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

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E. Submission
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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?: 


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?: 

Not really- see the detailed comments. The central question that the amendment aimed to answer - to clarify whether and when ethical review was required for research involving stem cells or stem cell lines is not answered - rather researchers are put to the task of finding out how the original bio-specimens from which the stem cell lines were derived were collected and used - a demand that is likely to be increasingly impossible. There is undue reliance on institutions choosing to exempt such reserach from ethical review and too vague a set of criteria offered for such decisions and those criteria conflict with the current criteria.  Further, there is limited and inadequate justification for the relaxation of ethical review requirements - and for the striking change in NHMRC stance that human tissue should no longer be regarded as in principle identifiable.

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

Only to the extent that the Australian situation, with which overseas collection and use procedures are to be compared, are clear -and these amendments do not make them so.

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

Yes - the central ethical and scientific issue of when stem cell lines cease to be regarded as ethically equivalent to donated human tissue.

Comment on specific Sections
Specific Comments: 
Chapter 3.4_6 Introduction

 Chapter 3.4_6


  1. 1.             Chapter number

It is not clear why the unusual numbering–3.4_6  has been used. There seems no reason against numbering the new chapter 3.4 . 


When the 2007 National Statement was issued, it was accompanied by advice that the document would be regarded as changeable in part  as and when necessary. As a result, informed users of the National Statement will be aware that the current version on which they should rely will always be that available from the NHMRC website and not the most recent printed version.


With this background, a change in numbering such as is presently proposed will simply remove chapter 3.6 and there is no need to retain an historical reference  (as seems to be the apparent reason for the unusual numbering) to the fact that there was once such a chapter.


  1. 2.             Chapter title

There seems no reason to include within the title the words in parentheses, namely, “ (including cell lines)” because the definition of human bio specimen proposed to be included in the glossary makes it clear that the term includes cell lines.


The title introduces the expression “laboratory-based research” but does not define this term, although the content of the chapter is said to be applicable only to such research.  Its meaning is rendered more ambiguous by the first paragraph under the heading “Uses of human bio specimens in research and application of this chapter” where it is said that human bio specimens are important for such research in two areas, the second of which is translating biomedical research into improvements in health care, “especially through advances in diagnostics and therapeutics.”   This seems to include research activities in diagnostics and therapeutics which would appear to occur outside the laboratory. 


 There are however more fundamental reasons against the introduction of such a vague term. The National Statement seeks to provide guidelines for the conduct of any human research and provided research falls within that major definition on page 8, of the National Statement will apply.


Further, whether research is laboratory-based or not seems irrelevant to its ethical acceptability.


 The introduction of the proposed term “human bio specimens” would also necessitate a change in the wording of the definition of human research on page 8.  If that definition remains unchanged, the National Statement will not apply to research using human bio-specimens that are not human tissue, as described on p.8.


The wording of the fifth dot-point in the definition of human research would need to change to wording such as “the collection and use of the human bio specimens” perhaps with a series of examples as is proposed in the glossary definition. 



  1. 3.             Introduction

In the first line of the second paragraph,  the word  “embryonic” should be inserted before the phrase “stem cell lines” to maintain consistency in the intended meaning.


 The bolded sentence about legislation, while an appropriate reminder, seems misplaced and would better appear immediately following the third paragraph under the heading “Uses of human bio specimens in research and application of this chapter”. This third paragraph with its acknowledgement that human bio specimens stored in pathology laboratories have been used for research purposes often without specific consent appears to indicate in the last sentence that this may continue. The fact that some State laws in Australia will now prohibit such non-consensual use of  these bio-specimens that has not been confronted by the proposed chapter and will potentially leave researchers and institutions with competing legal and ethical advice.


This has been a long-running and difficult issue and it needs to be confronted directly even if that confrontation only states that researches and institutions will need to conform to jurisdictional laws in relation to research uses of previously stored bio-specimens.   The National Statement has never and should not now profess to offer legal advice. However, it has been appropriate for the National Statement to note the need for researchers and institutions to conform to relevant laws.


