Elyse I. Summers, JD, President and CEO
Ms. 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.
Michelle Feige, MSW, LCSW-C, Executive Vice-President
a member of AAHRPP's senior management team, Ms. 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.
Harry C. Frazier, CFO
As a memb
er of AAHRPP's senior staff, Mr. 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. Mr. Frazier 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, Mr. Frazier 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.
Robert Hood, PhD, Director of Accreditation and Global Outreach
Dr. Robert Hood serves as Director of Accreditation and Global Outreach at AAHRPP, ensuring that the AAHRPP Accreditation Standards are consistent with evolving research ethics guidelines, laws and professional practice standards in the U.S. and internationally, and providing education and support for site visitors and
clients seeking accreditation. Dr. Hood provides substantive and process support for organizations seeking accreditation, including more than 40 organizations outside the US. Dr. Hood is a bioethicist with experience in academia, government,
and not-for-profit organizations. He has served as an IRB chair, and directed 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.
Nichelle Cobb,PhD, Senior Advisor for Strategic Initiatives
Nichelle Cobb, PhD served as the Director of the Health Sciences Institutional Review Boards
(IRBs) at the University of Wisconsin-Madison for 16 years and has worked with IRBs since 1999. Currently, she is the Senior Advisor for Strategic Initiatives at AAHRPP and the Director of Operations for SMART IRB. Prior to joining AAHRPP, Dr. Cobb
was the Human Subjects Protection Officer for the Institute for Clinical & Translational Research at the University of Wisconsin-Madison. Since 2007 she has been involved in the formation of several statewide and regional IRB consortia.
Her SMART IRB work involves developing resources and providing educational materials to help institutions transition to single IRB review. In addition, Nichelle serves as a member of the SMART IRB Harmonization Steering Committee and participates
in working groups that develop harmonized approaches for key human subjects issues. Nichelle was also an AAHRPP Council Member and site visitor.
Kate Vulakovich, CCRP, Director of Operations
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, she 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, including but not limited to FDA and NIH. She was also significantly involved with several quality assurance
projects, which lead to education, training, and monitoring of her staff and hospital clinical staff. It was through her work with research subjects that she 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.
Lori Kravchick, Director of Administration
Lori Kravchick joined AAHRPP in January 2018. Her
responsibilities include planning and executing AAHRPP’s Annual Conference and quarterly 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, Ms. Kravchick 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.
Mary Fields, CIP, Quality Assurance Manager
Mary Fields, CIP, joined AAHRPP in March 2019 as Quality Assurance Manager. In her role, Ms. Fields participates
in the creation, review, and revision of policies and procedures and ensures they are rigorously adhered to within AAHRPP. She assists in establishing the quality policies, goals, and metrics for AAHRPP. Ms. Fields ensures the timely execution while
preserving the high quality and professionalism of the accreditation operation, including receipt of accreditation materials from clients, processing of applications, correspondence to clients, site visits, and activities of the Council on Accreditation.
Ms. Fields tracks activities involved in the accreditation operation to ensure staff meet assigned deadlines and provides a quality assurance review of all documents associated with the accreditation process. Prior to joining AAHRPP, Ms. Fields had
20 years of experience with a variety of programs at the U.S. Department of Energy (DOE), most recently serving as the Program Manager for the DOE Former Worker Medical Screening Program. She also served as a member of the Central DOE IRB Management
Team, overseeing and funding the Board. She continues to serve as an unaffiliated member of the DOE Classified Central IRB. Ms. Fields received a degree in Psychology from the University of Maryland College Park.
Jemelle Williams, Senior Operations Coordinator
Jemelle Williams joined AAHRPP in October 2018. As the Senior Operations Coordinator, she processes applications and provides process support for organizations
and site visitors. In her role, Ms. Williams assists with the site visits process from start to finish. Prior to joining AAHRPP, Ms. Williams had 10 years of experience as a Project Manager. Ms. Williams received a degree in Psychology
from the Renssealaer Polytechnic Institute.
Dominique Hunter, BS, MS, Senior Operations Coordinator
Hunter, BS, MS, joined AAHRPP in November 2018. Ms. Hunter assists with the accreditation operations, and facilitates processes that support organizations, site visitors, and members of the Council on Accreditation. Her support ensures that documents
are assembled and processed according to AAHRPP’s requirement. Ms. Hunter’s attentive processing support is contributed to over 80 percent of the submissions from clients at AAHRPP. Her high-quality organizational skills ensure clients
are meeting their milestones in the accreditation process. Prior to AAHRPP, Ms. Hunter studied and received her bachelor’s degree in Multimedia Journalism and Communications at Morgan State University. Most recently, she received a master’s
degree in Management - Marketing from the University of Maryland Global Campus
Danielle Randolph, Marketing and Operations Coordinator
Danielle Randolph joined AAHRPP in January of 2019. Ms. Randolph helps coordinate daily accreditation activities and prepare for quarterly Council on Accreditation meetings. In addition, Danielle plans events throughout the year, such as webinars
and the annual conference. She creates and maintains the registration system and provides technical help to AAHRPP staff, participants, speakers and exhibitors. In addition, Ms. Randolph assists senior management and the operations team with
daily activities and site visit preparation. Before AAHRPP, Ms. Randolph 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.