AAHRPP - Key Persons
Job Titles:
- Associate Vice Chancellor for Regulatory Compliance / University of Colorado
Job Titles:
- Member / Chief Scientific Officer, Office of Scientific Affairs and Research
Amal Al-Omari holds a PhD degree in Clinical Pharmaceutical Sciences from the University of Iowa, Iowa City. She has more than 20 years of experience spanning pharmaceutical research & development, academia, oncology research and research administration. In her capacity as the Chief Scientific Officer at King Hussein Cancer Center she leads the Office of Scientific Affairs & Research which hosts the KHCC's Hospital-Based Cancer Registry, the Center for Research Shared Resources (with a dedicated clinical trials unit) and the Center for Grants and Contracts Management. Dr. Al-Omari is also responsible for review of institutional research collaboration agreements, material transfer agreements, research grant agreements and all clinical trial contacts with CROs and pharmaceutical companies. She is also a member of the KHCC's Research Council.
Amal's research interests are mainly related to the epidemiology of Non-Communicable Diseases (NCDs), in particular oncologic malignancies in Middle Eastern populations, especially in Jordan. In addition to research exploring genetic and epidemiologic predictors of outcome to cancer treatment among Jordanians and other Middle Eastern populations. Dr. Al-Omari initiated a research quality assurance project at KHCC by establishing and implementing a comprehensive Human Research Protection Program. The program was awarded Full AAHRPP accreditation in June 2019 and KHCC was the first institution in Jordan and among very few cancer centers worldwide to have this quality designation. She also oversees strategic networking with leading institutions at the regional and international level to promote and advance clinical research activities, increase patient access to clinical trials, as well as research training and capacity building.
Job Titles:
- Executive Director of the the Fenway Institute
Amy Ben-Arieh is the Executive Director of the The Fenway Institute (TFI) at Fenway Community Health. She is a member of Harvard Catalyst's Regulatory Foundations subcommittee on SBER, and a member of Portsmouth Regional Hospital's research ethics committee. Prior to joining TFI, Amy served for several years as an associate chair of Partners Human Research Committee. Her educational background is in health law, bioethics, and human rights.
Job Titles:
- Director, Human Research Protection Program / University of Cincinnati
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- Director, IRB and HRPP / University of Utah
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- Assistant Vice Chancellor for Regulatory Affairs / University of Nebraska Medical Center
- Assistant Vice Chancellor for Regulatory Affairs, and Professor of Pediatric Hematology / Oncology at the University of Nebraska Medical Center
Bruce Gordon is Assistant Vice Chancellor for Regulatory Affairs, and Professor of Pediatric Hematology/Oncology at the University of Nebraska Medical Center (UNMC). Dr. Gordon has been a member of the UNMC institutional review board since 1992, served as chair since 1996, and as executive chair since 2011. He has served on numerous national committees, including the DHHS Secretary's Advisory Committee on Human Research Protections Subpart A Subcommittee, the American Society of Clinical Oncology Task Force on Oversight of Clinical Research, the AAMC Informed Consent Working Group, and the NIEHS Best Practices Working Group for IRB Review of Disaster Research. He was the first chair of the National Cancer Institute Pediatric Central IRB. Dr. Gordon has served on the Board of Directors for PRIMR and was the co-chair for the 2009 AER Conference. He has been a faculty member at every ARENA/PRIMR national meeting since 2002. He is an active participant in PRIMR's "At Your Doorstep" educational programs, including IRB 101, 200 and 250 programs. He co-developed of the Investigator Responsibility pre-conference workshop, the "Collaborating for Compliance" workshop, the "IRB Chairs Boot Camp" program, and the "Vulnerable Subjects" program, and has presented at numerous PRIMR webinars. He is a founding member of the Collaborative Institutional Training Initiative (CITI) and served on the Executive Advisory Committee for the program.
In addition to authoring several core modules for the Biomedical Research course, Dr. Gordon co-developed a course on research involving vulnerable subjects. Bruce currently serves on the AAHRPP Council on Accreditation, is a frequent AAHRPP site visitor, and has been has been a faculty member at numerous previous AAHRPP conferences. Dr. Gordon is co-editor of the 3rd edition of "IRB: Management and Function", and is the author of numerous original papers, chapters, review articles, and abstracts regarding human subject protections and research ethics.
Job Titles:
- Senior Operations Coordinator
Calla Anderson is a Senior Operations Coordinator at AAHRPP. She joined AAHRPP in November of 2021. In her role, Calla assists with accreditation operations and provides support to organizations, site visitors, and members of AAHRPP's Council on Accreditation. Her facilitation ensures that documents are assembled and processed according to AAHRPP's requirements.
