Use of human tissue for research - Essay Example

?Use of human tissue for research Introduction Studies involving human tissue samples are central to biomedical research. Human tissue refers to any material collected from a living or a deceased person which consists of human cells. Human tissue is used extensively in basic research, diagnostics, biotechnology and the pharmaceutical industry. Human tissue-based models are important to understand the vital proteomic and genomic differences that occur in human disease that will help develop proper diagnostic tools and treatments. In the western world, samples of human tissue have been collected and archived for over a century, with about twenty million new ones being added each year in the U.S. alone (Murray, 2006). A number of important scientific breakthroughs have occurred, thanks to tissue specimens. The development of PAP smear test for cervical cancer that was mainly enabled by studies on abnormal cervical tissue which showed the presence of dysplastic changes prior to the development of cervical cancer, and the strong link observed between smoking and progressive changes in the bronchial tissue in studies of autopsied tissue are but only two discoveries that research using human tissue has achieved so far. The scientific value of human tissue continues to increase as newer and highly sophisticated techniques in molecular biology and genetics become available. In certain cases, the tissue could acquire significant commercial value as well. For this and several other reasons, the use of human tissue for research has evoked much concern about ethical issues. Ethical concerns dealing with participant safety, informed consent, and confidentiality have given rise to complex regulations and doctrine with adequate legal provisions to govern human tissue research. In the U.K., the Human Tissue Act covering England, Wales and Northern Ireland received Royal Assent in November 2004 after months of debate in the Parliament (legislation.gov.uk, 2004). The enactment was in response to the scandals at Bristol royal infirmary and Alder Hey hospital in Liverpool in 1999, when children's organs were kept for research without parental consent. The new act that repealed and replaced the Human Tissue Act 1961, the Anatomy Act 1984, and the Human Organ Transplants Act 1989, had its origins in events of serious public concern, primarily the Alder Hey retained organs scandal. The act established the Human Tissue Authority (HTA) to regulate activities related to the removal, storage, use and disposal of human tissue. The Act has a very broad regulatory power in relation to 'relevant  material', which includes most human material such as organs, tissue, blood but excluding material already regulated under the Human Fertilisation and Embryology Act 1990 (Liddell and Hall 2005; McHale 2006; Price 2005). The key points of the Human Tissue Act 2004 pertaining to the collection and use of human tissue, as summarised by HTA (2010), are: (a) The act “regulates the removal, storage and use of human tissue. This is defined as material that has come from a human body and consists of, or includes, human cells,” and (b) the act “creates a new offence of DNA ‘theft’. It is unlawful to have human tissue with the intention of its DNA being analysed, without the consent of the person from whom the tissue came”. Ethical theories and the Act Various kinds of human tissue are collected or removed from patients for purposes of diagnosis of disease. And it has been the general practice for the remnants of the material collected to be used for other studies which could be deemed as human rights violation (Kurosu, 2008). Under the Human Tissue Act 2004, removing, storing or using human tissue without appropriate consent would be an offence. The Act has adopted informed consent (as against presumed consent) for collection and use of human tissue for medical research. Informed consent which is a legal obligation under the Act, finds moral foundations in ethical theories of autonomy (Delaney, 2008a). The Act, thus, seeks to use both law and ethics as tools in understanding and implementing informed consent in medical research. Informed consent must satisfy the following legal aspects: consent must be voluntary; it must cover all parts of the intended procedure; patients must be provided adequate information to enable them to decide for themselves; and the patients must have legal competence to decide (Delaney, 2008b). As applied to children, in the Act “appropriate consent” refers to the children who might consent themselves if they have capacity to do so (section 2). Alternatively, consent of a person who has parental responsibility for the child is to be obtained. If researchers rely on what is a very broad general consent as enacted in the legislation and obtain the consent from or for a child, there is the possibility of it leading to human rights challenges in the future if the child changes its mind on approaching adulthood (McHale, 2006: McHale et al., 2007). Failure to obtain specific consent could be construed at a later date as a denial of the right to autonomy and self-determination regarding the use of their own bodily material (McHale, 2008). From the viewpoint of ethics and philosophy, respecting patients’ autonomy is respecting their right to choose as well as respecting their capacity to choose. The deontological theory following the ethical principle of autonomy requires the physician, while obtaining informed consent, to respect the patient’s equal ability to reason and not merely treat the patient as a means to an end (Kant, 1785). Informed consent follows Mill's utilitarian ethical theory as well, since the patient perceives his ability to predict the consequences of his decision (Flick, 2003). Informed consent while upholding individual autonomy, is also in accordance with the ethical principle of voluntary beneficence. The principle of beneficence leads the ethical theory to do what is good (Rainbow, 2002). Some potential constraints that could be envisaged for informed consent vis-a-vis beneficence are failure to respect autonomy if patient and doctor differ regarding disease management, and failure to appreciate or consider the rights of the patient. Thus, while the ethical and philosophical background bestow a moral tone to informed consent, the legal aspects of the exercise introduce mundane but niggling doubts related to whether all obligations have been fulfilled, or whether the forms have been filled correctly and so on (Delaney, 2008b). Teachers, students and researchers in the medical field have always depended on a supply of human tissue. Most of the biomedical breakthroughs have happened after intensive studies of archived laboratory samples of human tissue. According to Lord May, the former president of the Royal Society, the definition of consent should allow for the fact that the scope of research programmes inevitably changes over time, and it would be “impractical and impossible to predict in advance all of the possible research uses for samples” (Radford, 2004). Also, according to Lord May, the need for consent had been made too broad in the Act although the aim of the Act itself that is, to increase public confidence in the collection and use of