Edward E. Bartlett, PhD - Office for Human Research Protections (OHRP)
Dr. Ed Bartlett received his undergraduate degree in the behavioral sciences from Ohio University, his Master of Public Health degree from the University of Illinois at Chicago, and his doctorate from Johns Hopkins University.
He was an assistant professor in the School of Public Health at the University of Alabama at Birmingham for six years. He was the editor-in-chief of Patient Education and Counseling journal for eight years. He has published over 100 scholarly articles on informed consent, confidentiality, and other topics.
Dr. Bartlett previously was the administrator and member of an IRB at a tertiary care medical center in Washington, DC. Since 2003, he has served as the International Human Research Liaison at the Office for Human Research Protections.
Nancy Bellamy - Consumer Safety Office, Food and Drug Administration, Detroit District Office
Nancy Bellamy is a bioresearch specialist in the Detroit District Office. She is the BIMO coordinator for the district, and tracks assignments from headquarters for BIMO inspections in Michigan and Indiana. Mrs. Bellamy graduated from Mercy College in Detroit and started her career in FDA’s Chicago District. Later, she spent four years in the Saginaw, Michigan FDA Resident Post and transferred to the Detroit District office. She is active in the International Inspection cadre and has traveled to many interesting parts of the world on BIMO inspections, including Egypt, Europe, China, India, South Africa, Zambia and South America.
Elizabeth Buchanan, PhD - University of Wisconsin-Stout, Center for Applied Ethics
Dr. Elizabeth Buchanan is endowed chair in ethics and director of the Center for Applied Ethics at the University of Wisconsin-Stout. She is a scholar in the fields of research ethics, information/communication technology ethics, and research methods. Her work is particularly focused on the intersections of research regulation, internet or online venues and tools, and the subsequent ethical challenges that arise for researchers and research board reviewers. She is professionally active in Public Responsibility in Medicine and Research, the International Society for Ethics and Information Technology (Co-Director), and the Association of Internet Researchers. Elizabeth serves as an associate editor for the Journal of Research on Human Research Ethics (JERHRE), on the Editorial Boards of the International Review of Information Ethics and Philosophy and Technology, and reviews for many other scholarly journals and granting agencies.
Dr. Buchanan currently serves on the UW Stout's Institutional Review Board, and has served on both social science and medical school research ethics boards, and has presented her National Science Foundation-funded research on IRBs and Internet research to the Secretary's Advisory Committee to the Office for Human Research Protections in 2010 and 2012.
Kristin Burt, JD - Community Research Institutional Review Board (CRIRB), Michigan State University
Kristen Burt, J.D., is the interim director of the Michigan State University Human Research Protection Program (HRPP). Joining the MSU Institutional Review Board office in 2001, she has performed case management of human research projects, has led MSU’s application processes to AAHRPP, Inc., and coordinated IRB education programs. Ms. Burt currently leads policy and planning initiatives within the Office of Regulatory Affairs and is presently serving as the director of the HRPP. Kristen Burt obtained a Bachelor of Science in Human Biology and a Bachelor of Arts in General Business Administration from Michigan State University (MSU) and a Juris Doctor from the MSU College of Law.
Rozelle Copeland, PhD - Associate Director, IRB Administration, Wayne State University
Dr. Copeland is the associate director of IRB Administration at Wayne State University, which has five IRBs. She has experience with regulatory compliance, developing resources for IRBs, policies, processes, forms, and the administration of IRBs. Dr. Copeland also serves as a consultant in continuous quality improvement and program development and evaluation for mental healthcare provider companies. Dr. Copeland has over 25 years of experience in the mental health field, experience with programs for juvenile justice, and has been a research investigator at Wayne State University. Dr. Copeland is the co-author of a book on autism and co-author of two transition planning assessment tools for persons with cognitive and developmental disabilities.
Linda Darga, PhD - Grant Development Specialist, Office of Research Administration, Oakland University
Linda Darga has a PhD in Biological Anthropology from Wayne State University. She had a three-year NIH Research Fellowship at Children’s Hospital of Michigan and then conducted research at the Beaumont Weight Loss Clinic with numerous publications in weight loss and its physiological correlates and also worked with drug studies conducted at the clinic. She then conducted studies at the Karmanos Cancer Institute and Wayne State University in breast cancer and prostate cancer. She also held positions in Oncology at Children’s Hospital and Karmanos working with clinical trials. She has taught many years, both undergraduate and graduate courses in anthropology at Wayne State University, Oakland University, and the University of Windsor.
