Luminaries Lecture Series

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OHRP offers a series of lectures by esteemed individuals with thought-provoking insights on human subjects research protections. Many of these lectures are recordings of keynote addresses at OHRP-sponsored Research Community Forum (RCF) events that take place approximately three times a year at locations across the United States.

All lectures in the Luminaries Lecture Series meet the Certified IRB Professional (CIP) recertification guidelines and are eligible for 0.25 CIP credit hours per 15 minutes of lecture. [Please have a supervisor sign a log indicating the title and duration of the video and the date in which it was watched as proof of attendance for CIP purposes.]

Highlighted Lecture Recordings

Thumbnail of Use of eConsent in Human Subjects Research video

February 4, 2020

Use of eConsent in Human Subjects Research

Thumbnail of What is identifiable? HIPAA vs. Common Rule 2021 Research Community Forum video

June 16, 2021

What is identifiable? HIPAA vs. Common Rule 2021 Research Community Forum

Thumbnail of The Yale Model and Our Partnered Approach: Increasing Clinical Trial Representation Through Community Collaboration and Innovation video

June 16, 2021

The Yale Model and Our Partnered Approach: Increasing Clinical Trial Representation ...

Thumbnail of Making Mobile Clinical Trials a Reality video

April 18, 2019

Making Mobile Clinical Trials a Reality

Thumbnail of Community Consultation in Dallas Fort-Worth: An Opportunity to Learn from Our Neighbors video

June 15, 2021

Community Consultation in Dallas Fort-Worth: An Opportunity to Learn from Our Neighbors

Thumbnail of Supporting Ethical Research Involving American Indian/Alaska Native (AI/AN) Populations video

August 26, 2021

Supporting Ethical Research Involving American Indian/Alaska Native (AI/AN) Populations

Thumbnail of Finding the Key in Key Information video

June 15, 2021

Finding the Key in Key Information

Thumbnail of Crossing Borders: Transnational Research and Human Subjects Protections video

June 16, 2021

Crossing Borders: Transnational Research and Human Subjects Protections

Thumbnail of Saving Lives with Community-Based Research video

June 15, 2021

Saving Lives with Community-Based Research

Thumbnail of the FDA Real World Evidence Program – Opportunities and Challenges video

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] exit disclaimer icon

 
Robert Winn, M.D.

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] exit disclaimer icon

 
Dr. Blizinsky

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] exit disclaimer icon

 
Joseph Garner

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] exit disclaimer icon

 
Joseph Garner

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] exit disclaimer icon

 
Joseph Garner

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] exit disclaimer icon

 
Stephen Kingsmore

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] exit disclaimer icon

 
Thumbnail of Common Rule Revision video

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

 
Christine Grady, PhD

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] exit disclaimer icon

 
Joe Konstan, PhD

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] exit disclaimer icon

 
Joni Rutter, PhD

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] exit disclaimer icon

 
Pearl O'Rourke, MD

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] exit disclaimer icon

 
Stuart L. Goldberg, M.D.

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] exit disclaimer icon

 
Benjamin E. Berkman, J.D., M.P.H.

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] exit disclaimer icon

 
Thumbnail of the Big Data, Privacy, and the Public Good video

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] exit disclaimer icon

 
Camille Nebeker, Ed.D., M.S.

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] exit disclaimer icon

 
Ivor Pritchard, Ph.D.

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] exit disclaimer icon

 
Mark Barnes, J.D.

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] exit disclaimer icon

 
Richard Gorman, M.D.

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] exit disclaimer icon

 
Celia B. Fisher, Ph.D.

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] exit disclaimer icon

 
Dr. Fauci

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] exit disclaimer icon

 
OHRP commemorated the 25th anniversary of the publication of the Belmont Report a milestone in Federal responsibility, leadership and commitment, with a ceremony held on November 16, 2004. That event honored the writers of the Belmont Report – the members, consultants, and staff of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1974-78.
 
OHRP also developed a short video that provides the context for the Belmont Report for those who are not familiar with its principles and uses.
 

Oral History Collection

This collection includes interviews conducted in 2004 with members and staff of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Transcripts of these interviews are available as well.

Duane Alexander, M.D. (Commission Staff)
Tom L. Beauchamp, Ph.D. (Commission Staff)
Robert Cooke, M.D. (Commissioner)
F. William Dommel, J.D. (NIH Liaison to Commission)
Norman Fost, M.D., M.P.H. (Consultant to Commission)
Dorothy Height, Ph.D. (Commissioner)
Albert R. Jonsen, Ph.D. (Commissioner)
Miriam Kelty, Ph.D. (Commission Staff)
Patricia King, J.D. (Commissioner)
Karen Lebacqz, Ph.D. (Commissioner)
Bonnie M. Lee, B.A. (Commission Staff)
Robert Levine, Ph.D. (Consultant to Commission)
Charles R. McCarthy, Ph.D. (NIH Liaison to Commission)
Barbara Mishkin, J.D. (Commission Staff)
Rep. Paul Rogers (U.S. Congress)
Donald Seldin, M.D. (Commissioner)
Stephen Toulmin, Ph.D. (Commission Staff)
LeRoy Walters, Ph.D. (Commission Staff)
Michael Yesley, J.D. (Commission Staff)

 

We provide these videos solely for our users’ information and convenience. The opinions expressed in the videos are those of the speakers. They do not necessarily reflect the views of the Office for Human Research Protections or the U.S. Department of Health and Human Services.The inclusion of external hyperlinks does not constitute endorsement or recommendation by the U.S. Government, HHS, or OHRP of the linked Web resources or the information, products, or services contained therein. OHRP does not exercise any control over the content of these sites.

