FINAL_DC_DoH_SpeakersAndAgenda

1
North American
Regional Meeting
on the Declaration
of Helsinki
Aug. 15–16
Westin Washington, D.C.
City Center
2
Thursday, Aug. 15
7:30–8:30 a.m. Breakfast buffet available
National C and West
8–9:30 a.m. Registration
National Ballroom Foyer
9–9:20 a.m. Opening remarks
National Ballroom
Lujain Alqodmani, MD, president, World Medical Association
Robert M. Califf, MD, commissioner, food and drug administration
(remote)
9:20–10 a.m. The proposed revision: A review
Jack Resneck Jr., MD, chair, Declaration of Helsinki (DoH)
Revision Workgroup
10–10:30 a.m. Break
10:30 a.m.–
2:30 p.m.
The proposed revision: Challenges and changes
Description: This extended session will feature four parts showcasing
expert perspectives on a prominent topic of the DoH revision.
10:30 a.m.–
noon
Challenges and changes: Focus Session Part 1,
Vulnerability, community engagement and global
justice (panel presentation)
SPEAKERS
Lainie Ross, MD, PhD, dean, chair and professor, University of Rochester
Nancy Kass, ScD, Phoebe R. Berman Professor of Bioethics and
Public Health, Johns Hopkins University
RESPONDENT
Noon–1 p.m. Buffet lunch for all attendees
National Ballroom C and West
1–1:30 p.m. Challenges and changes: Part 2, Data research
and privacy
SPEAKER
Jay Shaw, PT, PhD, research director, AI, Ethics & Health,
University of Toronto
RESPONDENT
Kayte Spector-Bagdady, JD, MBe, interim co-director, Center for Bioethics
and Social Sciences in Medicine, University of Michigan
Agenda
3
1:30–2 p.m. Challenges and changes: Part 3, Public health
emergencies and compassionate use
SPEAKER
Arthur Caplan, PhD, Mitty Professor of Bioethics, New York University (via
Zoom)
RESPONDENT
Jonathan Moreno, PhD, Silfen Professor of Ethics, University of
Pennsylvania
2–2:30 p.m. Challenges and changes: Part 4, Scientific and
social value
SPEAKER
Gustavo Ortiz Millán, PhD, Universidad Autónoma de México
RESPONDENT
Barbara Bierer, MD, Multi-Regional Trials Center, Brigham and Women’s
Hospital, Harvard
2:30–3 p.m. Break
3–4:15 p.m. Health research ethics across North America
Description: This session represents researchers, ethics committee
members and patient advocates from different geographies across North
America. Each panelist will discuss what ethical guidance and protections
they find particularly helpful, what issues they continue to struggle with,
and where the health research ethics efforts are needed next. If applicable,
speakers will consider these topics through the DoH: what aspects of the
DoH have been particularly relevant or helpful to their work; what proposed
DoH revisions are they pleased to see; what challenges do they foresee in
implementing and interpreting the DoH; and how could future iterations of
the DoH continue to further develop ethical guidance.
MODERATOR
Amber Comer, PhD, JD, director, Ethics Policy, American Medical Association
SPEAKERS
Patricio J. S. Doherty, head, National Bioethics Committee of Mexico
Missy Heidelberg, BS, MBE, global bioethics lead, Takeda Pharmaceuticals
Peter Pronovost, MD, PhD, chief quality and clinical transformation officer,
University Hospitals, Cleveland
Susan Marlin, president and CEO, Clinical Trials Ontario
4:15–4:30 p.m. Closing remarks
Jack Resneck Jr., MD, chair, Declaration of Helsinki Revision Workgroup
6 p.m. Reception for all attendees
National Academy of Sciences—bus transportation will be provided
7 p.m. Monuments by Moonlight Walking Tour
For those who registered, tour will leave from the National Academy of
Sciences and return to the Academy at 8:45 p.m. for transportation back to
the hotel.
4
Friday, Aug. 16
8–9 a.m. Breakfast buffet available
National Ballroom West and C
8 a.m. Registration available
National Ballroom Foyer
9–9:15 a.m. Opening Remarks
Bruce Scott, MD, president, American Medical Association
Major General (ret.) Paul Friedrichs, MD, director, Office of Pandemic
Preparedness and Response Policy
9:15–10:15 a.m. The U.S. government and health research ethics
Description:This educational learning panel will provide a window into
how the U.S. government approaches health research ethics. Each panelist
will address their agency’s unique role and responsibilities in helping to set
and implement ethical standards, as well as how the three agencies work
together to do so. Speakers can also address what ethical issues have been
particularly important to the U.S. government, both recently and historically,
and what ethical issues will be increasingly poignant in the future.