Michael P. Diamond, MD - OB-GYN Chair, Medical College of Georgia, VP for Clinical and Translational Science, Georgia Regents University-Augusta
Michael P. Diamond, MD, is the Brooks professor and chair of the Department of Obstetrics & Gynecology, associate dean for Research of the Medical College of Georgia, and vice president for Clinical and Translational Science at Georgia Regents University Augusta. Prior to his current appointment, Dr. Diamond was Kamran S. Moghissi professor and associate Chair of the Department of Obstetrics and Gynecology, and assistant dean for Clinical and Translational Research at Wayne State University School of Medicine in Detroit, Michigan. He is an internationally renowned clinical and translational investigator, who is recognized for many scientific contributions, including within the field of Reproductive Endocrinology and Infertility.
Dr. Diamond has been funded by six NIH Institutes, including NICHD to conduct randomized clinical trials utilizing the euglycemic, hyperinsulinemic clamp and hyperglycemic clamp techniques to evaluate the role of androgens on insulin sensitivity in men and women. He also served as WSU’s PI on the NICHD Cooperative Reproductive Medicine Network grant, which has conducted clinical trials on diagnosis of luteal phase defects, ovulation induction for women with polycystic ovarian syndrome, and ovarian stimulation for unexplained infertility.
Jaci Goldberg, JD - National Cancer Institute (NCI), Central Institutional Review Board Initiatives
Jacquelyn L. Goldberg, JD, is currently at the National Institutes of Health, where she is the head of the National Cancer Institute's Central IRB Initiative. Prior to joining the federal government, she worked at the University of Missouri-Columbia as the compliance officer for the Health Sciences IRB and as an adjunct professor in the School of Nursing focusing on ethics in clinical research. While at the University, she was also involved in post-conflict health and development issues in Bosnia through the University's International Center for Psychosocial Trauma and co-taught a university-wide undergraduate course on women's issues in global health. In addition to her expertise in the ethical and regulatory aspects of biomedical research, she has extensive program and policy experience in women’s health, hospital risk management, and community health planning. She is a graduate of Brandeis University and Antioch School of Law.
Barbara Higgins, BSN - Research Education Manager, Research Institute, Beaumont Health System
Barbara Higgins has been the research education manager for Beaumont's Research Institute for over ten years. She plans and provides educational offerings, auditing services and also participates in policy development. Her educational background includes a Bachelor of Science in Nursing from the University of Western Ontario, and her experience as a nurse, study coordinator, and educator have given her a comprehensive base from which to approach many topics.
Stuart Horowitz, PhD, MBA - Managing Director, Western Institutional Review Board
Stuart Horowitz, MBA, PhD, serves as president, Institutions and Institutional Services at WIRB-Copernicus Group. In this role, Dr. Horowitz is responsible for WIRB-Copernicus Group's consulting services, Institutional Biosafety Committees, Data and Safety Monitoring Services and international services. Dr. Horowitz holds a PhD in cell and molecular biology. He has focused his career on the growth and success of institutional clinical research enterprises. Dr. Horowitz has held leadership positions within institutions, at the CardioPulmonary Research Institute at Winthrop-University Hospital (NY), the Center for Advanced Medicine at Jewish Hospital (Louisville, KY) and the Miami Children's Hospital Research Institute (FL). As a consultant, Dr. Horowitz has advised scores of research-intensive organizations in the U.S. and the Middle East, assisting in the creation and growth of laboratory and clinical research programs. Dr. Horowitz earned his Bachelor of Arts degree from the State University of New York at Binghamton, his PhD in Biology from the University of Rochester, and his Executive MBA from Bellarmine University.
John M. Koerber, PharmD - Beaumont Health System
Dr. Koerber received his Bachelors of Science Degree from Wayne State University in Detroit, Michigan and his Doctorate of Pharmacy Degree from the University of Florida in Gainesville, Florida. He completed a general practice pharmacy residency at Beaumont Hospital, Royal Oak. Dr. Koerber is currently the coordinator for the Investigational Drug Service at Beaumont Health System. He has been a member of the Beaumont Health System Human Investigation Committee (Institutional Review Board) for over eight years and is currently serving as the chairperson (past four years). Dr. Koerber is a member of Public Responsibility in Medicine and Research and the American College of Clinical Pharmacy.
Gayle Kusch, MSA - Wayne State University
Gayle Kusch is the senior director for Compliance at Wayne State University’s Research Compliance Office, where she directs the operational and regulatory activities associated with the human and animal protection programs, financial conflict of interest, export control, and research misconduct. A lifelong Michigan resident and a graduate of both University of Michigan–Dearborn and Central Michigan University, she has been involved in the research enterprise her entire career. Prior to the oversight of regulatory areas impacting research, she worked as the manager for the clinical trials office at the Meyer L. Prentis Comprehensive Cancer Center (now Karmanos), and was the project director for the National Heart, Lung, and Blood Institute’s Women’s Health Initiative – Detroit Clinical Center.
