Tamiko Eto, MA, CIP | Director, Research Operations – Human Research Protection Program (HRPP) & Institutional Review Board (IRB)
Mayo Clinic
Tamiko Eto serves as Director of Research Operations at Mayo Clinic, one of the leading healthcare institutions globally in developing and deploying AI/ML-enabled digital health tools (DHT), where she co-developed an enterprise-wide framework for rapid translation of safe and effective novel technology into healthcare settings. She has nearly two decades of experience in the field of research compliance and human subjects protections, implementing policies and guidance for the conduct of research and development of novel technology. To enable innovators and their IRBs she has developed various tools and checklists, and published several training modules and webinars for CITI Program and PRIM&R. Ms. Eto serves as an AI Ethics Advisory Board member for the Institute of Experiential AI (EAI) at Northeastern University, a Policy Advisor and Teaching Fellow at the Center for AI and Digital Policy (CAIDP), an AI Expert for the AI-OECD workgroup, and a member of the IEEE Society on Social Implications of Technology and Standards Association.
David Wayne, Ph.D
Chief Artificial Intelligence Officer (CAIO), University of Miami
David Wayne is the Chief Artificial Intelligence Officer at the University of Miami, where he drives AI strategy, governance, development, and implementation across the university and its healthcare system. David has held leadership roles in AI at multiple organizations including UKG, True Fit, and Lightcast, where he has delivered innovative solutions and spearheaded strategic initiatives. He holds a Ph.D. in Mathematics from the University of Colorado at Boulder, is the recipient of multiple technology patents, has been a featured speaker for global technology events and conferences, and has a proven track record of leading high-performing teams and driving impactful change in the realms of artificial intelligence and data-driven decision-making.
Megan Kasimatis Singleton, JD, MBE, CIP
Associate Dean, Human Research Protections and Director of the Human Research Protections Program
Office of Human Subjects Research
Johns Hopkins University School of Medicine
Megan Kasimatis Singleton, JD, MBE, CIP is Associate Dean for Human Research Protections and Director of the Human Research Protections Program at Johns Hopkins University School of Medicine. In this role she is responsible for oversight and direction of the Johns Hopkins Medicine IRBs. Ms. Singleton is a licensed attorney in Pennsylvania. She earned her law degree from Temple University and her Masters in Bioethics from the University of Pennsylvania. Ms. Singleton serves as a member of the SMART IRB Harmonization Steering Committee, member of the PRIM&R Board of Directors and as PRIM&R’s Board Secretary and is Co-Chair of the AAHRPP Council. She also serves as a member of the Steering Committee for AEREO, a consortium designed to advance effective research ethics oversight through empirical research. Ms. Singleton currently teaches at the graduate level at the University of Pennsylvania and Johns Hopkins University, leading courses in research ethics and clinical trial management. She has developed research ethics curriculum and practical training in IRB administration tailored for national and international audiences.
Peter Iafrate, Pharm.D.
IRB-01 Chair, Assistant Director Research Programs & Services
UF Research |University of Florida
Dr. Peter Iafrate is the Chairman of the Institutional Review Board (IRB-01) for the Health Science Center at the University of Florida since 1996. This board oversees nearly 7,000 active human research protocols. He has served on this board since 1986. He has served on the national planning committee for the Public Responsibility in Medicine & Research organization’s annual meetings, has served on several national advisory boards on the topic of human subjects' research, and has numerous national presentations and several publications in this area. He has coordinated the IRB activities for an international study involving over 23,000 subjects and over 1200 investigators. Dr. Iafrate is presently the full time Chairman, IRB-01, and Associate Clinical Professor at the University Of Florida College Of Pharmacy.
José "Joey" Casanova, BBA, CIPT, CHRC, CIP
Data Broker Manager
Office of the Vice Provost for Research + Scholarship
Research Privacy
Joey plays a leading role in the analysis, development, refinement and implementation of appropriate practices with the goal of standardization of clinical data requests process and the fulfillment of such requests, including reviewing, manipulating and formatting data as needed. Specializing in analysis of the Information Security and privacy components of laws and regulations; development of training material to facilitate compliance; and investigating complex, large incidents and developing responses to data breaches, providing Information Technology expertise, especially as it applies to health care and related privacy/security compliance issues. Previously served as the Associate Director for Educational Initiatives at the University’s Human Subject Research Office for 12 years, where he supported UM’s 5 IRBs, served as a regulatory representative during the convened meetings, assisted in the development of UM’s policies, procedures and associated tools for human subject research and presented educational programs for IRB staff, IRB members and the research community.
