Public Consultation on Proposed Revisions to the National Statement on
Ethical Conduct in Human Research 2007
Submission to the Australian Health Ethics Committee
25 October 2012
Professor Martin Pera
[Personal information removed by NHMRC]
I welcome the revisions to the National Statement on Ethical Conduct in Human
Research 2007. The revised Chapter 3.4: Human Biospecimens will provide more effective guidance to scientists on use of biospecimens, including stem cells, in research.
I am satisfied that the majority of the comments raised in my previous submission have been adequately addressed in the latest revisions. In particular,
I welcome the clarification provided in relation to commercial considerations.
However, I would recommend that AHEC consider the following points in relation to Chapter 3.4 and issues raised previously in relation to other Chapters of the National Statement that may need to be amended in due course.
Import and export of human biospecimens
Section 3.4.13-3.4.15 provides guidance regarding import and export of human biospecimens.
As pointed out in my previous submission, it is quite often very difficult for investigators to obtain complete information regarding the provenance of human biospecimens from abroad, and to conduct a thorough review of such data.
In the case of cell lines, inclusion on established registries such as the NIH Stem
Cell Registry, the UK Stem Cell Bank, and others, might be taken as sufficient evidence of compliance with widely accepted ethical standards. In the case of other biospecimens, such as blood or tissue, evidence of review of protocols for donation by an appropriately constituted Institutional Bioethics Committee, operating under internationally accepted standards, could be taken as sufficient.
I would suggest that additional guidance could be included in 3.4.13 to reflect this point.
Glossary
Within the additional Glossary terms, there is an implication that mesenchymal stem cells have been used in clinical practice, along with haematopoietic stem cells, for many years. Whilst it is true that mesenchymal stem cells are currently being investigated in many clinical trials for a range of indications, there is only one approved use of these cells. Neural stem cells are also undergoing trial in a

range of central nervous system disorders.
I would suggest that the reference to mesenchymal stem cells should be removed
:
'Stem cells and their sources can be described as follows:'
somatic stem cells (also known as non-embryonic stem cells or adult stem cells), which are obtained from the human body at any stage after embryo implantation. They are found in many (possibly most) of the tissues and organs of the body and include fetal and umbilical cord stem cells, as well as haematopoietic stem cells, that have been used in clinical practice for a number of years, and mesenchymal and neural stem cells, which are currently undergoing clinical trials for a number of conditions. They are capable of self-renewal and their differentiation or specialisation is mainly restricted to forming the cell types of that tissue or organ. The chief role of somatic stem cells is to maintain and repair the tissue in which they are found;
Chapter 3.2 Databanks
Introduction- it is important to clarify the definitions of identifiable, reidentifiable and non-identifiable data. A DNA sequence from tissue or a cell line provides the potential for identification.
Chapter 3.5 Human Genetics
3.5.1 and 3.5.7: Major applications of induced pluripotent stem cell (iPSC) technology lie in functional genomics and disease modeling. Also, DNA sequencing is liable to become a routine part of quality control for iPSC cell lines.
Thus, many studies iPSC are liable to discover or generate genetic information of importance to the potential health of donors or their blood relations. We must also remember that in addition to single gene disorders, the number of single nucleotide polymorphisms associated with disease susceptibility is growing rapidly. Moreover, iPSC are likely to be distributed widely to other researchers, who may in turn discover genetic information of medical significance concerning the donor. Because alterations to DNA sequence can occur during the process of generating and propagating iPSC, traceability will be essential to confirm any findings with potential health implications for donors.
It is critical that those deriving induced pluripotent stem cells understand the implications of this section of the National Statement for their research, and that the AHEC provide guidance on compliance with these provisions to stem cell researchers. It may prove challenging for secondary users of iPSC lines that were derived by others to implement the appropriate plan for disclosing or withholding such information. In short, the implications of these provisions for the research field of iPSC, which is growing exponentially, are quite substantial.
We recommend further discussion of the ethical implications of human genetic information arising from iPSC research, and further consideration of how best to

protect the interests of donors of tissue whilst enabling important research to go forward without undue restriction.