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ISSUES

Like many scientific fields, tissue engineering has many ethical, social, and legal issues. Some of these issues are:

Ethical/Social Issues

 

Use of Embryonic Stem Cells: In order to extract embryonic stem cells, the embryo has to be destroyed. This is a problem for many people, particularly Christians, as it goes against their beliefs. According to Christian beliefs, an embryo is a life, and killing it is just like murdering someone. As a result, countries such as Germany have banned embryonic stem cell research. However, there are many counterpoints, such as the possibilities of using embryonic stem cell research to come up with new cures for diseases. 

 

Ownership of Cells: For many years, human donors have been an important part of science, donating cells, tissues, and organs to help research and further our understanding of the human body. However, one question that has arisen from this is the issue of consent, particularly when using the cells. One famous example is Henrietta Lacks (pictured on the right), who had her stem cells taken without permission and used to the advantage of scientists everywhere. Her family hasn't gotten any money, and are suffering from bad health care. This raises the question: Should we inform the patients or not? On one hand, it respects the privacy of the donor. On the other hand, what if they say no, and their cells had a special substance that could cure cancer?

 

Who Gets the Organs First? As of right now, growing organs are incredibly hard in regenerative medicine. However, the field is rapidly advancing, and scientists will find themselves addressing this issue sooner than later. Some people say that older people should get first-priority, while others say that young people should be the first on the list since they have a full life ahead of them. But it gets even more complicated than that. Life choices also matter. Should an alcoholic be pushed aside for a sober person, since the alcoholic is destroying their organs by drinking? Some doctors say that people shouldn't be judged on their vices and virtues, while others say that the alcoholic should at least try to stop drinking so they don't ruin the organs. 

       

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Legal Issues 

 

Who Owns the Human Body? Today, the question of ownership of the body is very complex. Some people argue that people have the right to decide what they wish to do with their cells, while others propose that people don't actually own their bodies.

 

Two court cases that illustrate the complexity of the ownership of the human body:

 

  • Doodeward vs. Spence: In this case, Doodeward purchased a two-headed fetus and wanted to display it. The prosecution argued that Doodeward couldn't own the corpse because of ownership of rights. However, the fetus was preserved in a bottle, so the Court ruled that the fetus should be considered a nonentity and returned to Doodeward.

  • Anthony-Noel Kelly: In this case, the artist Anthony-Noel Kelly (pictured right) stole some body parts from the Royal College of Surgeons in England to make molds for sculptures. However, unlike Doodeward, Kelly went to jail. The Court ruled that the body parts were the property of the Royal College, so Kelly served 9 months in prison. 

 

These two cases represent the complexity of this issue. They both address the ownership of body parts, yet they have completely different endings. Doodeward got his fetus, while Kelly went to jail. So how do we define what's legal and illegal? How do we know if a case is an exception, and when it's not?   

 

Who Regulates Tissue Engineering? The FDA (Food and Drug Administration) regulates tissue engineering. Their goal is to provide safe practices and technology for the public and to prevent scientists from promoting dangerous material. Here are some of their rules:

 

  • Products of tissue engineering are called HCT/Ps

  • These products are regulated either under 21 C.F.R. Part 1271 or Part 1271, FDCA (Food, Drug, and Cosmetic Act), and section 351 of the PHS Act.

  • "The Application of Current Statutory Authority to Human Somatic Cell-therapy and Gene-therapy Products provides a framework for the use of HCT/Ps."

  • The cell products must follow GMP (Good Manufacturing Practice) and GTP (Good Tissue Practice).

  • "Therapies with HCT/Ps will require a determination of donor eligibility."

 

Even though these rules have good intentions, it limits scientists. HCT/Ps have to go through many tests, which slows down the process of making a discovery that will forever change the field of regenerative medicine.        

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