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

ID: 
25
This submission reflects the views of
Organisation Name: 
NHMRC Clinical Trials Centre
Personal Details
Additional Information
Please identify the best term to describe the Organisation: 
Biomedical research institute / organisation
Specific Comments
Comments: 
Sources of human biospecimens

We suggest that an explanation of why ‘Some jurisdictions may also have legislation that required pathology practices to retain human biospecimens’ be included - either be reinstating the original wording ‘Hospitals and pathology laboratories are required by law to retain archival samples for diagnostic or forensic purposes’ or inserting equivalent wording.

Other chapters and documents that should be considered

Whilst cross-reference is made to ‘Chapter 2: Themes in research ethics: risk and benefit, consent’ in this section in that it is also applicable to biospecimen research, we recommend inserting specific direction to paragraphs 2.2.14 - 18  as this is particular to ‘Consent to future use of data and tissue in research’.

Prospective collection of human biospecimens for research – paragraphs 3.4.1 – 3.4.4
  • Before people consent to donation of their biospecimens, they should be given information about 3.4.4 (b) for how long the biospecimens will be stored or used.
    We recommend that this be extended to include provision of information relating to plans to return biospecimen/s to the originating pathology laboratory or to their destruction.

 As in our earlier submission, we again recommend that the National Statement also give guidance relating to:

  • 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 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 for participation in a clinical project:
    eg required (mandatory) biospecimen collection as part of a clinical trial
    vs
    optional biospecimen collection
Cost recovery for human biospecimens – paragraph 3.4.12

The revised Chapter 3.4 requires that prior to consenting to donation of their biospecimens, people should receive information about:

  •  paragraph 3.4.4 (h) any cost recovery arrangements that may apply to the collection, retrieval, handling, storage and distribution of their biospecimens

In contrast elsewhere in the National Statement  (Chapter 2) is silent in relation to providing information to research participants about cost recovery for other clinical research activities -  paragraph 2.2.6 (a)-(m).

For consistency on this issue with the rest of the National Statement, we recommend the following for the revised Chapter 3.4 draft:

  • Remove paragraph 3.4.4 (h)
  • Edit section 3.4.2 as follows:
    1.4.12      It is recognised that there are financial costs associated with the collection, retrieval, handling, storage and distribution of human biospecimens. Any proposal to recover these costs must be reviewed by an HREC who must be satisfied that the proposed cost recovery is ethical, that it is subject to transparent and accountable reporting and that full disclosure is made in the consent process (see paragraph 3.4.4 (h)).

Furthermore, details of cost-recovery are not necessarily known at the time of consent and collection of biospecimens for example if (partial) funding for some of these activities is dependent on future funding sources. It would be preferable that cost-recovery details pertaining to ‘collection, retrieval, handling, storage and distribution’ are conveyed to the HREC where possible however this information is not made a requirement for the patient information consent form.

General Comments
Comments: 

In the Glossary, we recommend:

  • that the definitions of ‘community’ and community benefit’ be consistent, so suggest that the definition of community to also include ethnic in its list of potential groupings ie ‘A collection of individuals, which may extend from the whole population to a smaller grouping associated by cultural, ethnic, geographical, social or political factors or some other commonality.’
  • that the definition for 'human biospecimen' use the plural of protein (ie proteins) to 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’.

 

OTHER COMMENTS

  • We recommend that Australian English be used throughout this revised Chapter 3.4 for consistency with the rest of the National Statement eg the words foetal, foetus, recognise.
  • Replace the term ‘tissue’ with ‘biospecimens’ throughout the other relevant chapters and sections of the National Statement including:
         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: 3 June, 2013