Maintaining Public Trust in the Face of Emerging Trends in Research
The Augusta University Human Research Protection Program (HRPP) in partnership with Georgia State University, Georgia Southern University, the University of Georgia, Emory University, and the U.S. Department of Health and Human Services' Office for Human Research Protections (OHRP) will co-host a community forum February 19-20, 2025 at the Crowne Plaza in North Augusta, South Carolina.
OHRP sponsors Research Community Forums (RCF) each year, at various research institutions across the U.S. to promote the protection of human subjects in research. At this 2-day conference, attendees can expect to hear from a wide range of well-versed speakers on topics including different types of conflicts in research, community engagement and maintaining public trust, and flexibility and innovation to respond to the evolving field of research. The forum includes a keynote presentation, several plenary and breakout sessions, and an interactive workshop focusing on the interpretation and application of HHS regulations and policies on human research protections.
Participants are expected to have a working knowledge of the HHS regulations on human research protections.
All the presentations at this event meet the criteria in the Certified IRB Professional (CIP) recertification guidelines at https://www.primr.org/cip/cip-recertification/. A maximum of 315 mins of content are eligible for continuing education units for day 1 and 390 mins of content for day 2 .
Jump to: Registration Location Agenda Day 1 Agenda Day 2Exhibitors
We are thrilled to collaborate with the Crowne Plaza North Augusta to host our Research Community Forum on February 19 - 20, 2025.
Overlooking the Savannah River and the award-winning SRP Stadium (home of the Augusta Green Jackets), Crowne Plaza North Augusta is a modern Augusta hotel whose ties to the heritage, history, and natural surroundings are evident throughout the thoughtful and welcoming design.
Conference attendees wishing to reserve a hotel room at the Crowne Plaza North Augusta can purchase rooms at a discounted rate using the link below.
Location: Crowne Plaza North Augusta
Address: 1060 Center St, North Augusta, SC 29841
Primary Goal: The one-day Research Community Forum Workshop provides an opportunity for the research community to engage directly with OHRP staff to explore important aspects of human research protections. Distinct from the Forum Conference, the Forum Workshop combines didactic instruction and engaging interactions to help participants understand how to interpret and apply the U.S. federal regulations and policies on human research protections.
Registration & Breakfast
“Independently sponsored by Augusta University”
Welcome & Introductions
user icon Speakers: Yvonne Lau, MBBS, MBHL, PhD, OHRP and Tiffany Coleman, MPH, CIP, Augusta University
Yvonne Lau, MBBS, MBHL, PhD
Tiffany Coleman, MPH, CIP
Case Discussion Part 1 - Reviewing Research Under the Common Rule
user icon Speaker: Yvonne Lau, MBBS, MBHL, PhD, OHRP
During this interactive session, OHRP will invite the audience to review and make decisions on the ethics and aspects pertaining to the human research protections regulations regarding a variety of research projects.
Yvonne Lau, MBBS, MBHL, PhD
Case Discussion Part 2 – Applying the Common Rule to Human Subjects Research
user icon Speaker: Marianna Azar, MA, OHRP
This interactive session will explore how the Common Rule regulatory requirements apply to non-exempt human research.
Marianna Azar, MA
Marianna Azar is a Program Specialist with the Division of Education and Development at the Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services. Before joining OHRP, Ms. Azar served as Director and Chair of the Institutional Review Boards for the New York City Department of Education. Prior to that, she was employed as a Human Research Protection Program Manager at the City University of New York Graduate Center, and as an IRB Specialist at Columbia University’s Human Research Protection Office. Marianna holds a BA in Philosophy from the State University of New York at Oswego, an MA in Philosophy and a Graduate Diploma in Health Services and Policy Research from York University in Toronto, Canada, and is also working on completing her Ph.D. in Bioethics at York University.
Networking Lunch
“Independently sponsored by Augusta University”
Overview of the CDC Human Subject Research Program
user icon Speaker: Robert Chirila, CDC
This session will provide an overview of the CDC Human Subject Research Program and describe the research commonly conducted or supported by the CDC.
Robert Chirila
Robert Chirila began his Federal career as an intern with the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) in 2005 in the position of a Research Assistant. Robert worked as an Investigator for OCR in NY, NY, during which time, Robert worked on high impact HIPAA cases that led to total monetary settlements of $6.9 million. Starting in 2019, Robert led a team of five investigators in the Atlanta, GA office of OCR. In three years as a supervisor, Robert’s team obtained nine (9) high impact Right of Access monetary settlements. Robert began working at CDC in January 2023 as the Lead of CDC’s Human Research Protection Office where Robert implemented an annual check in process for exempt and non-exempt studies that do not require continuing IRB review. Robert is married to his beautiful wife, Anna, and has a 7-year old daughter named Olivia and a 4-year old son named Landon.
Community and Household Entry Procedures for the Violence Against Children and Youth Survey
user icon Speaker: Laura Chiang, MA, CDC
The presentation will cover the community and household entry procedures employed by the Violence Against Children and Youth Survey (VACS). VACS focuses on sensitive topics and collects data from children and youth. The survey has a careful approach to entering communities and households aimed at maximizing safety and confidentiality, which in turn facilitates disclosure.
