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Ethical Review of Quality Improvement Activities in Health Services submission

ID: 
20
This submission reflects the views of
Organisation Name: 
South Eastern Sydney Local Health District
Please identify the best term to describe the Organisation: 
Health service
Personal Details
Specific Comments
Comments: 
General Comments
Comments: 
  •  The South Eastern Sydney Local Health District (SESLHD) welcomes the opportunity to provide the following feedback on the public consultation draft – Using the National Statement: Ethical Review of Quality Improvement Activities in Health Services.
  •  The SESLHD recognises that Quality Improvement (QI) programs are essential to ensure and improve the quality of activities and services carried out within its hospitals and health care facilities and supports the need for incorporating ethical considerations in the review process.
  •  The use of tissue samples for routine QI programs conducted by pathology departments is essential to the ongoing management of these departments.
  •  Page 6 of the public consultation draft document states “QI activities will sometimes use information that already exists and in some instances the secondary purpose related to QI may not be consistent with the original purpose for which the information was collected. It may not be possible or practicable to get consent from the persons whose information is to be used and there will be a need to qualify or waive the need for consent. Only an HREC can grant this under Federal Privacy and State Privacy legislation. The HREC must apply the guidelines approved under section 95/95a of the Privacy Act (1988/2001), as well as considering section 2.3.6 of the National Statement.” This statement, particularly the requirement for HRECs to waive the need for consent appears to be at odds with section 34(1) (b3) of the NSW Human Tissue Act: 34 Act does not prevent specified removals of tissue (1) Without affecting the operation of any other Act or law, this Act does not operate as to prohibit:…… (b3) the use of small samples of any tissue that is lawfully removed from the body of a person (whether living of deceased) for the purpose of carrying out analyses or tests: (i) That are part of a program (including any quality assurance program, quality control program, audit or evaluation) to ensure, or improve the quality of services carried out at or by a hospital, a forensic institution, a laboratory, an educational or research institution or a supplier of blood or blood products, or (ii) That are necessary for the delivery of services carried out at or by a hospital, a forensic institution, a laboratory, an educational or research institution or a supplier of blood or blood products.
  •  The SESLHD is concerned that this apparent discrepancy between the public consultation draft document and the NSW Human Tissue Act could lead to confusion for pathology services, institutions and HRECs and request that consideration be given to ensuring alignment between legislation, guidelines and policies.

Page reviewed: 17 June, 2013