MODERATOR
Bruce Scott, MD, president, American Medical Association
SPEAKERS
Julie Kaneshiro, MA, acting director, Office for Human Research
Protections, U.S. Dept. of Health and Human Services
Hilary Marston, MD, MPH, chief medical officer, U.S. Food and Drug
Administration
Adam Berger, PhD, division director, Clinical and Healthcare Research
Policy, Office of Science Policy, Office of the Director, National Institutes of
Health
10:15–10:45a.m. Break
5
10:45–11:45 a.m. Maximizing impact: Communications, advocacy and
implementation
Description: This session will focus on next steps to increase awareness and
implementation of the revised DoH. Topics will include: 1) coordination with
partners and aligning other guidelines, such as the Council for International
Organizations of Medical Sciences’International Ethical Guidelines for
Health-related Research Involving Humans; 2) communicating with
research participants and patients; and 3) the approach and experience of
countries that have adopted the DoH as codified law.
MODERATOR
Lujain Alqodmani, MD, president, World Medical Association
SPEAKERS
Otmar Kloiber, MD, secretary-general, World Medical Association
Hans Van Delden, professor, University Medical Center
Lara Bloom, board member, International Alliance of Patient Organizations
Chieko Kurihara, BA, ethics working group, International Federation of
Associations of Pharmaceutical Physicians
11:45 a.m.–noon Closing remarks
Jack Resneck Jr., MD, chair, Declaration of Helsinki Revision Workgroup
Noon–1 p.m. Buffet lunch for all attendees
National Ballroom C and West
2:15 p.m. Optional visit to the National African American Museum
of History and Culture
1400 Constitution Ave.
AMA has secured 75 tickets for a 2:15 p.m. entry.
6
Lujain Alqodmani, MD
President
World Medical Association
Dr. Lujain Alqodmani, a global health and medical professional, currently holds
the prestigious position of President at the World Medical Association (WMA) for
the term 2023-2024. Renowned for her leadership, she spearheads the WMA’s
initiatives, advocating for global healthcare excellence and ethical medical
practices worldwide.
Alongside her role as WMA President, Lujain serves as the Director of Global
Action and Project Portfolio at EAT, leveraging her expertise to steer the
implementation of strategic goals and oversee impactful projects at EAT.
Previously, Dr. Alqodmani contributed significantly to various health sectors.
Her experiences range from serving as an emergency physician in Kuwait to
holding vital roles such as the co-chair of the WMA Environment Caucus and the
International Relations Director at Kuwait Medical Association. Moreover, she held
influential positions at Women in Global Health and the International Federation
of Medical Students’Associations (IFMSA), where she represented the Eastern
Mediterranean Region and led crucial internal affairs portfolios.
With a medical degree from Kuwait University and a Master’s in international
healthcare management, economics, and policy from SDA Bocconi, Lujain
Alqodmani remains dedicated to elevating healthcare standards worldwide.
7
Adam Berger, PhD
Division Director
Clinical and Healthcare Research Policy
Office of Science Policy
Office of the Director, National Institutes of Health
Adam Berger is the Director of the Division of Clinical and Healthcare Research
Policy at the NIH Office of Science Policy, Office of the Director. In this role, Adam
oversees a wide range of policy issues related to clinical trials, biospecimen
research, privacy, bioethics and human research participant protections, and
translation of biomedical discoveries. Prior to joining NIH, Adam was part of
the personalized medicine staff at the FDA where he addressed a wide range
of policy and regulatory issues related to precision medicine, next generation
sequencing, real world evidence, and digital health.
Adam also previously served as a Senior Fellow to the Secretary of Health and
Human Services, overseeing the development and implementation of the
Precision Medicine Initiative (PMI). In this role, he served as the main liaison
between and representative of HHS to the White House and other United States
Government Departments involved in the PMI. Prior to working in government,
Adam was a Senior Program Officer and Director of the Roundtable on
Translating Genomic-Based Research for Health in the Board on Health Sciences
Policy at the Institute of Medicine, now the National Academy of Medicine.
Adam received his doctorate from Emory University in Biochemistry, Cell and
Developmental Biology and his B.S. in Molecular Genetics from The Ohio State
University. He completed his postdoctoral training at the National Cancer
Institute of the NIH.
8
Barbara E. Bierer, MD
Professor of Medicine
Harvard Medical School
Barbara E. Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at
Harvard Medical School and the Brigham and Women’s Hospital (BWH). Dr.
Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of
BWH and Harvard (MRCT Center, www.mrctcenter.org), a collaborative effort to
improve standards for the planning and conduct of international clinical trials to
harmonize policies for and approaches to clinical trial regulation. In addition, she
is the Director of the Regulatory Foundations, Ethics, and the Law program at the
Harvard Clinical and Translational Science Center. She is the Director and PI of
SMART IRB (www.SMARTIRB.org), a national effort to align single site IRB review of
multi-site trials. She serves as Faculty in the Center for Bioethics, Harvard Medical
School, and as Affiliate Faculty in the Petrie-Flom Center for Health Law Policy,
Biotechnology, and Bioethics at Harvard Law School. From 2003 – 2014, Dr. Bierer
served as Senior Vice-President, Research at the Brigham and Women’s Hospital
(BWH). During her tenure, Dr. Bierer founded and served as Executive Sponsor of
the Brigham Research Institute and the Brigham Innovation Hub (iHub), a focus
for entrepreneurship and innovation in healthcare. She has authored over 300
publications.
Dr. Bierer received a B.S. from Yale University and an M.D. from
Harvard Medical School.
9
Robert M. Califf, MD
Commissioner of Food and Drugs
U.S. Food and Drug Administration (FDA)
Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs.
As Commissioner, Dr. Califf oversees the full breadth of the FDA portfolio and
execution of the Federal Food, Drug, and Cosmetic Act and other applicable
laws. This includes assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human use, and
medical devices; the safety and security of our nation’s food supply, cosmetics,
dietary supplements, products that give off electronic radiation; and the
regulation of tobacco products.
Dr. Califf has had a long and distinguished career as a physician, researcher, and
leader in the fields of science and medicine. He is a nationally recognized expert
in cardiovascular medicine, health outcomes research, health care quality, and
clinical research, and a leader in the growing field of translational research, which
is key to ensuring that advances in science translate into medical care.
This is Dr. Califf’s second stint as Commissioner. He also served in 2016 as the
22nd Commissioner. Before assuming the position at that time, he served as the
FDA’s Deputy Commissioner for Medical Products and Tobacco.
Prior to rejoining the FDA in 2022, Dr. Califf was head of medical strategy and
Senior Advisor at Alphabet Inc., contributing to strategy and policy for its health
subsidiaries Verily Life Sciences and Google Health. He joined Alphabet in 2019,
after serving as a professor of medicine and vice chancellor for clinical and
translational research at Duke University. He also served as director of the Duke
Translational Medicine Institute and was the founding director of the Duke
Clinical Research Institute.
Dr. Califf is a graduate of Duke University School of Medicine. He completed a
residency in internal medicine at the University of California, San Francisco and a
fellowship in cardiology at Duke.
10
Arthur Caplan, PhD
Drs. William F and Virginia Connolly Mitty Professor Founding
Head of the Division of Medical Ethics
NYU School of Medicine
Prior to coming to NYU School of Medicine, Dr. Caplan was the Sidney D.
Caplan Professor of Bioethics at the University of Pennsylvania Perelman School
of Medicine in Philadelphia, where he created the Center for Bioethics and
the Department of Medical Ethics. Caplan has also taught at the University of
Minnesota, where he founded the Center for Biomedical Ethics, the University
of Pittsburgh, and Columbia University. He received his PhD from Columbia
University and holds eight honorary degrees from colleges, universities and
medical schools.
Caplan has served since 2015 as the co-chairperson of the Compassionate
Use Advisory Committee (CompAC), an independent group of internationally
recognized medical experts, bioethicists and patient representatives which
advises Johnson & Johnson’s Janssen Pharmaceuticals about requests for
compassionate use of some of its investigational medicines. Dr. Caplan is a
regular commentator on bioethics and health care issues for WebMD/Medscape,
WGBH radio in Boston, WOR radio in New York City and KNX-CBS radio, Los
Angeles and appears frequently as a guest and commentator on various other
national and international media outlets. Dr. Caplan is the recipient of many
awards and honors including the McGovern Medal of the American Medical
Writers Association and the Franklin Award from the City of Philadelphia. During
the Covid-19 pandemic, he co-directed an advisory group on sports and
recreation for the US Conference of Mayors, created a national working group
on coronavirus vaccine challenge studies, developed an ethical framework for
distributing drugs and vaccines for J&J, helped develop rationing policies for
NYU LMC and many other health systems, and was a member of the WHO
advisory committee on Covid, ethics and experimental drugs/vaccines. In 2024
he was honored as the mentor of the year by the NYUGSOM Department of
Population Health.
11
Amber R. Comer, PhD, JD
Director, ethics policy and secretary, Council of Ethical and Judicial Affairs
American Medical Association
Amber Comer, PhD, JD is the Director of Ethics Policy and the Secretary of the
Council of Ethical and Judicial Affairs at the American Medical Association.