Laura Chiang, MA
Innovative Approaches to Informed Consent
user icon Speakers: Marianna Azar, MA, OHRP, Yvonne Lau, MBBS, MBHL, PhD, OHRP and Kelly FitzGerald, Ph.D., WCG
Audience members will be invited to share institutional best practices and innovative approaches to informed consent. Session will feature an overview of OHRP’s Participant-Centered Informed Consent Training Program and observations from WCG review of informed consent practices.
Marianna Azar, MA
Yvonne Lau, MBBS, MBHL, PhD
Kelly FitzGerald, Ph.D.
Kelly FitzGerald is the IRB Executive Chair and Vice President of IBC Affairs at WCG where she oversees the review teams of both the IRB and several hundred institutional IBCs. She is responsible for the compliant and efficient operation of both the IRB and IBCs. Kelly joined WCG IRB in 2014 as the Director of Expedited Review. Kelly is a chemical engineer, and her graduate training was in the area of genetic engineering, which led to an interest in medical diagnostic device technology. Prior to joining WCG, she worked in general research administration and invention licensing at the University of Washington for over 10 years.
Break
Community Engagement & Maintaining Public Trust
Augusta University Institutional Review Board Community Outreach - How We’ve Built Trust
users icon Speakers: Tiffany Coleman MPH, CIP, Darryl Nettles DPA., Melissa Toomer CIC, Bianca Marsh BA and Robert Hood, Ph.D.
In this session, Dr. Robert Hood, Director of Accreditation and Global Outreach, Association for Accreditation of Human Research Protection Programs, will discuss the role of AAHRPP Accreditation in promoting the involvement of community members in the design and implementation of research and the dissemination of results. Attendees will then hear about ways that the Augusta University Human Research Protection Program (AU IRB) has collaborated with their local community and community partners to reach underrepresented populations and build trust in research.
Tiffany Coleman, MPH, CIP
Darryl Nettles, DPA
Melissa Toomer, CIC
Bianca Marsh, BA
Robert Hood, Ph.D.
Closing Remarks
Primary Goal: On the second day of the conference, attendees can expect to hear from a wide range of well-versed speakers discussing different types of conflicts of interest that arise in the conduct of contemporary research, strong programs of community collaboration and education, current AI-capabilities in human subject research, and flexibility and innovation in the evolving field of research. Day 2 will feature a Keynote from Carl Elliott “Blowing the Whistle on Abuses to Human Subjects”, five plenary sessions, and several breakout sessions.
Registration & Breakfast
“Independently sponsored by Augusta University”
Welcome & Opening Remarks
user icon Speaker: Russell T. Keen, EdD, Augusta University President and Yvonne Lau, MBBS, MBHL, Ph.D.
Yvonne Lau, MBBS, MBHL, Ph.D.
Keynote: Blowing the Whistle on Abuses to Human Subjects
user icon Speaker: Carl Elliott, PhD, Professor, Department of Philosophy, University of Minnesota
In popular culture, whistleblowers are conscience-driven heroes who triumph against the odds. Yet when research abuses occur, medical institutions deny wrongdoing even when it is glaringly obvious, and rarely do mistreated research subjects or their families get any real justice. Whistleblowing is the exception, not the rule. In many scandals, doctors and other staff members remain silent for years while unwitting research subjects are abused. If abuses do come to light, the researchers are usually protected by the medical establishment while the whistleblowers are punished.
Carl Elliott, PhD
Carl Elliott grew up in Clover, South Carolina, where his father was a family doctor and his mother was a librarian. He attended Davidson College, the Medical University of South Carolina and Glasgow University in Scotland, training first in medicine and then in philosophy. After postdoctoral positions at the University of Chicago, the University of Otago in New Zealand and the University of Natal Medical School in South Africa, he joined the faculty at McGill University in Montreal. Elliott moved to the University of Minnesota in 1997 to join the Center for Bioethics. He is currently a professor in the Department of Philosophy.
Elliott is the recipient of a Guggenheim Fellowship, a National Endowment for the Humanities Public Scholar Award, the Cary and Ann Maguire Chair in Ethics and American History at the Library of Congress, a resident fellowship at the Rockefeller Center in Bellagio, and a Weatherhead Fellowship at the School for Advanced Research in Santa Fe. His writing has appeared in The New Yorker, The Atlantic, The New York Review of Books, The New York Times, Mother Jones and The American Scholar. He has been a visiting faculty member at the Institute for Advanced Study in Princeton, the University of Sydney, and the University of Otago, where he is an affiliate of the Bioethics Centre. He and his wife, Ina, have three children and live in Minneapolis.
Plenary 1- Looking Beyond the Almighty Dollar: Addressing Non-Financial Conflicts of Interest in Research
user icon Moderator: Laura A. Meyer Chapman, MA
users icon Panelists: Carl Elliott PhD, Leandra Smollin, PhD, Angus Chen, and David Borasky, MPH, CIP
A panel will discuss different types of conflicts of interest that arise in the conduct of contemporary research as well as in the review and oversight of research for regulatory compliance and ethical purposes. The panel will examine potential conflicts held by members of the community involved in research, the growing role of commercial and other non-institutional IRBs, conflicts driven by the increasing competition among university medical and academic centers, and consider how institutions can address and mitigate these conflicts to ensure public trust in research.