Denise Dimitriu, MS
IRB Regulatory Analyst
Human Subject Research Office
Denise is a regulatory analyst for the HSRO. She started at University of Miami in 2001 in the Fiscal Affairs office of the Ophthalmology department and joined HSRO in 2019. She earned her undergraduate and graduate degrees from the University of Miami.
Angel Gallusi, BA
IRB Regulatory Analyst – Reliances
Office of the Vice Provost for Research + Scholarship
Human Subject Research Office
Angel Gallusi is an IRB Regulatory Analyst that works as part of the Reliance team at the University of Miami's Human Subjects Research Office with a focus on Single IRB submissions for which the UM serves as the IRB of record. With 5 years of working experience at the HSRO and a Bachelor of Arts in English literature, he strives to conduct thorough reviews and provide regulatory support for the research community. Angel believes that effective communication can improve the administrative process of research submissions and help investigators better achieve their research goals.
Ashley Kaufman, MA, CCRP
Sr. Quality Assurance Auditor
Research Quality Assurance
As a Sr. Quality Assurance Auditor, Ashley conducts internal Quality Reviews of Human Subjects Research across the University of Miami, provides education for and assists with the creation of Corrective and Preventive Action (CAPA) plans, advises study teams in preparation for FDA and sponsor audits, and consults on research-related inquiries.
Ashley began her career as a Clinical Research Coordinator and Research Data Specialist at the University of Miami Sylvester Comprehensive Cancer Center (SCCC). She brings extensive experience in Phase I-III studies across different therapeutic areas in Cutaneous Malignancies, Uveal Melanoma, Cellular Therapy, Gastrointestinal, Urology and Surgical Urology, and was involved in conducting departmental quality assurance reviews, trial oversight, staff training and working closely with multiple sponsors and CROs.
She holds an MA in Health Communication from the University of Miami and obtained her Certified Clinical Research Professional (CCRP) certification through the Society of Clinical Research Associates (SOCRA) in 2023.
Nicole S. McCullough, MS, CCRP
Director, Regulatory Support
Investigator Initiated Trial Services at the U (IITS-U)
Office of the Executive Dean for Research
University of Miami Miller School of Medicine
Nicole McCullough is currently the Director of the Investigator Initiated Trial Services unit at the University of Miami Miller School of Medicine. The unit provides support to University of Miami investigator-initiated clinical trials conducted under an IND or IDE for FDA submissions, monitoring, safety management, data management and project management. Prior to re-joining the University of Miami in May 2022, Nicole worked at Nicklaus Children’s Health System where in her final three years she served as the Director of the Research Institute. Nicole has 24 years of research experience in the following areas: clinical research (protocol writing, operations/ coordination, regulatory, monitoring and compliance), laboratory research, and grants management (applications/pre-award and post-award financial management). Nicole earned a BS in Microbiology and a Master of Science in Molecular Biology from Louisiana State University. She has been a Certified Clinical Research Professional since 2005.
Cynthia Gates, JD, ADN, CIP
Regulatory Consultant
Cynthia Gates, brings more than 20 years of experience in human subject protections and IRB leadership. Cindy has worked in top roles across the country—including as Executive Director of the Human Subject Research Office right here at the University of Miami, and previously as Director of IRB Administration at UC Davis and Vice President of WIRB. Cindy's background spans regulatory guidance, law, and nursing, and she’s also helped shape national training through her work with CITI and as a consultant for institutions like Houston Methodist Hospital and George Washington University. With her legal training, clinical knowledge, and practical experience, she offers a well-rounded and thoughtful perspective on research ethics and compliance.
Vivienne Carrasco, MPH, CIP
Associate Director- Regulatory Oversight
Human Subject Research Office
Vivienne Carrasco has dedicated her career to the ethical and regulatory oversight of human subjects research, a commitment solidified by her Master's Degree in Public Health from Florida International University (FIU) in 2002.