Additional, Dr. Comer is an Associate Professor of Health Sciences and Medicine
at Indiana University. Dr. Comer is a bioethicists and palliative care researcher who
is an expert in medical decision making with a focus on hospitalized patients
with critical illness. Dr. Comer serves on the Board of Trustees of the International
Neuropalliative Care Society and holds an appointment on the Public Policy
Committee of the American Academy of Hospice and Palliative Medicine.
Dr. Comer has received numerous awards for her work, including named Indy’
Best and Brightest (2024), and receiving an Early Career Achievement award from
the Indiana University School of Law (2018). Her teaching has been recognized
through receipt of the Indiana University Trustees Teaching Award (2023) as
well as the Indiana University School of Health and Human Sciences Emerging
Teaching Award (2018). Dr. Comer was selected as an American Academy of
Hospice and Palliative Medicine Research Scholar (2018).
12
Patricio Santillan-Doherty
Professor, thoracic surgery and bioethics
Faculty of Medicine-UNAM (National Autonomous University of Mexico)
Head of the National Bioethics Commission
Thoracic surgeon and Head, Dep. of Experimental Surgery, National Institute
of Respiratory Diseases (1992-1997). Thoracic surgery consultant and Head
Dept of Experimental Surgery, National Institute of Medical Sciences and
Nutrition Salvador Zubiran (1997-2013). Member, secretary and president of the
Committee on Research Ethics at the National Institute of Medical Sciences and
Nutrition Salvador Zubiran (2000-2012).
Medical Director, National Institute of Respiratory Diseases. México City
(2013-2022).
Member of the National Academy of Medicine of Mexico and the Mexican
Academy of Surgery. Member of the Colegio de Bioética (past president 2015-
2021). Member of the Nationa Investigators System.
13
Major General (ret.) Paul Friedrichs, MD
Deputy assistant to the president
Director, Office of Pandemic Preparedness and
Response Policy (OPPR)
The White House
Dr. Paul Friedrichs currently serves as Deputy Assistant to the President and as
the inaugural Director of The White House Office of Pandemic Preparedness
and Response Policy. In this role, Paul coordinates U.S. government efforts to
enhance the United States and its partners’ability to prepare for and respond
to pandemics and other biological events. Paul previously served as Special
Assistant to the President and Senior Director for Global Health Security and
Biodefense at the White House National Security Council, where he coordinated
U.S. policy to detect, prevent, prepare for, and respond to, infectious diseases and
biological threats.
Paul concluded a 37-year military career by serving as the Joint Staff Surgeon
at the Pentagon, where he provided medical advice to the Chairman of the
Joint Chiefs of Staff on Department of Defense (DOD) operations and served
as the medical advisor to the DOD COVID-19 Task Force. He was also the U.S.
representative to the North Atlantic Treaty Organization’s Committee of the
Chiefs of Military Medical Services. In addition to caring for patients in combat,
Antarctica and other austere locations, he has led DOD’s global medical
evacuation system and assisted in multiple major domestic and international
responses to natural disasters and biological outbreaks, as well as multiple global
health engagements. As Chair of the Military Health System’s Joint Task Force
on High Reliability Organizations, Paul oversaw development of a roadmap to
continuously improve care for more than 9 million service members, retirees and
their dependents.
Paul received his commission at Tulane University through the Reserve Officer
Training Corps in 1986 and his Doctor of Medicine degree (M.D.) from the
Uniformed Services University in 1990. He was a Distinguished Graduate of the
National War College, where he received a Master’s Degree in Strategic Security
Studies and also received an honorary Doctorate in Science from the University
of Nebraska Medical Center. He has commanded multiple medical units, served
as an Assistant Professor of Surgery and led joint and interagency teams which
earned numerous awards. He has been awarded the Defense Distinguished
Service Medal, the Bronze Star and has been named a Chevalier in the French
Ordre National du Mérite.
14
Melissa (Missy) Heidelberg, BS, MBE
Bioethics and technology ethics lead; Digital ethics & compliance chief of staff
Takeda Pharmaceutical Company Limited
Missy is a mission-based, socially conscious biopharmaceutical bioethicist with
a passion for evolving and implementing ethical frameworks at the intersection
of bioethics, data ethics, digital/technology ethics and policy in clinical research
and drug development to benefit patients and society. She has over 20 years
of experience in drug development and believes the life sciences industry has
tremendous opportunity and responsibility to advance science for better health
while maintaining ethical obligations to patients.
