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National Statement on Ethical Conduct in Human Research 2007 Human biospecimens submission

This submission reflects the views of
Organisation Name: 
University of Sydney
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Please identify the best term to describe the Organisation: 
Educational Institution – tertiary
Specific Comments

Page 5, ‘Introduction’: Paragraph 2 states ‘The definition of ‘human biospecimens’ is broad: it encompasses any material taken from a human body and including, but not limited to, tissue, blood, urine, sputum, gametes, embryos and fetal tissue, and any biological material obtained from them including cell lines.’ With reference to the mention of cell lines in this context: cell lines can be derived from donor materials, and presumably this is the context intended here. However, another category of cell line frequently used in research are the large number of cell lines provided to researchers by national or international repositories (such as the ATTC). These lines haveoften been in culture for decades or more, and their supply to researchers by cell line repositories is presumably not intended to fall within scope of this Statement. It would be helpful to provide this clarification in the ‘Cell lines’ section on page 9, ‘Glossary’.


Sources of human biospecimens

Page 5, ‘Sources of human specimens’: Given the reality of where biospecimens derive from, first sentence should say "material taken for clinical AND DIAGNOSTIC purposes"

Potential for identification

Page 5, ‘Potential for identification’: Although it is true that ‘Human biospecimens that include all or part of a human genome contain markers that are unique to the individual donor’, identification of that donor using only a donor’s biospecimen is not feasible. Normally in order to identify an individual donor from a biospecimen taken from that donor, areference sample is required. It would be useful to include this clarification in this section.

Prospective collection of human biospecimens for research – paragraphs 3.4.1 – 3.4.4

Page 6, ‘Guidelines’ 3.4.1. (c): Suggested edit ‘ensure that those involved are suitable qualified AND THAT THE METHODOLOGIES  USED TO PRESERVE THE MATERIAL ARE FIT FOR PURPOSE


Prospective collection of human biospecimens for research – paragraphs 3.4.1 – 3.4.4

Page 6, ‘Guidelines’ 3.4.4 (h): Does this section imply that cost recovery arrangements need to be detailed in the Patient Information Sheet? If this is the case, it would be helpful to know how much detail is required (for instance, dollar amounts for each type of biospecimen – which may be challenging in terms of maintaining currency of the information? Or a link to a website where the cost information is detailed?)

Ethical review before human biospecimens are used in research – paragraphs 3.4.6 – 3.4.11

Page 7, ‘Guidelines’ 3.4.9 First sentence: 'non-HREC review' is unclear. If this refers to review via the Low and negligible Risk route,  it would be helpful to state this.

Cost recovery for human biospecimens – paragraph 3.4.12

Page 8, ‘Guidelines’ 3.4.12: It would be helpful to clarify the type of cost recovery detail that will need to be provided to the HREC, presumably via the NEAF. As in the response to 3.3.4 (h) above, will the NEAF request information on dollar amounts for each types of biospecimen (which may be challenging in terms ofmaintaining currency of the information)? Or will it be preferable to provide a link to a website where the cost information is detailed? How will the costrecovery rates set by the NHREC via DRCs inform this process? 


General Comments

Feedback was received from our research comunity as follows:

In general, the revisions to Chapter 3.4 and 3.6 were fair and reasonable and I would suggest no amendments. As a general observation, in light of recent discussions, I am very happy with the amendments as it is very clear that researchers must be fully cognizant of 3.4.4(a) referencing 2.2.1 and 2.2.16. Researchers wishing to use foetal tissue may wish to review this consultation statement to clarify the specific requirements of consent to donate tissue, particularly relating to participants' rights to be informed specifically as to the nature of proposed experiments in which dontated tissues may/will be used, and also secondary usage by other researchers/groups.

Page reviewed: 3 June, 2013