Ms. Anderson holds a degree in Psychology from Seattle Pacific University and has three years of experience in research data collection at the University of Washington-Seattle.
Job Titles:
- Associate Vice President for Research, Office of Research Protections / the Pennsylvania State University
Cindi Hart is a Registered Nurse working in medical informatics supporting principal investigators. A two-time cancer survivor and caregiver to her husband who is also a cancer survivor, Cindi is an internationally recognized cycling and speed skating coach, and President and Founder of Spokes of Hope, a nonprofit organization focused on survivorship.
Ms. Hart and Spokes of Hope support patients with cancer; survivors in remission, "emphasizing that cancer isn't contagious, but that hope is, Cindi is changing the way cancer is perceived and cycling towards the future to empower, unify and inspire cancer survivors." Cindi comes to AAHRPP with the intention of optimizing her experiences and paying it forward.
Job Titles:
- Regulatory Analyst, Human Research Office / George Washington University
Job Titles:
- Event and Social Media Manager
Danielle Randolph joined AAHRPP in January of 2019 as Program and Public Affairs Coordinator and now serves as Event and Social Media Manager. Ms. Randolph maintains AAHRPP's internet presence by managing social media and maintaining AAHRPP's branding. In addition, Danielle helps plan and execute events throughout the year, such as webinars and the annual conference, and creates and maintains the registration sites for all events. Ms. Randolph also assists senior management with daily activities and meeting preparations.
Before AAHRPP, Danielle worked for a non-profit organization within the finance field. She was contracted as a conference developer and later filled other roles within the marketing department. Ms. Randolph graduated from Randolph-Macon College in 2018, where she earned her degree in Business Management with a minor in Asian Studies.
Job Titles:
- Associate Dean, Regulatory Affairs & Research Compliance / Harvard T.H. Chan School of Public Health
Job Titles:
- Professor of Medicine at Tufts University Medical Center
Elizabeth Jacobs is Professor of Medicine at Tufts University Medical Center. In previous roles, Liz was the Vice President for Research at MaineHealth, the Inaugural Chief of Primary Care and Valued Based Health, Professor of Medicine and Population Health Science and Associate Chair for Research in the Department of Medicine at the University of Texas at Austin's Dell Medical School. She attended medical school at the University of California at San Francisco and trained as a general internist at Brigham and Women's Hospital in Boston. She completed a Robert Wood Johnson Clinical Scholars Fellowship and an Associate Masters in Public Policy at the University of Chicago.
After struggling to care for limited English-speaking patients during medical school and residency, she decided to pursue a research career investigating disparities in health care. Dr. Jacobs' research interests include access to, and cultural specificity of, medical care delivered to patients, the impact of interpreter service interventions on the cost and quality of healthcare, health literacy and numeracy, and the role that trust in health care plays in racial/ethnic disparities in health care. Her research has been supported by grants from the National Cancer Institute, the National Institute on Aging, The Robert Wood Johnson Foundation, The California Endowment, The Russell Sage Foundation, The Patient Centered Outcomes Research Institute and the Office of Minority Health.
She is recognized as an expert on the provision of linguistically accessible and culturally competent care and has served on Office of Minority Health, Joint Commission, National Quality Forum, Patient Centered Outcomes Research Institute and AHRQ expert panels. She has published numerous peer-reviewed journal articles, edited two books, and authored numerous book chapters. In addition, she works with other investigators to design culturally specific research, and teaches residents and medical students about practicing culturally sensitive medicine. Dr. Jacobs has practiced as a primary care physician in Federally Qualified Health Centers her entire career and looks forward to continuing to practice in Maine.
Elyse I. Summers has been AAHRPP's President and CEO since October 2013. She provides strategic and substantive leadership and oversight on all aspects of AAHRPP's operations and is looking forward to leading AAHRPP well into the 21st century as the indispensable global organization for the accreditation of human research protection programs. Prior to AAHRPP, Ms. Summers was the Director of the Division of Education and Development at the US Department of Health and Human Services' Office for Human Research Protections (OHRP), a position she held from 2008-2013. Ms. Summers first began working for OHRP's predecessor organization (the Office for Protection Research Risks [OPRR]), in 1998, first in the Division of Compliance Oversight and then in the Division of Education. Prior to joining OPRR/OHRP, Ms. Summers practiced law pertaining to food, drugs, and other medical products (Buc & Beardsley). Included in her practice was the provision of guidance and counseling on Federal and State law, regulations, and ethical issues related to the conduct of biomedical research. Prior to that, Ms. Summers spent five years in the Office of the Commissioner at FDA, as Special Assistant to the Deputy Commissioner for External Affairs, and later as an original staff member of FDA's Office of Women's Health.
