November 2012 marks a significant amendment in the research protocol of Auckland Breast Cancer Register (ABCR) research project since its inception in 2000 as the Northern A Health and Disability Ethics Committee(external link) (Northern A HDEC) approved the removal of the need to obtain consent from eligible patients for their clinical details to be recorded into the database. Further approval on researching and integrating previous non-consented data was issued in March 2013.
Prior to March 2013, ABCR was given temporary dispensation in July 2011 by the Ethics Committee in accessing, researching and analysing the missing non-consented patient data. The temporary access aimed at checking whether the missing non-consented data is compromising or skewing any conclusions and outcome with the overall data.
The Study Group’s Chairperson and Principal Investigator reported back at the end of the dispensation period with a general result comparing the rates of consented and non-consented groups according to age, ethnicity, progression of disease, survival status and cause of death. The worse outcome on non-consented cases was accepted by the Ethics Committee as an evidence of a research bias, thus abandoning the need for consent and keeping the non-consented data.
The approvals given in November 2012 and March 2013 amending the ABCR research protocol have given Auckland Breast Cancer Study Group (ABCSG) a comprehensive set of data of all breast cancer types, diagnoses and treatments for analysis towards gaining more accurate information on diagnosis, patterns of care, and survival outcomes occurring in this population.