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

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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)?: 

It seems obvious to me that those doing OMICS research with an aim to move their discoveries into the clinic would have to comply with existing documents such as the National Statement (NS) and the Australian Code for the responsible conduct of research (Code), as well as any other relevant guidelines/laws (TGA, NPAAC, APPs etc). I therefore feel it would be very useful to take the opportunity in the introduction to make it clear that the principles here build upon those already articulated by the NHMRC. It is my experience that one cannot re-emphasise (and redirect) those doing such work to read and re-read as necessary those two excellent documents (NS and Code). I would therefore like to see it stated much more prominently in the introduction that anyone doing OMICs for medical research involving humans must comply with the NS and Code. 

For the most part the principles are motherhood statements that could be said for any type of research involving the development of a diagnostic tool. As such it is important to state that OMICS should not be treated any differently to any other type of human research and that this document serves as a reminder, or a how to, for using existing guidlelines. There is one area that could be bolstered and that would be around incidental findings.

This document could benefit from having a section that was a bit more of a practical guide for healthcare managers to ensure that they can apply the gudielines of the NS and code in the context of OMICS. 

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 fine for the most part although there is a lot more overlap between the domains than is noted here. In fact, almost all the principles are true of any kind of research or technology and perhaps some more comment on the overlap and integration could be made as it is not always possible to make clear distinctions between healthcare practice and research.

Some of the ethical principles outlined on pages 5 and 6 are not particularly well expressed. Bullet points 1 and 3 are not ethical principles as far as I can tell but are statements of fact. Point 4 is an aspirational statement that could be said about any element of healthcare and I do not understand why it is being held up as a specific principle here. The three operational principles are similarly generic statements applicable to all medical research and so I do not understand why they are being presented here as being particularly relevant to the tool of OMICs, other than to reemphasise that OMICS should be subject to the standards we expect of all research. 

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 first case study is useful insofar as it points out an egregious error that would be made by only the most inexperienced clinician. It is astonishing to me that any person would have their treatment altered by a test done in a research laboratory that didn’t have appropriate levels of confidence or be the subject of a proper ethically defensible plan that had been approved by an HREC. Perhpas the case study could make a note about the need to have a proper HREC approved ethically defensible plan to connect it clearly to existing NHMRC guidelines. 

Case study 2 is a good illustration of a real situation that can arise and is quite helpful. 

Case Study 3 appeared to be incomplete. It asks questions without providing illustrations that were present in 1 and 2.

Case study 4 states that there is a right to life insurance. As far as I know this is not a right.

Case study 5 raises an interesting debate point. Should the omic profiling used to stratify patients into a clinical trial be done in a NATA accredited facility? This appears to misunderstand NATA a little. A test in a NATA accredited lab doesn’t necessarily mean it is completely validated. It needs to be a NATA accredited test. The test should be well validated before being used in a trial regardless of it being done by OMICs and there is lots of evidence around about such tests being used that were subsequently adjusted (eg EGFR testing). Perhaps this example could flesh that distinction out a little to help the audience. 

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

Personally I would not find this document any more useful than my using the National Statement, Australian Code, Privacy Act, NPAAC and CIOMS/HUGO notes on genetics and the TGA guidance on IVDs. But then I have a somewhat unusual angle it seems as frequently I am reminded that there are far fewer researchers that have actually read these than should have done so. Given my somewhat biased view that both the NS and the Code actually articulate a large amount of what is presented here I think it would be helpful if there were a greater emphasis on how to use the existing sections of the NS and Code using examples in this document. eg referring to section 3.3 when speaking about clinical trials and 3.4 when discussing use of human biospecimens. 

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?: 

I would like to have believed that this advice was not needed from the NHMRC because everyone was conversant with the NS and Code and other relevant documents. However, my experience has been that there is a very broad range of experience and knowledge of those documents amongst those engaged in this work and so this document has a specific role for those people. It is my view that OMICs technologies are just another set of tools quite similar to those in use for decades and that whilst they promise some significant improvements in throughput there is no case for them to be outside of standard ethical norms. If the document could make a few more links to the NS and Code to illustrate why OMICs is not different and still subject to standard guidelines applicable to all medical research that would improve the document. 

Page reviewed: 15 April, 2015