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More than Meets the IRB: A joint initiative of Washington University in St. Louis and PRIM&R

Washington University in St. Louis and PRIM&R

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More than Meets the IRB: A joint initiative of Washington University in St. Louis and PRIM&R
More than Meets the IRB: A joint initiative of Washington University in St. Louis and PRIM&R

More than Meets the IRB: A joint initiative of Washington University in St. Louis and PRIM&R

Washington University in St. Louis and PRIM&R

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A series of appropriate, relevant, and educational podcasts, designed to illuminate the compelling need for the consideration of research ethics in research protocol writing and review, and across the research enterprise. The podcast will feature a series of interviews, panel discussions, and reviews of issues related to human research ethics by discussing current events in the human research world, talks with investigators and research subjects, and reviews of literature relevant to those interested in research ethics.

Latest Episodes

Rebecca Dresser: Rethinking Our Perspective in Pursuit of Empathy

This week’s episode of More than Meets the IRB brings back the podcast’s very first guest! The new episode aims to shift the perspective of IRBs to include the often-neglected point of view of actual participants when designing consent. It also taps into the role of empathy and how researchers and IRB members can channel it to better protect subjects. Rebecca Dresser is an expert in biomedical ethics. She has taught law and medical students about legal and ethical issues in end-of-life care, biomedical research, genetics, assisted reproduction, and related topics. She has written extensively in her field and is the co-author of a casebook on bioethics and law and a book on the ethical treatment of animals. She is the sole author of Silent Partners: Human Subjects and Research Ethics. Dresser cites her own experience with a cancer diagnosis to illustrate and explicate a critical distinction: that between hypothetical research subjects and the actual, living individual who is faced ...

22 MIN2017 NOV 1
Comments
Rebecca Dresser: Rethinking Our Perspective in Pursuit of Empathy

Dr. Elizabeth Buchanan: Internet Research Ethics through the Lens of History

This episode of More than Meets the IRB takes us back to the early days of the internet, internet research, and internet research ethics. The advent of this powerful tool presented a new kind of challenge for IRBs, who must figure out whether and how the existing bioethics research principles apply in online spaces. Elizabeth Buchanan, PhD, currently serves as the acting director for the Office of Research and Sponsored Programs at the University of Wisconsin-Stout. Dr. Buchanan sorts internet research ethics into three broad phases reflecting technological and cultural shifts, each of which demanded that the field flexibly adapt to new ethical issues and considerations. The first phase marks a period starting from mid 1990s to around the year 2005 when internet research was in its early stages. Between 2005 and 2010 came the proliferation of social media, and its extensive use demanded a readjustment and reevaluation of internet research. Beginning around 2010, internet research et...

17 MIN2017 OCT 11
Comments
Dr. Elizabeth Buchanan: Internet Research Ethics through the Lens of History

Gigi McMillan: Personal Narratives in Research Ethics History

Today’s episode of More than Meets the IRB explores the research ethics field’s origin and the values behind its foundation. Given the impending implementation date of the revised Common Rule, now is an excellent time to reflect and discuss the research ethics field, the history of the IRB, and the reasons why it all started. While experience in the field research ethics abounds, no collected body of personal narratives on the subject existed prior to the launch of PRIM&R's People & Perspectives project. The website is comprised of stories from eminent members of the research field community that shed light on the genesis of the IRB and the conflicts, compromises, and passions that gave rise to the field. In this episode, we talk with Gianna McMillan, who stewarded the project and its conversations to illuminate the human narratives that coalesced to give rise to the field of research ethics and the regulations that undergird it. Gianna McMillan is the Bioethics Institute Graduate...

18 MIN2017 AUG 16
Comments
Gigi McMillan: Personal Narratives in Research Ethics History

Benjamin Wilfond: Informed Consent with ROMP

In this installment of the More than Meets the IRB: A Joint Initiative of Washington University in St. Louis, and PRIM&R, we talk about the ethical and regulatory considerations of research on medical practices (ROMP). Dr. Benjamin Wilfond, director of the Treuman Katz Center for Pediatric Bioethics and a pulmonologist at Seattle Children’s Hospital, recently published a study on the ethical and informed consent considerations of research on the types of care that work best in clinical practice. Such research blurs the line between clinical risk and research risk, which can present novel questions and challenges to IRBs. That the research involves the use of clinical practices on real patients, suggests Dr. Wilfond, means that innovative approaches to informed consent are needed. For example: in a survey Dr. Wilfond conducted on a general population, 85% of respondents said that they would prefer to discuss their participation in a randomized treatment trial with their doctor rathe...

