Knowledge Center Advisory Group

Meet the Members of the Knowledge Center Advisory Group

Lois BrakoLois Brako, PhD, is the assistant vice president for research–regulatory and compliance oversight at the University of Michigan, Ann Arbor (U-M). Her responsibilities include coordinating activities related to the development and modification of campus-wide research policies and procedures and strategic planning for regulatory compliance oversight. She is the director of U-M’s Human Research Protections Program, which includes four IRB offices and nine IRBs, with oversight of more than 5,600 projects. At U-M, Dr. Brako chairs the IRB council, co-chairs the human pluripotent stem cell research oversight committee, serves as a member of the institutional biosafety committee, is a consultant to the university committee on the use and care of animals, and a member of U-M’s leadership team for electronic information systems. At the national level, she is co-chair of the Federal Demonstration Partnership’s Human Subjects Protections Subcommittee, a group dedicated to reducing regulatory burden for investigators, and is a member of the Council on Governmental Relations’ Board of Directors. Dr. Brako chairs the Knowledge Center Advisory Group.

Hila BergerHila Berger, MPH, CIP, is the Montclair State University (NJ) compliance administrator. She is the institution’s policy expert and officer, ensuring compliance with the institutional animal care and use committee (IACUC), US Public Health Service, financial conflict of interest, Medicare, and Health Insurance Portability and Accountability Act regulations. She is responsible for outreach and educational activities for faculty and students conducting human subjects research, and she also provides expertise and guidance in the conduct of inquiries and investigations into the ethical conduct of research. She also volunteers as a committee member on the Rutgers University IRB. In previous positions, Ms. Berger served as compliance manager for several multi-site high-risk clinical trials among vulnerable populations, and prior to that, as a researcher in tobacco control and policy evaluation. Ms. Berger received her MPH from Rutgers University, formerly the University of Medicine and Dentistry of New Jersey-School of Public Health. Ms. Berger has been a PRIM&R member since 2011 and has participated in past conferences as a poster presenter.

Melissa EpsteinMelissa A. Epstein, PhD, CIP, is currently an administrator for the Einstein IRB—East Campus at the Albert Einstein College of Medicine. She holds a PhD in linguistics from the University of California, Los Angeles, where she conducted her doctoral dissertation on vocal cord vibration patterns in English. Dr. Epstein received additional training as a postdoctoral fellow at the University of Maryland Dental School studying three dimensional modeling of tongue motion during speech. Upon completing her postdoc, Dr. Epstein pursued a career in research administration and human subjects protections. In 2009 she obtained a certificate in bioethics from the Montefiore-Einstein Center for Bioethics, and she is currently pursuing a master’s in bioethics from the center, while working at the IRB. Dr. Epstein has been a member since 2007 and has contributed as a subject matter expert to several PRIM&R initiatives.

Amy KingAmy Neuman, MPH, works as an IRB coordinator at Oregon State University (OSU). Ms. King’s career in research ethics began as an undergraduate student at the University of Wyoming, where she worked with the institution’s animal care and use program. By the time she graduated from the University of Wyoming, she had begun to take on more responsibility within the program and was coordinating many of the daily administrative functions of the IACUC. She continued working with the IACUC during her graduate studies at OSU, where she received a Master of Public Health with an emphasis on international health. Upon graduation, she began working for the IRB. The transition from animals to human subjects was an excellent fit for Ms. King since the focus of her studies was on culture and people, not animals and pathogens. In addition, the majority of research at OSU is social and behavioral research with a growing number of international research endeavors, all of which are more suitable to her expertise. Ms. King has been a PRIM&R member since 2013.

Babu KrishnamurthyKaarkuzhali Babu Krishnamurthy, MD, is an assistant professor of neurology at Harvard Medical School. A graduate of the University of Maryland School of Medicine and Johns Hopkins University, Dr. Krishnamurthy completed an internship at Yale-New Haven Hospital before training in the Harvard-Longwood Neurology Program. Upon conclusion of her fellowship in neurophysiology at Beth Israel Deaconess Medical Center (BIDMC), Dr. Krishnamurthy established and developed their women’s health in epilepsy program, a comprehensive and integrative clinic designed to minimize the risk of pregnancy in women with epilepsy. In the decade since this program was initiated, more than 300 healthy babies have been born to women in the practice. A significant component of the program is a commitment to outcomes research, and publications have resulted demonstrating that closer monitoring of anticonvulsant blood levels decrease the occurrence of seizures during pregnancy in women with epilepsy, while there are no significant increases in the risks of pregnancy-related comorbidities. Another portion of Dr. Krishnamurthy’s academic path includes the development of training programs to help clinical researchers carry out studies in adherence to IRB standards and federal regulations. For five years, she directed the human subjects protection office at BIDMC, and prior to that, she served as a vice chair for the committee on clinical investigations, BIDMC’s IRB. Dr. Krishnamuthy has been a PRIM&R member since 2010 and has participated in past conferences as a poster presenter.

