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The use of human blood and tissue is critical to biomedical research. A number of treaties, laws, and regulations help to guide the ethical collection of these specimens. However, there are no clearly defined regulations regarding the ownership of human tissue specimens and who can control their fate.
This review discusses the existing regulations governing human studies and the necessary components of patient consent. Legal cases that have addressed the issue of ownership of human tissue are reviewed, including recent settlements that have led to the destruction of millions of specimens of patient tissue.
The unique regulations that guide the use of tissues collected postmortem are also examined. Potential changes in the future of biomedical research that uses human tissue, including genetic material, are also discussed. The use of human tissue is directed by numerous laws and regulations.
Awareness of these rules and of how and when to obtain meaningful informed consent from patients is essential for laboratorians and researchers, who should also be familiar with situations that have led to lawsuits and in some cases the destruction of valuable human tissue specimens.
The study of the human body and its tissues dates back to ancient Greece. Unfortunately, after the fall of the Roman Empire, anatomical studies came to a near standstill and in many places the use of cadavers became illegal.
For many years researchers were prosecuted for postmortem dissections. It wasn't until the 15th century that researchers at medical schools in Europe were able to study the human body and its tissues without the fear of prosecution 1.
Human studies have come a long way since then, and tissue samples have become critical to the research enterprise.
Research specimens are obtained from the following four sources: With the increased use of human tissue in medical research, researchers, research institutions, and human research participants have asked: Who gets to determine the fate of such specimens? In the US, a country that prides itself on property rights, this question has prompted another: This question has been at the heart of several closely watched court cases.
In this review we explore the governing treaties, laws, and regulations that guide human studies; the necessary components of informed consent; legal cases that have examined the issue of ownership of human specimens; and the unique situation of specimens obtained postmortem.
We also provide a brief look into the future of research that uses human tissue. Governing Treaties, Laws, and Regulations To understand the court rulings in legal cases that have involved the use of human specimens, it is important to be familiar with treaties, laws, and regulations that govern human research.
Most aspects of the interactions between research and human research participants are heavily controlled by federal regulation, although it is important to note that these regulations do not address the issue of ownership. The laws governing the use of human research participants have their origin in the Declaration of Helsinki, which was developed by the World Medical Association as a set of ethical principles regarding human experimentation 2.
The Declaration of Helsinki was the first important effort of the medical community to regulate such research. The Declaration of Helsinki is not a legally binding instrument in international law, but it has greatly influenced national legislation and regulations.
The Declaration of Helsinki was originally adopted in and has since undergone 6 revisions.
The regulation that addresses the protection of human research participants is referred to as the Common Rule. Sixteen federal agencies have adopted the Common Rule in the form set forth by the Department of Health and Human Services HHS in Title 45 public welfare part 46 protection of human subjects 3.
The federal Food and Drug Administration FDA has adopted a slightly different version of the Common Rule 21 CFR part 50 that allows the FDA to concurrently enforce regulations that protect human study participants in the conduct of studies generating drug, device, or in vitro diagnostic data that will be submitted to the FDA 4.
Institutions engaged in research with human participants that is conducted or supported by HHS must submit a Federalwise Assurance to the Office of Human Research Protection stating that the institution will comply with the human research participant protection regulations of all federal agencies.
Most universities have agreed to apply the Common Rule to all human research, not just studies supported by federal dollars. The Common Rule sets forth, in detail, the composition, function, and role of institutional review boards IRBs in protecting human participants in research activities.
The Common Rule also outlines the requirements for obtaining informed consent from human research participants. In addition, HHS has adopted additional protections for special research groups such as pregnant patients, fetuses, neonates, children, and prisoners.
The Common Rule does not address the question of who owns human tissue specimens used in research. It also does not apply to tissue obtained postmortem, though the Health Insurance Portability and Accountability Act of HIPAA does regulate the use of information associated with those tissues.
Some states have also enacted laws governing research with human participants. A comprehensive review of state laws is beyond the scope of this article.2 Human Tissue and Biological Samples for Use in Research: Operational and Ethical Guidelines Foreword The Medical Research Council (MRC) is dedicated to improving human health through excellent medical.
Use of human samples in medical research Human tissue legislation summaries. Our summaries offer a quick and easy explanation of the UK legislation for those carrying out research using human tissue or biological samples.
Research into the use of animal embryos instead has been successful in creating embryonic stems cells that could be used for human medical therapies. For example in , human cells were fused with rabbit eggs to create an embryonic chimera (a mixture of two animals in one body) that was then used to harvest embryonic stem cells5.
Dec 30, · The United States government recently proposed sweeping revisions to the Federal Policy for Protection of Human Subjects, or the Common Rule, which governs research on humans, tissues and genetic.
Those who oppose the stem cell research have the fundamental argument that the life of a human being is inviolable. Life only results from human sperm cell fertilizing the ova. However, the medical and scientific research argues their points that stem cell research has .
Human Tissues in Medical Research Essay - We have known the amazing benefits of human tissue in medical research. These cells have helped with some of the most important advances in the sciences. They are used to develop vaccines for rabies, smallpox, and measles or used for radiation, drugs, cosmetics and viruses research .