Recent scientific discoveries have opened an era where humans can alter the genetic makeup of any organism at will. Is this type of power safe in our hands? What will our future world look like, and who will decide?
A technology developed from a bacterial immune-system protein (CRISPR/Cas9) will change life on Earth faster than we think. CRISPR/Cas9 allows scientists to edit genomes at specific target sites, theoretically altering the genome of any organism (e.g., yeast, bacteria, plant, mosquito, animal, or human) at will. And with more than 30,000 researchers using CRISPR/Cas9, the potential changes already at hand are staggering.
We find ourselves facing the first CRISPR/Cas9 human clinical trial in the United States and the first manipulation of healthy human embryos with CRISPR/Cas9 in a UK lab. Despite some significant challenges in using CRISPR/Cas9, such as off-target activity, the science speeds ahead. Christians better keep up.
Researchers Use CRISPR/Cas9 for Good Causes
Researchers at the University of Pennsylvania have cleared the first hurdle in using CRISPR/Cas9 in human clinical trials.1 The NIH Recombinant DNA Advisory Committee (RAC) has granted approval to alter T cells of 18 cancer patients using CRISPR/Cas9 in hopes of making tailored T cells better at fighting myeloma, melanoma, and sarcoma.
This trial will apply CRISPR/Cas9 technology in a highly focused and limited arena. By removing a patient’s T cells, altering the DNA coding for three proteins, and then reintroducing the modified cells back into the person from whom they originated, these trials should be fairly safe. Genetic modifications should affect only the specific T cells, improving their ability to fight and persist in their anticancer activities. If successful, this could reduce cancer recurrence in patients, and it would be a significant advancement in the fight against cancer.
Across the pond at London’s Francis Crick Institute, researcher Kathy Niakan has been granted permission to study early human development in embryos using CRISPR/Cas9 technology. Niakan will examine multiple specific genes in order to identify those most critical for normal human development. It is hoped that her research findings will lead to treatments preventing miscarriages and facilitating healthy pregnancies and births.
Unlike the proposed cancer treatment, where the scope of CRISPR modification is limited to specific T cells in a few individuals, the genetic modification of human embryos by CRISPR/Cas9 has the potential to affect all subsequent generations. When genetic manipulation introduces changes into a zygote, every cell in the resulting adult organism will contain the modification, including the germ cells (eggs or sperm). It follows that such genetic modifications (both intended and unintended) will be passed on to any subsequent offspring and enter the human population.
Gene-Editing Research Needs Regulation
Niakan required permission before she could embark on her manipulation of human embryos. UK law allows research in human embryo development up to 14 days under careful regulation and only upon informed consent by the germ cell donors. UK regulators ensure, through periodic inspections, that the embryos are only being used for specific, approved research projects. Each embryo is documented and traceable through each step, from the time it enters a research facility to the time it is used in an approved project.
No such federal regulation occurs in the United States. Federal regulations ban federal monies from funding such research, but if funding comes from a private (nongovernmental) source, these types of experiments are largely unregulated. US federal regulation of science occurs only if experimentation crosses into human trials or commercial veterinary or agricultural uses. Otherwise, any specific regulations vary from institution to institution, state to state, and internationally, from country to country. Some countries tightly regulate human embryonic research, some only have unenforceable guidelines, but in our global village, changing the human genome at a germ-line level in any country has the potential of altering human genetics for the broad population in every country.
For this reason, many are calling for caution, others for a moratorium, and still others for international consensus on regulating gene-editing of human embryos.