At Takeda, Missy leads the strategy, evaluation, and integration of bioethics and
technology ethics into policies, positions, processes, initiatives, and consultations.
This includes chairing the Takeda Ethics Advisory Council (TEAC), which brings
together external ethics experts and internal senior leaders to develop ethical
guidance for priority topics in bioethics, technology ethics, and responsible
innovation. She represents Takeda in multiple industry and professional
associations that promote bioethics and ethical behavior in life sciences. She
also remains active in the Columbia University Bioethics Master’s Program and is
a parent representative for the International Rare Diseases Research Consortium
(IRDiRC) Task Force focusing on developing a“Framework to assess impacts
associated with diagnosis, treatment, support, and community integration”. Missy
is truly honored to be a panelist at the North American Regional Meeting on the
World Medical Association’s Declaration of Helsinki in Washington, DC.
15
Julie Kaneshiro, MA
Acting director
Officer for Human Research Protections
U.S. Department of Health and Human Services
Julie Kaneshiro is the Acting Director of the Office for Human Research
Protections (OHRP), and has been the Deputy Director of OHRP since 2014.
Her recent work has focused on the revisions to the Common Rule, ethical
and regulatory issues related to standard of care research, deceased donor
intervention research, and the ethics of mandatory research biopsies. Prior
to joining OHRP she worked at the National Institutes of Health for over ten
years and worked with the Office for Civil Rights and the Office of the Assistant
Secretary for Planning and Evaluation where she assisted in drafting the HIPAA
Privacy Rule. Ms. Kaneshiro received her undergraduate degree in English
Literature from the University of Maryland in 1991, and her graduate degree in
Public Policy with Concentrations in Philosophy and Social Policy (M.A.) from
George Washington University in 1996.
16
Nancy Kass, ScD
Phoebe R. Berman Professor of Bioethics and Public Health
Johns Hopkins University
Nancy Kass, ScD, is the Phoebe R. Berman Professor of Bioethics and Public Health
at Johns Hopkins, where she is also both the Deputy Director for Public Health in
the Berman Institute of Bioethics and Professor of Health Policy and Management
in the Johns Hopkins Bloomberg School of Public Health.
Dr. Kass conducts empirical work in bioethics and health policy. Her publications
are primarily in the field of U.S. and global research ethics, HIV/AIDS ethics policy,
public health ethics, and ethics and the learning healthcare system. From June
2023-June 2024 she served as Ethics Advisor, Office of the Commissioner, at the
Food and Drug Administration through an Intergovernmental Personnel Act
(IPA) arrangement. From 2017-2023 Dr. Kass served as Vice-Provost for Graduate
Education for Johns Hopkins University. In 2009-2010, Dr. Kass was based in
Geneva, Switzerland, working with the World Health Organization (WHO) Ethics
Review Committee Secretariat. Dr. Kass is an elected member of the National
Academy of Medicine and an elected fellow of the Hastings Center.
17
Otmar Kloiber, MD
Secretary general
World Medical Association
Dr Otmar Kloiber was appointed as Secretary General of the World Medical
Association (WMA) in February 2005. Before joining the WMA, Dr Kloiber
served as Deputy Secretary General of the German Medical Association. As
WMA Secretary General, he is the head of its Secretariat and is responsible
for managing and directing the WMA staff and the activities of the WMA. He
provides overall leadership and strategic direction to the organisation and
represents the WMA to the Association’s members, the medical profession,
the international community, representatives of government, the business
community, and the public.
18
Chieko Kurihara, BA
Specially appointed professor
Kanagawa Dental University
Chieko Kurihara, BA, Ethics Working Group of the International Federation of
Pharmaceutical Physicians and Pharmaceutical Medicines Development (IFAPP);
Specially appointed Professor at Kanagawa Dental University; and Vice-Chair
of the Certified Review Board/Senior Researcher at the National Institutes for
Quantum Science and Technology, Japan. Editor of a Japanese medical journal
Clinical Evaluation; a founding co-representative of the Center for Bioethics
Policy Study, a non-profit academic study group. After graduation from the
Department of Economics, School of Political Science and Economics, Waseda
University in 1983, she has been engaged in journalistic and artistic works, and
then in bioethics, especially focusing on research ethics. Not only Task Groups
on GCP regulations designated by the Ministry of Health, Labour and Welfare,
Japan, she has been engaged in developing international ethics documents and
literatures as a member of several Task Groups of the International Commission
of Radiological Protection (ICRP), as well as Ethics Working Group of the IFAPP.
