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Section 3 (Chapters 3.1 & 3.5), Glossary and Revisions to Section 5 National Statement on Ethical Conduct in Human Research, 2007 submission

ID: 
59
This submission reflects the views of
Organisation Name: 
SA Health and Medical Research Institute
Personal Details
Specific Comments
Comments: 
2. Chapter 3.1

Section 3.1 – The elements of research

We would like to make the following comments in relation to section 3.1 of the National Statement:

  • The National Statement should be revised to ensure that the ethics processes adopted by researchers fully understand and protect the rights of vulnerable communities and individuals with respect to big data and data linkage research. This may require education of HRECs in relation to these research methodologies.
  • The growing movement in relation to data sovereignty (with cloud data storage) and the rights based Indigenous data sovereignty movement should be considered in the preparation of applications to HRECs.
  • Consideration should be given to issues associated with protecting individual, family, community and organisational IP.
  • The grey area of clinical/service audit vs research continues to challenge HRECs. There is inconsistency in relation to how this is applied across committees, services, hospitals, organisations etc. Direct and clear national advice would be welcomed.
  • Consideration should be given to the issues associated with the layering of consent at individual, family, community and organisational levels.
  • Publicly available data and its use to explore/explain/frame Indigenous issues is a significant ‘black-hole’. The use of publicly available data in all research should still require HREC approval as the results can equally impact community interests negatively (and often do).
3. Chapter 3.5

Section 3.5 – Genomic Research

We would like to make the following comments in relation to section 3.5 of the National Statement:

  • The disclosure of incidental findings in the growing age of genomic research needs to be considered.
General Comments
Comments: 

We would like to make the following general comments:

  • The need for consultants/consultancies to undergo ethical review is an area that requires further exploration. Consultants rarely seek ethical approval for their work, but frequently use data relating directly to human participants. Specific advice outlining ethical approval requirements for consultancies would be useful.

Page reviewed: 10 July, 2018