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Stem Cells in Focus

ISSCR’s Stem Cell Guidelines: A Commitment to Patients and the Public

Stem cell science is advancing at a pace greater than ever before, and researchers are making significant discoveries toward medical therapies to treat diseases and injuries - many of which currently have no cure.

The pace of discovery and the international nature of research makes it critical for the stem cell field to operate by a standard set of guidelines and principles. These directives can help assure researchers and the public alike that the science is sound and that treatments developed are shown to be safe and effective. Recognizing that need, the ISSCR established an international task force to update earlier guidelines to reflect recent developments in science and changing ethical and societal norms around the world.

In the course of the last two years, the task force of 25 experts in stem cell science, clinical research, and bioethics, from nine countries, addressed key issues in the field, and integrated principles and best practices to drive progress in basic, translational, and clinical research. In May, the ISSCR released their work, the 2016 Guidelines for Stem Cell Research and Clinical Translation. At their core, the guidelines promote principles of rigor, oversight, and transparency in all aspects of practice, and they prioritize patient welfare. The ISSCR and its members are disseminating the guidelines to researchers and clinicians around the world and to international scientific organizations, regulatory agencies, patient groups, and others.

While adherence to the guidelines is voluntary, it represents a commitment to the public that research is undertaken ethically, that it follows set standards, and that treatments are developed based on proven science.

One key element of the guidelines is the call for those in the field to responsibly communicate the progress, setbacks, benefits, and risks of stem cell research and emerging treatments. “The stem cell research community should promote accurate, balanced, and responsive public representations of stem cell research,” and communicate about scientific advances and potential therapies in ways that are “accurate, circumspect, and restrained,” the guidelines read. With that in mind, the ISSCR provides scientifically vetted information for the public on A Closer Look at Stem Cells, where visitors can find facts about stem cells, what is known and unknown about treatments, and tips on what to ask when considering stem cell trials or therapies.

Other core principles in the guidelines include:  

  • Robust standards for research evidence, both before determining whether to begin clinical trials and as trials progress;
  • Tests for safety and effectiveness in well-designed clinical trials before any potential stem cell treatment is approved for sale;
  • A specialized oversight process for all ethically sensitive stem cell research projects; and
  • Stringent informed consent from donors of biomedical materials used in stem cell research or its clinical application and from participants in clinical trials.

The guidelines go a long way in helping protect the integrity of stem cell research and assuring the public that the research will proceed efficiently and remain responsive to public interests.

Learn more from the Press Release about the 2016 Guidelines for Stem Cell Research and Clinical Translation. You can also find previous guidelines for stem cell research and clinical translation on ISSCR.org.

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