Greg Koski, PhD, MD is President and CEO of the Alliance for Clinical Research Excellence and Safety (ACRES). Greg is an Associate Professor of Anesthesia, Harvard Medical School and Honorary Anesthetist, Massachusetts General Hospital and is an expert faculty at Partners Health International (PHI.) He is a Senior Scientist at the James Mongan Institute for Health Policy and currently serves on the Board of Directors for SAFE-BioPharma Association. He is an internationally-recognized leader in clinical research, advocating a systemic approach to transforming the infrastructure and ecosystem for conducting clinical research globally.
As the first Director of the Office of Human Research Protections at the U.S. Department of Health and Human Services (OHRP,) Dr. Koski championed a “culture of conscience” in human research, emphasizing the values and processes of professionalism and quality improvement, moving beyond mere regulatory compliance. Aware of growing globalization of clinical research, he created the Program of International Activities within the OHRP.
Greg has been influential in many efforts to enhance human subjects research including development of accreditation for human research protections programs and certification of physician investigators, including consulting with the World Health Organization (WHO) to coordinate and strengthen global mechanisms for ethical conduct of human research and engaging with the World Medical Association to clarifying the intent and applicability of the Declaration of Helsinki regarding the use of placebos in clinical trials.
Today, he leads ACRES public interest efforts to build a shared, open global system for clinical research to benefit all stakeholders by aligning ethical principles with good business, scientific and medical practices while accelerating the development of medicines.