Ms. Summers has spoken extensively and published several articles and book chapters on biomedical and behavioral research and human research protections. She has also practiced the law of tax-exempt organizations (with, respectively, Baker and Hostetler, and, Steptoe and Johnson), and has spoken and written on that topic as well. Ms. Summers began her career at the Association of American Universities, representing research universities. She earned her J.D. from the George Washington University National Law Center and her B.A. from the University of Michigan. She is a member of the Bar of the District of Columbia and of the Commonwealth of Pennsylvania.
Job Titles:
- University Research Compliance Officer / the City University of New York
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- Medical Director, HRPP, and Chair IRB, Pediatrics and Neurology / Connecticut Children 's Medical Center
Job Titles:
- Treasurer
- Treasurer / Retired
Harold (Hal) Hackerman was a director in Ellin & Tucker's Audit and Accounting Department. He was an engagement leader for many of the firm's largest clients, and as such, is well-versed in the technical audit and financial reporting standards of privately owned companies, both nationally and internationally. Hal is a trusted advisor for a significant number of the firm's employee benefit plan engagements. Hal has been a driving force behind the growth and development of the firm's Wholesale Distribution Services Group. His experience with the wholesale distribution industry started with his father, who owned a food wholesale distribution company for many years. This connection gives Hal a unique perspective into the financial operations and accounting and financial reporting standards for these types of companies. Representing more than 50 distribution companies with operations globally, Hal has a strong grasp on audit and accounting best practices and procedures, as well as the consulting expertise to maximize profitability and operational capacity, regardless of the demographic or complexity of the engagement.
As a member of AAHRPP's senior staff, Harry Frazier assists in the development and implementation of sound fiscal policy and procedures. He helps organizations, staff, and site visitors navigate and understand the application fee process and site visitor expense reimbursements. He is also responsible for accepting conference and webinar payments as well as any matters involving accounts receivable and accounts payable.
Harry brings over 28 years of accounting experience to AAHRPP by having served in a variety of industries including non-profit organizations, financial institutions, and in the education sector. Prior to AAHRPP, he was the Director of Accounting at the Art Institute of Washington, overseeing all aspects of accounting and finance for the campus. He also served as the corporate accounting trainer for the Art Institutes across the U.S. Mr. Frazier has also served as Treasurer and is a founding member of the International Capoeira Angola Foundation, an international non-profit working to preserve the history and traditions of Capoeira Angola. Mr. Frazier received his BA degree from Strayer University, Washington, D.C.
Job Titles:
- Director, OHSRP Office of Policy and Accreditation
Job Titles:
- Vice Chair
- Acting Chief Scientific Officer, Senior Director for Science Policy
Heather Pierce is the Acting Chief Scientific Officer, Senior Director for Science Policy and Regulatory Counsel at the Association of American Medical Colleges (AAMC) and the Director of Policy for the AAMC's Center for Health Justice. She serves as AAMC's leader for scientific regulatory issues including human subject protections, clinical research, conflicts of interest, research data sharing, evidence-based regulation, diagnostic test development, and collaborations between industry, government, and academia in biomedical research. She is the subject matter expert for the AAMC's Forum on Conflict of Interest in Academe and for Convey, the AAMC's global financial interest disclosure system. During the COVID-19 pandemic, she has led the organization on issues related to COVID-19 testing and regulatory aspects of vaccine and treatment development.
Ms. Pierce currently serves on the Board of Directors for the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and was previously the Chair of the Board of Directors of Public Responsibility in Medicine and Research (PRIM&R). She regularly speaks at national forums on issues related to the protection of human subjects, regulatory burden, research security, research ethics, biospecimens, scientific misconduct, and legislation and policymaking related to research, and has published articles and commentaries on these topics in Nature, Science, The New England Journal of Medicine, JAMA, the Journal of Public Health Management and Practice, and The American Journal of Bioethics. She has served on committees, working groups and task forces of organizations including the National Academies of Sciences, Engineering, and Medicine, The Pew Charitable Trusts, and the National Dialogue on Healthcare Innovation. Prior to joining AAMC, Ms. Pierce was an attorney in the Health Care Group of the law firm of Ropes & Gray LLP in New York. Her regulatory practice focused on medical research and clinical care. She received her law degree from NYU School of Law and her MPH in Health Law from Boston University.
