Ethics of Stem Cell Science
Ethics Violation: The Case of Woo Suk Hwang
International Guidelines
In addition to overarching general ethics guidelines, the International Society for Stem Cell Research has created a 30-page document on Guidelines for Stem Cell Research and Clinical Translation7. Not only does it coalesce a number of different medical and scientific ethics and principles, but tailors those ethics to working with stem cells. The fundamental principles of this document are:
Embryonic Stem Cells: Research Guidelines
But what about embryonic stem cell research? The type of stem cell that has caused the most controversy and misunderstanding. There is an entire section dedicated to any research using human embryonic stem cells that emphasizes (by putting in bold) these experiments “shall be subject to review, approval, and ongoing monitoring by a specialized human embryo research oversight (EMRO) process capable of evaluating the unique aspects of the science”. The very first stipulation on working with these materials emphasizes that “appropriate scientific justification for performing the research using the specified materials is required”. This means that if there is any other available method or material that would allow scientists to come to the same conclusion, then their research using embryonic stem cells is not to be approved. Thankfully, the development of inducible pluripotent stem cells (iPSCs) has significantly influenced this clause by decreasing the need to use embryonic stem cells to study something that iPSCs can be used for.
Concerns regarding research using embryonic stem cells stems predominantly from how they are procured. Materials are donated by patients who have given informed consent to use their tissue for research, which is the case for all tissue acquired from patients used in biomedical science. The majority of embryonic stem cells are donated from couples who visit in vitro fertilization clinics to assist them in getting pregnant8. In vitro translates to a process that is performed or taking place in a test tube, culture dish, or elsewhere outside a living organism. Essentially, sperm and oocytes (eggs) acquired from the prospective parents are placed together in an artificial environment to encourage the sperm to fertilize the egg. As this is a very expensive procedure with room for error, many eggs, and of course billions of sperm, are used to increase the chance of in vitro fertilization occurring. As very few mothers are interested in carrying multiple babies simultaneously to term, only one or two successfully fertilized eggs, called blastocysts, are implanted and the rest of the blastocysts are discarded. It is at this point where couples are given the opportunity to consent to donate their un-utilized blastocysts for use in biomedical research. Interestingly, the stage that the blastocyst is implanted in the mother during in vitro fertilization is the exact same stage when the blastocyst would attach to the uterus in in vivo (occurring in a living organism) fertilization. In fact, it is impossible to tell if a female is pregnant until the blastocyst attaches itself to the uterus because that is when hormones from the blastocyst can be detected in the mother using a pregnancy test. Essentially, it is impossible to safely evaluate if a female is pregnant until the blastocyst attaches to wall of the uterus which occurs at the same time in both in vitro and in vivo pregnancy. Surprisingly, embryonic stem cell material is not too hard to come by as it is estimated that 1 in 60 babies born in America occurred as a result of in vitro fertilization and as many as 1 in 25 babies born in countries like Denmark, Israel, and Japan9.
Additional Precautions for Egg Donors
It is also possible to procure un-fertilized eggs for stem cell-related research. The scientific community recognizes that “women carry more burdens than men during the procurement of their [eggs], women’s efforts should be acknowledged fairly and appropriately[…] Precaution is needed to avoid the potential for exploitation”7. There is a comprehensive list of standards outlined in the ethical guidelines for stem cell research regarding female involvement, including:
Conclusion
Medical science is an ever-evolving field that pushes the boundaries of possibility, while figuring out how to approach novel technologies in an ethically conscious society. There are a variety of international organizations that ensure accountability of research at a global scale, whose ethical mandates are enforced at an institutional level. Publications are the currency of a research scientist, where the number and/or impact of their research is largely determined by their publication record. Publications are evaluated when pursuing jobs, applying for funding, and earning awards. In order to publish, all peer-reviewed scientific journals in biomedical research require a clause indicating which specific ethical guidelines were followed to perform the research. This is traditionally the very first sentence under Materials and/or Methods in a primary science paper. This article summarizes the extensive ethics documentation used by researchers all over the world. Check out the references section for links to complete ethics documentation.
References/More Information
Takahashi K and Yamanaka S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors . Cell 2006; 126: 663-676.
Cyrnoski D. Rise and Fall: Why di Hwang fake his data, how did he get away with it, and how was the fraud found out? Nature News 11 January 2006.
Campbell KH, et al. Sheep cloned by nuclear transfer from a cultured cell line. Nature 1996; 380:64-66.
Cyranoski D. Korea's stem-cell stars dogged by suspicion of ethical breach. Nature 2004;429:3.
Disgraced cloning researcher convicted in South Korea. CNN 26 October 2009.
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. World Medical Association 9 July 2018.
Guidelines for Stem Cell Research and Clinical Translation. International Society for Stem Cell Research 12 May 2016.
Bethesda, MD. Stem Cell Information: Stem Cell Basics III. National Institutes of Health 2016.
The Fertility Business is Booming. The Economist 8 Aug 2019.