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
21 episodes
7 months ago
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.
All content for More than Meets the IRB: A joint initiative of Washington University in St. Louis and PRIM&R is the property of Washington University in St. Louis and PRIM&R and is served directly from their servers
with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
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.
Dr. Anthony Fauci: The Ethical Challenges of Addressing the HIV/AIDS Pandemic
More than Meets the IRB: A joint initiative of Washington University in St. Louis and PRIM&R
16 minutes 10 seconds
8 years ago
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 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.”
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.