Laura A. Meyer Chapman, MA
Laura Meyer Chapman is a distinguished professional with a career dedicated to ensuring ethical and compliant research practices in academia. With nearly 30 years of experience in research compliance and biomedical research, she has consistently demonstrated leadership in developing and implementing effective compliance programs and policies.
Laura currently serves as the Director of Research Ethics & Compliance at Augusta University in Augusta. In this capacity, she has been instrumental in establishing and overseeing the university’s Research Ethics and Compliance Program and promoting a culture of ethical conduct in research. During her tenure in this position, Laura has revamped the university’s conflict of interest program and established new programs in research security and human subjects research monitoring.
Laura holds a Master of Arts in Biology and Biomedical Sciences from Washington University in St. Louis and a Bachelor of Science in Biology from the University of Tennessee, Chattanooga. In her personal time, Laura enjoys photography, fostering kittens, and travelling. She is married and has two adult daughters and two grandchildren.
Carl Elliott, PhD
Carl Elliott grew up in Clover, South Carolina, where his father was a family doctor and his mother was a librarian. He attended Davidson College, the Medical University of South Carolina and Glasgow University in Scotland, training first in medicine and then in philosophy. After postdoctoral positions at the University of Chicago, the University of Otago in New Zealand and the University of Natal Medical School in South Africa, he joined the faculty at McGill University in Montreal. Elliott moved to the University of Minnesota in 1997 to join the Center for Bioethics. He is currently a professor in the Department of Philosophy.
Elliott is the recipient of a Guggenheim Fellowship, a National Endowment for the Humanities Public Scholar Award, the Cary and Ann Maguire Chair in Ethics and American History at the Library of Congress, a resident fellowship at the Rockefeller Center in Bellagio, and a Weatherhead Fellowship at the School for Advanced Research in Santa Fe. His writing has appeared in The New Yorker, The Atlantic, The New York Review of Books, The New York Times, Mother Jones and The American Scholar. He has been a visiting faculty member at the Institute for Advanced Study in Princeton, the University of Sydney, and the University of Otago, where he is an affiliate of the Bioethics Centre. He and his wife, Ina, have three children and live in Minneapolis.
Leandra Smollin, PhD
Leandra Smollin, Ph.D., has expertise in social and community-engaged research, LGBTQIA+ health, and violence prevention. She holds a Ph.D. From Northeastern University in Sociology, and B.A. from Stonehill College. Before joining the Fenway Institute Office of Research Compliance, she acquired professional experience as an Assistant Professor of Sociology at SUNY Potsdam; researcher at the Prevention Innovations Research Center at the University of New Hampshire and the Maurico Gaston Institute for Latino Community Development and Public Policy at the University of Massachusetts Boston; and the Massachusetts Commissions for LGBTQ youth.
Currently, Leandra manages Research Compliance and the Human Subjects Protection Program at The Fenway Institute in Boston, MA. Fenway Health is a federally qualified community health center that advocates for and delivers innovative, equitable, accessible health care, supportive services, and transformative research and education. The mission of The Fenway Institute is to optimize health and well-being for sexual and gender minorities (SGM) and those affected by HIV.
Angus Chen
David Borasky, MPH, CIP
David Borasky serves as Vice President of Compliance for WCG Clinical’s Review Solutions division. In this role he is responsible for leading the quality and compliance activities for WCG Clinical’s institutional review board, institutional biosafety committee, endpoint adjudication committees and data monitoring committee services. This includes maintenance of WCG’s AAHRPP accreditation and ISO 9001 certifications. In addition, Borasky serves as WCG’s liaison to regulatory agencies that oversee these activities.
Borasky has more than 25 years of experience in managing IRBs in settings that include global public health organizations, large academic medical centers, and independent IRBs. He has facilitated training activities on basic research ethics and IRB operations and management for IRB staff and members for institutions and IRBs throughout the US and abroad. He has served as a consultant for the Office for Human Research Protections, the US Department of Energy, the World Health Organization, and numerous other institutions. He currently serves as co-chair of the Subpart A Subcommittee of the DHHS Secretary’s Advisory Committee on Human Research Protections.
Borasky is a Certified IRB Professional and former member of the board of directors of Public Responsibility in Medicine and Research (PRIM&R). In 2018 he was named a Distinguished Leader of PRIM&R. He received his undergraduate education at Le Moyne College and his master’s degree in public health leadership from the University of North Carolina at Chapel Hill.
Break
Plenary 2- AI in Drug and Medical Device Development – perspectives on research ethics
user icon Speaker: Karla G. Childers, BA, MSJ, MSBE
While the foundational principles of modern-day bioethics are well-established, innovative technologies like artificial intelligence have the potential to challenge some of these norms and how we think about human research protection. This talk will explore the use of AI in the regulated environment of drug and medical device development and suggest an approach that (1) emphasizes existing principles and guidelines and (2) advocates for discipline in creating new ethical frameworks. Examples will be shared that elucidate this approach.