Job Titles:
- Associate Vice President for Research
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- Executive Secretary, Human Research Protection Center / National Taiwan University Hospital
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- Executive Director / Public Responsibility in Medicine and Research ( PRIM & R )
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- Professor of Pediatrics, Division of Neonatology / University of Connecticut
Job Titles:
- Quality Assurance Coordinator
- the Quality Assurance Coordinator
Jamie McMaster joined the AAHRPP team in August of 2022 as the Quality Assurance Coordinator. In this role, Ms. McMaster is primarily responsible for all quality assurance activities within AAHRPP to ensure timely execution of reviews while preserving the high quality and professionalism of the entire accreditation operation.
Prior to joining AAHRPP, Ms. McMaster worked in research roles for over 22 years for the Department of Veterans Affairs at the VA hospital in Madison, WI, where she most recently served as the hospital's Research & Development Coordinator. Also while at the VA, Jamie spent ten years doing oncology research and nine years as a study coordinator conducting interventional clinical trials in mental health. From these roles and years of research experience, Jamie brings her knowledge and expertise in project management and human research protection programs to AAHRPP.
Job Titles:
- Assistant Director of Operations
Jemelle Williams joined AAHRPP in October of 2018 and currently serves as the Assistant Director of Operations. In this role, Jemelle manages the Operations Coordinators, oversess the processing of applications, and provides process support for organizations, site visitors, and AAHRPP's Council on Accreditation. In addition, Ms. Williams assists with the site visits process from start to finish, ensuring that both the organization and the site visitors are prepared for the visit. She also trains and mentors new Operations Coordinators.
Prior to joining AAHRPP, Ms. Williams had 10 years of experience as a Project Manager. Jemelle received a degree in Psychology from Rensselaer Polytechnic Institute and received her Project Management Professional Certification in 2022.
JODI ROBERTS, PhD is the former Director of Research Integrity and Compliance at Utah State University, where she oversaw the research Conflict of Interest and Responsible Conduct of Research programs as well as providing regulatory support to the IRB, IACUC, BioSafety, and Biohazards' compliance committees. She is also the former HRPP Officer at Mississippi State University. Jodi holds three degrees from Mississippi State University. Jodi has served as a site visitor and Step 1 Reviewer for AAHRPP and joined AAHRPP Council on Accreditation in 2023.
Job Titles:
- Associate Professor Emeritus IRB Chair / the University of Iowa
Dr. John Andrew Bertolatus received his undergraduate and medical degrees from Johns Hopkins University. After residency in internal medicine at the University of Kentucky and nephrology fellowship training at the University of Iowa, he joined the faculty at Iowa and has remained at this institution for his post-training career.
Dr. Bertolatus' clinical emphasis has been in the area of renal transplantation. He participated in a variety of industry- and NIH-sponsored clinical trials. Since 2004 he has been chair of the biomedical IRB at Iowa. He is currently a member of the AAHRPP Council on Accreditation, and has been a frequent site visitor and Step I application reviewer.
Job Titles:
- Associate Vice President for Research Compliance / Indiana University
Job Titles:
- Secretary
- Is Director
- Secretary / Director, Office of Human Subjects Research Protections
Jonathan Green, MD, MBA, is Director, Office of Human Subjects Research Protections for the National Institutes of Health where he oversees the human research protection program for the NIH Intramural Research Program. Prior to joining the NIH, Dr Green was professor of medicine, pathology, and immunology, as well as Associate Dean for Human Studies, and Executive Chair of the institutional review board at Washington University School of Medicine in St. Louis, MO. He received his medical degree from Wayne State University in Detroit followed by residency training in internal medicine at Boston City Hospital. He then completed a fellowship in pulmonary and critical care medicine at the University of Michigan Medical Center, and additional post-doctoral training at the University of Chicago. He received an MBA from Washington University Olin School of Business in 2017. He is board certified in internal medicine, pulmonary diseases, and critical care medicine.
Dr. Green continues to serve as an attending physician in the Medical Intensive Care Unit and Pulmonary Consult Service at the NIH Clinical Center and has conducted both basic science and clinical research on the regulation of the immune response. Dr Green has had a long standing interest in biomedical ethics. He had been a member of the Barnes Jewish Hospital Ethics Committee since 2000, leading the clinical ethics consultation service from 2001-2005 and serving as Chair of the Ethics Committee from 2005-2009. After joining the Washington University Institutional Review Board in 2008, he assumed the role of committee co-chair in 2009. In 2010, he was appointed Associate Dean of Human Studies and Executive Chair of the IRB at Washington University in St Louis. Dr Green served on the Secretaries Advisory Committee on Human Research Protections (SACHRP) from 2015-2018, also serving on the Subpart A subcommittee.
