Monday, 13 March 2017

Informed consent for biomaterial usage in Russian law

Any competition of two persons’ interests can likely to be deemed as collision of some values protected, at the highest level, by a constitution. Although such a conflict is to be balanced by a legislator and anyone who enforce the law, one of rival interests groups is usually stronger thus becoming general rules of the law while competing interests form exceptions which tends to harmonize the whole legislative system.
In using body samples the situation is exactly the same. Donor’s (and, unsurprisingly, her relatives') desire for privacy protection clashes with the researches and pharmacists wish to freely use it as the source of valuable data and raw material for drugs manufacturing, that is as the source of proaafit. If the legislator had chosen to consider tissues primarily as data, resulting from the fact that a single cell contains the whole DNA of a person, any way of cell usage would have been regarded as privacy intervention to be legally grounded and socially justified.
Meanwhile nowadays the general regime is entirely different as it was the property model, which was chosen as legislation framework for tissues and cells. So the conflict of interests arises only if this specific property belongs not to its progenitor but to the third party, mainly to medical, scientific and pharmacy institutions. I tried to show that Russian legislation in this field follows the law of the USA as well as that of the EU, so in all these countries the property law tends to protect an owner from anyone’s infringement, including from source individual’s one.
So it is the time to consider two main restrictions, which data protection law imposes on the owner of biosamples, these are rules on voluntary informed consent and privacy protection.
Informed consent
Voluntary informed consent (hereinafter simply ‘informed consent’) as a mandatory requirement of any biomaterial research is based on the concept that such studying is studying of a human being for the latter the informed consent has being a imperative requisite since the Nuremberg Code.  Its shortage forced the World Health Organization to develop a far more detailed ethical guide on medical studying of human beings as subject matter, which was enacted in Helsinki in 1964 and thus is famous as Declaration of Helsinki. Over the half of the century it has been updated time and again, the last version being issued in 2013.
According to the art (1)73 of the Health Protection Act all personnel of medical institutions shall act with compliance to medical ethics and to follow ethical rules is regarded as part of the principle of patient’s interests priority (see art. (1) 6 of the same Act). So the Declaration of Helsinky is widely recognized as part of Russian law despite the fact that the country has enacted no formal act to implement its provisions into the legislation.
The Declaration is said in its Preamble to be drafted as a set of ethical principles for medical research involving human subjects and their identifiable material and data. The remarks on human biomaterial had been added to the document during its fifth revision in 2000, basing on the concept that studying body material is studying a human being. Meanwhile this doctrine has been widely criticized recently for both its arguably wrong roots and harmful consequences. Indeed, the informed consent requirement in application to tissues and cells is rooted in the same principles of autonomy and a right to weight all risks of medical interventions that determines the universal foundation of the informed consent. However, as far as bodily materials after dissection are concerned, these ideas apparently do not work, for after separation any use of samples would never affect the subject’s health. Full and consistent operation of the autonomy right, in turn, would enable any patient to stop the whole body of medical research that evidently contradicts social interests. That is why the informed consent requirement has been weakened over the years, shifting to ‘broad consent’ model, which enables researchers to inform the donor on foreseeable usage of his material.
This tendency is reflected in Russian State Standard on Good Clinical Practice, which is said to be identical to ISO 14155:2011 «Clinical investigation of medical devices for human subjects — Good clinical practice». Art. 3.6 of the Standard provides a definition of clinical investigation which is described as any ‘systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a medical device’. It is entirely clear that, for example, a blood sample studying can never be viewed as an investigation ‘in human subjects’ as the only person with conscious and will in this investigation is the researcher herself and not at all the source individual.
However, nowadays denial of the informed consent cannot be said to overcome the traditional approach neither in developed countries legislation nor in legal or medical periodic. That is why, although Russian law does not expressly require the informed consent for human biomaterials research (or other usage as well), the huge importance and influence of the Declaration make the medical institutions obtain it from the patients.
Leaving behind general rules of the document we should mention its two main clauses on informed consent. First of all, art. 26 require each potential subject to be informed of the aims, methods, sources of funding, any possible conflicts of interest, the anticipated benefits and potential risks of the study and the discomfort it may entail and any other relevant aspects of the study. After ensuring that the potential subject has understood the information, the ‘qualified individual’ should seek the potential subject’s freely-given informed consent, preferably in writing. For biomaterial usage art. 32 of the Declaration further provides that in any medical research involving identifiable human material or data, such as research on material or data contained in biobanks, the informed consent should be obtained for either its collection, storage or reuse. However, this strict rule has an immediate exception namely when seeking for the consent is ‘impractical’, it can replaced be approval of an ethic committee.
As for any reuse of body material it is necessary to obtain the donor’s informed consent and because of absence of any hints on its content in national law, one should follow the European approach in the question. The Declaration’s requirement is deemed to be satisfied when, as was made in Catalana v. Washington University, the source individual is provided with the brochure with general information on the research and its foreseeable aims, which according to art. 11 of the Recommendations of the European Council expressly states that their composition and intensity could differ and the samples could be transferred to third parties for research purposes.

The post on personal data protection is coming soon...

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