 The second of the two bolded sentences may leave the reader in some confusion.  That legislation does not regulate stem cell lines may be little comfort if legislation does regulate access to the material from which those cell lines will be created.   Further, the statement is premised on an assumption that human stem cell lines are not human tissue for the purposes of relevant legislation. 


This is the issue to be resolved and the apparent method of resolution relied on – as revealed in later paragraphs of the proposed chapter – is that institutions will exempt research using stem cell lines.  The deficiencies of the details of this proposal are dealt with in detail below, but a basic shortcoming is that this solution does not address the fundamental issue of whether such research should still be treated as human research, but leaves this to institutions to decide.  This is an inadequate position for the NHMRC – the national source of advice on human research ethics.

Chapter 3.4_6 Uses of human biospecimens in research and application of this chapter
  1. 1.             Uses of human bio specimens in research and application of this chapter.

 These paragraphs need to address more clearly the ethical issues in the collection and use of human bio specimens. At present, the paragraphs acknowledge that this bio-specimens held in pathology centres have been used for research purposes without consent but in the fourth paragraph state that research biobanks obtain bio-specimens from pathology practices but with a prospective consent from donors. In between these two propositions is the statement that stored human bio-specimens will continue to be an invaluable resource.


What is left unclear is the ethical acceptability of using, for research, bio specimens stored in pathology centres where consent for research use has not been previously obtained. If  “such stored human bio specimens”  will continue to be an invaluable tool resource,  how will the resource be accessed in an ethically acceptable manner? The reference to research biobanks using prospective consent from donors will address the ethical use of research with bio-specimens collected in the future but will not address issues of access to specimens already stored without consent for research.


Waiver of the need for consent is one solution proposed as a solution, but whether such waiver is lawful in all jurisdictions will need to be considered.


Clearer ethical guidance on this issue would be timely and valuable. It may need to be circumscribed by advice that institutions and researchers will need to conform to relevant jurisdictional laws.


The first sentence in the third paragraph states an important matter but in a confused way. A clear alternative wording would be:


“Human bio-specimens collected in the course of clinical investigations  at healthcare institutions  are commonly provided to pathology centres for diagnostic and other testing. The National Association of Testing Authorities (NATA) accredits pathology centres according to the compliance with National Pathology Accreditation Advisory Council (NPAAC) guidelines. One criterion for accreditation is that pathology centres retain bio-specimens for designated periods.”


  1. 2.             Commercial uses of human bio specimens

 Although the issues canvassed in these paragraphs are of ethical significance, they have marginal relevance for the ethical conduct of human research.


 The National Statement strives to retain a clear focus on the ethical conduct of human research. It is not an ethical discussion paper on related matters and should not be used for such purposes.


The proposition that “this chapter provides ethical guidance on when it may be ethically acceptable to use products derived from human bio specimens for commercial purposes”  mis-uses the National Statement by seeking to extend its scope to activities that are not human research.


The second paragraph under this subheading does state an appropriate focus for ethical guidelines, namely, research uses of human bio specimens, although it is unclear what “any of the above sources “refers to.     If it is intended to state that the guidelines relate to research uses of products derived from human bio specimens, then this seems an appropriate extension of National Statement guidance. However, this is not clear in the way the paragraph is expressed.


The fifth dot-point under the heading “Additional ethical guidance on research uses of human bio specimens” is inappropriate. This not only refers to “forthcoming” guidance–an unwise assumption both that the guidance will be forthcoming and that it will be relevant–but because the guidance is obviously not about research but about commercial deployment of human tissue products.


There is no bolded paragraph at the end of the introduction requiring HREC review of all research to which the proposed chapter applies (as is the case with, for example, chapter 3.5) despite the fact that the number of the proposed new chapter is added to the list of chapters in NS paragraph 5.1.6.  Is it proposed that only an HREC can review such research? Some of the proposed paragraphs – 3.4.9 – suggest otherwise?  The proposal appears thoroughly confused on this point.


