Speakers and Panelists

Pearl O’Rourke, MD

Pearl is retired from Partners HealthCare, where since 2001 she served as Director of the Human Research Protection Program with responsibility for the system of human subject protections for over 9,000 protocols conducted by investigators at Partners hospitals.  She was also the chairman of the ESCRO Committee. 

Trained in pediatric critical care she worked as a pediatric critical care physician at the Children's Hospital, Boston and at the Children’s Hospital, University of Washington in Seattle.  At both institutions she was also the director of Extracorporeal Membrane Oxygenation (ECMO) Program.

In 1995–1996, Dr. O’Rourke was a Robert Wood Johnson Health Policy fellow and worked for Senator Edward Kennedy: following this fellowship, she became the Deputy Director of the Office of Science Policy in the Office of the Director at the NIH where she worked on issues such as privacy, gene therapy (transfer) embryonic stem cells and genetic discrimination.

She remains an Associate Professor of Pediatrics at Harvard Medical School where she is active in teaching research ethics.  She is a co-director of the Ethics and Regulatory Core for the NIH Pragmatic Trials Collaboratory and is also the board chair for an Equine Center in Connecticut.

Elyse I. Summers, J.D., President and CEO

Association for the Accreditation of Human Research Protection Programs, Inc.© (AAHRPP)

Ms. Summers has been AAHRPP's President and CEO since 2013.  She provides strategic and substantive leadership and oversight on all aspects of AAHRPP's operations and has enjoyed leading AAHRPP well into the 21st century as the indispensable global organization for the accreditation of human research protection programs.

Prior to joining AAHRPP, Ms. Summers was the Director of the Division of Education and Development at the Office for Human Research Protections, from January 2008 – August 2013. Ms. Summers began working for OHRP and its predecessor, the Office for Protection Research Risks (OPRR), in 1998, in the Division of Compliance Oversight before moving to the Division of Education.  Before serving the federal government at OPRR/OHRP, Ms. Summers practiced law pertaining to food, drugs, and other medical products.  She offered guidance and counseling on Federal regulations and ethical issues related to the conduct of biomedical research, at the law firm of Buc & Beardsley.  Ms. Summers spent five years during the mid-1990s in the Office of the Commissioner at FDA, as Special Assistant to the Deputy Commissioner for External Affairs, and later as one of the creators and 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 (at respectively, Baker Hostetler and Steptoe and Johnson), and has spoken and written on that topic as well.  At the start of her professional career, Ms. Summers represented research universities at the Association of American Universities.  She earned her J.D. from the George Washington University National Law Center and her A.B. from the University of Michigan.  She is a member of the Bar of the District of Columbia and of the Commonwealth of Pennsylvania.

Nichelle Cobb

Dr. Cobb is the senior advisor for strategic initiatives for the Association for the Accreditation of Human Research Protection Programs and 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 for 16 years at the University of Wisconsin-Madison and has worked with IRBs for 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 serves as a senior advisor and ambassador for SMART IRB, a federally funded project that supports the implementation of single IRB. In addition, Dr. Cobb is a member of the SMART IRB harmonization steering committee and has co-led working groups to harmonize IRB and Human Research Protection Program practices, such as for reportable events, ancillary reviews, continuing review, and local context. Dr. Cobb also has been a member and co-chair of the Workshop and Didactic Subcommittee for the Public Responsibility in Medicine and Research annual Advancing Ethics in Research Conference, contributed to the third edition of "IRB Management and Function," authored academic articles on single IRB and informed consent, and developed and taught PRIM&R courses for new IRB administrators and about the common rule.