Felix A. Khin-Maung-Gyi, PharmD, MBA, CIP, RAC, an active and valued leader in the field of human subjects protections and proud family man, passed away on October 2, 2014.

A pharmacist by training, Dr. Gyi received a bachelor’s degree in pharmacy from the University of Maryland School of Pharmacy in 1983, and went on to receive his doctorate in the subject from Duquesne University in 1986. He also obtained a master’s in business administration from Loyola University Maryland (The Baltimore Sun).

Among his many accomplishments, Dr. Gyi founded Chesapeake Research Review LLC, an independent IRB, in 1993, and served as its CEO for more than 20 years. During his time at Chesapeake IRB, Dr. Gyi helped raise important questions about the growing role of central IRBs.

Dr. Gyi was also instrumental in the creation of the Certified IRB Professional (CIP®) credential. Gary Chadwick, PharmD, MPH, another of the credential’s founders, spoke to Dr. Gyi’s contributions: “He was one of the first persons I tapped to get the CIP credential off the ground back in 1999. I saw firsthand his dedication and extensive knowledge, which, when put with his easy going nature and great sense of humor and fun, produced outstanding results and spurred others to excel.”

Dr. Gyi also served alongside Gary Chadwick, Susan Delano, Marianne Elliot, Nancy Hibser, Moira Keane, Susan Kornetsky, Peter Marshall, Daniel Nelson, and Lucy Pearson as inaugural members of the Council for Certification of IRB Professionals. Ms. Delano reflected: “He could always be relied on for his sound judgment and in-depth knowledge of the complex regulations and guidance governing research involving human subjects. He demonstrated a deep commitment to the ethical conduct of research and the welfare of research subjects. His positive attitude, generous spirit and sense of humor were very much appreciated by his fellow Council members and the IRB community.”

Dr. Gyi also offered his expertise on issues related to human subjects protections to the Secretary’s Advisory Committee on Human Research Protections (SACHRP), for which he served as a member from 2003 to 2006. Later, he was also a member of SACHRP’s Subpart A Subcommittee, charged with reviewing and making recommendations related to the regulations found at 45 CFR 46 Subpart A.

Throughout his career, Dr. Gyi was a sought-after speaker both in the United States and abroad. His ability to capture the spirit of human subjects protections served as a passionate reminder to all about the importance of such work. At the 2013 Association of Clinical Research Professionals Global Conference and Exhibition, Dr. Gyi spoke on a panel  titled, “Should We Exploit Hope to Enhance Enrollment of Oncology Research Participants?”, about Nicole Wan, a 19-year old student at the University of Rochester who died as a result of her participation in a non-therapeutic research study. He lamented:

We failed Nicole because we didn’t stop to think about what was in her best interest. Would it not have been simpler if some nurse had said to the physician: ‘Doc, I’ve seen you do this [procedure] hundreds of times—this is particularly difficult. Let’s not distress the poor lady anymore; give her $75 and let’s call it a day.’ 

But, we didn’t do that, and I believe we failed because we were stuck on the culture of obtaining data, and, to use a phrase that the first [Office of Human Research Protections] director, Greg Koski, used early on in his career, we were stuck on [a] ‘culture of compliance.’ We did not shift to a culture of caring, or a culture of excellence, in a way that [would have allowed] us to do what we need[ed] to do in a societally responsible manner.

Dr. Gyi’s unique ability to elucidate the importance of human subjects protections has ensured that his legacy will endure. The countless individuals who had an opportunity to hear him present over the years were without a doubt struck by the dedication and commitment with which he spoke about human subjects protections.

“Felix was a tireless worker and supporter of human subject protection. He always made himself available for any organization or group that was trying to improve the system,” reflected Dr. Chadwick. Dr. Gyi will also long be remembered for his spirit and attitude, as Dr. Chadwick attested: “Felix was an absolute joy to be around–he always had a kind word and was supportive of family and friends. His generosity was boundless–he personally hosted many a dinner and reception for ‘official functions’ of organizations that didn’t have the funds to support this important professional networking or provide amenities.”

Immediately prior to his death, Dr. Gyi was elected to the PRIM&R Board of Directors. While Dr. Gyi was not aware that he had been elected to the board at the time of his passing, he was aware of his nomination and indicated that he was eager to contribute. The PRIM&R Board and staff were looking forward to welcoming Dr. Gyi to the Board, and we feel a deep the sense of sorrow that he will not be joining us come January.

Ethical, humble, and generous, Dr. Gyi was an extraordinary leader, whose impact can be felt in the way the regulations governing the conduct of research with human subjects are interpreted and operationalized throughout the research enterprise. He touched the lives of many in the field and his wisdom, warmth, and humanity will be deeply missed.