6. There is a typographical error in the paragraph in bold–namely–the second sentence should read “the guidelines and headings below…”.

Chapter 3.4_6 paragraph 3.4.1
  1. 7.             Ethical review, information and consent before human bio specimens were collected for research.

 3.4.1 The paragraph,  as written, only requires an application for approval before collecting bio specimens for research.   The paragraph should require that approval has been granted by an HREC before the collection commences.


3.4.3 The paragraph should require that the following information should be given to donors before  they give their consent -  examples of appropriate language appear particularly in chapter 3.5 at 3.5.8 and 3.5.12.   Reference to “the consent process” is not the way that the National Statement states the obligation to provide information.


 3.4.3 (a) -   the references to the  NS paragraph 2.2.1 should be 2.2.2, (see the comparable reference in 2 .2 .14)


 3.4.3 (b) -  the page reference at the end of the paragraph may change as a result of the proposed amendments and should be left blank at this stage.


 3.4.3 (d) -  this matter is already addressed in paragraph 2.2.6 (g)  and other comparable language appears in paragraph 3.5.12 (f).   Simpler  expressions that are consistent with the way the same issue is described in the National Statement should be used.


 3.4.4 It is unclear what the expression  “commercial research applications” refers to and why it is used. Does this mean research conducted by  for-profit entities or does it include research conducted by any entity where there is an aim to generate property of commercial value? Even with a clarified meaning, what is the ethical significance of this kind of research?


3.4.4 (a)–it is unclear why the task of determining that a product is functionally different from original tissue be given to an HREC. The judgment appears to be more a matter of scientific than ethical expertise. 


3.4.4 (b)–this paragraph seems to mix concepts of practice and research. It is not clear why the word “practice” is used instead of research and suggests that whole paragraph–3.4.4–mixes commercial practice with research and seeks to impose ethical guidelines on practice. As noted earlier, this is a misuse of the National Statement whose scope is the ethical conduct of human research not the ethical conduct of any practice that might be ethically sensitive because it uses humans or human bio-specimens.


3.4.4   (c) The  point made in relation to the previous subparagraph is equally applicable here. There is no reference in this subparagraph to research but only to commercial use of bio specimen derived product. Although these uses do raise ethical considerations, it is not appropriate to   distort the function of the National Statement to address these.


3.4.5 The opening sentence is awkwardly worded-  it is not clear what “post-mortem tissue “is. A preferable wording would be “Any wish expressed by a person about the post-mortem use of their tissue for research should be respected.” 


 The second sentence in the paragraph is gratuitous ethical advice irrelevant to human research and has no place in  a National Statement.


It would perhaps be simpler, in place of the remainder of the paragraph, to simply state that researchers seeking to obtain human bio specimens post-mortem should seek consent in accordance with jurisdictional laws.


Ethical review before human bio-specimens are used in research


3.4.7   The proposal inherent in this paragraph raises important issues about the scope of research that institutions may choose to exempt from ethical review. At present, the only possibilities are where research involves negligible risk and uses existing collections of data that contain only non-identifiable about human beings. This is a narrow category.


 The provision of this opportunity for institutions is not well understood. Some researchers appear to assume that the National Statement, of itself, creates exempt research categories and use this argument to avoid ethical review. This is simply a misunderstanding or misreading on what the National Statement provides. It is clear that it is an institutional choice as to whether any research is exempted from ethical review: all the National Statement does is provide the criteria for that decision. It is nationally important that those criteria remain clear so that there is institutional consistency about research that can be exempted from ethical review. Adding additional categories of research may be justifiable, but this proposal adds an apparently open range of activities– the proposed criteria in 3.4.7 are introduced by the phrase “these may include”–that can only promote inconsistency in interpretation and even greater confusion among institutions with resulting frustration for researchers.


