In Vitro Infidelium
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This is no doubt an accurate summation of the contract law as would be currently understood by the legal codes of most developed nations. However it does not take into account the differing Regulatory regimes that govern medical practice in every country; specifically in the UK, the burden on doctors is unequivocal and reference to the case of Dr Andrew Wright held earlier this year makes this very clear. Wright was held to have ordered tests which were of no medical value, and order tests from a (US) laboratory which had no competence to deliver medical tests as deemed appropriate to the standard required by UK medical authority.A US based company selling a test abroad would be liable along with its directors. A doctor in the US or another country including the UK would be entitled to trust that these tests are clinically validated, which is not matter of interpretation. This is established by the laboratory selling the test. Testing for research purposes does not come under CLIA regulations.
If VIPdx required that all tests were ordered via a doctor, then any doctor on the UK register who ordered such a test would patently have failed in the professional duty as defined by the GMC (and now MPTS ). Of course if VIPdx were actually accepting orders direct from patients, or if some non UK based doctors were merely acting as order agents for a fee that would be a different issue. The role of R.E.D Labs (Belgium) becomes relevant in the latter case because they acted as a European agent for VIPdx, and it is therefore reasonable to ask whether any of the doctors (Profit and Loss ) associated with R.E.D labs participated in a ‘sign off’ service, something which might be considered unethical.
The protections in a genuine research project are very different from that which applies in the case of day to day testing, specifically the ethical basis of the study would (or at least should ) be independently assessed, and this would (or should) include full provision for specialist advice to participants on interpretation of the results. One of the dubious aspects of the WPI work is that there appeared to be no provision for any referral of patients to medical specialists qualified to interpret the results provided by WPI. And even more worrying was the rhetoric from WPI at one stage, that the results of commercially sold tests would be used for research, when there was no provision for any ethical protection in place to govern how the test results were used.I can't remember now how the same would have applied (or not) to the specific research that occurred in the UK, as part of the WPI programme I think it was. Presumably the collection of blood, processing, and revealing of results were not patient specific and therefore no UK doctor was involved in the process.
IVI