20 MIN2017 JUN 7
Comments
Benjamin Wilfond: Informed Consent with ROMP

Robert Klitzman: Exploring the Researcher-IRB Disconnect

In this episode of More than Meets the IRB: A Joint Initiative of Washington University in St. Louis and PRIM&R, we speak with Dr. Robert Klitzman about transparency and consistency of IRBs in addition to their sometimes-fraught relationship with investigators. Dr. Klitzman is Professor of Clinical Psychiatry in the College of Physicians and Surgeons and Director of the Masters of Bioethics Program at Columbia University. He is the author of The Ethics Police?: The Struggle to Make Human Research Safe, which constituted some of the first broad, qualitative research on “how IRBs actually make decisions.” In a conversation at PRIM&R’s 2016 Advancing Ethical Research Conference, Dr. Klitzman talks about the factors that generate tension between IRBs and researchers, including the structural incentives researchers face and internal inconsistencies in decision-making by IRBs that “send a confusing message to the research community.” We discuss what’s missing in the world of IRBs th...

23 MIN2017 APR 28
Comments
Robert Klitzman: Exploring the Researcher-IRB Disconnect

Frederic Koning: The IRB and the Community It Serves

In this episode of More than Meets the IRB: A Joint Initiative of Washington University in St. Louis and PRIM&R, we speak with Fred Koning, M.Div, Th.M, M.S., about the role of the non-scientist community member on the IRB. The non-scientist member (often discussed as the “community member”) role is “notoriously” difficult to define, and in this episode we discuss with Koning—a longtime non-scientist IRB member and former parish minister—how he perceives the role. After exploring what IRBs owes its community, we discuss how Koning’s own personal background with family members in clinical trials informs his work with the IRB. The episode closes with an acknowledgment that “scientific or medical naiveté” on the part of the non-scientist IRB member can open up important lines of ethical inquiry that experts wouldn’t necessarily think to examine.

15 MIN2017 MAR 31
Comments
Frederic Koning: The IRB and the Community It Serves

Proposals for the Future of the Consent Process with Dr. Elisa Hurley

On today’s episode of More than Meets the IRB, we talk with PRIM&R Executive Director Elisa Hurley about the controversial elements of the NPRM and those which ultimately made it into the final rule. This episode considers challenging questions about the future of research: what might change in how we build policy within the United States? Dr. Elisa Hurley is the Executive Director of Public Responsibility in Medicine and Research. Dr. Hurley holds a PhD in philosophy from Georgetown University and held a Greenwall fellowship in bioethics and health policy at the Johns Hopkins Berman Institute of Bioethics and Georgetown University's Kennedy Institute of Ethics. How Appropriate is the Consent Process? Recent advances in science and research methods have demanded a renewed engagement in the principles that guide ethical research, which Dr. Hurley cites as an occasion to “rethink how we operationalize this basic principle of respect for persons.” This is also an opportunity to enga...

17 MIN2017 FEB 22
Comments
Proposals for the Future of the Consent Process with Dr. Elisa Hurley

Dr. Anthony Fauci: The Ethical Challenges of Addressing the HIV/AIDS Pandemic

In today’s episode of More than Meets the IRB, we hear from awardee of the Presidential Medal of Honor Dr. Anthony Fauci on some of the ethical challenges he faced in addressing the HIV/AIDS pandemic. It’s an engaging and wide-ranging narrative: from Fauci’s publicly denouncing the FDA’s process of delivering certain drugs to individuals to his receiving presidential acknowledgement for a creative idea of how to bring drug access to these patients. Dr. Anthony Fauci has been the director of the National Institute of Allergy and Infectious disease for over 30 years . He has played a critical role in research of HIV/AIDS and other immunodeficiencies. Early Drug Development When the government didn’t make available certain drugs quickly to the community of HIV/AIDS patients, they would acquire them through illicit groups known as Buyers Clubs (as featured in the 2013 film The Dallas Buyers Club). We learn about the iconic randomized control trial of AZT as well as the treatment of...

