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

Personal Details
Organisation Name: 
NHMRC Clinical Trials Centre, Sydney
Additional Information
Organisation description: 
Biomedical research institute / organisation
E. Submission
Submission methods: 
Online Submission (specific questions)
General Comments

The NHMRC Clinical Trials Centre, Sydney, wishes to make the following comments regarding the proposed revisions (Nov 2011- Jan 20012) to the National Statement on Ethical Conduct in Human Research 2007, put forward by the Australian Health Ethics Committee Advisory Group (AHEC).



We commend:

  1. The use of the broad and inclusive term ‘biospecimen’ to replace ‘tissue and stem cells’ in the National Statement to reflect biological material that may be collected from volunteers for research
  2. Providing greater clarity and background relating to the practice of retention of biospecimens by pathology departments ie by the inclusion of references to national accreditation guidelines (National Association of Testing Authorities NATA and National Pathology Accreditation Advisory Council NPACC) and the mention of jurisdictions that may have legislation requiring retention of biospecimens
  3. The inclusion of guidelines relating to circumstances where institutions may choose to exempt research using existing biospecimens from full ethical review (in section 3.4.7 and 5.1.22 (c))


  1. In section: Introduction – Commercial uses of human biospecimens

‘. . . NHMRC holds that it is acceptable for organisations to cost recover.’ The National Statement should provide further clarification as to what activities would be considered appropriate to cost recover eg collection processing, storage and shipping or only a subset of these activities.


  1. In section Guidelines

As part of information provided to potential donors during the consent process (section 3.4.3), it would be useful to include guidance relating to inclusion (if at all) of information pertaining to:

   i.     Potential destruction of biospecimens after completion of specified experiments

  ii.     Observation of relevant practices of ethnic groups relating to consultation, collection, transport and destruction of biospecimens

  iii.     Retention of remaining biospecimens for future unspecified research eg manner and period of retention


  1. In section 3.4.3 Donors of human biospecimens should be told as part of the consent process:

      We propose that the National Statement provide guidance for:

  • Those circumstances where biospecimens have been collection from donors for future unspecified research, under what circumstances will subsequent additional ethics approval be required when a new research proposal using those biospecimens arises.


  • Whether the geographical location of research needs to be specified ie conducted within state or territory boundaries, cross state or territory borders or exported for overseas research


  • Whether volumes and quantities of biospecimens need to be specified


  • Those circumstances where it is necessary for a distinct consent form for biospecimen collection as separate from a consent form to participation in a clinical trial:

               Eg required (mandatory) biospecimen collection as part of a clinical trial


               optional biospecimen collection


  1. We agree that the National Statement cross references the Assisted Reproductive Technology (ART) guidelines regarding the use of human gametes, embryos or embryo derived stem cells for research; ensuring that the full guideline title is used




  • Chapter 3.4_6 Human biospecimens: (including cell lines in laboratory-based research) - Introduction

                    Paragraph 1, sentence 2: use of the plural of protein (ie proteins) would clarify the breadth of protein products and also be consistent with other plural items listed in the same sentence ‘ . . . and biological products obtained from them such as DNA, RNA, proteins and cell lines’.


  • Replace ‘fetal’ with ‘foetal’ for consistency with existing text in the National Statement. Chapter 3.4_6 Human biospecimens: (including cell lines in laboratory-based research)/Introduction – paragraph 1: last sentence


  • Replace the term ‘tissue’ with ‘biospecimens’ throughout the following chapters and sections of the National Statement:

Chapter 2, subsection: Consent to future use of data and tissue in research, 2.2.14-2.2.18

Chapter 3.2 Databanks

Page reviewed: 4 September, 2012