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

ID: 
34
This submission reflects the views of
Organisation Name: 
Northern Sydney Local Health District
Personal Details
Additional Information
Please identify the best term to describe the Organisation: 
Biomedical research institute / organisation
Specific Comments
Comments: 
Introduction

The original Chapter 3.4 definition explains the context of using tissue in a clinical and research setting and this is helpful for users of the National Statement who often do not have a medical or science background. It is suggested this approach be used in the new wording as the opening sentence in the new introduction launches straight into the term ‘biospecimens’, which is daunting for a lay person to read. The user needs to feel comfortable and understand the context of how this applies to them.

It is recommended that the definition of biospecimens be moved up to the opening paragraph.

If is recommended that the term ‘broad’ to describe human biospecimens in the paragraph commencing; “The definition of ‘human biospecimens’ is broad:…” be amended or removed so that it does not leave this open for interpretation. It is recommended that the introduction instead simply state that the definition includes or encompasses the listed categories.

This paragraph also states that the definition of ‘human biospecimens’ includes gametes and embryos then the preceding paragraph advises that these are not covered under the Chapter. It is recommended that the paragraph be amended to state something like; “for the purpose of this chapter the definition of ‘human biospecimens’ includes: tissue, blood, urine, sputum”. Then the next paragraph state what the process is for gametes, embryos, fetal tissue and cell lines to avoid any confusion.

Reference to the relevant State, Territory and National Legislation is not included and should be inserted, this is included in the previous Section 3.4 and formed an entire section; ‘Legislation’ in Chapter 3.6. It needs to be very clear what the requirements are for each State/Territory in addition to the broader national requirements.

There is a lot of information and context lost with the merge of Chapter 3.6 into the new Chapter 3.4. The definitions now form part of the glossary however this is at the back of the Chapter so is somewhat lost to the reader.

The sections entitled ‘Stem Cell Research’ and ‘Scope’ in Chapter 3.6 describe the history and provide a good explanation of this type of research. This is helpful and again puts it into context and explains how the guidance/chapter applies to users. It is recommended the key components of these sections be included in the new iteration as they are not sufficiently covered under ‘Sources of Human Biospecimens’ or ‘Potential for Identification’.

Sources of human biospecimens

All of the terminology needs to be defined it should not be assumed that the reader knows what is meant by each term (eg. post mortem, biobanks) or expected that the reader continually flick back to the glossary.

In addition, “Post Mortem” and “Biobank” are not included in the glossary.

It is recommended that a statement be included to reference the relevant State, Territory and National Legislation.

Potential for identification

The first paragraph uses the terminology “human genome”, this should be explained.  It should not be assumed that the reader knows what is meant by each term or expected that the reader continually flick back to the glossary.

In addition, “Human Genome’ is not included in the glossary.

This paragraph is not written very plainly and as such the point of its inclusion is not made clear. It is recommended this be re-written to clearly explain what the issues to be considered are under this section.

Other chapters and documents that should be considered

A more direct reference/statement should be included about the relevant State, Territory and National Legislation as it was in the original sections 3.4 and 3.6. The current wording, “Researchers and institutions will also need to meet any general or specific legislative requirements that relate to the collection, retention and use of human biospecimens” is not specific or direct enough.

 It needs to be very clear what the requirements are for each State/Territory in addition to the broader national requirements.

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

3.4.2: It is recommended that a statement be included to reference the relevant State, Territory and National Legislation. It needs to be very clear what the requirements are for each State/Territory in addition to the broader national requirements.

3.4.3: A statement should be included to refer to cases where the waiver of consent by the HREC can be applied. This is referenced at 3.4 (b) of the current Chapter.  It is recommended that the statement about when this waiver can be applied include clear reference to these examples such as; Where tissue is removed after 1 November 2003 and is held in a tissue block or tissue slide, the law allows the tissue to be used for research without consent being obtained (on the proviso that section 2.2 of the NS is met and deemed applicable by the HREC).

 The statement should also include a clear reference to Chapter 2.2 of the NS for further advice on the general requirements for the waiver of consent.

3.4.4: A statement should be included to advise of the potential insurance implications for participants and then reference provided to Section 3.5 for further advice on this issue.

Use of human biospecimens obtained after death – paragraph 3.4.5

Direct reference to the applicable section of the Human Tissue Act should be included and a statement to make it clear that where tissue has been removed from a deceased person (either for the purposes of a post mortem examination or otherwise), and is not a tissue block or tissue slide, that written consent to the use of the tissue for research, (by the deceased prior to death or their next of kin) is required. It should also be stated that in addition to this the written authorisation of a designated officer of a hospital is required.

Furthermore it should be stated that the law does not allow consent to be waived in this circumstance even if the requirements of NS 2.2 are met. The law overrides the NS.

Sections 3.4.8 and 3.4.9 of the current chapter give a context to this issue that is missing from the new section.

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

3.4.10: It should be stated clearly that participants should be aware of any potential insurance implications there involvement in any research could have for them in the future. Reference should then be provided to NS Section 3.5 for further advice on this issue.

A statement needs to be included regarding commercialisation as per Section 3.4.10 of the current Chapter 3.6.10.

3.4.11: Reference needs to be made to the Human Tissue Act as the law overrides the National Statement.

Cost recovery for human biospecimens – paragraph 3.4.12

Cost recovery is an ethical consideration but is also a governance consideration for each institution to consider it should be clear that this is not solely the role of the HREC

Import and export of human biospecimens – paragraphs 3.4.13 – 3.4.15

Section 3.4.4 currently states what the process is if it cannot be established that an appropriate policy exists for the ethical review of research in the destination overseas, it would be helpful if this was also clearly stated in the revised statement.

It should be stated that an agreement should be put in place between each of the parties before any transfer occurs.

A statement should be included as per 4.4 of the current NS regarding when the HREC can waiver participants consent for their samples to be transferred.

A statement should be included advising of the process when stem cell lines have been created O/S as per 3.6.8 of the current Chapter.

Page reviewed: 3 June, 2013