Michael LearyMichael Leary, MA, CIP, is an education and compliance specialist in the human research protection office at Washington University in St. Louis. He is involved with educational program development and assessment, media production, and open-access publication on IRB policy and guidance. Mr. Leary produces and hosts More Than Meets the IRB, a widely visited research ethics podcast for research participants and the people who study them. He is also currently conducting research on IRB decision-making and effectiveness that produces models of IRB member performance for quality improvement. Mr. Leary has contributed to PRIM&R as a guest blogger and has been a member since 2013.

Gina Prochilo-CawstonGina Prochilo-Cawston, MS, CPIA, PMP, is a senior scientist in regulatory compliance at Pfizer Worldwide Research and Development. Ms. Prochilo-Cawston has spent more than 15 years working in positions related to animal care and use—ranging from clinical care to animal use to regulatory compliance—in various settings, including academic institutions, veterinary hospitals, medical centers as well as the pharmaceutical industry. Throughout her career, Ms. Prochilo-Cawston has developed a comprehensive knowledge of the many regulations and guidelines that pertain to animal care and use in research. She also has extensive experience participating in policymaking, planning, directing, and evaluating program requirements, activities, and functions. Ms. Prochilo-Cawston earned a Bachelor of Science in biology from University of Massachusetts, and a Master of Science in biomedical science from Eastern Virginia Medical School. Ms. Prochilo-Cawstona has been a member of PRIM&R since 2011.

Lauren SolbergLauren Solberg, JD, MTS, is an assistant professor at the University of Florida in the department of community health and family medicine’s program in bioethics, law, and medical professionalism, with secondary appointments in the department of aging and geriatric research and the department of psychiatry. Professor Solberg teaches bioethics to medical, graduate, and undergraduate students as well as other learners, and conducts research on various issues in bioethics including the protection of human subjects in research, and in particular the uses of social media in biomedical and social/behavioral research. Previously, Professor Solberg was an assistant professor of graduate studies and research and the assistant vice president of human subjects protection and research integrity at Meharry Medical College. There, she was responsible for overseeing activities related to the conduct of research with human subjects; providing advice on ethics and regulatory compliance to researchers, IRB and other compliance committee members, and institutional officials; and overseeing general and research-specific ethics education of researchers. Professor Solberg has served as a member of three IRBs and two IACUCs. She earned her JD from Vanderbilt University, her Master of Theological Studies from Harvard University, and her BA in English and religion from the University of Florida. Professor Solberg has been an active PRIM&R member since 2011, contributing as a poster presenter, a member of the Poster Abstract Sub-Committee, and a faculty member for PRIM&R’s annual Advancing Ethical Research Conference.

Matt ZembrzuskiMatt Zembrzuski, MEd, is the research compliance manager at American University (AU) in Washington, DC. In this role, he supervises administrative functions and education initiatives for the university’s IRB, IACUC, and IBC. In 2011, he established the AU’s Office of Research Integrity and helped restructure the institution’s three compliance committees, and is currently working to further develop the university’s responsible conduct of research and export control programs. Originally hired in 2007 in AU’s Office of Sponsored Programs as operations manager, he started assisting with IRB proceedings in 2009. Prior to AU, Mr. Zembrzuski taught computer courses and worked in academic administration at trade schools and junior colleges. He holds a MEd in curriculum and instruction with a concentration in adult education from George Mason University, and a BS from North Carolina State University. Mr. Zembrzuski has been an active PRIM&R member since 2010. He lives in the Maryland suburbs of DC with this wife and two young children.

About the Knowledge Center Advisory Group

Launched in 2012 with the help of external subject matter experts, the Knowledge Center is a resource-rich, members-only section of PRIM&R’s website. Since its launch, PRIM&R has recognized a clear need to have members share their expertise in the field of research ethics and oversight to further the development of this resource. To address this need, the Knowledge Center Advisory Group was established in March 2014.

Composed of PRIM&R members, the Knowledge Center Advisory Group is charged with guiding the development of the Knowledge Center. This group contributes to goal setting and strategic planning for the site. Advisory group members also participate in the development of new resources. Through its work, the group will be an integral part of PRIM&R’s continued efforts to provide human subjects protections and animal care and use professionals with the resources they need to do their jobs effectively and efficiently.

Get Involved

Knowledge Center Advisory Group members serve twelve- and sixteen-month terms. Announcements about openings for the group will appear in the PRIM&R Member Newsletter.

Please contact Maeve Luthin, professional development manager, by email or by phone (617.303.1873) with any questions.