New developments in Biotechnology hold significant promise in advancing knowledge, in various life forms, and improving human lives (USOTA, 2002). In addition to this promise, comes enormous responsibility for scientists and policy makers. Human biological materials (tissues and cells) can be used to develop commercial products like hybridomas, cultured cell lines, and for diagnostic and therapeutic purposes (USOTA, 2002). The use of human tissues and cells for research and commercial purposes causes weighty legal, ethical and economic issues. These issues raised resemble those of organ donation. Two laws regulate organ donation: uniform anatomical gift act 1968 and national organ transplant act 1984. On the contrary, human tissues and cells used in scientific research raises questions that have not been answered (Novakovic & Freshnev, 2006). Who should set the standards defining the acquisition of tissues and cells or under what circumstances the acquisition should be permitted or denied?
In her book, the immortal life on Henrietta Lacks, Rebecca Skloot traces the history of human cell research. The author also examines the ethical and legal issues emanating from this research. Henrietta Lacks, the main character of the book, tested positive with cervical cancer at the Johns Hopkins Hospital. Researchers took cervical cells (HeLa cells) from Henrietta Lacks during the diagnosis process without Lack’s consent and used them to conduct medical research. Henrietta Lacks signed a statement permitting surgery to be conducted on her. However, the doctor never informed her that her cells would be used in cervical cancer research. The doctor neither informed Henrietta nor her family about his intentions to conduct research using HeLa cells. In addition, the researchers kept Henrietta’s family in the dark about the billions of shillings earned from HeLa cells research. HeLa cells formed the first immortal cell line and contributed to the development of Polio vaccine, gene mapping and cloning.
In her afterword Skloot (2010) presents two controversial issues that surround the subject of human tissues and medical research. Skloot affirms the vitality of consent. In the past, researchers did not put into consideration the donor’s consent. In fact, the researchers cared less about the patients’ rights, and they would use the tissues in whatever way they felt like. Currently, tissue rights activists emphasize the need for researchers to have patients’ consent prior to collecting their tissues for research. However, controversy still rages on the use of diagnostic tissue leftovers. On the other hand, money made from human tissues medical research contributes to the ongoing controversy. Controversy exists whether scientists need to inform tissue donors that their tissues would be used in commercial research. Stakeholders need to set the standards defining what sought of rights can be employed under such circumstances. In this regard, patients’ rights, consent issues and commercial gains from tissue research are the cause of the current controversy.
Currently, several regulations protecting patients whose tissues participate in research exist. However, no regulation indicates the controversy of commercial gains (Novakovic & Freshnev, 2006). As stated earlier, scientific research contributes to the improvement of life through novel inventions. This research requires raw materials some which come from humans. If the benefits of medical research based on human tissues can be put in the bigger picture, a majority of the people will agree that this research is necessary. Experts just need to come up with laws that address consent and commercial benefits issues. Some experts warn that giving patients control over their tissues would be detrimental to academic research and nascent biotechnological firms. Stakeholders need to realize the importance of granting patients rights of ownership of their tissues. This can only be done through the indulgence of all stakeholders.
The current common law does not provide a definitive answer to address the issues surrounding the source, right of ownership and commercial gains of human tissues used in research (USOTA, 2002). When faced with such challenges, judges have to reason by analogy using legal principles and precedent developed from other circumstances. In another incident, reported by Skloot (2010), David Galoe a cancer researcher used Mr. Moore’s spleen for cancer research. Apparently, the circumstances under which Moore signed the consent to give away the rights of his cells were not clear. Moore retracted his earlier statement after realizing that Galoe had used his cells for commercial purposes. Moore sued the researcher. However, the judge ruled in favor of the researcher indicating that Moore’s claim was unjustifiable. Moore appealed, and the Supreme Court ruled in his favor indicating that a patient needs to know what becomes of his or her tissues. Galoe appealed in another court of appeal that gave a final statement on the issue: when a doctor extracts a tissue from a patient’s body for medical examination, and the tissue remnants remain in the doctor’s lab or office, with or without the patient’s consent, the patient loses any claim of them. This case reveals the ambiguity surrounding consent and commercial benefits of human tissues involved in research. Therefore, definitive laws indicating the circumstances under which consent and commercial benefit issues can be used need to be formulated. This will allow enhance academic research without undermining the integrity and ownership rights of patients. At the end of it all, people must agree that both patients’ rights of ownership of their tissues and academic research are essential.
References
- Novakovic, G., and Freshnev, R. (2006). Culturing of cells for Tissue engineering. New Jersy: John Wiley and Sons.
- Skloot, Rabecca (2010). The Immortal of Henriettah Lacks. Lodon: Pan MacMillan.
- U.S Office of Technonological Assessment (USOTA) (2002). Ownership of Human Tissues and Cells: New Developments in Biotechnology. London: Minerva Group.