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
As 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 member 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
Dr. Robert Hood serves as Director of Accreditation 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.
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.