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February 4, 2020

Use of eConsent in Human Subjects Research

Megan Doerr, MS, LGC, principal scientist at Sage Bionetworks delivered a lunch-and-learn webcast for OHRP in January 2020. Ms Doerr described various forms of e-consent, the importance of accessibility and readability, the use of apps for research purposes, and shared case studies to explore ways of approaching e-consent to satisfy regulatory requirements and ethical standards. Sage Bionetworks posted this video for public distribution.

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June 16, 2021

What is identifiable? HIPAA vs. Common Rule 2021 Research Community Forum

Speakers, Frank Conte, MS, Director at Huron Consulting Group and Joan M. Podleski, CHPC, CCEP, CHRC, CHC, Chief Privacy Officer at Children’s Health System of Texas, detailed the critical differences between HIPAA and the Common Rule on the understanding of what is identifiable and related policies at the OHRP Research Community Forum co-sponsored with the University of Texas Southwestern in June 2021.

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June 16, 2021

The Yale Model and Our Partnered Approach: Increasing Clinical Trial Representation Through Community Collaboration and Innovation

Speakers Tesheia Harris, MBA, MHS (formerly Johnson) Deputy Director and Chief Operating Officer, YCCI, Director for Clinical Research, Yale School of Medicine and Reverend Dr. Leroy O. Perry, Jr. Pastor, St. Stephens AME Zion Church discussed the Yale experience in community outreach and engagement to promote the recruitment of diverse participant populations in clinical trials. Their presentation was delivered at the OHRP Research Community Forum co-sponsored with the University of Texas Southwestern in June 2021.

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April 18, 2019

Making Mobile Clinical Trials a Reality

Michele Russell-Einhorn, J.D., chief compliance officer and institutional official for Advarra, and Greg Licholai, M.D., MBA, chief medical and information officer at PRA Health Sciences and co-director of the Center for Digital Health at Yale School of Management, partnered to deliver a plenary presentation at the OHRP RCF in Overland Park, Kansas in April 2019. They shared experience and recommendations from the Clinical Trials Transformation Initiative, discussed the science and the ethics with incorporating mobile technologies into clinical trials, and highlighted the practical considerations for investigators, study staff and IRB reviewers. RCF host KU Medical Center of the University of Kansas posted this video for public distribution.

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June 15, 2021

Community Consultation in Dallas Fort-Worth: An Opportunity to Learn from Our Neighbors

Speakers Ahamed Idris, MD, Professor of Emergency Medicine and Internal Medicine and the Director of the Dallas-Fort Worth Center for Resuscitation Research at University of Texas Southwestern Medical Center and Pamela J. Okada, MD, MS, Professor of Pediatrics, Division of Pediatric Emergency Medicine at University of Texas Southwestern Medical Center presented their experience of conducting clinical trials for emergency problems such as cardiac arrest and severe traumatic injury that required special exception from informed consent (EFIC). The speakers outlined Dallas-Fort Worth’s (DFW) community consultation methods required for EFIC, including random digit dialing surveys, focus groups, community advisory panels, and one-on-one discussions with citizens attending large-scale community events.

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August 26, 2021

OHRP hosted a virtual workshop on research involving American Indian and Alaska Native (AI/AN) populations with a special welcome address from Dr. Rachel L. Levine. The workshop discussed important considerations for conducting research involving AI/AN populations, including how to incorporate indigenous interests in the design of the research and obtain appropriate approvals. The workshop also provided an overview of helpful materials from the Indian Health Service, and training resources for committees reviewing AI/AN research.

Find details about the event at https://www.hhs.gov/ohrp/education-and-outreach/educational-collaboration-with-ohrp/workshops/ohrp-hosted-workshops-aug2021/index.html exit disclaimer icon.

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June 15, 2021

Finding the Key in Key Information

Speakers John R. Baumann, PhD, Associate Vice President for Research Compliance at Indiana University and Ryan McDowell, Director of the Office of Research Integrity at Children’s Mercy Research Institute, discussed approaches for how to develop and communicate “key information” to prospective research participants. Their presentation was delivered at the OHRP Research Community Forum co-sponsored with the University of Texas Southwestern in June 2021.

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June 16, 2021

Crossing Borders: Transnational Research and Human Subjects Protections

Speakers John R. Baumann, PhD, Associate Vice President for Research Compliance at Indiana University and Mariette Marsh, MPA, CIP/CHPC,CHRC, Senior Director of Research Ethics & Quality at the University of Arizona discussed the challenges of research oversight that arose from conducting transnational research involving different cultural, regulatory, and institutional contexts. Their presentation was delivered at the OHRP Research Community Forum co-sponsored with the University of Texas Southwestern in June 2021.

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June 15, 2021

Saving Lives with Community-Based Research

Ahamed Idris, MD, Professor of Emergency Medicine and Internal Medicine and the Director of the Dallas-Fort Worth Center for Resuscitation Research at the University of Texas Southwestern Medical Center presented findings from clinical trials for emergency problems such as cardiac arrest and severe traumatic injury conducted by the NIH-sponsored Dallas-Fort Worth Resuscitation Outcomes Consortium (ROC).

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