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

ID: 
10
Personal Details
Organisation Name: 
Deakin University
Additional Information
Organisation description: 
Educational Institution – tertiary
E. Submission
Submission methods: 
Online Submission (specific questions)
Specific issues requiring particular consideration
1. Would it be useful to refer to one document (i.e. Part C of the ART guidelines) regarding the use of human gametes, embryos or embryo derived stem cells for research?: 

It is always preferable to be able to refer to a single set of guidelines if possible.

2. Has all relevant guidance from Chapters 3.4 and 3.6 of the National Statement been retained in the draft Chapter 3.4_6 so that the ethical issues are made clear and can be addressed by researchers and HRECs?: 

Yes

3. Are the guidelines for the importation of human biospecimens clear and appropriate?: 

There are potential problems if the proposed guidelines are interpreted strictly, see comments on 3.4.12-3.4.15 below.

4. Are there additional ethical issues that need to be considered in this chapter?: 

We have commented in more detail on the particular issues below.

Comment on specific Sections
Specific Comments: 
Chapter 3.4_6 Introduction

[Comment specifically relates to paragraph 3 commencing ' Human biospecimens collected during clinical investigations...']

Use of stored pathology samples for quality control and teaching purposes without consent or human ethics approval is a known and often legally required process. It should not impact on the use of such samples for human research. This paragraph suggests that requirements for use of stored pathology samples in research are different from those relating to other human tissue without specifying how. This is ambiguous and potentially illegal in some states, depending on how health privacy requirements are interpreted.

Given these proposed changes to the National statement guidelines and specifically the proposal to create an exemption category for non-identifiable tissue, separate guidelines for stored clinical or pathology samples do not seem necessary.  As with any other banked or prospectively collected sample the options to allow use of the tissue are:

  • Exemption
  • Waiver of consent by an HREC
  • Consent by the donor (or an appropriate surrogate)

These options appear to cover all likely scenarios.

Chapter 3.4_6 paragraph 3.4.1

This includes human tissue studies in the categories of research requiring HREC review  as opposed to any other level of ethical review. (Currently stem cells and human genetics require HREC review, but not human tissue as such.) This is inconsistent with the proposed 3.4.7 (exemption) and 3.4.9 (low risk review).  The revised section 5.1.6 also lists research under this chapter as requiring HREC review, so this needs to be clarified.

We support the appropriateness of low risk review or exemption for some human tissue studies.

Chapter 3.4_6 paragraph 3.4.3

(a) and (b): These requirements are simply repeating what is required elsewhere in the National Statement.

(d): This seems appropriate, at a certain point it will become impracticable to withdraw tissue or data, because they are either non-identifiable or no longer separable from other tissue/derivatives/data.

(e): Additional information is required about the level of information to be provided to donors regarding the 'sale' of their biospecimens. General information is appropriate, but if detailed information is required for purposes which may not be fully known or understood at the time of collection, this could cause problems.

(f): Should guidelines be given regarding who SHOULD benefit from commercial outcomes arising from research involving biospecimens? (See also comments below about potential commercial uses of biospecimens.)

Chapter 3.4_6 paragraph 3.4.4

3.4.4 (a): Please explain what “functionally different” means in this context. Perhaps an example could be provided to aid the committee in determining whether applications meet this requirement?

3.4.4 (b): If as per the glossary definition of “attenuation” provided, this clause is referring to biospecimens that have lost the significant properties to which importance may ordinarily be attached (eg: genomic or cellular properties), there are perhaps two points that need to be made:

  1. It is questionable whether people in the community ordinarily consider the properties of their biospecimens or attach importance to them beyond their personal significance to the health of the person or their family, in the way that seems to be implied here; and
  2. Assuming people do attach importance to “significant” properties, and given that involvement in research in Australia is normally for altruistic reasons, why would people object to certain components of their biospecimens being used but not others? It is appropriate for the researcher to explain the ramifications of the proposed use of the tissue as far as they are known, and the participant can then choose whether to freely consent

3.4.4 (c) (ii): With regard to a researcher’s possible “obligation to make available information derived from the material that is relevant to the future health of the donor(s), their family or a particular community”; this is a broad responsibility which is also noted in 3.4.11. Is the intention here to ensure that commercialisation does not remove the moral obligation to inform participants (where practicable) about information of this sort? If so, perhaps this could be phrased more clearly.

Chapter 3.4_6 paragraph 3.4.7

This is a welcome development, and Deakin will move to establish exemption criteria once these amendments are finalised.

Chapter 3.4_6 paragraph 3.4.10

The requirements for use of stored clinical samples are no different from any other biospecimen. Waiver of consent can only be approved by an HREC according to law. This clause should be deleted as it could be read as authorising waiver of consent without complying with the legal requirements.

If it is necessary to stipulate that an HREC may also provide a waiver of consent for the use of stored human biospecimens then I suggest alternative wording. An example might be “Where prospective consent for the use of stored biospecimens in research has not been obtained (eg. where the biospecimens were originally collected for diagnostic purposes), a waiver of the requirement for consent may be granted by an HREC subject to applicable legislation and guidelines”

Chapter 3.4_6 paragraph 3.4.12

See comments on 3.4.15 below

Chapter 3.4_6 paragraph 3.4.15

The provisions of 3.4.12 and 3.4.15 are potentially impracticable as it may be impossible to establish the details of collection of a tissue sample or cell line in detail, particularly tissue collected for diagnostic purposes. This could have a significant negative impact on some areas of research. We suggest that as with the current guidelines, the biospecimens be confirmed as obtained from a reputable source in a country which has equivalent guidelines to the National Statement under the Declaration of Helsinki or CIOMS guidelines.

Chapter 3.2 What are data?

We support the removal of the presumption of identifiability.

Chapter 3.2 Data Linkage

Please provide a definition in the glossary for “Data linkage units”

Chapter 5.1 paragraph 5.1.22

5.1.6 (b): The inclusion of Chapter 3.4_6 in this list contradicts Section 3.4.9 that allows for low risk ethics applications for projects involving human biospecimens.

5.1.22: Deakin supports the possibility of an exemption for tissue and tissue products that are practicably non-identifiable.

General Comments
Comments: 

In general we support the proposed changes, in particular the simplification of the guidelines, and the availability of a category of exempt research with non-identifiable tissue.

There still remain some points to address in relation to the research use of stored clinical and pathology samples. Separate guidelines seems unnecessary with the proposal for an exemption category, as provision of these in non-identifiable form or waiver of consent seems to deal with most situations in which consent for their use is not available.

It appears from 3.4.4 that commercialisation of tissue derivatives is still problematic. We understand that work is being done in relation to this, but at this stage these requirements seem ambiguous in terms of administration by an ethics committee, and we consider that clearer guidelines are crucial if these are to be meaningfully implemented.

The final point to raise is the level of scrutiny required of tissue samples or derivatives sourced from overseas.  As noted above, these are appropriate in principle, but the level of actual information to be obtained by researchers needs to be clear. In practice it should be possible to determine that the biospecimens derive from a reputable source, and were collected and produced under appropriate guidelines, and this should be considered sufficient unless there is reason to believe that the biospecimens were not sourced ethically.

Page reviewed: 4 September, 2012