Karla G. Childers, BA, MSJ, MSBE
Karla Childers joined Johnson & Johnson (J&J) in October 2013 in the Office of the Chief Medical Officer where her primary responsibility has been leading and coordinating various ethics-based, science and technology policy projects. Her longest running responsibility has been the support and coordination of Johnson & Johnson’s Clinical Trial Data Transparency Initiative, including the management of the Yale University Open Data Access (YODA) Project data sharing collaboration.
Ms. Childers is the Chair of the J&J Bioethics Committee, which serves as an internal forum providing advice on bioethical questions within J&J. She is responsible for the management and conduct of that committee and relevant bioethics consultations. She serves as a bioethics subject matter expert for various internal and external science and technology policy work and coordinates the internal bioethics educational program sponsored by the Office of the Chief Medical Officer.
Ms. Childers has also been actively engaged outside J&J in various R&D and ethics-based work. She has volunteered in the Drug Information Association (DIA) in various roles for the past decade, including the Annual Meeting Program Committee, Annual Meeting Steering Committee, and most recently co-founded the DIA Bioethics Community. She is presently serving on the DIA Americas Regional Advisory Council for the Americas. She served three years on the Public Responsibility in Medicine & Research (PRIM&R) planning committee for the Advancing Ethical Research (AER) conference and continues to be an active speaker and member for PRIM&R. Most recently, she joined the Board of Directors for FASPE (Fellowships at Auschwitz for the Study of Professional Ethics). She also serves as a teaching assistant and lecturer in the Columbia University Master of Bioethics Program.
Before joining J&J, she was an Associate Director in Global Project Management (GPM) in Merck Research Laboratories (MRL), where she managed cross functional drug development teams in various therapeutic areas and stages of development. Prior to joining GPM, Ms. Childers began her career in industry as a bench chemist in MRL’s Process Chemistry group.
She received her Bachelor of Arts Degree in Chemistry from Indiana University-Purdue University in Indianapolis and a Master of Science in Jurisprudence with a concentration in Health Law from Seton Hall Law School. She is also a graduate of Columbia University with a Master of Science in Bioethics.
Plenary 3- OHRP Staff Presentation
user icon Speaker: OHRP Staff
Networking Lunch
“Independently sponsored by Augusta University”
TRACK 1: Values, Practices and Systems Advancing Community-Engaged Research Trust
user icon Speaker: Tabia Henry Akintobi, PhD, MPH
Morehouse School of Medicine (MSM) holds to an applied, cross –cutting, definition of community engagement research that includes the systematic allocation of educational, clinical, research and clinical resources applied to advance its vision to lead the creation and advancement of health equity. The MSM Model, steeped the pursuit of trustworthiness and positioning community/patient groups as leaders, rather than simply holding roles in supporting recruitment and retention and ongoing, systematic assessment (priority community/patient groups, partnerships dynamics, and research impacts/outcomes), has been the foundation to these relationships and outcomes. Beyond the conduct of Community-based Participatory Research and Community-Engaged Research are essential institutional systems and structures that facilitate or serve as barriers to community engaged research practices. This workshop will cover the multilevel (individual, relational and institutional) determinants of effective community engaged research trustworthiness. This session will discuss values, practices, and tools that academic institutions can employ to integrate and facilitate community-driven research as an institutional pillar of their research enterprise.
Tabia Henry Akintobi, PhD, MPH
TRACK 2: Ethical Dilemmas in AI-Driven Substance Use Disorder Research
user icon Speaker: Brenda Curtis, Ph.D.
This talk will delve into the unique ethical challenges posed by the integration of artificial intelligence in substance use disorder research. Dr. Brenda Curtis will explore the potential risks to participant autonomy, the complexities of consent in digital phenotyping studies, and the ethical implications of AI-driven interventions. Attendees will gain insights into navigating the ethical landscape beyond regulatory compliance, ensuring the protection of personal preferences and behaviors in AI research.
Brenda Curtis, Ph.D.
Break
TRACK 1: A Conversation Between Participants and Researchers: What Can We Learn From Each Other?
user icon Moderator: David Borasky, MPH, CIP
user icon Participant Representative: Darryl Nettles, DPA
users icon Researcher Representatives: Samantha Jones, PhD, Marlo Vernon, PhD, MPH, David Augustin Hodge, PhD
In this session, speakers (past participants and researchers) will talk about the good and the bad of research recruitment and participation. Researchers and former participants will reflect on barriers to recruitment and research engagement and partake in an open dialogue on how to develop strategies to improve the research experience for all involved.
David Borasky, MPH, CIP
David Borasky serves as Vice President of Compliance for WCG Clinical’s Review Solutions division. In this role he is responsible for leading the quality and compliance activities for WCG Clinical’s institutional review board, institutional biosafety committee, endpoint adjudication committees and data monitoring committee services. This includes maintenance of WCG’s AAHRPP accreditation and ISO 9001 certifications. In addition, Borasky serves as WCG’s liaison to regulatory agencies that oversee these activities.
