If human tissue was removed from living individuals after September 1, 2006 and consent for the research was not obtained, ethics clearance for the research would be required. Human tissue must also be anonymized for researchers. You must apply to an REB for an ethics review of the original project with IRAS. Ethical approval authorizes the storage of human tissue only for the duration of this project. If the human tissue has sustained value before the end of the project, you must take one of the following steps to make it lawful to store the tissue for further research: Under common law (and the Mental Capacity Act 2005), consent is still required to remove human tissue from living tissue. However, the consent of the living person may be given for diagnostic or therapeutic purposes. 10 It is prohibited, directly or indirectly, to buy, sell or otherwise exchange tissues intended for transplantation or cadavers or parts other than blood or blood components for therapeutic, medical education or scientific research purposes in exchange for an eruption. 6 If, in the opinion of a physician, the death of a person as a result of injury or disease is imminent and the naturopath has reason to believe that section 2, 3 or 4 of The Coroners Act may apply if the death occurs and consent has been obtained under this Part for a post-mortem body tissue transplant, A coroner: who is capable, even if death has not yet occurred, may give such instructions as the physician considers appropriate for the removal of such tissues after the death of the person, and any instruction given has the same effect as if it had been given after the death under section 13 of the Coroners Act. According to the Human Tissue Act, ethical approval with respect to DNA research is only required by law if body material (including gametes) derived from live animals (e.g. Blood) with the intention of performing DNA analysis without the consent of the person whose body produced the DNA. 2 Transplantation from one living human body to another living human body may be carried out in accordance with this Act, but not otherwise. The diagnostic archive does not require a storage license for search. The authorisation requirement would only apply if an archive systematically wishes to store human tissue for research purposes.
The government has insisted that consent is the “golden thread” of legislation, but the NHS has maintained the view that recording every patient`s wishes is not practical. This is despite evidence that patients would prefer to be asked the question only once, with the answer covering all future samples.1 Lord Warner, speaking on behalf of the government, said that collecting and obtaining consent for each sample would cause “a significant bureaucratic problem”. 2 There was therefore a gradual adjustment. The Chief of Staff initially claimed that consent was required to use living tissue in audits or courses,3 but this was withdrawn before the legislation was passed. Research with anonymized samples of living persons without consent remains legal if an ethics committee agrees. Licensing requirements for the storage of tissue from living persons have been reduced by recent Ministerial Orders.4 The Human Tissue Authority has worked to ensure that the law does not interfere with activities for the benefit of patients. Human organs and tissues can be donated for transplantation by living and deceased donors. As intended purposes, these require consent for tissues from deceased persons, although this relates to the act, and not for tissues separated from living organisms. However, because all terms are vaguely defined and overlap, it can be very difficult to distinguish between audit, quality assurance and research.
Various decision matrices have been developed to allow project developers to determine how the activity will be categorized. In general, in case of doubt, it is advisable to obtain appropriate consent; In the case of a research project, consent is required. If the research tissue bank plans to distribute tissue to external researchers, it may apply to an REB for “generic ethics approval” for these research programs. This would allow for the ethical approval of projects receiving human tissue from the Bank under the terms agreed by the ERC (e.g. human tissues are delivered in anonymous form and projects have received appropriate scientific criticism). It is important to note that the objectives contemplated in the Highway Traffic Act, 2004 exclude the use of equipment relevant to diagnosis and treatment, so these activities are not regulated by law and remain at common law. However, the law covers the use of one person`s equipment for diagnosis, if this is done primarily for the benefit of another person. The use of one person`s material for the benefit of another person (usually to allow for a more accurate prediction or diagnosis of risk in a parent) has been relatively rare so far, but it is likely to become more common as “genetic medicine” spreads.