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Principles for the translation of ‘omics’-based tests from discovery to health care submission

ID: 
2
This submission reflects the views of
Organisation Name: 
General Ethical Issues Sub-comm, Alfred Hospital Ethics Comm
Please identify the best term to describe the Organisation: 
HREC
Personal Details
Questions
Q1. Is the draft document presented and written in a manner that is appropriate for the target audience (ie medical researchers, health professionals, health administrators and policy makers with responsibility for oversight of research or clinical care)?: 

The draft document is complex and difficult to understand for ethics committees (i.e. policy makers with responsibility for oversight of research).

It is too limited in a key area of concern for ethics committees and researchers: how and when to advise people about their results from ‘omics’-based research.  There is nothing, for example, about how to deliver such information, informed consent, or providing information to genetic relatives.

Q2. The draft document includes governing principles that apply across all domains and specific principles that apply to each of the four domains. Is this structure useful?: 

The structure is not particularly helpful. It makes the document more complicated and has the effect of compartmentalising areas that are actually more fluid and interrelated.

The issues have been complicated by bringing in a difference between research and therapy.

The focus now is much more on validation. However, it is difficult to tease out analyst/lab validation and clinician/utility validation.

Q3. The draft document includes five case studies. Are the case studies appropriate and do they sufficiently cover the range of situations that might be encountered in practice?: 

The case studies are hard to follow and too complex to clarify the concepts they are intended to illuminate.  We did not find them useful for promoting discussion or clarifying a concern. 

It would be helpful to have research examples.

Q4. Would you be able to use the document as the basis for drafting specific principles, policy or actions in your local context?: 

No – the Ethics Committee does not find the document particularly helpful.  The focus of the consultation has shifted from the return of results to the translation of results.  The former is the key area of concern for ethics committees.

Q5. Is the draft document comprehensive and does it cover the key issues in terms of principles? Is there further advice that should be included in the draft document?: 

Is the draft document comprehensive and does it cover the key issues in terms of principles?

The governing ethical principles [pp.5-6] do not explicitly include the principle, or value, of autonomy.  The view of this Committee (expressed strongly in our last submission) is that a fundamental principle should be that any feedback of results is participant-led and the choice ‘not to know’ should be respected.  Domain 2, Principle 2.8 (or 2.10*) touches on this.  

*Note that there is an error in the draft Principles document – sub-sections 2.8 and 2.10 are identical.

Is there further advice that should be included in the draft document?

The document needs to include the following:

  • Explicit reference to the development, by researchers of an ‘ethically-defensible plan’ for returning/not returning results to participants (as required by the National Statement).
  • The fundamental ability of patients/research participants to ‘say no’ to receiving information revealed by ‘omics’ tests.
  • The imperative to develop and maintain a list of a limited number of clinically important abnormalities / mutations (with the ability to add or remove conditions) that should be reported on/fed back to participants who wish to receive the information.  [Who should/could do this is an area where the NHMRC could make recommendations.]
  • The ability for ethics committees to make the final decision about the reporting/non-reporting of results (without legislating what ethics committee have to do).

However overall, rather than including further advice, it would be better if the document were simplified.

Page reviewed: 15 April, 2015