Jonathan E. Miller, MPPA, CIP, is the Assistant Vice President for Research Regulatory Oversight at the University of Alabama at Birmingham where he works with the Offices of the Institutional Review Board, Conflict of Interest Review Board, Institutional Animal Care and Use Committee, and the Research Safety Committees.
Job Titles:
- Director, IRBMED / University of Michigan
Job Titles:
- IRB Executive Director, HRPP Associate Director
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- Senior Director, Global Regulatory Policy at Merck
Julie Anne Zawisza is Senior Director, Global Regulatory Policy at Merck, a leading pharmaceutical company that works to bring forward medicines and vaccines for many of the world's most challenging diseases. Prior to serving in her current role, Ms. Zawisza was Global Head of Regulatory Policy and Intelligence with Baxalta, a biotechnology company focused on rare diseases. Ms. Zawisza previously served in a variety of roles at FDA including Associate Director for External Relations at the Center for Device Evaluation and Research, Senior Advisor, Global Regulatory Policy, Director of the Center for Drug Evaluation and Research's Office of Communications, and Assistant Commissioner for Public Affairs.
Ms. Zawisza holds an undergraduate degree in medical technology from the University of Michigan, a master's degree in Science, Technology and Public Policy from The George Washington University, and a certificate in public health from Georgetown University.
Job Titles:
- Assistant Vice President / University of Maryland, Baltimore
Kate Vulakovich is Director of Operations at AAHRPP. Ms. Vulakovich oversees accreditation operations, and provides process support for organizations, site visitors, and members of the Council on Accreditation. Prior to joining AAHRPP in 2017, Kate spent over a decade in academia in research administration where she conducted and provided research support for researchers conducting high risk clinical trials in the perioperative setting. She eventually managed and directed a large clinical trials program that spanned several academic departments with a large portfolio of sponsored research projects under a variety of funding mechanisms. She was also significantly involved with several quality assurance projects, which led to education, training, and monitoring of her staff and hospital clinical staff.
It was through her work with research subjects that Kate came to appreciate the value of AAHRPP accreditation on human research protection programs. She holds a Bachelor of Science and is certified by the Society of Clinical Research Associates (SOCRA) as a certified clinical research professional. Ms. Vulakovich has co-authored and published several articles in peer reviewed journals.
Job Titles:
- Associate Vice President for Human Subject Protection / University of Rochester
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- Director, Human Subject Research Office / University of Miami
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- Assistant Vice President for Research / University of Texas Health San Antonio
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- Executive Director for HRPP / Case Western Reserve University
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- Senior Director, Office of the Human Research Protection Program ( OHRPP ) University of California
Kristin Rochford, EdD, MPH, CIP is the Senior Director for The Office of the Human Research Protection Program (OHRPP) at the University of California Los Angeles. She received her B.A. from Boston University, her Master's in Public Health from UCLA and her Doctorate in Higher Education Leadership from the University of Southern California.
Kristin serves Chair of the Council on Accreditation, site visitor, and Step 1 reviewer for the Association for the Accreditation of Human Research Protection Programs (AAHRPP). She was also the recipient of the 2016 Distinguished Site Visitor Award for AAHRPP.
Job Titles:
- Director, Office of Regulatory Affairs and Research Compliance / Harvard T.H. Chan School of Public Health
Linda Coleman is the Director, Human Research Protection Program at Yale University. Before joining Yale in 2016, Ms. Coleman held several positions at Quorum Review an independent IRB and consulting company acquired by Advarra in 2019. (She was Vice President of Legal & Regulatory Affairs in 2016, Director of Regulatory Affairs & General Counsel from 2011-2016, and Director of Regulatory Affairs from 2007-2011). Prior to Quorum, Ms. Coleman was an attorney at Bennett, Bigelow & Leedom where her practice focused on health and employment law including Medicare and Medicaid reimbursement, litigation, transactional, and behavioral health.
