Speakers:
Elyse Summers, JD
President and CEO
AAHRPP
Michelle Feige, MSW, LCSW-C
Executive Vice-President
AAHRPP
Topic: Building a Robust HRPP and Changes to AAHRPP Guidelines following the new Common Rule
Session Time: 11.30am
Session Objectives:
• Describe features of a strong HRPP
• Overview the Guideline Review Process triggered by the new Common Rule
• Discuss AAHRPP's approach to amending Guidelines
• Outline proposed Guidelines changes and areas where more review is being undertaken
Speaker Bio:
Elyse Summers, JD, 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.
Speaker Bio:
Michelle Feige, MSW, is the Executive Vice-President of AAHRPP. 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.
Speaker Contact Details:
(202) 783-1112
Washington DC 20015
Speaker Contact Details:
(202) 783-1112
Washington DC 20015