More Than Meets The Irb: A Joint Initiative Of 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

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 subs

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 Loyol

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

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 rese

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.

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 engage with the degree to whic

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 patients with AIDS and

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. Giving the opportunity

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 our gaps in knowledge treme

Today’s episode of More Than Meets the IRB includes segments from a panel discussion entitled “Increasing the Public’s Understanding of Clinical Research” and focuses on the question of why minority groups are less likely to participate in research. The answer revolves around the issue of trust. Distrust of research among African Americans stems from a history of racial discrimination, exploitation and ethical misconduct in this country. This distrust extends all the way back to the history of enslavement, including medical and surgical experimentation on slaves and robbery of black graves for cadavers. African Americans are more likely to believe that doctors would ask them to participate in harmful research, expose them to unnecessary risks, not explain research, or include them in experiments without their consent. The research community can approach and address these issues of distrust in a couple of different way. 1. Thinking About Benefit Researchers can attempt to better convey the following benefit

Dr. Susan Lederer is the chair of the Department of Medical History and Bioethics at the University of Wisconsin, and the author of "Flesh and Blood and Subjected To Science". During this panel from the 2014 Advancing Ethical Research Conference, Dr. Lederer discusses the significant and compelling role Henry K. Beecher played in the world of clinical research ethics with his paper Ethics and Clinical Research - http://www.nejm.org/doi/full/10.1056/NEJM196606162742405.

Today we’re talking to Karen Masterson, the scientific journalist who wrote The Malaria Project, a book detailing the history of the US government’s attempts to find a cure for malaria during World War II. Karen discusses the role journalism plays in research ethics and how the scientific community’s treatment of human research participants has shifted dramatically since the 1940s.

In this panel session from the 2013 PRIM&R Advancing Ethical Research Conference, we continue to look at the shifts and trends in social media use that impact the way we culturally perceive privacy and risk. The speaker is Dr. Joseph Konstan, a professor in the department of computer science and engineering at University of Minnesota who has conducted research in the field and also advises the IRB on data security and IT issues related to internet research.

With the proliferation of social media in our daily lives, the way we communicate has been completely transformed. Our guest is Jeff Hancock, formerly a professor of information science and communication at Cornell and currently a communications professor at Stanford, who is well known for his research and TED Talk on how people use deception with technology.

In this podcast, Dr. Ochsner looks at the complicated nature of consent in neuroscience and behavioral research, acknowledging that the risks and benefits of this type of research can be hard to define, making it difficult for IRBs to review.

During this podcast, we talked to Nicolle Strand and Elizabeth Fenton of the Presidential Commission for the Study of Bioethical Issues (PCSBI), which is an incredible but surprisingly underutilized resource when it comes to reviewing human subjects research. We are going to specifically discuss the PCSBI's report Gray Matters: Integrative Approaches for Neuroscience, Ethics and Society, which looks at the ethical issues associated with neurological research.

Today we’re learning from John Wilbanks, chief commons officer at Sage Bionetworks, who has authored numerous publications about data sharing. On this panel, The Evolving Nature of Privacy and Confidentiality from the 2014 AER Conference, he discusses the evolving nature of privacy, confidentiality and anonymity when it comes to collecting and analyzing “big data.”

Camille Nebeker: Goals for Improving the Informed Consent Process in Behavioral Research by Washington University in St. Louis and PRIM&R

The issues surrounding human subject protections and the participant-researcher relationship do not lie in technical non-compliance. The problem lies with the human ability to be trusted and to be counted as trustworthy. The words ‘trust’ and ’trustworthiness’ are not found in guidance provided by federal agencies. These words are much more associated with human relationships and friendship.