16 MIN2017 JAN 6
Comments
Dr. Anthony Fauci: The Ethical Challenges of Addressing the HIV/AIDS Pandemic

Henrietta Lacks - The Importance of Consent, Communication and Ethics in Medicine

In today’s episode of More than Meets the IRB, we listen in on a conversation from PRIM&R’s AER14 Conference among members of Henrietta Lacks’ family, a member of the NIH, and a representative from Johns Hopkins University. We hear the initial perspectives and processes the Lacks family went through in understanding the choices they had to make regarding genomic data from the HeLa cells, in addition to what has changed since Rebecca Skloot’s book, The Immortal Life of Henrietta Lacks, was published. Importance of disclosing as much information as clearly as possible. Several of the Lacks family members describe the process by which they were informed about what a genome was in addition to benefits and risks of the information being used for research. They also discuss being given the opportunity to ask as many questions as they needed of NIH director Dr. Francis Collins, which enabled them to fully understand the issue and make the best possible decision for each family member. ...

17 MIN2016 SEP 19
Comments
Henrietta Lacks - The Importance of Consent, Communication and Ethics in Medicine

The Century of the System with Dr. Atul Gawande

Today’s episode of More than Meets the IRB investigates the role of ethical review in a dramatically changing scientific landscape where ineptitude, not ignorance, is becoming a focus of public health. Dr. Atul Gawande reveals a practical solution that is successfully addressing ineptitude among surgery teams across eight different locations around the world. Renowned speaker Dr. Gawande is a general and endocrine surgeon, professor at the Harvard School of Public Health and Harvard Medical School, executive director of a lab for health-systems innovation, and chairman of a nonprofit making surgery safer globally. “We’ve entered a world where ineptitude has become as big a problem as ignorance.” – Dr. Atul Gawande Ignorance and Ineptitude The major change in knowledge today is the emphasis on systems over research. There are two sources of failure in anything humans set out to do: 1. Ignorance—we have not learned how to solve all of our problems, but research has helped close ...

18 MIN2016 AUG 18
Comments
The Century of the System with Dr. Atul Gawande

Latest Episodes

Rebecca Dresser: Rethinking Our Perspective in Pursuit of Empathy

This week’s episode of More than Meets the IRB brings back the podcast’s very first guest! The new episode aims to shift the perspective of IRBs to include the often-neglected point of view of actual participants when designing consent. It also taps into the role of empathy and how researchers and IRB members can channel it to better protect subjects. Rebecca Dresser is an expert in biomedical ethics. She has taught law and medical students about legal and ethical issues in end-of-life care, biomedical research, genetics, assisted reproduction, and related topics. She has written extensively in her field and is the co-author of a casebook on bioethics and law and a book on the ethical treatment of animals. She is the sole author of Silent Partners: Human Subjects and Research Ethics. Dresser cites her own experience with a cancer diagnosis to illustrate and explicate a critical distinction: that between hypothetical research subjects and the actual, living individual who is faced ...

22 MIN2017 NOV 1
Comments
Rebecca Dresser: Rethinking Our Perspective in Pursuit of Empathy

Dr. Elizabeth Buchanan: Internet Research Ethics through the Lens of History

This episode of More than Meets the IRB takes us back to the early days of the internet, internet research, and internet research ethics. The advent of this powerful tool presented a new kind of challenge for IRBs, who must figure out whether and how the existing bioethics research principles apply in online spaces. Elizabeth Buchanan, PhD, currently serves as the acting director for the Office of Research and Sponsored Programs at the University of Wisconsin-Stout. Dr. Buchanan sorts internet research ethics into three broad phases reflecting technological and cultural shifts, each of which demanded that the field flexibly adapt to new ethical issues and considerations. The first phase marks a period starting from mid 1990s to around the year 2005 when internet research was in its early stages. Between 2005 and 2010 came the proliferation of social media, and its extensive use demanded a readjustment and reevaluation of internet research. Beginning around 2010, internet research et...