Since the time of the 2000 revision of the Declaration of Helsinki (DoH), she
has published substantial number of peer-reviewed papers, interview articles,
proceedings of discussion meetings, and most recently a book titled“Ethical
innovation for global health: pandemic, democracy and ethics in research”(Springer;
2023), including chapters on patient/public opinions on the DoH, as well as
historical analysis on ethics of placebo-controlled study and post-trial access
considering pandemic experience.
19
Susan Marlin
President and CEO
Clinical Trials Ontario
Susan Marlin is the President and CEO of Clinical Trials Ontario (CTO), an
organization supported by the Province of Ontario. CTO’s flagship program is its
streamlined research ethics review program, supporting single research ethics
review for multi-site studies. Prior to joining CTO served as the Associate Vice-
Principal at Queen’s University. Susan worked with the Canadian Cancer Trials
Group for many years coordinating clinical trials and leading the development
and implementation of the Ethics and Regulatory Office.
Susan has actively engaged in research ethics for many years. She served as
President of the Canadian Association of Research Ethics Boards, as a member
of the Canadian Institutes of Health Research (CIHR) Research Integrity
Committee, the Ontario Cancer Research Ethics Board and the Tri-Agency Panel
on the Responsible Conduct of Research. She is an Adjunct Lecturer at Queen’s
University in Kingston, Ontario and is the nominated principal investigator on
a Canadian Institutes of Health Research funded project to streamline research
ethics review for child health research across Canada.
20
Hilary Marston, MD, MPH
Chief medical officer
U.S. Food and Drug Administration
Hilary Marston, M.D., M.P.H., Chief Medical Officer, FDA, serves as the primary
clinical advisor to the Commissioner and oversees the Office of Clinical Policy
and Programs. She leads cross-cutting initiatives that support the FDA’s centers in
making effective, safe, and innovative medical products available for patients.
Dr. Marston previously served as the Senior Advisor for Global COVID-19
Response on the White House COVID-19 Response Team. Her previous roles
also include Director for Medical Biopreparedness and Response at the U.S.
National Security Council and Medical Officer and Policy Advisor for Pandemic
Preparedness at the National Institute of Allergy and Infectious Diseases, National
Institutes of Health. Dr. Marston also served in positions with McKinsey &
Company and the Bill & Melinda Gates Foundation.
Dr. Marston trained in Internal Medicine and Global Health Equity at Brigham &
Women’s Hospital. She completed her M.P.H. at the Harvard T.H. Chan School of
Public Health.
21
Gustavo Ortiz-Millán, PhD
Professor
Institute of Philosophical Research
National Autonomous University of Mexico
Gustavo Ortiz-Millán is research-professor at the Institute of Philosophical
Research, National Autonomous University of Mexico (UNAM), and member of
the National System of Researchers of Mexico’s National Council for Science and
Technology. He holds a PhD in philosophy from Columbia University in New York.
He has taught philosophy at Columbia University, New York University, Brooklyn
College, and UNAM. He has also been a visiting researcher at the University of
California at Berkeley, Duke University and Oxford University. He has been a
Fulbright Scholar twice. He is the author of the books The Morality of Abortion, and
Abortion, Democracy and Empowerment, both of them published in Spanish. He
has co-edited several books, the most recent of which are Mind, Language, and
Morality (with J. Cruz, Routledge, 2018) and COVID-19 and Bioethics (in Spanish,
with M. Medina, UNAM Press, 2021). He is also the author of more than 100
peer-reviewed articles, book chapters and critical book reviews. His articles have
appeared in journals such as the Journal of Medicine and Philosophy, Cambridge
Quarterly of Healthcare Ethics, Journal of Bioethical Inquiry, Global Bioethics,
International Journal of Gynecology and Obstetrics, International Journal of Health
Policy and Management, Revista de Bioética y Derecho, Indian Journal of Medical
Ethics, Dilemata, among others. He has also published on topics of metaethics,
moral psychology and epistemology.
Academia webpage: https://unam.academia.edu/GustavoOrtizMillan
22
Jonathan D. Moreno, PhD
Daivd and Lyn Silfen University Professor Emeritus
University of Pennsylvania and
Advisor, Center for Health, Ethics and Society
University of Hamburg
Jonathan D. Moreno is the David and Lyn Silfen University Professor Emeritus at
the University of Pennsylvania and an advisor for the Center for Health, Ethics and
Society at the University of Hamburg, Germany.
He is a member of the National Academy of Medicine, a fellow the Hastings
Center, a member of the Philadelphia College of Physicians, a fellow of the New
York Academy of Medicine, a faculty affiliate of the Kennedy Institute of Ethics at
Georgetown University, and a member of the Committee on Human Rights of
the National Academies of Science, Engineering and Medicine.
