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. 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.

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 which IRB work is, or can be considered, a “conversation.”

One challenge brought on by these advances is the distance—sometimes literal, in the case of remote review boards—they put between the reviewer and the research. One of the advantages of IRBs has always been their ability to locate research within the context of the community in which it takes place to evaluate important ethical questions; this is less the case in the era of big data and biobanking. As Dr. Hurley says, “there aren’t algorithms to answer these questions about ‘is this an ethical study or not,’ or is ‘this a just way of finding your subjects or not.’ The idea was a group of people, who come with different backgrounds and expectations, are going to have a conversation and arrive at judgment.”

What is the future of research education? What should it be?

The focus then turns to how the public is educated about research and how that needs to change. Identified in particular is the problem wherein many people’s first interaction with research is when they are given a “25-page informed consent document,” which represents an effort to “educate [the subject] and get [him/her] on board all at once.” This is an inadequate model of education, according to Dr. Hurley, and exacerbates already difficult questions of respect for persons.

What is needed, according to Dr. Hurley, is a more systematic and widespread commitment to education about research, implemented nationwide, to bring future potential participants and partners in the research endeavor to a level of understanding that enables them to be able to make educated and appropriate decisions about participation in research well before the official informed consent process begins.

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 similar diseases. A double-blind placebo controlled trial, published in the New England Journal of Medicine in 1987, successfully demonstrated the effectiveness of AZT. The delivery of the drug to those that needed it wasn’t easy (or approved) so the researchers came up with a creative solution on how to provide AZT to those who so urgently needed it.

What is Parallel Track?

Parallel Track denotes access to unproven drugs after a proven drug exists. It makes available (with appropriate informed consent) experimental drugs to those who do not meet the requirements for a drug trial for various reasons, such as geographic or demographic incompatibility.

Parallel Track represented a way to get HIV/AIDS drugs to the gay community outside the confines of a randomized controlled experiment, but doing so violated the rigid and durable guidelines of the regulatory bodies; Dr. Fauci recalls that “the federal government and the FDA thought this was anathema.” The passion of the activists and Dr. Fauci’s experience meeting with patients convinced him that this extraordinary measure was both appropriate and necessary for dealing with the AIDS crisis.

“Either you go blind or you die” –HIV/AIDS Patient

During the AIDS crisis, the rigor and ingrained nature of drug development regulations came up against the urgency and vigor of the activist community. In Dr. Fauci, this conflict caused a “sea change in my attitude toward the flexibility versus the rigidity of the scientific and regulatory community: that is, my relating to and putting myself in the place of a patient or a potential patient…. That was brought home to me by the AIDS activists.”

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 for consent after there wasn’t any initially.

To help answer remaining questions about who would have access to the HeLa genome, NIH members worked to explain what Henrietta Lacks’ tissue cells had done for the world of medicine and the possibilities that her (and their) genomic data could provide to further research. After careful consideration, the NIH and the Lacks family came to a decision wherein access to the genome would be allowed, but under restricted circumstances: the information would be placed in a protected database in which would only be available on request to NIH-approved researchers, and researchers would be required acknowledge the contribution of Henrietta Lacks and her family in addition to carefully reporting any findings and intellectual property implications derived from use of the genome.

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 tremendously.

2. Ineptitude—knowledge may exist, but people fail to apply the knowledge correctly. Today, we may know a great deal but fail to put the pieces together in solving a problem. What is the best way to address this?

The Importance of Effective Medical Systems

A three-year-old girl in Austria fell into an icy pond and drowned. After not breathing for 30 minutes and having a body temperature of 30 degrees below normal, she was miraculously restored to a breathing, functional state through CPR and several machines over a period of weeks.

She had multiple disabilities initially, but after two years, she regained all of her faculties and became a typical five-year-old girl. The revealing truth was that she was restored—not with cutting-edge medicines or technologies—but with a successful system that coordinated hundreds of professionals in executing standard medical procedures.

The Ethics of Implementing Systems

• Ethical questions to review boards such as IRBs are now posed amidst the democratization of once-elite methods of science.

• The “province of professors” has become the domain of medical students, nurses, and pharmacists who interact with data and trials in research.

• We are tinkering with systems that have known levels of harm, trying proven ideas but not understanding how to put the pieces together. In this setting, how can we ensure the ethics of implementing effective systems?