The draft guideline uses a term  - “full HREC review” – not known to the National Statement which refers to ethical review that can be conducted by an HREC or another ethical review body and ethical review by an HREC.  Paragraph 5.1.22 authorises institutions to exempt research that meets certain criteria from ANY ethical review.  This is apparently what is proposed.  The expression “full HREC review”  should have been “ethical review”. 


The proposal is to add another category, namely, research that is negligible risk research and uses human bio-specimens that meet certain criteria.  

 However, the proposal appears to choose to exempt uses, or categories of human bio-specimens, rather than research. This is conceptually different from the existing provision in 5.1.22  in which the only activity that can be exempted is research–not other “uses” or categories of anything. In spite of this, the proposal retains the stem of 5.1.22  so that an institution can still only exempt research and not uses or specimens.  The confusion is compounded.


The three criteria appear internally inconsistent. The first relies on practicable non-identifiability  but the second and third assume identifiably. If they did not, there would be no point in the judgment as to whether there is information of direct relevance to the health of donors or likelihood of harm to donors. Those two paragraphs will only be relevant if it is possible to identify the donors or their families. It is difficult to see why (b) and (c) would apply if (a) is satisfied. Further, the considerations in both (b) and (c)  contemplate a degree of risk that exceeds negligible risk, which is a requirement of paragraph 5.1.22 that the proposal retains and, if so, they will be irrelevant. Further still, it is difficult to see how researchers could meet the requirements of (b) and be able to state, categorically, that proposed research “will not produce” information of the kind described.


Further, there is no recognition that such institutional exemption is accompanied by obligations on researchers as set out in paragraphs 5.2.9 and no consideration of how feasible this will be for the proposed new categories.


In summary, the proposal to extend the circumstances in which institutions may exempt research from any ethical review does not appear to have been thought through.  It also needs justification.



3.4.8 There is no basis in the current National Statement for the creation of exempted bio-specimens and the flawed proposal contained in 3.4.7 and the amendment to 5.1.22 do not change this. The paragraph should be removed.


 3.4.9 This paragraph is simply unnecessary. The National Statement contains adequate criteria for determining whether research can be reviewed by a body other than HREC.


This proposal is inconsistent with another proposal, namely, the proposed change to paragraph 5.1.6. That change requires HR EC review of all research to which the new chapter applies. However, paragraph 3.4.9 proposes otherwise. This is a clumsy contradiction.


 3.4.10   As with the previous proposed paragraph, this paragraph is unnecessary.   The criteria that must be satisfied for an HREC to waive the requirement for consent are clearly spelt out in paragraphs 2.3.6.


The drafting is also vague because, yet again, a term that has a specific meaning in the National Statement is used, namely, specific consent – see NS 2.2.14.  Is it intended that waiver should be available only for consent to a designated research project? The uncertainty is the result of a number of other apparent misunderstandings of NS terminology and repeated ambiguity.  For example, what does “not specifically for research” (in the last line of 3.4.10) mean?  IS this what the NS defines as specific consent?  As it reads could also mean extended and even unspecified consent. 


The clause should be deleted.


 3.4.11 This paragraph is a further example to that in 3.4.7 of failing to distinguish clearly circumstances in which donors  and their blood relatives or communities remain practically identifiable and situations where they do not.

 If it is the case that these two situations arise, it would be simpler and clearer to spell out the consequences of each situation in two separate sets of clauses. This would also help to clarify the proposal to add a category of exemptable research.


 As noted above, page references in this proposal will need to be adjusted.


Imported human bio-specimens

3.4.12 This paragraph contains the undefined and vague “laboratory-based research” term  and earlier comments about this expression apply here.


3.4.13 this paragraph reproduces the confused mix of terminology between the proposed 3.4.7 and additional subparagraph to 5.1.22. At least this  subparagraph refers to research, but it needs revision to be consistent with National Statement terminology.


The reference to “ Australian regulations”  should be “Australian legislation”.


3.4.14 This proposal continues the confusion apparent in the proposed 3.4.8–by  changing the National Statement concept  of exemption from one that institutions can apply to limited types of research  to one that institutions can apply to uses or categories of entities.     The authority for institutions to exempt  should be confined to types of research and this proposed paragraph should be deleted.