23
Peter Pronovost, MD, PhD, FCCM
Chief quality & clinical transformation officer, University Hospitals
Professor, Department of Anesthesiology and Critical Care Medicine
Case Western Reserve
The Veale Distinguished Professor in Leadership and Clinical Transformation
Peter Pronovost, MD, PhD, is a world-renowned patient safety champion,
innovator, critical care physician, a prolific researcher (publishing over 800 peer
review publications), entrepreneur (founding a healthcare start-up that was
acquired), and a global thought leader, informing US and global health policy.
His scientific work to reduce catheter-related bloodstream infections has saved
thousands of lives and earned him high-profile accolades, including being
named one of the 100 most influential people in the world by Time Magazine,
receiving a coveted MacArthur Foundation“genius grant”in 2008. Dr. Pronovost
currently serves as the Chief Quality & Clinical Transformation Officer for
University Hospitals, Cleveland, a comprehensive health system with a national
reputation for providing world class healthcare, research and education with
annual revenues of $4.4 billion, 20 hospitals, more than 50 health centers and
outpatient facilities, and over 200 physician offices located throughout
16 counties.
As Chief Quality & Clinical Transformation Officer, Dr. Pronovost is charged with
fostering ideation and implementation for new protocols to eliminate defects
in value and thereby enhance quality of care; developing new frameworks for
population health management for UH’s more than one million patients; and
managing the UH Accountable Care Network comprising more than 581,000
members. In this role, Dr. Pronovost leads the system in championing a new
narrative that focuses on Keeping People Healthy at Home. He created a new
list of key principles for eliminating defects in value and has incorporated the
framework into an analytic platform integrating claims, electronic medical record
(EMR), and scheduling data, to make defects in value visible to clinicians. In just
12 months, this work fueled a reduction in annual costs per patient in the UH
ACO by 9 percent. Dr. Pronovost also serves as a Professor in the Department of
Anesthesiology and Critical Care Medicine at the Case Western Reserve University
School of Medicine and School of Nursing.
24
Jack Resneck Jr., MD
Former president
American Medical Association
Dr. Jack Resneck Jr., a nationally recognized leader in health policy from the
San Francisco Bay Area, was the 177th president of the American Medical
Association. A passionate advocate for patients and physicians, he is a prominent
spokesperson for advancing quality care, innovation, and public health, and he is
a champion for a more equitable health care system.
Dr. Resneck is the Bruce U. Wintroub Endowed Professor and Chair of the UCSF
Department of Dermatology and holds a joint appointment as an affiliated
faculty member at the Philip R. Lee Institute for Health Policy Studies. He has
a long and decorated record of service in organized medicine, including as an
AMA Trustee from 2014-2022 and serving as AMA Board chair in 2018-2019. He
served on the boards of the National Quality Forum and the American Academy
of Dermatology.
Dr. Resneck currently chairs the World Medical Association’s process to revise the
Declaration of Helsinki. He also serves as Chair of Finance and Planning for the
World Medical Association Council. He is active in health services research, and
his studies on patient access to care, health care delivery, digital medicine, and
public health have been published in prominent journals and attracted national
media attention.
Raised in Louisiana, Dr. Resneck received his BA in public policy from Brown
University and his MD from UCSF—where he also completed his internship in
internal medicine, residency in dermatology and fellowship in health policy.
25
Lainie Ross, MD, PhD
Dean’s professor and inaugural chair
Department of Health Humanities and Bioethics
Professor, Departments of Pediatrics, Neurology, and Philosophy
Director, Paul M Schyve MD Center for Bioethics
University of Rochester
Lainie Friedman Ross, MD, PhD, a pediatrician and philosopher, is the Dean’s
Professor and Inaugural Chair of the Department of Health Humanities and
Bioethics, and the Director of the Paul M Schyve, MD Center for Bioethics at the
University of Rochester School of Medicine and Dentistry where she also holds
secondary appointments in the Departments of Philosophy, Pediatrics, and
Neurology. Dr. Ross is a graduate of Princeton University (AB from the School of
Public and International Affairs), University of Pennsylvania Perelman School of
Medicine (MD) and Yale University (MPhil and PhD in Philosophy). She trained
in pediatrics at the Children’s Hospital of Philadelphia and the Morgan Stanley
Children’s Hospital of New York-Presbyterian.
