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National Statement on Ethical Conduct in Human Research Chapters 3.4 & 3.6 submission

ID: 
3
Personal Details
Organisation Name: 
Cells and Tissue Domain, IHBI, QUT
Additional Information
Organisation description: 
Biomedical research institute / organisation
E. Submission
Submission methods: 
Online Submission (specific questions)
Specific issues requiring particular consideration
1. Would it be useful to refer to one document (i.e. Part C of the ART guidelines) regarding the use of human gametes, embryos or embryo derived stem cells for research?: 

Researchers in the Cells and Tissue Domain at IHBI, QUT do not utilise human gametes, embryos or embryo derived stem cells for research and thus we can not comment on this question.

2. Has all relevant guidance from Chapters 3.4 and 3.6 of the National Statement been retained in the draft Chapter 3.4_6 so that the ethical issues are made clear and can be addressed by researchers and HRECs?: 

Yes. The clarity about the use of commercially acquired human cell lines and primary cells has been particularly useful.  We would like to add that cell lines acquired through collaborators where that cell line has been previously published in a peer-reviewed journal should also be exempt from ethical review.

3. Are the guidelines for the importation of human biospecimens clear and appropriate?: 

Yes.

4. Are there additional ethical issues that need to be considered in this chapter?: 

No.

Comment on specific Sections
Specific Comments: 
Chapter 3.4_6 paragraph 3.4.7

 

We would encourage more specific examples be given in this paragraph.  It is our understanding that practical examples of biospecimens that are exempt from ethical review would include;  

i) Human cell lines and primary human cells purchased from established companies, both inside and outside of Australia, for example ATCC, Lonza and Invitrogen.  Payment for these biospecimens constitutes an understanding that the samples have been obtained in an ethical manner consistent with international and Australian Guidelines.

ii) Established human cell lines obtained from an Australian or international collaborator where those cell lines have been previously published in a peer-reviewed journal in which the HREC ethical approval number is stated.

iii) Human tissue samples obtained from an established tissue bank, both in Australia and overseas where the tissue has been obtained in a manner consistent with the ethical approval of that bank and the NHMRC guidelines.

Chapter 3.4_6 paragraph 3.4.8

It would be very useful if the NHMRC can provide all HREC committees with an existing registry that can be added to by individual researchers.  The would avoid each individual institute having to create their own list as they would be almost identical across the research institutes in Australia.

Chapter 3.4_6 paragraph 3.4.14

It would be very useful if the NHMRC can provide all HREC committees with an existing registry that can be added to by individual researchers.  The would avoid each individual institute having to create their own list as they would be almost identical across the research institutes in Australia.

Chapter 3.2 Data Banks

We strongly support the new clearer wording utilised here, particularly the non-usage of the term 'de-identified data'.  We agree the meaning is unclear.

Chapter 3.2 Data Linkage

We support this section.  Data linkage is crucial to the future of research and provides invaluable data for many research projects and should be supported and encouraged wherever possible.

Page reviewed: 4 September, 2012