Ms. Coleman is actively involved with several organizations. Some of her areas of involvement include the following: IRB harmonization; return of research results; diversity, equity, and inclusion in research; decentralized clinical trials; common rule and sIRB implementation strategies; research data protection; clinical trial process improvement; research quality and compliance; and the use of technology in research. She is also a frequent presenter on a variety of topics such as operations management, research integrity, good clinical practice, research oversight, the operationalization of regulatory and institutional requirements pertaining to research, and global bioethics. In 2019, Ms. Coleman was appointed as a member to the Secretary's Advisory Committee on Human Research Protection (SACHRP) and SACHRP's Subpart A Subcommittee (SAS) where she evaluates and provides recommendations on current issues related to human subjects research.
In addition to her work in human research protection, Ms. Coleman has been actively involved in the area of education access through her work as the Executive Director and Founder of Education Access Network, a nonprofit organization dedicated to providing students with limited financial resources with free and low cost access to courses and programs aimed at helping students prepare for and succeed in higher education and other career endeavors.
Job Titles:
- Executive Director, Office of Research Integrity and Compliance / University of New Mexico
Job Titles:
- Director of Administration
Lori Kravchick joined AAHRPP in January of 2018 and serves as the Director of Administration. Her responsibilities include planning and executing AAHRPP's Annual Conference and ongoing webinars, managing the Human Resources division, coordinating vendor relationships, and operationalizing AAHRPP's administrative strategic plan. Prior to AAHRPP, Ms. Kravchick managed a small telecommunications office for 14 years.
Before her office management roles, Lori managed several marketing, sales, and customer service teams in various industries. She sold yellow page advertising, recruitment advertising, and sponsored inserts in financial and health newsletters. Ms. Kravchick ended her sales/marketing career in the student loan industry where she trained and managed a special sales team designed to upsell and cross-sell additional products and services to callers/clients.
Job Titles:
- Research Integrity Manager / Children 's Hospital of Wisconsin
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- Vice President, Human Research Affairs / Mass General Brigham Incorporated
- Vice President, Human Research Affairs Mass General Brigham
Martha F. Jones, MA, CIP, is Vice President, Human Research Affairs at Mass General Brigham. Ms. Jones is a past Chair of the Council on Accreditation of the Association for the Accreditation of Human Research Protection Programs (AAAHRP) and serves as a site visit team leader for the organization. In 2017, she received the AAHRPP Distinguished Team Leader Award. Ms. Jones is a member of the Public Responsibility in Medicine & Research (PRIM&R) Board of Directors. She co-leads the National Comprehensive Cancer Centers (NCCN) IRB Directors group and is also a member of the SMART IRB Harmonization Steering Committee. Martha is a member of the Mass General Hospital Chelsea Community Research Advisory Board.
Ms. Jones previously worked at Washington University in St. Louis and The University of Iowa in research and administration roles. She has a background in clinical research ethics, epidemiology, biostatistics, speech pathology, audiology, public health, and the coordination of multicenter research studies. Martha co-developed a research application and data management system currently used at two large academic research institutions.
Job Titles:
- Vice President, Research Compliance & Regulatory Affairs / Children 's Hospital of Philadelphia
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- Associate Dean, Human Research Protections & Director of the Human Research Protections Program / Johns Hopkins University School of Medicine
- Director of Central
Megan Kasimatis Singleton, JD, MBE, CIP is Associate Dean for Human Research Protections and Director of the Human Research Protection Program at Johns Hopkins University School of Medicine. In this role she is responsible for oversight and direction of JHM's 8 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.
In addition to her role in leading the Johns Hopkins Medicine HRPP, Megan serves as the director of central IRB (CIRB) activities for the Johns Hopkins/Tufts Trial Innovation Center (TIC), leading the charge for innovations in operationalizing single IRB (sIRB) review. She serves as Vice Chair of the AAHRPP Council on Accreditation, and is an AAHRPP site visitor. Ms. Singleton serves as a member of the SMART IRB Harmonization Steering Committee, co-chair of the PRIM&R Advancing Ethical Research Conference Workshop/Didactic Subcommittee and member of the PRIM&R Board of Directors. She is also a member of the Steering Committee for AEREO, a consortium designed to advance effective research ethics oversight through empirical research.
Job Titles:
- Senior Operations Coordinator
Melinda Renuart is a Senior Operations Coordinator at AAHRPP. She joined AAHRPP in November of 2021. In her role, Melinda assists with accreditation operations and provides support to organizations, site visitors, and members of AAHRPP's Council on Accreditation. Her facilitation ensures that documents are assembled and processed according to AAHRPP's requirements.
