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

ID: 
16
This submission reflects the views of
Organisation Name: 
Plunkett Centre for Ethics
Personal Details
Additional Information
Please identify the best term to describe the Organisation: 
Ethics / Bioethics organisation
Specific Comments
Comments: 
Introduction

Re proposed changes to National Statement 3.4 and 3.6:

Re Introduction

Comment: We question the use of the term 'biospecimens' - this is a ‘term of art’, a term invented for a specific purpose, and not one used naturally by scientists.  The definition provided is so broad that it obscures the importantly different ethical considerations raised by (a) different kinds of 'human tissue' and (b) differently attenuated 'human tissue products'.  Presumably it is this very broad definition that paves the way for the proposed removal from the National Statement of the prohibition on trade in human tissue.  [If nothing is any longer defined as human tissue, there is no trade to prohibit!]  It seems very strange for this revision of the National Statement not to engage with the NHMRC’s own recent publication in relation to commercialisation of human tissues (see: Ethics and the exchange and commercialisation of products derived from human tissue - background and issues (2011)). On this more below. 

Recommendation: [Changes in bold]

Introduction

The category of ‘human biospecimens’ is broad, covering both (a) human tissue and (b) products derived from human tissue.  It encompasses…  that live on or in a person.

[Add] Because the category of human biospecimens is so broad, researchers need to be alert to the different degrees of significance that different kinds of biospecimens are likely to have for donors and their families, the different risks associated with different kinds of biospecimens, and the different ethical considerations that are raised by tissues and products for individuals and the community.  In particular, a product derived from human tissue may be so altered that donors and their families may reasonably regard it as no longer belonging to the person’s body or physical remains.

There should be no trade in human tissues obtained for and/or used in research.  A HREC may approve for-profit commercial arrangements involving products derived from human tissue only if the product is so altered that it would no longer be reasonable to regard it as belonging to the person’s body or physical remains.  (see below 3.4.  )

Potential for identification

 Potential for Identification

Comment: This paragraph fudges the issue of re-identifiability. It needs to be stated that, in principle, all human tissue is re-identifiable.  The proposed examples of what would not be 'realistic' concerns mixes up two quite different issues: one is cost - yes, in some cases a researcher might tell a donor not to worry about re-identification on the grounds that it would be too expensive for someone to bother doing it; but the other reason cited is that identification is not part of the research project – this amounts to telling the donor to trust the researcher not to identify a specimen even though she could!

Recommendation:

Human biospecimens that include.....unique to the individual donor.  Such specimens are always in principle re-identifiable, even though this may be unlikely in practice because, for example, the cost of doing so would be prohibitive.  Donors and their families should be informed that human tissue is always in principle re-identifiable and also of the particular considerations which make its re-identification unlikely. 

 

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

Re Guidelines:

Re the proposed 3.4.1

Comment: Researchers must not only understand the ethical issues, they need to comply with the relevant ethical standards.

Recommendation: Those proposing to collect human tissues or biospecimens prospectively….

e. understand the ethical issues involved and comply with these and any other relevant ethical guidelines.

3.4.2     

Comment: It is always important that issues of research are quite distinct from issues of clinical care, and that coercion is avoided.

Recommendation:

The consent…… [add:].  The consent process for donation of tissue for research should be separate from the consent process for the clinical or diagnostic procedure from which the tissue will be obtained.

 

3.4.4

Recommendation: …given information about

h.         any reasonable, nonprofit, cost recovery arrangements that may apply to the collection, retrieval, handling, storage and distribution of their biospecimens (see paragraph 3.4.12).

i.          any foreseeable commercial research use involving products developed from their biospecimens, how these will be managed and to whom the benefits, if any, will be distributed (see 3.4.12 below)

 

General Comments
Comments: 

Comment: New subheading: in place of ‘Cost recovery for human biospecimens’

Commercial arrangements

This section should be re-written in the light of the NHMRC’s own issues paper, Ethics and the exchange and commercialisation of products derived from human tissue - background and issues

 

Recommendation: Commence with a new 3.4.12 (thus restoring the current 3.4.10)  Re-number subsequent clauses.

3.4.12            There should be no trade in human tissues obtained for or used in research.  A HREC may approve for-profit commercial arrangements involving products derived from human tissue provided:

            a.         the product is so altered that it would no longer be reasonable to regard it as belonging to the person’s body or physical remains.

            b.         the commercial arrangements will not create perverse incentives for donors or researchers, nor undermine the altruistic basis of organ and tissue donation in Australia. 

3.4.13                    The proposed new 3.4.12 becomes 3.4.13

Page reviewed: 3 June, 2013