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

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Researcher – stem cell
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Online Submission (specific questions)
Comment on specific Sections
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Chapter 3.4_6 Introduction

Chapter 3.4_6.  Human Biospecimens (including cell lines) in laboratory-based research


  1. Introduction/Commercial Uses of Biospecimens: The scope of the proposed revisions around commercial uses of biospecimens is too broad, given that the new definition of biospecimens includes derivatives of human tissue.  The legitimate concern behind these recommendations is to protect the existing system of altruistic donation of tissue for research.  This goal can be achieved by simply ruling out any financial consideration in recompense for tissue donation, and by requiring that consent protocols make clear, where appropriate, that future use of any biospecimen might involve commercialization without compensation to the donor.  Beyond this, it is neither necessary nor desirable to impose restrictions on the commercial use of biospecimens subsequent to the act of tissue donation.
Chapter 3.4_6 paragraph 3.4.3
  1. 3.4.3f Consent:  It is not always possible to predict or foresee commercial outcomes from research on human biospecimens.
Chapter 3.4_6 paragraph 3.4.4
  1. 3.4.4: These stipulations are problematic due to their lack of clarity and the breadth of their requirements for approval of commercial use of derivatives of biospecimens.  Their implementation might impede ethically responsible research that could produce important medical advances.  In (a), it is not clear what is meant by a product that is “functionally different from the original tissue”.  In (b), it is not clear what is meant by “sufficiently attenuated from the donor”.  In (c), it is often impossible to assert definitively at an early stage that commercial use will generate community benefit, or that there will be equity of access to such benefit.  Also relating to (c), many legitimate applications of research on biospecimens might indeed draw profit from a unique property or characteristic of the donor, for example a unique nucleic acid sequence that confers resistance to viral infection. 
Chapter 3.4_6 paragraph 3.4.7
  1. 3.4.7 and elsewhere:  It is critical to define or clarify what is meant by the phrase “practicably traced back to the donor.”  Current DNA sequencing technology makes it possible to track any biospecimen back to a donor.  It might be preferable to define “practicably traced” to mean traceable through existing records or datasets.
Chapter 3.4_6 paragraph 3.4.12
  1. 3.4.12: It is quite often very difficult 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. 
Chapter 3.2 Data Banks
  1. Introduction-it is important to clarify the definitions of identifiable, re-identifiable and non-identifiable data.  A DNA sequence from tissue or a cell line provides the potential for identification.
Chapter 3.5 paragraph 3.5.8
  1. 3.5.1 and 3.5.7:  Some of the most important applications of induced pluripotent stem cell (iPSC) technology lie in functional genomics and disease modeling.  Also, DNA sequencing will likely 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, so the scope for discovering information of potential medical significance through DNA sequencing is now very broad.  Moreover, following derivation, iPSC are often 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 thus 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. For example, it may prove challenging for secondary users of iPSC lines that were derived by others to implement an appropriate plan for disclosing or withholding genetic information with potential medical consequences. In short, the implications of these provisions for the research field of iPSC, which is growing exponentially, are quite substantial.  I 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.

General Comments
  1. The Guidelines on Assisted Reproduction Technology should deal specifically with derivation of stem cell lines from human embryos.  The National Statement should deal with the use of pluripotent stem cell lines from any source.

Page reviewed: 4 September, 2012