Borasky has more than 25 years of experience in managing IRBs in settings that include global public health organizations, large academic medical centers, and independent IRBs. He has facilitated training activities on basic research ethics and IRB operations and management for IRB staff and members for institutions and IRBs throughout the US and abroad. He has served as a consultant for the Office for Human Research Protections, the US Department of Energy, the World Health Organization, and numerous other institutions. He currently serves as co-chair of the Subpart A Subcommittee of the DHHS Secretary’s Advisory Committee on Human Research Protections.
Borasky is a Certified IRB Professional and former member of the board of directors of Public Responsibility in Medicine and Research (PRIM&R). In 2018 he was named a Distinguished Leader of PRIM&R. He received his undergraduate education at Le Moyne College and his master’s degree in public health leadership from the University of North Carolina at Chapel Hill.
Darryl Nettles, DPA
Darryl Nettles, PhD is a Postdoctoral Research Fellow in the Cancer Prevention, Control, and Population Health (CPCPH) program in the Georgia Cancer Center (GCC) at Augusta University (AU). His current focus has been on studying SDOH, health disparities, and obesity prevention as it relates to cardiovascular disease and cancer. Dr. Nettles’ long-term career goals are to become an independent investigator and study Social Determinants of Health (SDOH) in disparate populations and relate these to health disparities within these groups.
Samantha Jones, Ph.D.
I am an Assistant Professor in the Department of Family and Community Medicine, with secondary appointments in the Georgia Cancer Center and Georgia Prevention Institute, all housed within the Medical College of Georgia at Augusta University. I received PhD training in pharmacology/toxicology, with a specific focus on cancer biology. My work involved identifying therapeutic targets for aggressive cancers which disproportionately affect disadvantaged populations. In my last six years at Augusta University, I have focused on eliminating racial/ethnic and socioeconomic health disparities regarding cancer prevention and control among minority and underserved populations. My current research interests include understanding the role of psychosocial and cultural influences in disease etiology among minority and disadvantaged populations. Allostatic load (AL), the cumulative wear and tear on the body as a result of chronic stress and life events, is elevated among minority and underserved populations and is associated with increased risk for cardiovascular disease, diabetes complications, pregnancy complications, and cancer mortality among others. Cultural differences in health behaviors which also serve as coping mechanisms (i.e., diet, exercise, smoking, and alcohol use) can have a heavier impact on disease incidence and mortality when coupled with social determinants of health such as low socioeconomic status and poor neighborhood characteristics. Equipping individuals with knowledge regarding disease prevention and early intervention, improving self-efficacy for achieving optimal health, and catalyzing positive changes in community norms and health policy in underserved communities are my career goals. In addition to serving as Principal Investigator of Psychosocial, sociocultural, and environmental influences on physiological and behavioral responses: Exploring predictors of cancer disparities among Black women, I also serve as a Co-Investigator on Perceived Equipoise and Researcher Credibility Study (PERCs) that provides preliminary data for the current proposal.
As a native of an underprivileged and largely racial/ethnic minority community in Georgia, I am intimately driven to improve the health conditions of vulnerable communities. I have the unique position of understanding cultural and behavioral influences on health for underserved communities through my own personal experiences. I believe that my passion for community-engaged research, strong community relationships, and expertise in CBPR will serve as substantial assets to Element E of the AU/GSU Georgia Research Institute for Translational Science (GRITS) project. I am confident in my ability to connect with stakeholders who are enthusiastic and committed to working to meet the needs of our community and establish higher standards of care for the population that our institution serves. My long-term research career goals include: 1) increasing community-engaged research approaches to address allostatic load and the impact of stress response on current health disparities among minority and underserved populations in the state of Georgia and nationally, and 2) increasing minority representation in health science research, with the ultimate goal of eliminating health disparities and achieving health equity.
Marlo Vernon, Ph.D., MPH
David Augustin Hodge, Ph.D.
Dr. David Augustin Hodge, Sr. is a native of St. Thomas, U.S. Virgin Islands. He earned his Bachelor of Arts degree in Bible, Theology, and English from American Baptist College in Nashville, Tennessee (1988); his Master of Arts in Education degree from Oral Roberts University in Tulsa, Oklahoma (1994); his Master of Theological Studies degree from Candler School of Theology, Emory University, Atlanta, Georgia (1997); his Doctor of Ministry degree from Columbia Theological Seminary, Atlanta, Georgia (1998); and his Ph.D. in Philosophy from the University of Miami (2015).
Dr. Hodge is married to Theresa Paula Hodge, an enthusiastic and passionate elementary school teacher in Gwinnett County, Georgia. They have three children: David II, B.S. in Science Education from Florida Memorial University; Avia, who holds an MPH from Tuskegee University and a Masters in Genetic Counseling from the University of North Carolina, Greensboro; and Jonathan, a junior at Tuskegee University.