17 MIN2017 OCT 11
Comments
Dr. Elizabeth Buchanan: Internet Research Ethics through the Lens of History

Gigi McMillan: Personal Narratives in Research Ethics History

Today’s episode of More than Meets the IRB explores the research ethics field’s origin and the values behind its foundation. Given the impending implementation date of the revised Common Rule, now is an excellent time to reflect and discuss the research ethics field, the history of the IRB, and the reasons why it all started. While experience in the field research ethics abounds, no collected body of personal narratives on the subject existed prior to the launch of PRIM&R's People & Perspectives project. The website is comprised of stories from eminent members of the research field community that shed light on the genesis of the IRB and the conflicts, compromises, and passions that gave rise to the field. In this episode, we talk with Gianna McMillan, who stewarded the project and its conversations to illuminate the human narratives that coalesced to give rise to the field of research ethics and the regulations that undergird it. Gianna McMillan is the Bioethics Institute Graduate...

18 MIN2017 AUG 16
Comments
Gigi McMillan: Personal Narratives in Research Ethics History

Benjamin Wilfond: Informed Consent with ROMP

In this installment of the More than Meets the IRB: A Joint Initiative of Washington University in St. Louis, and PRIM&R, we talk about the ethical and regulatory considerations of research on medical practices (ROMP). Dr. Benjamin Wilfond, director of the Treuman Katz Center for Pediatric Bioethics and a pulmonologist at Seattle Children’s Hospital, recently published a study on the ethical and informed consent considerations of research on the types of care that work best in clinical practice. Such research blurs the line between clinical risk and research risk, which can present novel questions and challenges to IRBs. That the research involves the use of clinical practices on real patients, suggests Dr. Wilfond, means that innovative approaches to informed consent are needed. For example: in a survey Dr. Wilfond conducted on a general population, 85% of respondents said that they would prefer to discuss their participation in a randomized treatment trial with their doctor rathe...

20 MIN2017 JUN 7
Comments
Benjamin Wilfond: Informed Consent with ROMP

Robert Klitzman: Exploring the Researcher-IRB Disconnect

In this episode of More than Meets the IRB: A Joint Initiative of Washington University in St. Louis and PRIM&R, we speak with Dr. Robert Klitzman about transparency and consistency of IRBs in addition to their sometimes-fraught relationship with investigators. Dr. Klitzman is Professor of Clinical Psychiatry in the College of Physicians and Surgeons and Director of the Masters of Bioethics Program at Columbia University. He is the author of The Ethics Police?: The Struggle to Make Human Research Safe, which constituted some of the first broad, qualitative research on “how IRBs actually make decisions.” In a conversation at PRIM&R’s 2016 Advancing Ethical Research Conference, Dr. Klitzman talks about the factors that generate tension between IRBs and researchers, including the structural incentives researchers face and internal inconsistencies in decision-making by IRBs that “send a confusing message to the research community.” We discuss what’s missing in the world of IRBs th...

23 MIN2017 APR 28
Comments
Robert Klitzman: Exploring the Researcher-IRB Disconnect

Frederic Koning: The IRB and the Community It Serves

In this episode of More than Meets the IRB: A Joint Initiative of Washington University in St. Louis and PRIM&R, we speak with Fred Koning, M.Div, Th.M, M.S., about the role of the non-scientist community member on the IRB. The non-scientist member (often discussed as the “community member”) role is “notoriously” difficult to define, and in this episode we discuss with Koning—a longtime non-scientist IRB member and former parish minister—how he perceives the role. After exploring what IRBs owes its community, we discuss how Koning’s own personal background with family members in clinical trials informs his work with the IRB. The episode closes with an acknowledgment that “scientific or medical naiveté” on the part of the non-scientist IRB member can open up important lines of ethical inquiry that experts wouldn’t necessarily think to examine.

