Tissue Rights
It is not a secret that we, people living in the 21st century, are becoming the witnesses of the most amazing discoveries and breakthroughs in all areas of human life. This statement is also true about science, medicine, and the treatment of different diseases. Together with a great number of findings, there also are some dramatic points of morality and ethics when it comes to the developments in the sphere of medical research. One of such matters is the right to own a human body or specimens of human tissue, simply known as tissue rights.
The right to private ownership of the tissue samples and biological materials is the issue of controversies from legal as well as ethical perspective. What is more, there has been a decades-long conflict regarding whether a human being is a private owner of the samples of his or her body tissues once they are removed from the human body or whether the family members own their relative’s body and tissues after the person died. At the roots of the conflict is the fact that the tissue samples might have been used for accomplishing breakthroughs in various fields of both medical and medicinal research and combating terminal diseases such as cancer or treating genetic diseases.
The point is that no matter what happened to the owner of the body, to my mind, he or she is the one who can control the use of his or her tissue specimens for research and in the case of any discoveries based on his or her body samples should enjoy the results of such breakthroughs or, at least, gain financial reward or economic benefit. In the case of the body owner’s death, the financial reward should be granted to his or her family. But there is one exception to this rule. I am strongly inclined to believe that it is true only it the case when the researcher obtained the tissue samples illegally. If the patient signed the informed consent or the researcher obtained the tissue samples or biomaterials from the voluntary donor, then the tissue right can be objected. What is more, I believe that the right to ownership of body tissues has no place when the researcher studied the tissues excited from the body during the surgical procedures, so that they were to undergo the further process of utilization.
One should understand the origins and the legal aspects of the issue to make up a mind on tissue rights. At its roots, the issue of tissue rights owes its existence to Rudolf Virchow, who in 1858 suggested that every disease is cellular in its nature (Hakimian and Korn 2500). That means that it develops and can be treated and cured at the level of a single cell as well as it is enough to have a sample of just a few cells to investigate the nature of the illness. Nevertheless, this discovery has not brought up the issue of ownership rights to body tissues and cells. It rose when researchers and scientists started using the human biological materials in their experiments and studies. The very fact of the tissue used for the laboratory research might not have become an issue of conflicts unless the breakthroughs in the fields of investigations have not brought money.
Since the results of experiments have very often been patented and brought the researchers money, those who donated their tissues or the family members of the deceased whose body or cells was used for studies often wanted to obtain the financial reward for the biological materials. Very often, there were the cases in which body tissues were taken by the investigators without the patient’s knowledge or consent as the result of removal during the surgery – it can be true about various tumors. No matter what was the source of obtaining the tissue, the desire to profit has given birth to the matter of tissue ownership.
Generally speaking, there are four ways for the researcher to obtain samples of biological materials:
- tissues collected prospectively for a research project;
- excess tissue from samples taken specifically for clinical purposes, such as diagnosis or treatment, which are subsequently recognized as valuable for research;
- cadaveric tissues;
- tissues with reproductive or “human” potential, including eggs, sperm, zygotes, embryos, and fetal tissues, which are also often collected for clinical purposes, as in (a). (Allen et al. 1675)
All of them can be used either legally through the mechanism of informed consent or voluntary donations or illegally when the patient or the relatives of the deceased patient do not know that the samples of biomaterials will be used for laboratory researches. It is of significant importance to understand them to choose a certain position regarding tissue rights.
There are a lot of arguments against and just a few arguments for the statement that the samples of biological materials and tissues are the private property of the one to whom they belong. But the problem is that there is no unified legislation on the issue at both national and international levels. Instead, there are only laws regulating the ways that those materials and samples should be used and what is the scope of responsibilities of the doctors and researchers.
In general, at the international level, the moral and ethical issues of medical treating and human research participants are regulated by the Helsinki Declaration 1964 designed by the World Medical Association that, in turn, has its impact on the national legal regulations of these issues. In the United States of America, the aspects of interactions between research participants and investigators are ruled by the federal legislation. One of the primary legal acts in this sphere of life is the Federal Policy for the Protection of Human Subjects or as it is known as a Common Rule. It is the interpretation of the Helsinki Declaration, and it as well does not regulate the property issues (Allen et al. 1675). So, when it comes to legal proceedings regarding the tissue rights, the court order is very often based on how the samples were received.
One of the most frequently met arguments against the right to private property of tissue is the fact that in most cases, it is considered that one is the private owner of the biological materials and body tissues only until they are not removed from his or her body. In other words, if a person donated the samples or researches obtained them as the result of a surgery, they no longer belong to the one from whom they were obtained. Instead, they become a hospital’s property, and a hospital is free to use them in any way it finds necessary and right (Pawlowski 52). Moreover, the body parts or any biological materials or tissue samples are very often seen as the raw natural resources, so there is no need to protect or guarantee the right to own them (Rao 371).
Under this approach, the one who is protected and guaranteed property rights is the researcher in the case of scientific discovery because it is considered that the finding is his intellectual property no matter what was the way of obtaining the resources for it. This argument can be extended by the distinction between humans and things, which is often made to object to the ownership of the biomaterials and tissue specimens (Quigley 660). It is believed that the human body and biomaterials cannot be the objects of property because they are not the physical things that can be owned by one person or another.
