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

ID: 
7
Personal Details
Organisation Name: 
sub-Committee of Royal Brisbane & Women's Hospital HREC
Additional Information
Organisation description: 
Other
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?: 

Yes

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?: 

No.  There is much that is helpful and clearer in this amendment.  However, the first heading of Chapter 3.4_6 has changed.  It now relates to the Collection  of samples, not use.  This implies that ethical issues relate only to collection and not to the use to which they are put, who might have access to them, and where they may go.  There is failure to acknowledge that samples and data are often shared together.  The NS Chapters 3.2 and 3.5 both state that further use of data in a databank or genetic studies require further review by an HREC.  This is not the case in Chapter 3.4_6 and is therefore perpetuating an ambiguity which is confusing to researchers and HRECs alike.

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

No.  Why has reference to the values, guidance or regulations of the country of origin been removed?  This seems to be a backward step, as it fails to acknowledge other cultural sensitivities, and might be seen as implying the superiority of Australian guidance.

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

The section headed "Ethical review before human biospecimens are used in research" has not fully clarified previous ambiguities.  Who should be making the decisions here?  It states the institution, but is this the tissue custodian, the institution under which the samples were originally obtained or someone else (sponsor)?  This could result in a failure of independent oversight on use and on the compatability of the future research with the consent under which the tissue was collected.  How is direct relevance judged? This is also likely to be open to debate. It is felt to be important to distinguish who will be the custodian of the samples taken and the codes of conduct under which they operate, If this code is in contrast with NHMRC, the latter should be followed.  This can only be determined if the future study and researchers make a submission for use of the previously collected samples.    As it stands, this section does not fully foster transparency and independence in the oversight and conduct of future research, because no independent body will know of the future research.  Even if harm is likely to be minimal to the participant, the perception that potential uses of material which came from a participant and which they therefore have an interest in (regardless of the legal view) are irrelevant because no harm is likely, does not promote the principle of respect for the individual or for current community values (of autonomy).  In addition because of great scientific strides what might be feasible or imaginable now might not have been 5 years ago when the extended or non-specified consent was given.

There is no comment on the ethical aspects of sending biospecimens offshore which is a not-infrequent occurrence.

It is felt that some comment is necessary on storing biospecimens for future research and possible restrictions on the use of such specimens.

Comment on specific Sections
Specific Comments: 
Chapter 3.4_6 Uses of human biospecimens in research and application of this chapter

Ambiguity is generated through the reference to protocols.  The term protocol is used for a research study.  However, it is understood that here the term protocol is referring to collection of a sample.  Is the HREC review limited therefore to review of institutional protocols for collection or to a study protocol which as one of its features includes collection of samples?

Chapter 3.4_6 paragraph 3.4.3

3.5.8 will have to be part of any ”unspecified” consent as well as 3.4.3 and this would make strict adherence to this section very difficult.

Chapter 3.4_6 paragraph 3.4.4

Re a) Further clarity may be required. Certain “human” medications eg erythropoietin are similar functionally to the tissue from which they have been derived, and would be excluded on the basis of this section.

Chapter 3.4_6 paragraph 3.4.7

See above -(4).  Who are the institutions here? There is no way of knowing whether a pharmaceutical company, which would be the institution for many studies, has appropriate mechanisms/systems to abide by this section. In addition, there are different views of what is ethical, and to accept the judgement of a prior ethical review leaves huge room for undefined work. As community values guide consideration of what is ethical where prior ethical review is separated in time from a study, the review might have limited resonance with current values.

The term 'direct' is open to debate. Again how may it be monitored?

This section does not resolve fully the ambiguity of the first NS (2007) with respect to HREC review of future research.

The proposed boundaries are wide and because so, open to interpretation, They enable a view that all samples taken under consent for nonspecific consent will occupy a category which doesn’t require a full ethics review. 

As a minimum, the only exemption from HREC review should be 3.4.7(a) and (c) together.

Using the specimen for research that could be of relevance to members of a community should entail the respect of closer scrutiny by a HREC.

Applies also to 3.4.13

 

 

Chapter 3.4_6 paragraph 3.4.9

 

As above, using the specimen for research that could be of relevance to members of a community should entail the respect of closer scrutiny by a HREC

 

Chapter 3.4_6 paragraph 3.4.10

 

It is thought to be contrary to research integrity, respect and justice to use a specimen collected for diagnostic purposes to do research on without the patient (not participant) knowing about it.

 

Chapter 3.5 paragraph 3.5.8

Why has the original a) been deleted? This is a useful statement that a lay person is unlikely to know. Substitution by b) may be less clear.  The manner of holding is likely to be stated as coded or links destroyed.  The fact that data are often linked to samples makes non-identifiability to be highly unlikely: even when double codes are used and the first destroyed.

As before: 3.5.8 will have to be part of any ”unspecified” consent as well as 3.4.3 and this would make strict adherence to this section very difficult.

General Comments
Comments: 

This revision is very timely and helpful.  However we do not believe that it addresses the current problem of different and inconsistent interpretations of the NS with respect to further review of research on previously collected data or samples collected under extended and non-specific consent.  By contrast, the requirement for further HREC review of data extracted from databanks or genetic studies on samples seems to be explicitly stated in the chapters concerned.  Chapter 2 has not been altered to state that while consent may take various forms, this does not imply that no further ethical oversight is required.  We feel this should be corrected.  The two separate activities - consent and HREC review - appear to have been conflated in some interpretations of the guidance. In addition, the interpretation and recognition of what might constitute harm at the time of collection may well be very different in a few years time.  Should this be left up to an institution, possibly a research organisation, which is likely to have a bias to use samples for research without further independent oversight?  The guidance should be clearer.  The fear that HRECs hinder research (which has been one argument for HoMER) is unfounded, as relatively small numbers of studies are rejected (local data).  Certainly HRECs ask questions about research, as  is their role.  Questions are less likely to be asked if guidance is clear and unambiguous.  We thank you for the opportunity to contribute.

Page reviewed: 4 September, 2012