Before joining AAHRPP, Ms. Renuart worked at a not-for-profit in volunteer outreach management, as well as in youth development at a social enterprise. She graduated from Princeton University in 2018 with a Bachelor's degree in English.
Job Titles:
- Associate Vice Chancellor for Research Research, Innovation and Impact / University of Missouri
As a member of AAHRPP's senior management team, Michelle Feige assists the President and CEO of AAHRPP by providing strategic and substantive contributions to all aspects of AAHRPP's operations. Prior to joining AAHRPP, she spent eight years as the Senior Public Health Advisor in the Division of Education and Development at the Office for Human Research Protections (OHRP). At OHRP, Ms. Feige provided the research community with guidance and education regarding the Department of Health and Human Services' regulations for the protection of human subjects through presentations and quality improvement activities.
Ms. Feige also worked for eight years in the Office of the Clinical Director at the National Institute of Mental Health (NIMH). She was a founding member of a group of senior clinicians who started a novel program at NIMH designed to protect research subjects with severe psychiatric illnesses. Before joining NIH, Ms. Feige spent several years as a study coordinator conducting psychiatric clinical trials at Georgetown University Hospital. Ms. Feige received her MSW from the University of Michigan and her BA from the University of Wisconsin.
Job Titles:
- Assistant Vice President for Research, Office of Research Support & Compliance / University of Texas at Austin
Job Titles:
- Executive Director of Research Integrity
Monika Markowitz has retired as the Executive Director of Research Integrity and Ethics in the Office of the Vice President for Research and Innovation at Virginia Commonwealth University (VCU) in Richmond, Virginia. Monika directed the Research Conflict of Interests Program and chaired the Conflict of Interests Committee. She was the VCU Research Integrity Officer. Monika was a research ethics consultant and also directed the Responsible Conduct of Research program at VCU. She was involved with Public Responsibility in Medicine and Research (PRIM&R) initiatives, including At Your Doorstep programs, E-ROC, and IRB Management and Function, 3rd edition.
Monika is faculty with the Association for the Accreditation of Human Research Protection Programs (AAHRPP), the AAMC Forum on Conflict of Interests in Academe (FOCI-A), the Association for Research Integrity Officers (ARIO), and the Virginia IRB Consortium. Monika is a former two term member of the AAMC Forum on Conflict of Interest in Academe Steering Committee. She serves as an AAHRPP accreditation site visitor and is a member of the AAHRPP Council on Accreditation. Monika chairs the ARIO Communications Committee. She co-chaired the SMART IRB COI Harmonization Working Group.
Job Titles:
- Member / Professor of Social Sciences and Health Policy
- Professor
Nancy M P King is Professor in the Department of Social Sciences and Health Policy and Wake Forest Institute for Regenerative Medicine at Wake Forest University School of Medicine, and Co-Director of the Center for Bioethics, Health, and Society and the Bioethics Graduate Program at Wake Forest University. Her scholarship addresses a range of bioethics issues, including: informed consent, benefit, and uncertainty in health care and research; the development and use of novel experimental biotechnologies; international and cross-cultural questions in human subjects research; and equity and justice in health care and research.
Professor King has published over 100 scholarly articles and book chapters, and is co-editor of The Social Medicine Reader (3rd ed., Duke University Press, 2019), Beyond Regulations: Ethics in Human Subjects Research (UNC Press 1999), and Bioethics, Public Moral Argument, and Social Responsibility (Routledge 2012). Her new book, Bioethics: A Path Forward, coauthored with Larry R. Churchill and Gail E. Henderson, will be published by UNC Press in 2022. Professor King teaches a variety of courses in bioethics, medical humanities, and research ethics to medical students and faculty and to graduate students in bioethics and the health sciences, and has taught bioethics in national and international settings. She is a fellow of the Hastings Center, and has served on hospital ethics committees, IRBs, DSMBs, the NIH Recombinant DNA Advisory Committee, and the DHHS Secretary's Advisory Committee for Human Research Protections.
Job Titles:
- Senior Advisor for Strategic Initiatives
Nichelle Cobb is the Senior Advisor for Strategic Initiatives for AAHRPP and was previously a site visitor for AAHRPP and member of AAHRPP's Council on Accreditation. Prior to joining AAHRPP, she was the Director of the Health Sciences Institutional Review Boards (IRBs) for 16 years at the University of Wisconsin-Madison and has worked with IRBs for more than 20 years.
