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

ID: 
23
This submission reflects the views of
Organisation Name: 
Deakin University
Personal Details
Additional Information
Please identify the best term to describe the Organisation: 
Educational Institution – tertiary
Specific Comments
Comments: 
Introduction

Is somatic cell therapy covered by this chapter? Paragraph 3 implies that it is covered by Chapter 3.3 Interventions and therapies, but this seems less appropriate.

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

3.4.1 repeats requirements covered under research merit and integrity (NS section 1)

3.4.2 repeats requirements covered under consent (NS chapter 2.2)

3.4.3 repeates requirements covered under ethical review (NS chapter 5.1)

These requirements are not specific to biospeciments and do not appear to add anything to the existing requirements.

Similarly under 3.4.4 sub-clauses (a)-(c) and (g) are covered in existing requirements in NS chapter 2.2

Sub-clauses (h) and (i) are a useful addition

Use of human biospecimens obtained after death – paragraph 3.4.5

It would be helpful to specify whether the requirement for next-of-kin consent is or is not intended to apply to existing clinical samples from a person who has since died, which may be stored in tissue banks or health services. (This clause can be read either way.)

We suggest that existing clinical samples should be specifically excluded from this requirement, as they have been appropriately obtained during the life of the patient, and the exisiting consent or other circumstances will be considered by the ethics review body in accordance with the National Statement requirements.

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

Clauses 3.4.6 and 3.4.7 do not appear to add anything to the existing requirements of the NS chapter 5.1.

Regarding 3.4.8 and 3.4.9

We support the potential for projects involving biospecimens to be reviewed by a low risk process where appropriate. However, we had some problems with the meaning and intention of these clauses.

3.4.8 seems to relate to tissue obtained from any source and accepts the possibility that research involving it may be low risk based on the standard criteria (no risk greater than discomfort).

3.4.9 relates specifically to samples obtained with consent for research purposes. It is not clear whether this is meant to be an alternative to 3.4.8 or to specify the conditions under which speciments collected for research can be re-used for other research.

On our reading of this clause (3.4.9)

  1. It applies specifically to samples obtained with consent for research but seems to apply a higher or more specific threshold for consideration as 'low risk' than where the tissue was collected for clinical purposes or at autopsy, which is allowed under 3.4.8 by the ‘discomfort’ test.
  2. It was not clear to us whether the clause represented alternative criteria for 'low risk' research using biospecimens, or as a gloss on section 3.4.8 intended to clarify how risk might be assessed. If the latter, then it is too limiting.
  3. If this is considered to be the only situation in which re-use of human tissue collected for research is to be considered low risk, then it creates a problem for the conditions for waiver of consent (waiver is available only where research is low risk, see comments on 3.4.11 below).
  4. The various requirements of 3.4.9 are inconsistent.
  • If the proposed use of the stored sample is consistent with the original consent given (a), it doesn’t matter whether it is identifiable or not (b). Consent has been given for the use (or the general class of use), so provided confidentiality requirements are maintained, and ethics approval is obtained for the new project the sample may be used.
  • It is not clear why (c) and (d) are necessary. It is hard to see any risk other than breach of privacy in relation to a stored human sample which is being used in a manner consistent with the consent given (c), and if the donor/s cannot practicably be identified, then it is immaterial whether the research will give rise to information that is relevant to them, their family or community (d), as they cannot be reliably traced to be informed of it.

3.4.10

Particularly in the introduction and (c), there is no guidance given as to how and when blood relatives ought to be contacted and consent sought regarding the disclosure of informaiton that a study may reveal about their future health, nor is there any guidance regarding how researchers should approach identifying them or obtaining their contact details, given the requirements of Australian privacy legislation. These elements are well handled in chapter 3.5 Human Genetics. Referring to the various guidelines in that chapter would be a more appropriate way of dealing with these issues.

3.4.10(d)

Does this clause refer to whether any testing will be carried out by a diagnostics lab for example and does it therefore relate to clauses 3.4.1, 3.4.10(e) and (f) or is it referring to the possibility for data (biospecimen) sharing and does it therefore relate to 3.4.4(f)?

3.4.10(e)

This clause refers to prospective biospecimen collection, hence one would expect that if the biospecimens were intended to be identifiable, they would be. Inclusion of this item appears misconceived.

3.4.11

This clause needs to include the option of re-consenting the donors of clinical samples in the event that the requirements for waiver of consent are not met. (This is implied, but not stated in this clause.)

Currently the NS guidelines regarding a waiver of the requirement for consent stipulate that involvement in the research must carry no more than low risk (NS 2.3.6(a)). If clause 3.4.9 of this chapter is in fact stating that these are the only conditions under which research involving biospecimens may be considered low risk, then a waiver of the requirement for consent for use of biospecimens obtained without consent for research (3.4.11) can only be sought if the biospecimens were collected with consent for research purposes (3.4.9). This needs to be clarified.

Cost recovery for human biospecimens – paragraph 3.4.12

This seems intended to ensure that hospitals and tissue banks can recover the costs of providing samples to researchers, without creating the appearance of trafficking in human tissue. We support the intention, but not the means of achieving this.

It seems problematic to require HREC review of cost recovery, since this will usually lie outside of the ethical review processes for research, and if related at all (as in the case of surplus tissue available after the conclusion of a project) will post date the conduct of the research for which it was collected. (In most cases the researchers are the clients from whom the costs are recovered, rather than the provider who is recovering costs.) In the case of stored clinical samples or a tissue bank, cost recovery for the collection and supply of the samples is likely to be a financial decision made by the organisation which has custody of the stored tissue.

While it is appropriate for the NHMRC to set guidelines on what is a reasonable level of cost recovery for samples used for research, an HREC process for this is inappropriate and difficult to implement.

Import and export of human biospecimens – paragraphs 3.4.13 – 3.4.15

3.4.13 implies but does not state that if biospecimens collected overseas were not collected in a manner consistent with the requirements of the NS and relevant Australian legislation, they cannot be used. There appears to be a missing clause/sentence. Currently it only says that researchers should determine in biospecimens were collected in this way.

If this is what is intended, it is tighter than previous requirements, which required that reasonable steps be taken, and allowed reliance on policies of collecting institution. It is important that an HREC have sufficient discretion to consider the available information and make a determination for or against.

3.4.15

Is this intended only to apply to biospeciments imported from other countries? It seems appropriate to any class of biospecimens.

As noted in 3.4.13 above, given the potential complexity of how tissue (which may have been stored for many years) might be obtained, it is important that the HREC have scope to appropriately consider the ethical issues, rather than need to comply with rules that might not meet the particular situation (eg not all stored tissue will meet the requirements for waiver). This includes the option to determine that the tissue was not collected ethically and should not be used.

General Comments
Comments: 

The university supports the thrust of the revisions, in particular

  • specific treatment of clinical samples not collected for research purposes
  • recognition that in many cases tissue samples will be practicably non-identifiable
  • the potential for research involving human tissue to be dealt with by a low risk process

Issues that are of concern include

  • repetition in the chapter of elements which are already covered by other chapters of the National Statement such as specific consent requirements. This has the potential to create ambiguity if the same issue is dealt with in slightly different wording in two or more places.

Page reviewed: 3 June, 2013