Barbara Scott, MHSA - Beaumont Health System
Barbara Scott, MHSA, CCRP, CRHC, is the director of Research Regulatory and billing at Beaumont Health System, coordinating compliance activities for the Research Institute. Among her other responsibilities, Ms. Scott is the administrator of the research conflict of interest program at Beaumont, as well as co-chair of the Research Conflict of Interest Committee. She earned a Bachelor's of Science degree in Management from Oakland University and a Masters of Health Services Administration from Central Michigan University. Prior to joining Beaumont in 2000, Ms. Scott held various management positions in retail finance and accounting.
Robyn Shapiro, JD - Drinker Biddle & Reath LLP, Milwaukee Office
Robyn S. Shapiro, JD, health law partner and Regional Partner in Charge in the Milwaukee office of Drinker Biddle & Reath LLP, has significant experience with respect to bioethics issues, research compliance issues, medical staff matters, health information privacy issues, informed consent, and regulatory and licensing matters. Attorney Shapiro's position as Ursula von Der Ruhr Professor of Bioethics at the Medical College of Wisconsin, and 26-year leadership as director of the Center for the Study of Bioethics, complement her wide-ranging experience in health law. Ms. Shapiro is listed in the Best Lawyers in America, Who's Who in American Law, Who's Who in America, Who's Who of American Women, Who's Who of Emerging Leaders of America, Who's Who in the Midwest, International Who's Who, Who's Who in the World, Who's Who in American Education, and Wisconsin Super Lawyers; she was included in Nightingale's 2006 list of "Outstanding Hospital Lawyers" in the nation; in 2006 she was one of 12 honorees selected as "Leader in the Law" by the Wisconsin Law Journal and in 2011 was named "Woman of Influence” by the Milwaukee Business Journal and Milwaukee's Health Care "Lawyer of the Year" by Best Lawyers.
Christine Stiller, PhD - School of Health Sciences, Oakland University
Christine Stiller received her bachelor’s degree from Wayne State University in 1976, a master’s degree in Human Development from Wayne State University in 1982, and a PhD in Educational Psychology from Michigan State University in 1998. She has been a special instructor in the Physical Therapy Program at Oakland University since 1982, where she teaches both entry-level and post entry-level courses related to pediatrics, education, psychosocial aspects of patient management, and research methodology. As a pediatric physical therapist, she has worked in medical, educational, outpatient and home care settings. Dr. Stiller currently has a pediatric private practice through which she provides therapy services to schools in the Detroit Metropolitan area. She has conducted research in pediatric physical therapy and physical therapy education. Dr. Stiller has been a member of the Oakland University Institutional Review Board for approximately 15 years and is currently the chair of the Oakland University IRB.
Elyse I. Summers, JD - Office of Human Research Protections (OHRP)
Elyse I. Summers, JD, has been with the Office for Human Research Protections since 1998. Since 2008, she has been the director of OHRP’s Division of Education and Development. Prior to that, Ms. Summers practiced law with Buc & Beardsley in Washington, DC, where her work involved the law of food, drugs, and other medical products, and included providing guidance and counseling on Federal regulations and ethical issues related to the conduct of biomedical research. Before Buc & Beardsley, Ms. Summers spent five years in the Office of the Commissioner at FDA. Ms. Summers also practiced the law of tax-exempt organizations at Steptoe & Johnson, and Baker & Hostetler, respectively. She began her professional career representing research universities at the Association of American Universities. She received her JD from George Washington University and her BA from the University of Michigan. Ms. Summers holds bar membership in Washington, DC and Pennsylvania.
Linda Triemer, PhD - retired Van Andel Research Institute
Dr. Triemer retired in 2012 as the director of the Compliance Office at the Van Andel Research Institute (VARI), an independent research and education institute that focuses on biomedical translational science. She had oversight of the IRB and was a site-visitor for the Association for Accreditation of Human Research Protection Programs (AAHRPP). Prior to her work at VARI, she had similar roles at the University of Chicago, director of Research Integrity, and Michigan State University, Director of the Office of Regulatory Affairs. Dr. Triemer’s research spanned academic, private and non-profit institutions specializing in human health risk assessment, and use of medical records to assess the quality and provision of health care for special populations. She obtained her PhD in Public Health Sciences at the University of Illinois at Chicago, and post-doctoral training in Epidemiology at the Chemical Industry Institute of Toxicology.
Corey Zolondek, PhD - IRB Specialist, Office of Research Administration, Wayne State University
Corey Zolondek has served as a research subject advocate in Wayne State University’s Division of Research since October 2010. He assists research participants with questions related to volunteering, provides guidance to researchers and staff on the informed consent process, performs community outreach, and reviews the use of medical records in research studies. Until recently, Dr. Zolondek served as an IRB Specialist at Oakland University, where he provided administrative support in the review of research applications.