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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
The updated guidelines detail best practices for conducting research with human embryonic stem cells.
On May 12, 2016, the International Society for Stem Cell Research (ISSCR) released its Guidelines for Stem Cell Science and Clinical Translation, an updated version of the organization’s previous guidelines on stem cell research. The ethical and policy practices related to embryonic stem cell research have been highly debated among scientists and regulatory bodies alike. The guidelines detail best practices for conducting research with human embryonic stem cells, and attempt to navigate some of the complex scientific and ethical issues that have arisen related to stem cell research.
Stem cell research oversight
ISSCR outlines an embryo research oversight (EMRO) process, or a specialized oversight process for research involving human embryos. In an article in Nature, researchers indicate that one option for improving oversight may be repurposing the Embryonic-Stem-Cell Research Oversight (ESCRO) committee, in order to take a more expansive role in research supervision. Some other considerations, outlined by ISSCR, include scrutinizing scientific proposals to ensure scientific rigor, examining researcher expertise, and ethical transparency.
In the case of human-animal chimaeras, ISSCR provides guidelines for the welfare of transgenic animals. This includes prohibiting the breeding of animals that may have human gametes. ISSCR also writes induced pluripotent stem cells (iPS cells) should be excluded from specific stem cell research oversight. Instead, researchers should “call on the existing human subjects review processes to oversee donor cell recruitment,” ISSCR wrote in a press announcement.
The impact of communication
ISSCR places significant importance on the role of groups responsible for communicating information on stem cell science to the public. Those groups, ISSCR notes, include the media, scientists, clinicians, industry, and science communicators. The guidelines suggests that communicators play an important role in fairly representing the reality of stem cell science, which emphasizes “the need for balance, clarity and the avoidance of unrealistic optimism,” researchers express in the Nature article.
Whether or not stem cell research lives up to the media hype has been a popular discussion among experts, some of which believe communicators have neglected to emphasize the challenges associated with using stem cells. An article published in the New England Journal of Medicine discusses how stem cell research may be “less advanced than the public has been led to believe.” This leaves room for unlicensed stem cell clinics to take advantage of those seeking treatment, the authors assert. In one instance, leaked documents on Italy’s Stamina Foundation revealed that the foundation's protocol contained no method for testing pathogens in cells, a report in Nature revealed. Additionally, the report notes sections of the protocol contained errors and had been plagiarized from Wikipedia.
ISSCR advocates for robust safety precautions for clinical trials involving human embryonic stem cells. More specifically, ISSCR explains it will support laboratory-based research focused on “gene editing of the nuclear genomes of human sperm, egg, or embryos, when performed under rigorous review, but hold that any attempt to apply this clinically would be premature and should be prohibited at this time.”
Techniques such as mitochondrial-replacement techniques (MRT) and CRISPR-Cas9 can allow scientists to modify nuclear DNA of sperm and eggs in humans. While these new technologies may, in the future, provide viable treatment options, there still may be concerns with the safety of these processes. For this reason, according to Nature, “societal consensus is lacking on whether making changes that can be inherited to the genomes of individuals is something that humankind should pursue.”
ISSCR notes that while this guidance is not binding, it may provide an effective way for regulators and industry members to better understand stem cell research. The guidelines may be revised in the future to address additional ethics and safety concerns that arise.