BreastScreen SA Apologizes for Not Getting Approval for Research

BreastScreen SA apologized to almost 100 patients.

In short:

BreastScreen SA did research without approval or consent from patients.

The report said the Central Adelaide Local Health Network opposed a public apology.

What's next?

BreastScreen SA apologized to women who were not informed about the research.

South Australia's breast cancer screening service did research without approval.

BreastScreen SA did the research between September 2020 and September 2021.

The SA ombudsman started an investigation in May 2023.

The ombudsman wrote that BreastScreen SA did the study without approval.

BreastScreen SA did not get informed consent from participants.

The ombudsman also looked into another BreastScreen SA study.

BreastScreen SA did that study without seeking advice from the ethics committee.

The ombudsman made findings of 'administrative error' for both studies.

The ombudsman said the errors were serious but done in good faith.

The SA Salaried Medical Officers' Association said the findings were 'damning'.

The association's chief said clinicians would be 'appalled'.

The chief said it felt like hiding the truth from the community.

Study participants were not asked for their consent.

The first study started in September 2020 and involved repeat assessments.

The study was to determine if repeat assessments should be standard practice.

At the time, BreastScreen SA thought the study was part of improving care.

Patients consented to assessments but not to participate in research.

The human research and ethics committee determined the study was research.

The committee worked with BreastScreen SA to inform participants and get consent.

Patients were not informed about their biopsy findings.

The second study started in late 2019 and involved patients with abnormal cell growth.

The standard pathway was to do an open biopsy for women with abnormal cell growth.

BreastScreen SA changed its guidelines to require an additional needle biopsy.

Patients were told their initial sample was insufficient and they needed another biopsy.

Participants were not informed that their first biopsy had identified abnormal cell growth.

The ombudsman said an apology would be appropriate to strengthen public confidence.

The BreastScreen SA clinical director said advising patients of the preliminary diagnosis would be 'inappropriate'.

Patients were not given the option to choose between a repeat needle biopsy and an open biopsy.

Participants consented to a repeat needle biopsy but not to participate in research.

BreastScreen SA did not consider the repeat needle biopsy to be research.

The ombudsman wrote that there was a real risk that the study involved research.

BreastScreen SA apologized to the women impacted.

BreastScreen SA apologized unreservedly to the women who were not properly informed.

The ABC asked CALHN when the apology was first made.

CALHN responded that all women were sent an apology letter before the ombudsman's report.

The ADH project was reviewed by the human research and ethics committee.

The committee found it to be a quality improvement activity.

The ombudsman wrote that she had recommended a public apology in her provisional report.

CALHN rejected the proposed recommendation in the strongest terms.

CALHN said an apology could have unintended consequences and impact the effectiveness of the service.

The network said it was committed to making things right but the response needed to be proportionate.

The ombudsman said an apology would be appropriate to strengthen public confidence.

The ombudsman wrote that it is the error, not the apology, that presents a risk of reputational damage.

The ombudsman determined it was not appropriate to formally recommend a public apology.

The ombudsman was not persuaded that a reluctant apology would provide meaningful redress.