TRACK 2: Where is Artificial Intelligence within Human Subject Research Today?
user icon Speakers: Tamiko Eto, MA, Director of Research Operations, Mayo Clinic and Joshua Fedewa, MS, CIP, Director of Research Consulting at Advarra
AI is a fast-changing field with ever-evolving applications and advancements. Speaker will address the current profile of AI and AI capabilities, explain what AI tools do and how they do it, and touch on how AI may reflect existing human flaws, such as implicit and explicit bias. Speakers will also explain the different types of AI used in Human Subjects Research (HSR)-from trial design to participant screening, recruitment, engagement, and retention and discuss the pros and cons of using synthetic data in an attempt to diversify the research participant pool.
Tamiko Eto, MA
Ms. Tamiko Eto currently serves as Director of Research Operations at the Mayo Clinic. She has over 18 years of experience in the field of human subjects research protections managing research compliance, technology risk assessment, data sharing agreements; conducting the review of complex industry and federally funded AI research, and policy interpretation and development. She leverages this experience to implement policies and guidance to AI-enabled health care research projects, and works closely with AI researchers and regulatory bodies in addressing ethical and regulatory challenges related to AI.
To facilitate researchers and IRB professionals across the US she has developed tools and checklists for IRBs to use in their review of AI research. Ms. Eto also serves on the AI Ethics Advisory Board for the Institute of Experiential AI (EAI) at Northeastern University, and is a Policy Advisor at the Center for AI and Digital Policy (CAIDP).
Joshua Fedewa, MS, CIP
Joshua Fedewa is an expert in human subject research and the current Director of Research Consulting at Advarra. He has over fifteen years of experience in regulations and guidelines governing human subjects research. As Director of IRBMED at the University of Michigan, Joshua held direct responsibility for over 20,000 submissions as well as 5,500 active studies. Joshua’s experience also includes oversight over all IRB operations at academic medical centers. He has expertise in human subjects regulations oversight and operations (IRB), as well as HIPAA Privacy regulations, and research compliance investigations. He has been instrumental in managing animal care and biosafety oversight at an academic medical center affiliate. Josh has extensive experience with a variety of electronic IRB submission and review systems and is also skilled in helping institutions obtain and maintain initial AAHRPP accreditation. Josh has served as an AAHRPP site visitor and has helped guide several institutions through initial accreditation as well as through multiple re-accreditation cycles. Josh has proven expertise in leading projects to improve research document translations which resulted in significant decrease in costs, turn-around times, and an increase in translated documents available for non-English speaking participants. Joshua holds a master’s in research administration from Rush University and is a Certified IRB Professional (CIP).
Break
TRACK 1: Thinking outside the box: Creative approaches to human research protections training for community partners
user icon Speaker: Emily Anderson, Ph.D., MPH, Professor of Bioethics, Loyola University Chicago’s Neiswanger Institute for Bioethics and Healthcare Leadership
In this session, attendees will learn methods for crafting approaches to Human Subject Protection (HSP) training for community-based research. Speakers will discuss how to develop accessible education programs and products and consider what makes an HSP training program effective.
Emily E. Anderson, Ph.D., MPH
Emily E. Anderson, PhD, MPH, is a professor of bioethics at Loyola University Chicago’s Neiswanger Institute for Bioethics and Healthcare Leadership. She teaches research ethics and responsible conduct of research to graduate and medical students as well as courses in empirical bioethics and global bioethics. Her areas of interest and expertise include ethical issues that arise in community- and patient- engaged research; researcher and physician professionalism and misconduct; ethical issues in research with vulnerable populations; informed consent; institutional review board (IRB) policy; and the application of qualitative research techniques to the study of research ethics. Dr. Anderson has published articles in the American Journal of Bioethics, Ethics and Behavior, Journal of Law Medicine and Ethics, Academic Medicine, Accountability in Research, and the Journal of Empirical Research on Human Research Ethics (JERHRE). She serves as associate editor for Narrative Inquiry in Bioethics. She also has almost 20 years of experience serving on six different IRBs and frequently presents at conferences including the American Society for Bioethics and Humanities (ASBH) and Public Responsibility in Medicine and Research (PRIM&R).
Dr. Anderson is creator of CIRTification Online, a free human research protections training program tailored for community research partners, available in English, Spanish, and Haitian Creole. Dissemination of CIRTification is supported through the Center for Clinical and Translational Science at the University of Illinois Chicago (UL1TR002003). Dr. Anderson is also the Principal Investigator/Project Director of the Loyola University Chicago-Ukrainian Catholic University (LUC-UCU) Doctoral and Post- Doctoral Bioethics Fellowship Program.
TRACK 2: Designing Consent Processes with the Participant in Mind
user icon Speaker: Sylvia Baedorf Kassis, MPH, Program Director, MRCT Center
In this session, attendees will learn:
Sylvia Baedorf Kassis, MPH
Sylvia Baedorf Kassis, MPH, is a Program Director at the MRCT Center and has over 20 years of clinical research-related experience in Canada and the United States of America. Her expertise includes ethical/regulatory review of research, workforce training and capacity building, and study coordination, management, and oversight.
In her current role, Sylvia champions efforts to make clinical research more understandable and accessible to patients, participants, and caregivers. Her clinical research interests include: understanding study participants’ experiences in research and incorporating their insights into study processes; supporting research coordinators through networks and training; and ensuring study teams have the resources they need to conduct ethical and compliant research involving study participants and their data/samples.
