Why an IRB?
All research in the United States involving human subjects must be reviewed by an Institutional Review Board (IRB), unless specifically exempted by a federal regulation. The job of these review boards is to protect the rights, privacy and health of the research subjects, and to decide whether the research will be conducted in a safe and ethical manner.
Why the IRCM IRB?
The IRB of the Institute of Regenerative and Cellular Medicine is an Institutional Review Board that specializes in working with doctors and independent medical researchers conducting low-risk biomedical studies in the field of regenerative medicine. We specialize in investigator-initiated studies rather than institutional studies. We provide close individual support for investigators who are medical doctors wishing to validate their clinical studies with limited subject populations. We also advise on taking these studies to publication, and to Phase I FDA studies.
Mission, Values & Experience
The mission of the Institute of Regenerative and Cellular Medicine (IRCM) it to facilitate and validate regenerative and cellular medicine through collaborative and translational research, and through Institutional Review Board (IRB) certification. The IRCM IRB works with individual physicians and researchers one-on-one to guide and validate their studies in regenerative therapies, and to connect them with the larger community of researchers, scientists, academics and other physicians in cellular medicine.
To facilitate this mission, the IRCM IRB provides interactive reviews of proposed research projects to make sure they are correctly designed to bring advanced treatments to patients without compromising safety, and that they comply with all existing federal regulations. IRCM prides itself on rapid response and works to bring submissions into compliance as quickly as possible.
The first priority of the IRCM IRB will always be patient safety; with the goal of improving the health of patients everywhere, the IRCM IRB strives to bring the latest in scientific discoveries and clinical protocols to patients as safely as possible. Beyond its paramount concern with patient safety, the IRCM IRB is dedicated to the advancement of regenerative medicine through the execution of well-designed studies that produce valid and verifiable data.
The IRCM IRB brings to this mission a team of dedicated PhDs, MDs, regulatory experts and patient advocates with decades of experience in regenerative and cellular medicine, and in regulating research that uses human subjects. Since its inception more than five years ago, the IRCM IRB has reviewed and guided to approval hundreds of studies by independent researchers, individual doctors, clinics and academicians, many of which have led to publication of data and FDA INDs.
Accreditation and Compliance
The Institute for Regenerative and Cellular Medicine (IRCM) is a 501(3)(C) non-profit corporation created to validate regenerative and cellular medicine through Institutional Review Board (IRB) certification as well as collaborative and translational research.
The IRB which the IRCM houses is registered with the U.S. Department of Health and Human Services (HHS), with a primary goal of providing ethical oversight of research to ensure patient safety and the effectiveness of clinical protocols. The IRCM IRB is charged by the HHS with reviewing studies involving human subjects for compliance with federal, state and local laws.
The IRCM IRB operates in compliance with all federal regulations applicable to IRB organization and practice, including those of the Office of Human Research Protection (OHRP) in the Department of Health and Human Services (HHS), and those of the Food and Drug Administration (FDA), specifically 21 CFR Parts 50 and 56, and 45 CFR Part 46).
The IRCM IRB is registered with both the FDA and OHRP
• IRB Parent/Organization Number: IORG0007913
• IRB Registration Number: IRB00009500
The IRCM IRB is also a Federalwide Assurance FWA registered institution, which means that it is pledged to uphold the principles of the Belmont Report and its ethical principles and guidelines for the protection of human subjects used for medical research. The IRCM IRB is also pledged to uphold the World Medical Association’s Declaration of Helsinki, and its parallel ethical principles for medical research involving human subjects.
The IRCM IRB’s Federalwide Assurance has been approved by OHRP
The IRCM IRB’s FWA number is FWA00029753
The IRCM IRB is composed of a select group of PhDs with a background in stem cell research, physicians who work in the field, patient advocates, and professional privacy and regulation experts—all of whom are registered with the FDA.
The executive director of the IRCM IRB is Dr. Barbara Krutchkoff, PhD, a medical researcher, consultant and corporate scientific officer with extensive experience in regenerative and cellular medicine. She has consulted for individual physicians, clinics, biomedical startup companies, the FDA and the Health Ministry of Jamaica. She served until recently as the lead scientific advisor for Lipogems USA, while her A3Cell consultancy helps practitioners and biotech entrepreneurs navigate the regulatory pathway, as well as design and manage clinical studies. Barbara has worked tirelessly throughout her 30-year career to engage with university and industry leaders to help bring regenerative medicine safely to patients. Her educational background includes physics and computer science at the University of Florida, biomedical engineering graduate work at Virginia Tech, a PhD in behavioral psychology, a Doctorate in integrative medicine, and a UCLA Fellowship in stem cells. She is a board-certified Diplomat of the AARBM.
Current board members include Dr. Krutchkoff, PhD; Dr. Heripsime Ohanian, MD; Dr. Warren Sherman, MD; Matt Leonard, CIPP; James P. Faber, Secretary, (patient advocate). Past and alternate board members include Dr. Michael Price, MD; Beth Roxland, JDM Bioethics; Dr. Ramon Coronado, PhD. Dr. Mitchell Sheinkop, MD; and Dr. Charlie Mahl, MD.
Beyond guiding and validating studies in regenerative therapies, IRCM also facilitates collaborative research between physicians, scientists, academics and the cellular industry. A component of this is the collection and amalgamation of data from physicians and researchers nationwide in order to build models of safety and efficacy in regenerative medicine. The IRCM works with clients of its IRB to introduce them to other researchers with similar studies and to organizations and data cooperatives seeking to coordinate the collection of data to advance the study of regenerative medicine.