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

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HREC Chair
Specific Comments

Given the importance of research in human biospecimens and the sensitivities in the use of them, It is appropriate that all research proposals seeking to use human biospecimens to be considered by an HREC.

It is unclear whether therapeutic products includes products that are substantially manufactured from human tissues/biospecimens. Some explanation of whether this chapter covers such products should be included here. Alternatively, Chapter 3.3 should be revised to include advice and guidelines about the use of human biospecimens in the manufacture of therapeutic products.

No mention is made here of the NHMRC document Ethics and the Exchange and Commercialisation of Products Derived from Human Tissue. This is surely relevant here.

Other chapters and documents that should be considered

Page 6 under the dotpoints there should be mention of disposal of biospecimens also.

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

3.4.3 Ethical Review and approval should be undertaken by an HREC. Add "by an HREC" to the end of the statement.

3.4.4 Add a clause about how their biospecimens will be disposed of.

3.4.4 Add a clause informing participants whether the value of their biospecimen is because of a unique property it has and how it will be used.

3.4.4 Add a clause that the biospecimen will not be used to create cell lines or other products for profit but medical research. A separate clause should be included elsewhere if it is intended to use human biospecimens for the creation of therapeutic products.

Ethical review before human biospecimens are used in research – paragraphs 3.4.6 – 3.4.11

3.4.9 As stated previously, all research involving human biospecimens should be subject to review by an HREC, rather than via some non-HREC review.

3.4.10 from the previous version should be re-inserted in some form, as it deals with trade in human tissue. It should state:

1) that trade or creation of therapeutic products will not lead to commercial incentives for either donor or researcher;

2) Cost should ensure that any product is not beihg sold for profit and should be available on the basis of need;


Import and export of human biospecimens – paragraphs 3.4.13 – 3.4.15

3.4.13 This is very vague and needs to include not just the National Statement, but the names of the rellevant other Australian legislation, such as the  Ethics and the Exchange and Commercialisation of Products Derived from Human Tissue document mentioned above, as well as such documents as Declaration of Helsinki.

General Comments

There is a significant question about the use of human biospecimens that have been derived from overseas donors, as the way they have been acquired may not have been ethical. If the source of the tissues cannot be determined, then they should not be allowed to be used. This is good science also, since its provenace cannot be guaranteed.

There needs to be additions about the use of human biospecimens in the creation of therapeutic goods and their relation with the donor of the biospecimen. This is a singular omission.

HREC should always be asked to review research involving human biospecimens as this is the only way in which the interests of donors/participants can be secured.

Page reviewed: 3 June, 2013