12 August 2019 — The International Society for Stem Cell Research (ISSCR) today released a professional standard of informed consent for stem cell-based interventions performed outside of formal clinical trials, such as the unapproved and unproven “treatments” offered by clinicians at direct-to-consumer clinics. The standard is meant to help ensure that patients are informed about the potential benefits and risks of stem cell-based medical interventions, and was developed with input from clinicians, ethicists, researchers, and regulators from around the world.
“Patients need to be adequately informed about the scientific rationale and potential risks of stem cell-based medical interventions,” said ISSCR President Deepak Srivastava. “Some of the unproven interventions are highly speculative and complex in nature. This professional standard is meant to help ensure patients have the information needed to make informed decisions about their healthcare.”
“The ISSCR standard for informed consent is a professional guide that includes information patients should receive before choosing a potential stem cell-based treatment outside of a clinical trial,” said Roger Barker, co-chair of the ISSCR Patient Informed Consent Taskforce.
“This standard will help hold clinicians accountable for adequately informing patients about the risks and benefits of stem cell-based treatments,” said Jeremy Sugarman, co-chair of the ISSCR Patient Informed Consent Taskforce. “Many clinicians are delivering stem cell-based interventions that are not yet proven safe or effective. This standard will help ensure that clinicians give patients information that is essential to help with their decision-making. It is part of the informed consent process that ethically and legally must precede such treatment.”
The informed consent standard complements existing ISSCR resources for patients considering stem cell-based treatment available on https://www.closerlookatstemcells.org/.
Most stem cell-based interventions remain experimental and should only be offered in the context of well-regulated clinical trials that have the proper oversight and processes in place to assess the safety and efficacy of a therapeutic approach. There are currently clinical trials underway for conditions such as Parkinson’s Disease, macular degeneration, spinal cord injury, among others. The ISSCR supports the development of stem cell-based interventions through well-regulated clinical trials and has released guidelines to help researchers navigate the development process.
The ISSCR has cautioned against the premature marketing and commercialization of stem cell therapies that have not been tested in rigorous clinical trials, so it developed this consent standard as an additional tool to help protect patients. This is especially important given some of the recent problems that have arisen in patients receiving such therapies outside of formal clinical trials. This standard will be made widely available to physicians, healthcare advocates, medical boards, and others.
About the International Society for Stem Cell Research (www.isscr.org)
The International Society for Stem Cell Research is an independent nonprofit organization and the voice of the stem cell research community. The ISSCR was founded in 2002 to foster the exchange of information on stem cell research and now claims more than 4,000 members worldwide.
Contact:
International Society for Stem Cell Research
Julie Perlin, Science Communications and Education Manager
jperlin@isscr.org | 224-592-5757