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

ID: 
6
Personal Details
First Name: 
Daniel
Last Name: 
Catchpoole
Additional Information
Individual Background: 
Researcher – biomedical
E. Submission
Submission methods: 
Online Submission (specific questions)
Comment on specific Sections
Specific Comments: 
Chapter 3.4_6 Uses of human biospecimens in research and application of this chapter

This section highlights a dichotomy which exists with the use of biospecimens in scientific applications. Tissue samples collected from 'patients' during clinical investigations and use in laboratory-based scientific tests are not required to the same level of ethic consideration as tissue samples collected from 'donors' to answer research questions using the same laboratory-based scientific tests.

The NSW Tissue Act exemplifies this dichotomy in law  by requiring biospecimens collected for research to be obtained with written consent, although tissue 'blocks' are exempt from this consenting requirement. The Act was later amended so that biospecimens collected for the purposes of QA and education were similarly exempt from consent requirments under the law, which is similarly to that stated is the case for many pathology departments highlighted in this section.

The Chapter 3.4_6 submission as presented does not address when samples obtained from pathology departments for research should come under the same level of ethical scrutiny and consent requirements. As written in this section, the implication is that samples stored within pathology departments can be used for 'research purposes without consent' and that these are an 'invaluable resource'. Nor does it address how to recognise when the scientific test has been translated from a research endaevour to being adopted as a routine diagnostic test - and thus the biospecimens collected for that now diagnostic procedure performed by a pathologist should have all ethic boundaries removed and become open to research, QA and education 'without consent'. This situation is further complicated when research laboratories perform diagnostic tests used in clinical investigations which have research streams. Are the samples collected for routine procedures - and hence can be used by the laboratory for research 'without specific consent' or does a different level of ethical consideration for these samples need to be undertaken by the HREC? The same occurs when samples collected for diagnostic procedures are then processed into cell lines, stem cells or other derivatives which have future research applications - why does the ethical consideration suddenly change when the biospecimen shifts from a routine laboratory into a research laboratory. 

I would encourage the NHMRC to consider negating this dichotomy by promoting the considerable cross over and similarity of activity ongoing in medical and health institutions - which include both research and diagnostic laboratories - when it comes to procurement and use of biospecimens. For example, all patients should be consider 'donors' as the biospecimens provided have multiple uses beyond the immediate reason for why they were given. Hence, it should be common practice for all patients to be informed that QA, education and research could be performed with residual material remaining after procedures. This would include cell lines. Encouraging a common culture within our hospitals where biospecimen procurement  within our pathology departments and clinical services plan to 'biobank' samples for future use will negate much of the confusion. Opt-out consenting should then become the norm. Whilst confusion will reign if samples collected for diagnostics are exempt from consent whilst consent is mandatory for samples collected for research as if what happens during the collection procedure will determine the future use of the biospecimen. However, if all biospecimens can be used for 'research', regardless of whether it is material 'residual to diagnostic requirements' or if specifically donated, then the ethical question becomes more focussed on how the samples are going to be used and who is going to use them: research QA, education, diagnostic tests, optimization, medico-legal, cell line derivation, commercial use etc.

General Comments
Comments: 

In general I welcome the changes suggested in the Chapter 3.4_6 submission. The general shift made with the submission acknowledges that biospecimens are central to much of the medical and health research activity ongoing within Australia. These biospecimens impact on research in many ways. The consideration that derivatives from human tissue, such as stem cells, tissue products and cell lines, should carry the same ethical guidance as the biospecimens from which they were derived is a valuable simplification for the research community.

Page reviewed: 4 September, 2012