Thornton and Lynn Paltrow When George Washington University Medical Center "GWUMC" recently developed and adopted groundbreaking policies concerning the rights of pregnant patients to make health care decisions without court intervention, it not only reversed its position on the appropriateness of court-ordered medical care,' but resolved three years of daunting litigation against it for having subjected year-old Angela Carder to a life threatening court-ordered Caesarean section in June
Lacks died in from cervical cancer at the age of 30, leaving behind five children and her husband.
At that time, no one had successfully grown human cells in the laboratory. Prior to the HeLa cell line no human cells had ever been cultured for any meaningful period of time in the lab.
Today, there are many cell lines from many organisms available for scientific research e. HeLa cells have been used during some key discoveries in the 20th century, for example, they were used to test the polio vaccine and over the years have been used to screen for potential cancer drugs and many other medical technologies and therapies.
According to Skloot, the company Microbiological Associates, which became a part of Life Technologies and BioWhittaker, was the initial supplier of HeLa cells to the scientific research community.
Since that time period early s both the U.
Certain key events occurred in the s through to the s that led to informed consent guidelines that exist today. Inin response to the Nuremberg Trials of Nazi doctors who performed unthinkable experiments on prisoners of war in concentration camps, the Nuremberg Code was developed to provide a code of ethics for clinical research.
In the s, black males, many of whom were incarcerated, became part of a study on syphilis in what was referred to as the Tuskegee Syphilis Study. Many of the subjects were unaware of their disease and denied treatment even though treatment was available by Over the next 20 years research practices and policies were put in place to create fair and ethical medical procedures worldwide, which included a requirement that individuals be informed of the risks of procedures and require that they give their consent.
Cells and cell lines including the HeLa cells can be considered research tools, however, the value of such cells is actually downstream in the final products produced as a result of using the cells.
Does the donor of cells have a right to these downstream products that are made using the cellular starting material? The California Supreme Court ruled that Moore had no right to any profits gained from the commercialization of his cancer cells.
She explains that science and medicine must be open and honest with patients. However, it appears that Skloot and others are imposing modern-day thinking on bioethics and scientific research to events that occurred in the s when researchers were desperately trying to find human cells that could be grown in culture.
Skloot repeats several times that the Lacks family not only did not know about the valuable products that had been produced as a result of research using HeLa cells, but they never received any revenues from such products, and, in fact, many of them had no way to afford health insurance.
There is no doubt that growing human cells in culture was a significant step forward in scientific research, and Mrs.
Companies that sell cell lines today do not require the purchaser to pay them back a royalty or portion of revenues on any product derived from use of the cell line—this would be considered a reach-through right, which is prohibited.
The cell line is considered a tool, or a means to obtaining a useful end product, but a supplier of the cells has not created or invented the final commercially viable product.
It is important to understand that even if Mrs. Lacks had given consent to use her cells for scientific discovery, it is unlikely that she or her heirs would have benefited from profits realized on products discovered using her cells years later.CONTENT: 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.
In addition to facilitating patients' exercising their right to donate organs, however, clinicians have an obligation to ensure that the consent process is informed and voluntary.
Under the Conditions of Participation for Medicare patients, list five (5) items that must be documented in the patient record for developmental disability and/or mental health patients. Cells and cell lines including the HeLa cells can be considered research tools, however, the value of such cells is actually downstream in the final products produced as a result of using the cells.
the act allows a person to make a decision to donate organs at the time of their death and allows potential donors to carry an anatomic donor card. state statures regarding donation usually permit the donor to execute the gift during his or her lifetime. The legal and ethical principles that we follow universally with organ donation and transplantation are also important for the future as these may be used to resolve our conflicts related to emerging sciences such as cloning, tissue engineering, and stem cells.