Following the completion of her Master's, Ms. Carrasco transitioned into the field of research administration, joining the University of Miami in 2002 and the Human Subjects Research Office in 2004. For two decades, she has been an integral part of UM’s research enterprise, contributing significantly to the Human Subjects Research program. Her work has focused on ensuring the protection and welfare of individuals participating in research studies, a critical aspect of sound scientific practice.
Through her diligent work and expanding expertise, Ms. Carrasco has advanced within the regulatory affairs framework at the University of Miami. She currently holds the position of Associate Director of Regulatory Affairs. In this role, she plays a key part in navigating the complex landscape of regulations and guidelines that govern human research, upholding the highest standards of research integrity and ethical conduct. Her long-standing tenure at the University of Miami and her foundational knowledge in public health underscore her deep understanding of the importance of responsible and ethical research practices.
Stewart MacIntyre III, Esq.
Director, Office of Research Administration (ORA)
Stewart MacIntyre has been with the University of Miami for over 16 years. He is an attorney and director in the Pre-Award unit of the Office of Research Administration. He supervises the Clinical Research Initiation Services (CRIS) sub-unit. The CRIS unit handles all Industry Sponsored human subject agreements, unfunded collaboration agreements, CDA’s, MTA’s, DUA’s, and other agreement types as well as Medicare Coverage Analysis (MCA) development and budget negotiations for applicable studies.
Katuzka Barbery, EMBA
Director, Clinical Trials Office
Jackson Health System
Katuzka Barbery is a foreign medical doctor who obtained her degree in Medicine and Surgery at the Universidad Catolica de Santiago de Guayaquil., Ecuador. In 2006, after her training and practice as a physician she came to the US where she started her research path at the University of Miami. She is a University of Miami Alumni where she obtained her Executive MBA in Healthcare Management and Policy and now leads the Office of Research Administration at Jackson Health System as the Director of Clinical Research. She is passionate about healthcare operations, process improvement, enjoys the outdoors and 5k runs.
Stephanie Venero
Manager, IRB
Stephanie is a seasoned IRB professional with over 10 years of experience in research ethics and regulatory compliance. Responsible for oversight of (3) Biomedical IRBs, fostering a culture of research integrity, collaboration and compliance.
Meghan M. Stein
Sr. Regulatory Analyst, Human Subject Research Office
Meghan Stein is a dedicated and experienced regulatory professional currently serving as a Senior Regulatory Analyst with the Non-Committee team at the University of Miami's Human Subject Research Office. Her commitment to ethical and compliant research practices is underscored by nearly two decades of experience in the field. Meghan initially joined the University of Miami in 2006, contributing to the Human Subject Research Office. Following a period dedicated to broadening her understanding of regulatory frameworks and strengthening related processes, she strategically returned to the University of Miami in 2022 to further enhance the regulatory team's capabilities. In her current role, Meghan plays a crucial part in ensuring the integrity and ethical oversight of research endeavors. She holds a BA in Political Science.
Kanchan Sakhrani
Supervisor, Business Systems Analyst
Office for the Vice Provost for Research & Scholarship (OVPRS)
Research Intelligence & Capacity (RIC)
Kanchan Sakhrani is a Supervisor for Business System Analysts under the Research Intelligence and Capacity (RIC) unit within OVPRS at the University of Miami. In the 20+ years since she has joined the U, Kanchan has gained knowledge, skills, and data management experience, along with a fierce passion for quality and data integrity. She is grateful for all opportunities that come her way, and is eager to help those in research achieve their goals!
Lory Hayes
Director, Compliance
Office for the Vice Provost for Research & Scholarship (OVPRS)
Within the University of Miami’s (UM) Office of the Vice Provost for Research & Scholarship (OVPRS), Lory is Director of Disclosures & Scholarly Activities Management (DSAM). DSAM reviews the external relationships disclosed by UM’s Covered Persons and identifies personal conflicts of interest (COI)/commitment, institutional/organizational COIs, and relationships that could emerge as nefarious foreign influences on the UM community.
Lory received her Ph.D. from the University of Massachusetts and has held scientific and managerial positions in industrial and academic settings. After moving to UM in 2008, Lory joined the OVPRS in 2010 and took on her current position in 2017.