 3.4.15 The reference to “Australian regulations” should be “Australian legislation”.   The parenthetical reference to chapter 4.8 is quite irrelevant and should be omitted.

General Comments

Chapter 3.2: databanks


 The additional material added in introductory parts of this chapter on data linkage, while informative,  does not appear to be consequential on proposed amendments to chapter 3.4  Further, it does not add any guidelines and so remains as information only and, as noted below, of varied quality.


In the second paragraph under the heading  “data linkage”, the third sentence would be clearer if the words “about a unique data subject”  were inserted between “information” and “from different data collections” and the words  “who those data subjects are”  replaced the words “particular individuals.” at the end of a sentence.


 The fifth and last sentence in the paragraph would be clearer if the word “individuals” were replaced by the word “subjects” and the last two words “the person” were changed to read “those people”.


The proposition in the third paragraph is somewhat absolute–it would be better phrased to say that data linkage can provide a more accurate picture.


 The statement that “There are three distinct stages in data linkage that are subject to ethical review”  appears to be a statement of fact. However, there is no reference to the source of requirements for such ethical review–there is no such requirement in the National Statement.


 Further, the proposition that ethical review is required for the establishment of a data linkage unit seems anomalous. The National Statement does not require such approval, not even in comparable situations, for example there is no requirement for ethical approval to establish a genetic testing centre.  It is not clear why this is a matter of research ethics and not technical expertise in data linkage.


 The second stage said to be subject to ethical review, namely the linking of new data collections would only be required by the National Statement if it was part of a research project. Data linkage is not of itself research, as the prior description in the preceding paragraphs makes clear. Further, it is not clear why that ethical review is required only for linking “new” data collections rather than any data collections.


The third stage is the only one of which the National Statement would require ethical review, namely, an individual research application involving  access to and use of linked data.


 Accordingly, this paragraph is simply confusing–it states that ethical review is required but provides no authority for that proposition and is not framed as guidelines to create that requirement.


The final paragraph about data linkage appears not to understand that once data linkage has been achieved, the resulting data is no longer personal information for the purposes of privacy regulation  (because no person can be reasonably identified).   Accordingly it is very difficult to understand the reference to  waiver requirement for consent or the necessity of HREC approval under privacy  legislation.


Personal information is used in creating data linkages – it is provided by data custodians to data linkage units.  It is this disclosure and use of personal information that is subject to privacy regulation and, in some situations, HREC review.

However, the paragraph appears simply to be wrong and should be deleted.


3.5.8 The deletion of subparagraph (a) is controversial and it will be necessary, if the proposal proceeds, to justify why this is no longer regarded as true. If this was true in 2007 when the National Statement was issued, why is it now not true?


It would be preferable to explain the difference between in principle identifiability and practical identifiability and use the language that has previously been used in the proposal.


The addition of a new subparagraph (b) seems to be inadequate. It would appear that information not only about the manner in which buyers specimens will be held at the manner in which they will be used and particularly the genetic information that they contain will be used should be disclosed.


5.1.6      The proposed changes to this paragraph seem to be inconsistent with proposals for the amendment of chapter 3.4.   If what is proposed in chapter 3.4 is adopted, then no change will be needed to chapter 5.1.6 because, as was the case with the original chapter 3.4, some research using human bio-specimens will involve no more than low risk and can be reviewed by a ethical review body other than an HREC. .


5.1.22 This raises a wide range of issues discussed at some length above.


Concluding Comment

This submission is critical of the failure, in many specific points of the proposed changes, to understand, respect and maintain the terminological, procedural and substantive consistency and integrity of the National Statement.  Maintaining that integrity is nationally essential.


As someone with a sound knowledge of the design and structure of the National Statement, I would welcome the opportunity to assist the NHMRC and AHEC in revising these proposals, with whose aim I have sympathy, so that they achieve their aim an

Page reviewed: 4 September, 2012