Khemraj “Raj” Hirani

Special to UM News

Khemraj Hirani, director of regulatory affairs and quality assurance at the Diabetes Research Institute, has been named associate vice provost for human subject research. As associate vice provost, Hirani will be responsible for overall leadership of the Human Subject Research Office (HSRO), overseeing the activities of the Institutional Review Board (IRB) committees and of the HSRO staff, and acting as a liaison between the IRB and the research communities of the University of Miami.

Hirani succeeds Dushyantha Jayaweera,who was recently named interim executive dean for research and research education of the Miller School of Medicine.

“Dr. Hirani brings a wealth of experience in clinical research, regulatory affairs, IRB functions, and business processes to his new role,” said John Bixby, vice provost for research. “I am confident that he will be able to build on the foundation left by Dr. Jayaweera to bring our IRB and the HSRO to the next level.”

Known as “Raj,” Hirani graduated from the College of Pharmaceutical Sciences in Manipal, India, in 1999 and received advanced training in pharmacology at RIKEN Brain Science Institute in Wako-shi, Japan, the National Brain Research Center in India, and the Department of Anatomy at the College of Medicine at the University of South Florida. His research on neuroactive steroids and GABAergic/adenosinergic/serotonergic modulation has been published in leading journals, including Brain Research, Psychopharmacology, Neuropharmacology, British Journal of Pharmacology, European Journal of Pharmacology and Nature Neuropsychopharmacology.

Hirani has served on UM’s IRB since 2008. Prior to joining the DRI, he was accountable for more than 350 clinical trials across University hospitals, clinics, and satellites at Sylvester Comprehensive Cancer Center, Sylvester at Deerfield Beach, and Sylvester at Plantation. In addition to serving HSRO as a drug safety expert, he has been an invited expert on multiple committees across UHealth, including the Sylvester Data and Safety Monitoring Committee, Clinical Research Services (CRS) Advisory Committee, CRS Protocol Review Committee, Clinical Research Feasibility Committee, and UM Conflict of Interest Committee.

“I have been an IRB member for many years, and I’m a strong proponent of its efforts to assist investigators conduct research with high ethical standards,” Hirani said. “I look forward to partnering with the dedicated and expert board members and our talented staff at the HSRO. I am excited to be part of the mission of the VPR office to promote and guide research involving human subjects that provides social value by advancing scientific understanding and promoting human welfare, leading to improvements in health care.”