What happens to a blood sample, or tissue from a biopsy, once the procedure is done and a nurse walks away with it? Most patients simply assume that it is used for whatever medical test their doctor ordered, but they do not consider what happens afterwards. Contrary to what most assume, tissue and other bodily matters that are the “leftovers” of a medical procedure can be used for research purposes. In fact, under the old Common Law Rule, researchers do not need to notify or obtain permission from patients before using such leftovers. The only limitation is that the bio-specimen must be non-identifiable. However, in recent years, scientists have discovered a way to re-identify anonymous samples by relying on DNA testing and publicly available information. Ethical concerns about re-identifying bio-specimens are reminiscent of concerns that surround the famous case of Henrietta Lacks, who died in 1951; yet, her so-called “immortal cells” are still used in laboratories to this day.
In order to address these concerns, the Department of Health and Human Services (“HSS”) has recently proposed a rule that would change the consent requirements. In particular, the rule would require researchers to obtain very broad consent for use of all bio-specimens, even those that are anonymous. In short, patients would be consenting to the use of their tissue and other bodily matters in all potential and unknown future research. The consent would also include permission for the researchers to access the patient’s identifying information. HHS has not yet released a template for the consent form. And while this rule would be a step forward in mitigating ethical concerns, critics say that even stricter requirements must be in place to ensure truly “informed” consent.
From science fiction to fiction: the ability to choose your genes and your children’s genes is on the horizon and it has raised some serious concerns. Burgeoning advancements in genetic science have sparked widespread discussions. The UN’s International Bioethics Committee (IBC) has issued a report that focuses on the moral and practical implications of gene manipulation. The benefits of genomic “editing” are well known. Today’s scientists can now edit a person’s genome to treat or even cure illnesses. But many scientist, government ministers, and lawyers agree that this raises serious moral questions, including concerns about scientists “play[ing] god.” But morality is not the only concern. Genetic editing, particularly when applied to the germline, can change inherited traits, leading to unforeseeable consequences for future generations.
In addition, the IBC is concerned with direct-to-consumer genetic test kits. These kits come at a price, informed consent. Those who take the test, and learn about their own DNA often lack the medical and genetic counseling to react knowledgeably to the test results. The IBC report has called for a moratorium until proper public debate can consider the risks and the benefits of genomic editing. Nevertheless, the line between science fiction and science is wearing thin.
Prominent “gene editing” scientists have called for a freeze on genetic experiments that alter the DNA of human sperm, eggs and embryos. Concern in the scientific community spread following publication of an article in the MIT Technology Review that chronicled efforts of three groups to genetically alter human embryos.
The concerned scientists published a plea titled “Don’t edit the human germ line” in the journal Nature (the article can be viewed at http://www.nature.com/news/don-t-edit-the-human-germ-line-1.17111). This group of scientists is involved in experiments involving genome-editing in non-reproductive cells. They fear that unlike their work, the implications of editing the DNA of human embryos will have irreversible repercussions that could be passed to future generations. They note that modifying the DNA of human reproductive cells could be used for cosmetic rather than therapeutic purposes. This raises ethical and safety concerns.
The scientists call for an agreement within the community to ban modifying the DNA of human reproductive cells.
Within the next two years British scientists are confident that they will be able to prevent mitochondrial disease which effects 1,000 to 4,000 children in the U.S. However, the treatment would result in babies with three biological parents.
The procedure would allow doctors to use material from two women and one man with the goal of producing healthy embryos. Mitochondria mutations are inherited maternally, and scientists believe that they can help women who carry mutated genes by using the target couple’s “nuclear DNA” while substituting healthy mitochondrial DNA from another female donor.
There are legal and ethical questions that must be addressed before this type of procedure would be allowed in Britain. But the outlook for approval is bright considering the Human Fertilization and Embryology Authority group has reported that evidence “does not suggest that these techniques are unsafe.”
Boston University’s College of Engineering opened the Center of Synthetic Biology in the fall of this year. The Center is also known as “CoSBi.” The University plans to use to it educate “the next generation of researchers,” and to hold annual symposiums that include the world’s top researchers in the field.
U.S. researchers, from the University of Michigan Medical School, have taken skin stem cells and used them to create brain nerve stem cells (neurons). The researchers took the skin cells from children who suffer from Dravet syndrome, which is a rare form of epilepsy. The researchers were able to convert the skin cells into stem cells, and then created the neurons from the stem cells. The study could allow medical professionals to examine the brain neurons of their patients without brain biopsies.
The UK is now drafting regulations for the use of “three person IVF” – a technique designed to eliminate certain mitochondrial disease. Mitochondria produce energy within cells, and mitochondrial DNA, which comes only from the mother, determines how mitochondria function in an individual. Three-person IVF replaces “bad” mitochondrial DNA from the mother with mitochondrial DNA from a donor’s egg.
A new DNA-based vaccine for Type 1 diabetes in an early stage trial has shown that it has the potential to stall the manifestation of the disease, and even to prevent the disease from manifesting entirely.
A person with Type 1 diabetes has an immune system that attacks the cells in his or her pancreas that produce insulin; people require insulin to regulate blood sugar. The interesting facet of this DNA-based vaccine is that it does not enhance the immune system, but rather suppresses the part of the immune system that stops insulin production. Researchers find the result of the trial exciting because it suggests that shutting down one subset of dysfunctional immune cells is possible. Read more here.