The arguments mentioned above are all considering the people who are alive and can decide what to do with their bodies and the samples of their tissues by themselves. When it comes to the dead, there is also one argument against the tissue rights. It is known as the no-property rule. Under this rule, the dead body cannot be the object of property, so once the person died, his or her body and tissue samples can be used by the researchers without consent. On the other hand, the no-property rule is extended to be applied to those who are alive. It agrees that any biological material is the property but only until it is a part of a human body, so after the surgery or medical treatment, when the tissue is excised from the body, it no longer belongs to the patient (Pawlowski 36, 47).
Finally, one more argument used to object tissue rights is that if the researcher had no opportunity to define to whom the tissue samples belonged, the rights to the patient’s ownership of the biomaterials are not guaranteed and protected (Foster 175). This statement can be true in the case of many tissue leftovers from different surgeries or diagnostic procedures. It is considered that the researcher cannot identify the owner of the specimens because, for example, the donor was anonymous or the person who died had no relatives. So, under such conditions, there is no real opportunity to provide and protect the tissue rights.
The only argument for guaranteeing and protecting tissue rights is the situation in which the doctor or the researcher obtained the specimens of the tissues of biological materials illegally, i.e. without the consent of the patient, his or her family in the case of death or donor. If the patient or donor can prove the fact of theft of biological materials, then he or she should be guaranteed the right to ownership and financial reward in the case of breakthroughs in the medical area if such were accomplished using the illegally obtained samples. As the extension of such a case is the situation in which the patient or a donor was not informed of the findings based on his biological materials.
Providing some examples is a perfect way to justify my point of view. First of all, it should be said that in most proceedings before the court that involved the rights to own tissues “excised for clinical purposes [or] donated for research, courts have concluded that patients and other research study participants do not retain ownership rights of the excised tissue” (Allen et al. 1677). The very first case regarding tissue rights that can be recollected in the United States judiciary practice in Moore v. Regents of the University of California.
At the very essence of the case is the patient, who underwent cancer treatment at the University of California. During treatment, the researchers from the University used the samples of his tissues for research. Later on, he found out that the University patented the findings of the experiments (the developed cell line) and received commercial benefits from it. Even though Moore claimed that the researchers obtained the samples illegally, he did not win a lawsuit. Notwithstanding that the court determined that the University has not received informed consent from the patient, it distinguished between the property rights and the dignity interests, so Moore’s tissue rights were objected (Rao 372).
Another law case similar to that mentioned above is Greenberg v. Miami Children’s Research Hospital Institute. At the core of the case are the families that voluntarily underwent medical tests and donated samples for the study of Canavan disease that is the genetic illness. As a result of the laboratory experiments, the Hospital Institute patented a test that may be used for detecting the mutations in genes leading to Canavan diseases. Some of the families claimed that they had ownership interests in the results of the findings because of their tissue rights, but the court determined that these rights could not be provided because the donations were voluntary, and donors never expressed interest in the financial reward or any economic benefit (Allen et al. 1678).
In general, the judiciary practice has witnessed many other law cases involving tissue rights, but the court orders were the same every time. Such examples demonstrate that the right to private ownership of the human body as the whole and samples of biological materials or tissues, in particular, is very often objected. To my mind, the court will not guarantee and protect the tissue right until there is the unified legislation regulating this sphere of social relations. Bearing in mind that this is a relatively new area of social interactions, adopting such laws at a national as well as international level will take time.
So, I stand on the position opposing guaranteeing and protecting the right to private ownership of the samples of biological materials and tissues once they are excised from the human body no matter what was the way of such removal whether it was accidental or carried out in the course of diagnostic or surgical procedures. What is more, I believe that once the person stated that he or she does not claim the rights to tissue specimens, i.e. signed the informed consent, and decided that he or she has no interest in the outcome of the research in which his or her biological materials will be used, the one cannot change the initial decision no matter what is the result of the research or experiment or what economic benefits the researchers gain from it.
Works Cited
Allen, Monica J., Michelle L. E. Powers, K. Scott Gronowski and Ann M. Gronowski. “Human Tissue Ownership and Use in Research: What Laboratorians and Researchers Should Know.” Clinical Chemistry 56.11 (2010): 1675-1682. Print.
Foster, Charles. Choosing Life, Choosing Death: The Tyranny of Autonomy in the Medical Ethics and Law. Oxford, England: Hart Publishing, 2009. Print.
Hakimian, Rina and David Korn. “Ownership and Use of Tissue Specimens for Research.” The Journal of American Medical Association 292.20 (2004): 2500-2505. Print.
Pawlowski, Mark. “Property in Body Parts and Products of the Human Body.” Liverpool Law Review 30.1 (2009): 35-55. Print.
Quigley, Muireann. “Property in Human Biomaterials – Separating Persons and Things?” Oxford Journal of Legal Studies 32.4 (2012): 659-683. Print.
Rao, Radhika. “Genes and Spleens: Property, Contract, or Privacy Rights in the Human Body?” Journal of Law, Medicine and Ethics 35.3 (2007): 371-382. Print.