Dr Ross’research portfolio addresses ethical and policy issues in organ and
tissue transplantation, pediatrics, genetics, research ethics and human subjects
protections, and health care disparities. In research ethics, she authored a book
entitled Children in Medical Research: Access v Protection (Oxford UK: Oxford
University Press, 2006). She was the first author of 3 manuscripts published in
2010 in the Journal of Empirical Research on Human Research Ethics (JERHRE) that
addressed the ethics of community engaged research. These manuscripts were
adopted by the national consortium of Clinical and Translational Science Award
(CTSA). She was a member of the Department of Health and Human Services
Secretary Advisory Committee on Human Research Protections (SACHRP),
March 2010-March 2014 and the National Institutes of Health Recombinant DNA
Advisory Committee. September 2014-July 2018.
Dr. Ross is a Fellow of the Hastings Center, a John Simon Guggenheim Memorial
Foundation Fellow, and a member of the National Academy of Medicine.
26
Bruce A. Scott, MD
President
American Medical Association
Bruce A. Scott, MD, is the president of the American Medical Association and
a member of the Board of Trustees. Prior to this, he was a member of the AMA
House of Delegates for over 20 years, serving as speaker and vice speaker and
was the young physician member on the AMA Board of Trustees.
Dr. Scott has been president of his county and state medical associations and
served on the boards of the Greater Louisville Medical Society and the Kentucky
Medical Association (KMA) for over 20 years. As a leader in these associations,
he fought for access to care for vulnerable populations, improvement in public
health and reduction of administrative burdens in health care. He was awarded
the KMA Distinguished Service Award in recognition of his work on behalf of
Kentucky’s physicians and patients.
Dr. Scott is the president of his six-physician independent private practice group,
medical director of a multispecialty ambulatory surgery center and holds a
clinical appointment at the University of Louisville School of Medicine. He is
board-certified in both otolaryngology and facial plastic surgery.
27
Jay Shaw, PT, PhD
Research director, artificial intelligence, ethics & health
University of Toronto
Dr. Jay Shaw is Canada Research Chair in Responsible Health Innovation and
Research Director of Artificial Intelligence (AI), Ethics & Health at the University
of Toronto Joint Centre for Bioethics. Dr. Shaw is an Assistant Professor in the
Rehabilitation Sector of the Temerty Faculty of Medicine at University of Toronto,
with a cross-appointment to the Institute of Health Policy, Management and
Evaluation where he supervises research-focused graduate students. His program
of research addresses the ethical and social implications of digital innovations in
health care.
28
Kayte Spector-Bagdady, JD, MBe
Assistant professor, obstetrics and gynecology
Interim co-director, Center for Bioethics and Social Sciences in Medicine
University of Michigan
Prof. Kayte Spector-Bagdady, JD, MBe, is health law and bioethics faculty at the
University of Michigan (U-M) Medical School. At U-M she is also on the leadership
team of the Center for Bioethics and Social Sciences in Medicine, which won the
2022 American Society for Bioethics & Humanities (ASBH) Cornerstone Award.
She is an Associate Editor of the American Journal of Bioethics and a member of
the National Academies’committee on Newborn Screening: Current Landscape
and Future Directions. In the past, she was also Chair and lead author of the
American Heart Association’s“Principles for Health Information Collecting,
Sharing, and Use,”a member of the ASBH Board of Directors, and an Associate
Director for President Obama’s Presidential Commission for the Study of
Bioethical Issues.
The overarching goal of Prof. Spector’s work is improving the governance of
secondary research with health data and specimens to increase the accessibility
of data and generalizability of advances across diverse communities. To that end,
she was the PI of a NHGRI K01 studying how and why geneticists select datasets
for their research and is the PI both of an NCTAS R01 on hospitals sharing patient
data with commercial entities and a Greenwall Faculty grant on generative
AI technologies. She is also an active team scientist and have served as a co-
investigator on projects that have collectively received over $200 million in
extramural funding. Her recent articles have been published in The New England
Journal of Medicine, Science, JAMA, Health Affairs, and Nature Medicine, and her
research or expertise has appeared in the NY Times, The Washington Post, The
Wall Street Journal, TIME, and CNN.
29
Johannes JM van Delden
Professor, medical ethics
University Medical Center
Johannes (Hans) van Delden is full professor of medical ethics at the University
Medical Center of Utrecht University, the Netherlands. There he also leads the
project on patient and public participation in care, education and research.
He has worked for many years as a practicing nursing home physician. He has
published widely on the practice and ethics of end-of-life decisions, research
ethics, and ethical issues in the care for the elderly. He has built a strong
research team which has created a strong track record in the ethics of end-of-life
decisions, research ethics, and ethics of biomedical innovation. He served as the
chair of the International Bioethics Committee of UNESCO. He has also served as
the president of the Council of International Organisations of Medical Sciences
(CIOMS), and as the chair of the workgroup for the revision of the CIOMS ethical
guidelines for biomedical research.
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