Sylvia has a Master of Public Health degree in Global Health from Boston University School of Public Health (2008) and a Bachelor of Science from the University of Toronto (2001).
Snack Break
“Independently sponsored by Augusta University”
Plenary 4- Learning from the Community and Giving Back: A Regional Showcase of Institutions
user icon Moderator: Michael Diamond, MD
users icon Panelists: Christy Ledford, Ph.D., Neal Dickert, MD, Ph.D., Leslie E. Wolf, MPH, JD
In this session, a panel will discuss strong programs of community consultation, collaboration, and education and detail the importance of partnering with the community to ensure that research serves its participants. Panelists will detail successful methods of community outreach and discuss how some efforts have fallen short. Panelist presentations will be followed by an open forum of questions moderated by Dr. Michael Diamond, AU.
Michael P. Diamond, MD
Dr. Diamond completed undergraduate studies at Vassar College in Poughkeepsie, New York, medical school at Vanderbilt University in Nashville, Tennessee, followed by internship and residency in Obstetrics and Gynecology at the same institution; and his fellowship in Reproductive Endocrinology and Infertility at Yale University in New Haven, Connecticut. He has specific expertise, interest, and experience in many areas of investigation including the development of postoperative adhesions, surgical treatment of uterine fibroids and endometriosis, oxidative stress, carbohydrate metabolism, androgen physiology, and the induction of ovulation. Dr. Diamond has extensive experience in research study design, organization, and implementation. He has a long track record of conduct of prospective clinical studies, as well as randomized controlled clinical trials. He has played leading roles in design and conduct of the preclinical/clinical studies leading to FDA approval of the first two agents for reduction of postoperative intraabdominal adhesions approved and available in the United States (Interceed and Seprafilm). Dr. Diamond is an internationally renowned clinical and translational investigator, who is recognized for many scientific contributions, including within the field of Reproductive Endocrinology and Infertility. His contributions include publications of over 640 peer reviewed manuscripts, 140 chapters, and over 900 abstracts. Additionally, he has edited or co-edited over 20 books and journal issues and has given over 800 scientific presentations. Dr. Diamond has also been extensively involved in health care provider education, including participating in the training of medical students and OB/GYN residents. He has also served as Reproductive Endocrinology and Infertility Fellowship Director, in total training over thirty REI fellows.
Dr. Diamond has been funded by six NIH Institutes, served as AU’s PI on the NICHD Cooperative Reproductive Medicine Network grant, and served as AU’s PI for the NICHD Women’s Reproductive Health Research Career Development grant, which trains obstetrician/gynecologists to become independent investigators. He has also participated in the NICHD National Cooperative Program for Infertility Research examining hormonal perturbations in women with otherwise “unexplained” infertility, as well as collaborated in trials examining the effect of organochlorines on male factor infertility funded by NIEHS, studies examining the effect of testosterone replacement on cognitive function in hypogonadal men funded by NIA, and the effect of sex steroids and gender on apnic thresholds funded by the VA. Dr. Diamond has also served as Principal Investigator or Co-PI on over forty-five commercial clinical trials on diverse topics including postoperative adhesions, uterine fibroids, ovulation induction, menstrual migraines, osteoporosis, endometriosis, and sexual dysfunction. He has served on multiple study sections and special review committees for the NIH, as well as a member and subsequently a consultant to the Obstetrics and Gynecology Device Panel of the Center for Devices and Radiological Health of the Food and Drug Administration. He is a past President of his subspecialty Society, the Society for Reproductive Endocrinology and Infertility, and the Society of Reproductive Surgeons. He has served on the Board of Directors for many other national and international societies including the American Society for Reproductive Medicine, the Society for Gynecologic Surgeons, and the AAGL Advancing Minimally Invasive Gynecology Worldwide. Dr. Diamond served as Chair or Vice Chair of Institutional Review Boards at Wayne State University for over fifteen years, and has served as Augustas University’s Institutional Official for over the past decade.
Christy Ledford, Ph.D.
Dr. Christy Ledford is a professor in the Department of Family Medicine at the Medical College of Georgia at Augusta University.
Ledford is an acclaimed researcher who brings extensive experience in health and strategic communications to AU Health. Her work in health literacy and clinical communication has been published in several peer-reviewed journals, including "Family Medicine" and the "Journal of Health Communication."
She earned her bachelor's degree in corporate communication from the College of Charleston, a master's degree in technical communication from Colorado State University, a doctoral degree in health and strategic communication from George Mason University, and completed a fellowship in medical journalism with the Society of Teachers of Family Medicine.
Neal Dickert, MD, Ph.D.
Neal Dickert, MD, PhD, is the Thomas R. Williams Associate Professor of Medicine in the Division of Cardiology at the Emory University School of Medicine. He is a core faculty member in the Emory Clinical Cardiovascular Research Institute, holds a secondary appointment in the Department of Epidemiology at the Rollins School of Public Health, and is a senior faculty fellow at the Emory Center for Ethics. He is the Interim Director of the Emory Health Services Research Center and directs the Network Capacity Core and Recruitment Center of the Georgia Clinical and Translational Science Alliance.
Dr. Dickert is a board-certified cardiologist and attends in the Emory University Hospital Cardiac ICU and inpatient echocardiography lab. His research is focused on ethical issues relevant to cardiology practice and clinical research, and he has received research funding from multiple NIH institutes, the Agency for Healthcare Research and Policy, the Patient-Centered Outcomes Research Institute, the American Heart Association, and the Greenwall Foundation. A major focus of his work is ethical and regulatory aspects of conducting clinical trials, especially in acute care contexts. Dr. Dickert is also interested in and has published work regarding recruitment and consent for clinical research more generally, including the use of incentives and efforts to increase diversity in clinical trials. Dr. Dickert is a past member of the ACC Ethics and Compliance Committee and is a member of multiple Data Safety and Monitoring Committees and the HHS Secretary’s Advisory Committee on Human Research Protections.
Leslie E. Wolf, MPH, JD
Leslie E. Wolf is the Ben F. Johnson Jr. Chair in Law, Distinguished University Professor, and Director of the Center for Law, Health & Society at Georgia State University’s College of Law, jointly appointed in the School of Public Health, and an adjunct professor in the Department of Family and Community Medicine, Medical College of Georgia at Augusta University. She was on faculty at the University of California, San Francisco from 1998-2007.
Wolf conducts research in a variety of areas in health and public health law and ethics, with a particular focus on research ethics. She previously served on the Secretary’s Advisory Committee on Human Research Protections (SACHRP). She continues to serve on the SACHRP Subcommittee.
She is a graduate of Johns Hopkins School of Public Health, Harvard Law School, and Stanford University. She also was a Greenwall Fellow in Bioethics and Health Policy and a Greenwall Faculty Scholar.
PLENARY 5- Conversation with OHRP
user icon Speaker: OHRP Representatives
Closing Remarks
user icon Speaker: Michael P. Diamond, MD
Michael P. Diamond, MD
Dr. Diamond completed undergraduate studies at Vassar College in Poughkeepsie, New York, medical school at Vanderbilt University in Nashville, Tennessee, followed by internship and residency in Obstetrics and Gynecology at the same institution; and his fellowship in Reproductive Endocrinology and Infertility at Yale University in New Haven, Connecticut. He has specific expertise, interest, and experience in many areas of investigation including the development of postoperative adhesions, surgical treatment of uterine fibroids and endometriosis, oxidative stress, carbohydrate metabolism, androgen physiology, and the induction of ovulation. Dr. Diamond has extensive experience in research study design, organization, and implementation. He has a long track record of conduct of prospective clinical studies, as well as randomized controlled clinical trials. He has played leading roles in design and conduct of the preclinical/clinical studies leading to FDA approval of the first two agents for reduction of postoperative intraabdominal adhesions approved and available in the United States (Interceed and Seprafilm). Dr. Diamond is an internationally renowned clinical and translational investigator, who is recognized for many scientific contributions, including within the field of Reproductive Endocrinology and Infertility. His contributions include publications of over 640 peer reviewed manuscripts, 140 chapters, and over 900 abstracts. Additionally, he has edited or co-edited over 20 books and journal issues and has given over 800 scientific presentations. Dr. Diamond has also been extensively involved in health care provider education, including participating in the training of medical students and OB/GYN residents. He has also served as Reproductive Endocrinology and Infertility Fellowship Director, in total training over thirty REI fellows.
Dr. Diamond has been funded by six NIH Institutes, served as AU’s PI on the NICHD Cooperative Reproductive Medicine Network grant, and served as AU’s PI for the NICHD Women’s Reproductive Health Research Career Development grant, which trains obstetrician/gynecologists to become independent investigators. He has also participated in the NICHD National Cooperative Program for Infertility Research examining hormonal perturbations in women with otherwise “unexplained” infertility, as well as collaborated in trials examining the effect of organochlorines on male factor infertility funded by NIEHS, studies examining the effect of testosterone replacement on cognitive function in hypogonadal men funded by NIA, and the effect of sex steroids and gender on apnic thresholds funded by the VA. Dr. Diamond has also served as Principal Investigator or Co-PI on over forty-five commercial clinical trials on diverse topics including postoperative adhesions, uterine fibroids, ovulation induction, menstrual migraines, osteoporosis, endometriosis, and sexual dysfunction. He has served on multiple study sections and special review committees for the NIH, as well as a member and subsequently a consultant to the Obstetrics and Gynecology Device Panel of the Center for Devices and Radiological Health of the Food and Drug Administration. He is a past President of his subspecialty Society, the Society for Reproductive Endocrinology and Infertility, and the Society of Reproductive Surgeons. He has served on the Board of Directors for many other national and international societies including the American Society for Reproductive Medicine, the Society for Gynecologic Surgeons, and the AAGL Advancing Minimally Invasive Gynecology Worldwide. Dr. Diamond served as Chair or Vice Chair of Institutional Review Boards at Wayne State University for over fifteen years, and has served as Augustas University’s Institutional Official for over the past decade.