Legal Considerations

Is Human Research Ethics Approval Required

Human Research Ethics Committee (HREC) review is only required for research but clinical (surgical) audit does not constitute research as such. The National Statement on Ethical Conduct in Human Research (2007, revised in 2009) does not suggest that data, whether identifiable or not, collected in a database is a research activity. Rather, the National Statement only applies when that data is to be used in what would be recognised as a research activity. Even then, there are instances when such usage may be considered low or as negligible risk research that do not require review by a HREC.

The use of SurgicalPerformance requires collection of data by participating clinicians and only they have access to their own data. Other users can not access any other data. Summaries of overall performance from the whole data set are provided in a completely de-identified aggregate manner from which it is impossible to identify either individual patients or participating clinicians.

Due to the sensitive nature of the data collected it is not proposed that the raw data set be used by anyone outside of the participating clinicians and it is emphatically not a ‘research’ database. External researchers will not have access to this data therefore there is no requirement for Human Research Ethics Committee (HREC) review.

Surgical audit is recognised internationally as a critical component of steps aimed at enhancing quality and safety in surgical practice. The ethical question should be “why is this not being done routinely?” as a lack of such data will place patients at potential risk through a lack of checks aimed at improving patient safety.

If users wish to use data for research (to be published), an HREC application is required. In most instances a low-risk application would suffice.

Is it legal to enter patient data in web-based software?

It is legal to enter de-identified patient data. SurgicalPerformance undertakes all necessary steps to prevent the data from being interfered with from unauthorised persons. Despite all efforts, it could happen. Therefore, you must not enter patient names or any other information that could identify a patient.

Will I be reported if my complication rate exceeds the acceptable limit?

No, SurgicalPerformance will not report outcomes to third parties at anytime unless required by law. See our privacy policy.

Are data available for research?

Your own data – You will always have 24/7 access to your own data, which you can download into an excel spreadsheet.

Others’ data – If you wish to get access to other users’ data, you will need to make a submission to SurgicalPerformance [email protected] and apply. You will only receive de-identified data that will not allow patients or contributing clinicians to be identified.

Will I be required to disclose that I collect data in SurgicalPerformance?

We recommend that you disclose audit activities to patients as part of your practice’s Privacy Policy as a matter of administrative routine. However, there is no need to get audit approved by the hospital, the College or patients.

Will I be required to share my outcomes data with lawyers and the courts in case of legal proceedings?

The Australian Commonwealth has granted “Qualified Privilege” to SurgicalPerformance in May 2015.

Qualified Privilege encourages surgeon participation in self-audit by strictly protecting the confidentiality of information gained in the audit. It prevents third parties, such as legal representatives or courts from using surgical reports for purposes that could potentially be to the detriment of the surgeon in question.

Surgeons can now take advantage of knowing that the information they liberally divulge will be utilised exclusively for its designed professional development purpose and nothing else.

Qualified Privilege means that surgeons are not vulnerable any longer by entering data into SurgicalPerformance.