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