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

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 with a life-changing decision. Dresser suggests that our research culture has been built around the former, neglecting the very real implications that very real people face. In considering research ethics, the research community needs to be more attuned with the potential trial participant’s position when faced with a decision.
One of the things IRBs and ethicists underestimate, according to Dresser, is the powerful influence doctors have over their patients. The moment when a patient hears bad news can be overwhelming; as such, the consent decision is somewhat conditioned. Ethically, it is important to understand the role that trust of doctors plays in understanding a patient’s position.
Dresser argues for a the structural inclusion of empathy in research and regulation design by the actual inclusion of subjects’ input; as she notes in Silent Partners: Human Subjects and Research Ethics, “research decisions that rely on subject input will be ethically and practically superior to those who rely on speculation about such matters.” Regulations and studies that take these considerations into account are likelier to be “subject-friendly,” reflecting the full scope of priorities in subjects’ lives. Researchers could develop their sense of empathy by participating in other studies, Dresser suggests, exposing them both to the practical routines and the emotional implications of participation.

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 ethics has come to focus substantially on big data analytics, a cross-disciplinary tool as powerful as it is fraught with ethical problems.
Dr. Buchanan then explores the problem of privacy. Are there new ethical issues? Or are they still largely the same? Are we asking the right questions? How does privacy considered in the non-internet realm translate conceptually to digital spaces?
In closing, Dr. Buchanan advocates for bold inter-disciplinary work to take advantage of the changing landscapes around internet research.


Dr. Elizabeth Buchanan currently serves as the endowed chair in ethics and director at the Center for Applied Ethics at the University of Wisconsin-Stout.

Dr. Buchanan sorts internet research ethics into three broad phases, which reflect technological and cultural shifts that have demanded that the field flexibly adopt its considerations of the relevant ethical issues.

The first phase marks a period starting from mid 1990s to around the year 2005. Internet research was in its early stages.
Between 2005 and 2010 came the proliferation of social media, whose extensive use demanded a readjustment and reevaluation of internet research.
Beginning around 2010, internet research ethics has come to focus substantially on is big data analytics, a cross-disciplinary tool as powerful as it is fraught with ethical problems.

Then, Dr. Buchanan explores the problem of privacy. Are there new ethical issues? Or are they still largely the same? Are we asking the right questions? How does privacy considered in the non-internet realm translate conceptually to digital spaces?

In closing, Dr. Buchanan advocates for bold inter-disciplinary work to take advantage of the changing landscapes around internet research.

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 Program Coordinator at Loyola Marymount University and the content manager for PRIM&R’s People & Perspectives project.

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 rather than with an investigator or research administrator.

According to Dr. Wilfond, innovation in informed consent–which is necessary in the face of recent innovations in research–demands a willingness on the part of IRBs to shoulder some of the risk in determining how best to protect research subjects while advancing the general medical understanding.

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 that can bridge the gap with researchers, and new developments in the field that have the potential to facilitate (or hinder) the achievement of that goal.

We discuss a previous episode of More than Meets the IRB, with Dr. Laura Stark, which can be found here: http://digitalcommons.wustl.edu/hrpopods/6/

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.