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Published on February 23, 2009

Author: satishdara


Sales And Purchase Of Human Tissues In Research : Sales And Purchase Of Human Tissues In Research By : Kamini Kaushal Priyanka Pramanick Sudakshina Kashyap Satish Dara BACKGROUND : BACKGROUND Human tissue is defined as a functional group of cells. Human tissues means constituent parts of the human body such as: bones, skin, heart valves, cornea, tendons, arteries, veins, blood, serum, DNA Dura mater, foetal tissues obtained following abortions, placenta and umbilical cord cells intended for grafting , cell lines from cell cultures as well as cells used to produce proteins and other substances (e.g. monoclonal antibodies). Slide 3: Tissues are obtained from healthy people/patients Uses : diagnostic purposes therapeutic purposes research purposes: basic, epidemiological and clinical research Stem cell research holds great promise for improving human health by control of degenerative diseases and restoration of damage to organs by various injuries. Cosmetic purpose Some regulatory acts for sale and purchase of human tissue: : Some regulatory acts for sale and purchase of human tissue: The Health Act 1956 prohibits trade in blood and blood products . The Human Assisted Reproductive Technology Act 2004 prohibits the sale and purchase of gametes and embryos All Member States of the EU adhere to the principle that donations of human tissues must be free, following the example of blood. This rules out any payment to the donor. The donor may receive compensation for the constraints associated with tissue removal (e.g. travel expenses, loss of earnings, etc.). When the tissues become even indirectly a source of profit, donors should be paid. WHO has set forth 11 guiding principles. Consent and licensing provisions required under the HT Act. Ethical issues : Ethical issues • Respect for persons - trade in human tissues and cells ought to be limited if the body is considered part of the basic dignity of human beings. To the extent that the body is indivisible from that which makes up personhood, the same respect is due the body as is due persons. • Beneficence - marketing human tissues and cells might be justified if that would leadonly to good results or to a prevalence of good results over bad. • Justice - would a market setting be equitable to all members of society, including those who are financially disadvantaged? Case study : Case study The Moore case :A debate in the United States with regard to the removal of tissues from an individual whose cells had rare features. These tissues, removed as part of a medical treatment, had in reality enabled profitable industrial applications, and this information was withheld from the donor. The deficient and misleading information given to the donor was condemned by the Court. The judge did not accept that Moore should participate in the economic benefit derived from the use of these tissues. However, this case leads some commentators to call for payments to be made to tissue donors for the sake of equity. FOR : FOR As technology is becoming more sophisticated and techniques improve, the risks to the donor of live organ donation are relatively low. Maintaining medical alternatives to organ donation can be expensive . If there are people who would donate their organs if a payment were made, and who otherwise would not donate, then payment is justified. The commercialisation of human tissues encourages industry to invest in areas which will result in greater availability of tissues on the market. Most appropriate with regard to “engineered” tissues requiring sophisticated industrial processing techniques. FOR : FOR They should also be able to share any profit made from products that their tissue helped develop. Donor’s remuneration might increase the supply of tissues. Human bodies contain a number of elements that are useful in biomedical research, and payment for these may increase supply. Enabling the sale and purchase of tissue could help to improve the availability of organs and tissue for transplantation . Allow donors to benefit financially. AGAINST : AGAINST Cell and tissue transplantation carries the risk of disease transmission. Viruses (including HIV, hepatitis B and C), bacteria, fungi, parasites may be transmitted to tissue and cell recipients causing disease. Human person is regarded as an object (a source of organs and tissues). Not based on a regard for solidarity. Risk of exploitation of the most underprivileged who might be led, in doubtful conditions of health, to give tissue primarily for financial reasons. AGAINST : AGAINST Paying donors is likely to exploit poor people. Encourages people to take risks, such as the risk of surgery to be a live donor, which they may not otherwise have taken if no payment had been offered. People cannot give genuine voluntary informed consent when motivated by the idea of payment for their tissue. Court battles over the ownership of human tissue could be detrimental to academic researchers and the biotechnology industry. AGAINST : AGAINST Allowing the sale and purchase of human tissue may decrease the rate of tissue donation. Some tissue samples would never be developed into cell lines or products and yet would incur significant transaction costs. It would be difficult to negotiate a value for a particular human tissue at the time it is obtained. Many people find the idea that human tissue could be sold or purchased as an affront to human dignity. AGAINST : AGAINST Transaction costs of any payment system could add significant burdens to the process of developing biotechnological products and processes, and could dwarf the costs of actual payments to the source donors. Many of the cell lines used in research are used for purposes other than developing commercial products. Raises several ethical and social issues such as destruction of human embryos to create human embryonic stem (hES) cell lines. CONCLUSION : CONCLUSION Sale and purchase of tissues in research is not ethical as: It would violate the guidelines put forth by WHO for research involving tissues. The poor would invariably be unable to afford the cost of tissue obtained commercially, thus making them ineligible for transplantation. Reduces the motivation for donors to be altruistic ,the prospect of selling a part of their body distasteful. Hence, a proper balance between respect for persons and the collective interest in promoting research involving human tissue should be maintained Slide 14: The standard must include requirements for ethical approval of research using human tissue. While it is currently common practice for researchers to seek ethical approval for research using human tissue, there is no legislation that requires this Given the possible commercial uses of human tissue and the sensitivity around its use, there should be some requirement for ethical oversight of research in this area, with the ability to specify exemptions. LEGISLATION IS REQUIRED. THANK YOU……….. : THANK YOU………..

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