Developing Guidelines for the Field of Stem Cell Research
As a service to the field, the ISSCR has historically developed guidelines that address the international diversity of cultural, political, legal, and ethical perspectives related to stem cell research and its translation to medicine. All guidelines maintain and underscore widely shared principles in science that call for rigor, oversight, and transparency in all areas of practice. Adherence to these principles provides assurance that stem cell research is conducted with scientific and ethical integrity and that new therapies are evidence-based.
Responding to advances in science, the guidelines were updated in 2016 to encompass a broader and more expansive scope of research and clinical endeavor than before, imposing rigor on all stages of the research, addressing the cost of regenerative medicine products, and highlighting the need for accurate and effective public communication. At their core, the guidelines preserve the imperative for a specialized oversight process for research involving human embryos, in recognition of the unique sensitivities surrounding such research.
The 2016 Guidelines for Stem Cell Research and Clinical Translation have been adopted by researchers, clinicians, and organizations and institutions around the world.
The 2016 guidelines expand on earlier ISSCR guidelines, bringing together both documents and updating to reflect advances in science and the scientific enterprise around the world:
- Informed Consent Standard for Stem Cell-Based Interventions Offered Outside of Formal Clinical Trials
- Sample Material Transfer Agreements
U.S. Scientists Reportedly Correct Disease Genes in Human Embryos, May, 2016 News Release
"Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines," Stem Cell Reports by Daley and colleagues.
"Global Standards for Stem Cell Research," Nature, by Kimmelman and colleagues.
"Translating Stem Cell-Based Interventions Ethically: The ISSCR Guidelines," Lancet, by Kimmelman and colleagues.
"Confronting Stem Cell Hype," Science, by Caulfield and colleagues.