Nichelle has been involved in single IRB work for more than a decade and was instrumental in the development of the SMART IRB Master Reliance Agreement and served as a Senior Advisor and Ambassador for SMART IRB, a federally funded project that supports the implementation of single IRB. In addition, Nichelle is a member of the SMART IRB Harmonization Steering Committee and has co-led working groups to harmonize IRB and Human Research Protection Program (HRPP) practices, such as reportable events, ancillary reviews, continuing review, and local context. Nichelle also has been a member and co-chair of the Workshop and Didactic Subcommittee for the Public Responsibility in Medicine and Research (PRIM&R) annual Advancing Ethics in Research Conference, contributed to IRB Management and Function, 3rd Edition, and has taught PRIM&R courses for new IRB administrators.
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- Associate Director, Office of Research Integrity / University of Kentucky
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- Senior Director / University of Michigan
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- Assistant Vice President, Research Compliance / State University of New York
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- Director, Human Research Oversight, Office of Research Compliance and Regulatory Affairs / Cincinnati Children 's Hospital
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- Professor of Pediatrics, IRB Chair
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- Director of Accreditation and Global Outreach
Robert Hood is AAHRPP's Director of Accreditation and Global Outreach. In this role, Dr. Hood engages with stakeholders to ensure AAHRPP Accreditation Standards are consistent with evolving research ethics guidelines, laws, and professional practice standards. He establishes and maintains relationships with organizations to help them realize the benefits of AAHRPP's peer-review process for improving the quality, efficiency, and effectiveness of their HRPPs.
Dr. Hood has a background in applied ethics and has worked in academia, government, and not-for-profit organizations. He has served as an IRB chair, and managed the HRPP at the Florida Department of Health, the first public health agency to obtain accreditation. He has implemented public health ethics programs, and chaired a public health ethics advisory committee at the Centers for Disease Control and Prevention. Prior to this, he was Associate Professor of Philosophy (with tenure) at Middle Tennessee State University.
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- Chief Compliance Officer, Department of Legal Affairs / Utah State University
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- IRB Secretary / IRB Analyst / Samsung Medical Center
Job Titles:
- Chairman
- Executive Director
Stephen Rosenfeld is a hematologist who earned his medical degree from Cornell. He trained in internal medicine at Dartmouth and completed his hematology fellowship at the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH). He spent 19 years at NIH, holding positions at NHLBI and the NIH Clinical Center, doing both basic and clinical research, and finally working in medical informatics and administration. He ended his time at the NIH as the Chief Information Officer of the Clinical Center.
Dr. Rosenfeld moved from Bethesda, Maryland to Portland, Maine, where he was the CIO of MaineHealth, a large independent delivery network, before moving to Olympia, Washington as the CEO of the Western Institutional Review Board (WIRB) and then the Executive Board Chair of Quorum Review, a position he held until 2019. In addition to his medical degree, he holds a Master's in Business Administration from Georgetown. Dr. Rosenfeld received the honor of Distinguished Professor of Medicine from Daegu Catholic University Medical Center in Korea in 2013. In July 2013, he was appointed to the Secretary's Advisory Committee on Human Research Protections (SACHRP) and in 2016 he was appointed Chair of SACHRP, and served in that role until 2021. In 2019 he joined the board of the Association for Accreditation of Human Research Protection Programs (AAHRPP).
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- Associate Vice President, Research Compliance / the University of Texas Health Science Center
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- Consultant, IRB for Health Sciences Research / University of Virginia
Tracy Harmon Blumenfeld is a creative, experienced entrepreneur and health care executive with extensive experience helping life science companies, patient advocacy organizations, and health care institutions build and deploy networks of health care and clinical research professionals and organizations to accelerate clinical trials. Prior to starting her own companies, Ms. Blumenfeld worked for Baxter Healthcare, Booz Allen Hamilton, Parexel International, and as a consolidator of physical, occupational, and speech therapy services. Ms. Blumenfeld earned her MBA from Harvard Business School and her BA in economics from Northwestern University.
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- Interim Vice Chancellor for Research / the University of Tennessee Health Science Center
Wesley G. Byerly, Pharm.D, CIP is the Interim Vice Chancellor for Research for The University of Tennessee Health Science Center. Dr. Byerly is responsible for research compliance across both the academic and health sciences campuses, including the animal care and use program, human subject protections program, clinical trials billing, biosafety, stem cell research, financial conflict of interest, research integrity, export control, and environmental health and safety, to ensure the responsible conduct of research and compliance with applicable federal and state regulations.
Wesley is a certified IRB Professional through PRIM&R, maintains an active pharmacy license and holds an appointment as Associate Research Professor in the Department of Pharmacy Practice.