15 MIN2017 MAR 31
Comments
Frederic Koning: The IRB and the Community It Serves

Proposals for the Future of the Consent Process with Dr. Elisa Hurley

On today’s episode of More than Meets the IRB, we talk with PRIM&R Executive Director Elisa Hurley about the controversial elements of the NPRM and those which ultimately made it into the final rule. This episode considers challenging questions about the future of research: what might change in how we build policy within the United States? Dr. Elisa Hurley is the Executive Director of Public Responsibility in Medicine and Research. Dr. Hurley holds a PhD in philosophy from Georgetown University and held a Greenwall fellowship in bioethics and health policy at the Johns Hopkins Berman Institute of Bioethics and Georgetown University's Kennedy Institute of Ethics. How Appropriate is the Consent Process? Recent advances in science and research methods have demanded a renewed engagement in the principles that guide ethical research, which Dr. Hurley cites as an occasion to “rethink how we operationalize this basic principle of respect for persons.” This is also an opportunity to enga...

17 MIN2017 FEB 22
Comments
Proposals for the Future of the Consent Process with Dr. Elisa Hurley

Dr. Anthony Fauci: The Ethical Challenges of Addressing the HIV/AIDS Pandemic

In today’s episode of More than Meets the IRB, we hear from awardee of the Presidential Medal of Honor Dr. Anthony Fauci on some of the ethical challenges he faced in addressing the HIV/AIDS pandemic. It’s an engaging and wide-ranging narrative: from Fauci’s publicly denouncing the FDA’s process of delivering certain drugs to individuals to his receiving presidential acknowledgement for a creative idea of how to bring drug access to these patients. Dr. Anthony Fauci has been the director of the National Institute of Allergy and Infectious disease for over 30 years . He has played a critical role in research of HIV/AIDS and other immunodeficiencies. Early Drug Development When the government didn’t make available certain drugs quickly to the community of HIV/AIDS patients, they would acquire them through illicit groups known as Buyers Clubs (as featured in the 2013 film The Dallas Buyers Club). We learn about the iconic randomized control trial of AZT as well as the treatment of...

16 MIN2017 JAN 6
Comments
Dr. Anthony Fauci: The Ethical Challenges of Addressing the HIV/AIDS Pandemic

Henrietta Lacks - The Importance of Consent, Communication and Ethics in Medicine

In today’s episode of More than Meets the IRB, we listen in on a conversation from PRIM&R’s AER14 Conference among members of Henrietta Lacks’ family, a member of the NIH, and a representative from Johns Hopkins University. We hear the initial perspectives and processes the Lacks family went through in understanding the choices they had to make regarding genomic data from the HeLa cells, in addition to what has changed since Rebecca Skloot’s book, The Immortal Life of Henrietta Lacks, was published. Importance of disclosing as much information as clearly as possible. Several of the Lacks family members describe the process by which they were informed about what a genome was in addition to benefits and risks of the information being used for research. They also discuss being given the opportunity to ask as many questions as they needed of NIH director Dr. Francis Collins, which enabled them to fully understand the issue and make the best possible decision for each family member. ...

17 MIN2016 SEP 19
Comments
Henrietta Lacks - The Importance of Consent, Communication and Ethics in Medicine

The Century of the System with Dr. Atul Gawande

Today’s episode of More than Meets the IRB investigates the role of ethical review in a dramatically changing scientific landscape where ineptitude, not ignorance, is becoming a focus of public health. Dr. Atul Gawande reveals a practical solution that is successfully addressing ineptitude among surgery teams across eight different locations around the world. Renowned speaker Dr. Gawande is a general and endocrine surgeon, professor at the Harvard School of Public Health and Harvard Medical School, executive director of a lab for health-systems innovation, and chairman of a nonprofit making surgery safer globally. “We’ve entered a world where ineptitude has become as big a problem as ignorance.” – Dr. Atul Gawande Ignorance and Ineptitude The major change in knowledge today is the emphasis on systems over research. There are two sources of failure in anything humans set out to do: 1. Ignorance—we have not learned how to solve all of our problems, but research has helped close ...

18 MIN2016 AUG 18
Comments
The Century of the System with Dr. Atul Gawande
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