human tissue and organs, is support-worthy. Furthermore, the amount of paperwork that would be involved in obtaining consent for individual tissue samples would hamper vital research to understand the mechanism of diseases such as cancer, heart disease, Parkinson's and other degenerative diseases. A key problem of informed consent, according to O’Neill (2002) is that it is opaque. The author argues that it is not impossible for tissues to be “subjected to uses or handling that were not made explicit, but could be implied or inferred from what is agreed upon in the consent”. Provisions in the Act, their implications and human rights The Act has many provisions that have implications for the use of stored tissue or samples containing cells for medical research. The provisions, as described in schedule 4, paragraph 9, allow HTA to make a policy decision to permit access to human tissue for the purpose of obtaining scientific or medical information about a person (donor) for the benefit of another family member, without the consent of the donor. According to Lucassen and Kaye (2006), “despite its focus on consent the new Human Tissue Act 2004 allows for testing without consent where a relative could benefit.” A very important provision in the new Act for clinical genetics practice is that the non-consensual testing of DNA has been made a criminal offence under section 45. However, two situations have been stipulated under which HTA can make a policy decision to dispense with the requirement for consent. Either the donor of the material should have lost contact with clinical services and the possibility to trace him/her being very remote, or when reasonable efforts made to obtain the donor's consent to use the material yield no decision from the donor. According to Lucassen and Kaye (2006), this provision, in effect, means that “the Act has conflated the clear distinction made in clinical practice between carrying out a genetic test and disclosure of the results of a test, because once a direction is made, both activities are permissible.” In practical terms, HTA is empowered to make policy decision that DNA analysis can be carried out on the bodily material of a person without consent, and the results disclosed to a relative. In contrast to this, the Act does not say anything about access to, or use of, results of genetic test to which a donor has consented (Lucassen and Kaye, 2006). These continue to be governed by professional guidelines. The Act is also not clear about whether the holding of bodily material and the intention to analyse DNA without the necessary consent are both cases liable for prosecution for the criminal offence of the non-consensual DNA analysis. According to the Act, if a laboratory holds only extracted DNA with no remaining tissue cells, as is the practice in most genetic laboratories, then it is not punishable under the act because no bodily material is involved. “The provision would then have a restricted application to intention to analyse DNA in stored tissues (collected after the Act comes into force)” (Lucassen and Kaye, 2006). No explanation is available either in the Act or in the provisional codes of practice of HTA as to whether or how the result of the DNA analysis should be given to any person who has not consented to the test. Failure to impart vital knowledge about risks or management to the patient violates the ethical principle of beneficence and non-maleficence. Compliance with the need for fully informed consent is mandatory, without which a punishment of up to three years' imprisonment and/or fines for any deviation is possible (Bell, 2006). The exception allowing the use without consent of anonymized human biomaterial for ethically approved research purposes still is controversial (McHale, 2006). The provision allowing for the contravention of the original consent by permitting bodily material obtained and stored with consent for one purpose to be used without consent for another purpose, also flouts the doctrine of informed consent for the use of any human tissue which is the main focus of the Act. The above provision in the Act infringes on human rights and human dignity vis-a-vis Private life and right to information (European Union Convention on Human Rights and Biomedicine, 1997). Article 10, Chapter III of the above Convention states that (1) everyone has the right to respect for private life in relation to information about his or her health; and (2) everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed. Section 43 of the Act makes it lawful for hospital authorities “to take steps for the purpose of preserving the part for use for transplantation and to retain the body for that purpose”. However, there is no clarity in the Human Tissue Act 2004 insofar as the legal status of biological materials from either dead bodies or living persons especially in respect of the property- and non-proprietary rights is concerned (Hardcastle, 2007). The author debates the questions such as what rights, if any, the donors of biological samples should be accorded under the law, so that (a) they are able to control the outcome and use of their separated bodily materials; (b) they are able to protect their key interests namely, privacy, autonomy and dignity; and (c) potentially participate in the economic benefits that flow from research and development work using materials donated by them. Indeed, “….a person may attempt to bring an action in property law through the tort of conversion, in a situation in which they are unhappy that human material has been used for research purposes without their consent” (McHale, 2008). According to The Human Tissue Act Code of Practice on Consent, the obtained consent may be 'general' or that it may be 'specific', or in some special cases there could be general consent subject to some specific limitations (HTA 2006). Consent given for the use of a sample of tissue for a very specific research project poses no apparent problem. However, problems (due to religious and cultural reasons) could arise when the material is proposed to be stored and used over a long period of time, even decades, in a biobank. The HTA Code 2006 cautions researchers about this issue, yet puts the onus on the researchers (McHale 2008). Conclusion Human Tissue Act 2004 designed to regulate the use of human tissue, organs, or bodies for research is clearly a complex balance between respect for individual autonomy and a broader societal benefit in the background of informed consent. Consent of a child is permissible under the Act but it is fraught with possibilities of being challenged in the court of law for human right violation. The legislation has also been complicated by a provision that constrains the process of consent being rigidly standardised for every scenario and individual. References Bell MDD., 2006. 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Accessed on 4 May 2011 from http://www.bio.davidson.edu/people/kabernd/indep/carainbow /Theories.htm. The Bristol Royal Infirmary Inquiry Report 2001. Accessed on 5 May 2011 from http://www.bristol-inquiry.org.uk/final_report/report/index.htm The Royal Liverpool Children's Hospital (Alder Hey) Inquiry Report, 2001. Accessed on 5 May 2011 from http://www.rlcinquiry.org.uk/contents.htm Read More