, women with benign lumps were subjected to additional assessments without being told they were part of a research project. In another, patients with abnormal cell growth were misled about the purpose of repeat biopsies, with officials withholding specific diagnosis details. Although the ombudsman characterized these actions as administrative errors made in good faith to improve public health services, the findings have drawn sharp criticism. Bernadette Mulholland of the SA Salaried Medical Officers' Association described the report as damning, suggesting a lack of transparency that would appall clinicians. The Central Adelaide Local Health Network acknowledged that the activities were later determined to be research rather than quality improvement, prompting retrospective efforts to inform participants and seek consent for data use.
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