The 2016 guidelines update and expand the topic areas of early sets of guidelines (Guidelines for the Conduct of Human Embryonic Stem Cell Research, 2006;Guidelines for the Clinical Translation of Stem Cells, 2008) and bring all guidance together under common principles of research integrity, patient welfare, respect for research subjects, transparency, and social justice. At their core, the new guidelines preserve the imperative for a specialized oversight process for research involving human embryos, in recognition of the unique sensitivities surrounding such research. Responding to advances in science, the guidelines 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.
We gathered an international task force of 25 experts in stem cell science, clinical research, and bioethics, from 9 countries to develop a new set of guidelines, with review and feedback from 85 external individuals and organizations. These 2016 guidelines - Guidelines for Stem Cell Research and Clinical Translation - build on 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.
The new guidelines address several issues not included in previous versions; they:
- Define an Embryo Research Oversight (EMRO) process to encompass both human embryonic stem cell research and human embryo research that may not explicitly pertain to stem cells or generating new stem cell lines;
- Exclude the generation of induced pluripotent stem cells (iPS cells) from specific stem cell research oversight, and instead call on the existing human subjects review processes to oversee donor cell recruitment (iPS cells behave like embryonic stem cells but are derived by reprogramming more differentiated tissue cells);
- Support laboratory-based research that entails 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;
- Define principles for evaluating both basic and clinically applied research on mitochondrial replacement therapy, in concordance with recent deliberations in the U.K., U.S., and elsewhere;
- Determine that, with careful review to ensure there is no undue financial inducement to participate, it may be acceptable to compensate women who donate eggs for research;
- Recognize that the development of increasingly complex in vitro models of early stages of human development should undergo specialized review;
- Highlight opportunities to strengthen preclinical studies in stem cell research, including reproducibility and stringent standards for experimental design;
- Call for robust standards for preclinical and clinical research evidence as clinical trials progress and rigorous evaluation for safety and efficacy before marketing approval;
- Address the valuable contributions made by patients or patient groups to support clinical research and a framework to ensure this is achieved without compromising the integrity of the research;
- Highlight the responsibility of all groups communicating stem cell science and medicine—scientists, clinicians, industry, science communicators, and media—to present accurate, balanced reports of progress and setbacks.
Several published articles provide additional information about aspects of the new ISSCR guidance and the task force discussions: