Luminaries Lecture Series

M. Khair ElZarrad, Ph.D, MPH, deputy director of the Office of Medical Policy at FDA’s Center for Drug Evaluation and Research, delivered a plenary address at the OHRP RCF in Overland Park, Kansas in April 2019. Dr. ElZarrad described the framework of FDA’s Real-World Evidence (RWE) Program, and provided an overview of the opportunities and challenges associated with innovative technologies and novel study designs. RCF host KU Medical Center of the University of Kansas posted this video for public distribution.

Watch: FDA Real World Evidence Program – Opportunities and Challenges [32:39]

Robert Winn, M.D., the Associate Vice Chancellor for Community Based Practice at the University of Illinois, delivered the keynote address at the OHRP RCF in Greenville, NC in September 2018. RCF hosts East Carolina University, North Carolina State University, North Carolina Central University, UNC Wilmington, the University of North Carolina System, HRP Consulting Group, and Advarra have posted this video of Dr. Winn's keynote address for public distribution. Dr. Winn's presentation delves into the potential of science to impact the lives of all people in disparate communities. He identifies obstacles to access and delivery of medical treatment and points out environmental factors that influence the health and care requirements of communities to highlight health disparities. He promotes new ideas in community outreach and engagement as a means to begin addressing and improving the access to health care in those communities that historically have been overlooked.

Watch: Conducting Research with Communities in a Smart and Effective Manner [42:44]

Dr. Blizinsky, policy director for the All of Us Research Program, delivered a plenary address at the OHRP RCF in Greenville, NC in September 2018, co-sponsored with East Carolina University. ECU has posted this video of her presentation for public distribution. In her presentation, Dr. Blizinsky discusses the All of Us program's innovative engagement strategies. She also discusses the creation of a data enclave, the data security measures to protect it, and the program's intention to make the data widely available. All of these goals present unique ethical challenges, which Dr. Blizinsky addresses with emphasis on the informed consent process and participants' autonomous decision-making.

Watch: Overview of the NIH, All of Us Research Project and Innovative Ways for Community Engagement [30:30]

David Fajgenbaum, MD, MBA, MSc, Co-Founder and Executive Director of the Castleman Disease Collaborative Network and Assistant Professor at University of Pennsylvania Perelman School of Medicine, gave a keynote address at the OHRP RCF in Boston, MA in May 2018. RCF hosts Boston University School of Medicine and Harvard Catalyst/Harvard Clinical and Translational Science Center, in collaboration with Boston Children's Hospital, Partners HealthCare, Tufts Clinical and Translational Institute, and Yale Center for Clinical Investigation posted this video of Dr. Fajgenbaum's presentation for public distribution.

Dr. Fajgenbaum's keynote address describes his experience as a patient on the verge of death battling Castleman Disease, the translational research that he began in search of life-saving precision treatments for himself and others, and the Castleman Disease Collaborative Network (CDCN) he created, providing an innovative model for supporting research on orphan diseases. This presentation provides his remarkable and unique perspective of the patient, researcher, and advocate all at once.

Watch: Personalized, Personalized Medicine [55:35]

Steven Joffe, MD, MPH, Emanuel and Robert Hart Professor of Medical Ethics and Health Policy and Professor of Pediatrics at University of Pennsylvania Perelman School of Medicine, gave a keynote address at the OHRP RCF in Boston, MA in May 2018. RCF hosts Boston University School of Medicine and Harvard Catalyst/Harvard Clinical and Translational Science Center, in collaboration with Boston Children's Hospital, Partners HealthCare, Tufts Clinical and Translational Institute, and Yale Center for Clinical Investigation posted this video of Dr. Joffe's presentation for public distribution.

Dr. Joffe's presentation considers the complexities of informed consent including various purposes, strategies to achieve those purposes, and how to prioritize them in order to achieve the multiple purposes of informed consent.

Watch: Achieving the Multiple Aims of Informed Consent to Research [43:41]

Joseph Garner, DPhil, delivered the keynote address at an OHRP Research Community Forum co-sponsored by UC San Diego. UC San Diego has shared his presentation, which explores the challenges of translating drug discoveries (and other basic science findings) into human outcomes, and how changes in animal research could help address these problems. Dr. Garner is an Associate Professor of Comparative Medicine at the Stanford University Medical Center, where he runs Stanford's Technique Refinement and Innovation Lab, which provides a wide range of support services to help researchers maximize the efficiency of their work and the well-being of the animals involved. (February 28, 2018)

Watch: What is Ethical Today? [1:00:50]

Stephen Kingsmore, MD, DSc, President and CEO of Rady Children's Institute for Genomic Medicine delivered a plenary session at an OHRP Research Community Forum co-sponsored by UC San Diego. UC San Diego has posted his talk, in which he shares his experience and successes in using genome sequencing for rapid diagnosis of genetic diseases in neonates. Dr. Kingsmore's work on the cutting edge of personalized medicine has also earned him the Guinness World Records title for fastest genetic diagnosis. (February 28, 2018)

Watch: Taking off the blindfold: genetic testing for babies born with mysterious ailments [32:53]

Mark Barnes, JD, LLM, presented as co-chair of the SACHRP Subcommittee on Harmonization to the SACHRP Committee during its public meeting on October 17,2017. In the presentation, Mr. Barnes provided a detailed discussion of the “HIPAA Exemption” in the revised Common Rule and how it might be operationalized with the HIPAA regulations. For additional information, please see the following links:

• Watch the SACHRP discussion that followed Mr. Barnes’ presentation: https://videocast.nih.gov/Summary.asp?Live=26511&start=4171&duration=7295
• Read SACHRP’s recommendations on the Interpretation and Application of 46.104(d)(4)(iii): /ohrp/sachrp-committee/recommendations/attachment-b-december-12-2017/index.html

Watch: Common Rule Revision: HIPAA Exemption 46.104(d)(4)(iii) [3:46:01]

Christine Grady, PhD, Chief of the Department of Bioethics at the NIH Clinical Center, delivered a thought-provoking keynote address at the OHRP RCF in September 2017 in Cincinnati, Ohio. The co-hosts of the RCF, Cincinnati Children's Hospital Medical Center, Schulman IRB, University of Cincinnati, University of Kentucky Office of Research Integrity, Cincinnati Veterans Affairs Medical Center, the UK Center for Clinical and Translational Science, and the Center for Clinical & Translational Science & Training, posted this recording of Dr. Grady's presentation for public education purposes.

Dr. Grady's presentation explores the challenges of respecting the rights and welfare of research participants in a broad range of research including secondary research with data and biospecimens, and clinical trials studying usual care. Her discussion focuses on the role of the research team and their interactions with the IRB.

Watch: Jazz, Blues, and Improvisation – the Changing Rhythms of Ethical Clinical Research [1:01:00]

Joe Konstan, PhD, Distinguished McKnight Professor and Distinguished University Teaching Professor of Computer Science and Engineering at the University of Minnesota, gave a plenary speech at an OHRP sponsored RCF in Cincinnati, Ohio. The co-hosts of the RCF, Cincinnati Children's Hospital Medical Center, Schulman IRB, University of Cincinnati, University of Kentucky Office of Research Integrity, Cincinnati Veterans Affairs Medical Center, the UK Center for Clinical and Translational Science, and the Center for Clinical & Translational Science & Training, posted this recording of Dr. Konstan's presentation for public education purposes.

In this talk, Dr. Konstan discusses the distinctive challenges that exempt studies present for IRBs. Some areas of research need rapid review, and standard IRB policies are often silent when faced with changes in an exempt study and deciding when they rise to the level of review. Looking at exempt research from the PI perspective, he uses examples to draw lessons on how PIs and IRBs might better collaborate on ensuring compliance and safety in exempt research.

Watch: Improvised Exemptions: A Soloist's Perspective [45:15]

Joni Rutter, PhD, Director of Scientific Programs for the All of Us Research Program (an NIH initiative that seeks to advance precision medicine), was the keynote speaker at an OHRP sponsored RCF in Augusta, GA. Dr. Rutter discussed the All of Us program and the genetic components of the program's research initiative with a special focus on how the program is approaching development of the informed consent materials for genetic research.

Watch: The All of Us Research Program: An Overview and Focus on Genetics Research & Consenting [1:01:35]

Pearl O'Rourke, MD, is Director of Human Research Affairs at Partners HealthCare Systems and Associate Professor of Pediatrics at Harvard Medical School. Dr. O'Rourke gave a plenary speech at an OHRP sponsored RCF in Augusta, GA, in which she discussed revisions to the Common Rule and other regulations and what these changes might mean for genetic and genomic research in the future.

Watch: The Changing Regulatory Landscape and Genetic Research [41:37]

Stuart L. Goldberg, M.D., delivered a plenary presentation at the OHRP Research Community Forum co-sponsored with Hackensack University Medical Center in New Jersey, on the exciting opportunities of tailoring and maximizing value in cancer care through effective data-mining and management. Dr. Goldberg is hematologist/oncologist and Chief Medical Officer of COTA (Cancer Outcomes Tracking and Analysis), and a member of the Executive Steering Committee of the Simplicity Trial, the largest observational database for chronic myeloid leukemia.

Watch: The Impact of Personalized Medicine for Cancer Patients through Big and Small Data [35:41]

Benjamin E. Berkman, J.D., M.P.H., gave a plenary address at the OHRP Research Community Forum co-sponsored with Hackensack University Medical Center in New Jersey in April 2017. His presentation addressed various aspects of individuals' choice whether to receive information about genetic incidental findings that might arise in clinical care or research, and ethical considerations related to whether individuals have an absolute right not to know such information. Mr. Berkman is the Deputy Director of the NHGRI Bioethics Core and faculty member in the NIH Department of Bioethics, where he serves as the head of the section on the ethics of genetics and emerging technologies.

Watch: Reexamining the Right Not to Know [37:13]

Julia Lane, Ph.D., delivered the keynote address at the OHRP Research Community Forum co-sponsored with Hackensack University Medical Center in New Jersey. Her presentation explored the challenges of preventing re-identification of individuals represented in large datasets while maintaining the utility of the information for research purposes. Dr. Lane is a professor at the Center for Urban Science and Progress (CUSP) at NYU's Wagner Graduate School of Public Service, and serves as a Provostial Fellow for Innovation Analytics and a Senior Fellow at NYU's GovLab where she is helping to build the CUSP Data User Facility. (April 5, 2017)

Watch: Big Data, Privacy, and the Public Good [1:00:57]

Camille Nebeker, Ed.D., M.S., gave the keynote address at an OHRP sponsored RCF in Hartford, Connecticut, speaking about the ethical use of personal health data and data from mobile technologies in research. Dr. Nebeker is an Assistant Professor of Behavioral Medicine, Family Medicine, and Public Health in the UC San Diego School of Medicine.

Watch: Connected and Open Research Ethics: Ethical Research Using Personal Health Data [52:01]

Ivor Pritchard, Ph.D. is Senior Advisor to the Director at OHRP. Dr. Pritchard's plenary address at an OHRP-sponsored Research Community Forum in October, 2016 discussed how human research regulations pertain to social media and internet research, and how changing conceptions of privacy impact the ethics of research using social media and the internet.

Watch: Regulating Social Media and Internet Research: Public, Private, or What? [57:45]

Mark Barnes, J.D. is a Partner at Ropes and Gray LLP, faculty co-chair of the Multi-Regional Clinical Trials Center at Harvard and Brigham and Women's Hospital, and lecturer at Yale Law School and Yale School of Medicine. Mr. Barnes gave a plenary presentation at an OHRP sponsored RCF in Hartford, Connecticut addressing the contradictory regulatory requirements of the Clinical Laboratory Improvement Amendments (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as they relate to disclosing actionable incidental findings to research participants, and attempts to reconcile their requirements.

Watch: Return of Research Test Results [40:01]

Richard Gorman, M.D. is the Associate Director for Clinical Research at the Division of Microbiology and Infectious Disease at the National Institute for Allergy and Infectious Disease at NIH. Dr. Gorman gave the keynote address at an OHRP sponsored RCF in June 2016, on the design and conduct of clinical trials, the potential biases and errors, and examples of methods to reduce and eliminate bias and mismanagement.

Watch: How Do You Know What You Think You Know? [38:39]

Celia B. Fisher, Ph.D. is the Marie Ward Doty University Chair in Ethics and Professor of Psychology at Fordham University. Dr. Fisher gave the keynote address at an OHRP sponsored Research Community Forum in April 2016 in Miami, Florida. Her presentation discussed ethical challenges and regulatory considerations in research with vulnerable and marginalized at-risk adolescent populations.

Watch: Ethics & Social Justice in Health Research Involving Vulnerable Adolescents [49:48]

Reflecting on his 30 years as Director of the National Institute of Allergy and Infectious Disease, Anthony Fauci, M.D. speaks at PRIM&R about historical issues at the intersection of science, medicine, bioethics, policy, and politics. He recalls some of the difficult choices faced in the early years of the HIV/AIDS epidemic and connects them to current issues, including concerns around the Ebola vaccine.”

Dr. Fauci appeared as a keynote speaker at PRIM&R's 2014 Advancing Ethical Research Conference. For more information about the Conference and PRIM&R, Watch: Addressing the HIV/AIDS Pandemic: Ethical Challenges [43:28]