Podcasts about institutional review boards irbs

In this episode, Edye Edens and Darshan Kulkarni discuss the evolving landscape of IRB oversight in 2024, including the roles of HRPP, AAHRPP, and OHRP, and the need for greater federal agency involvement. They also cover the impact of new guidance, the Trump administration, and the FDA's relationship with IRBs.We discuss: 1. The FDA's Finalized Guidance on Decentralized Clinical Trials (DCTs): The recent FDA guidance formalizing decentralized elements in clinical trials raises critical questions for Institutional Review Boards (IRBs). While DCTs have existed for years, the official guidance now provides a framework for utilizing healthcare providers (HCPs), remote modalities, and flexible patient engagement. IRBs must consider:Approval Implications: How decentralized elements affect risk-based assessments and informed consent.Data Validity: Whether varying patient experiences impact trial control and data integrity.Protocol Design: Increased complexities in evaluating sponsor protocols that integrate hybrid or decentralized approaches.2. Human Research Protection Programs (HRPPs): IRBs are components of broader HRPPs, which also encompass research compliance, conflict of interest management, and quality auditing. Accreditation bodies like AAHRPP (gold standard for HRPPs) demand higher standards, which could necessitate additional adjustments to align with FDA guidance.3. Regulatory Overlap and Harmonization Challenges: IRBs must navigate overlapping jurisdiction from the FDA and other entities like the Office for Human Research Protections (OHRP). The lack of harmonized regulations between these agencies creates confusion for researchers and inefficiencies in clinical trial oversight.4. FDA Audits and Oversight of IRBs: While the FDA does not directly regulate IRBs, it audits them and issues warning letters or Form 483 observations. IRBs must remain vigilant about FDA compliance, especially with decentralized elements becoming more common.5. Decentralization's Efficiency Debate: There is no blanket conclusion about whether decentralized trials increase efficiency or diversity. IRBs must assess the appropriateness of decentralized approaches on a case-by-case basis, particularly for complex studies like oncology trials or early-phase research requiring hospital stays.6. Calls for Streamlining Oversight: There is growing discussion about reducing redundancy across regulatory bodies to enhance efficiency and lower costs for patients. However, skepticism remains about whether eliminating overlap would ensure adequate protection for trial participants.7. Future Considerations:Adaptation: IRBs must adapt to increased DCT submissions while maintaining rigorous risk-based evaluations.Consistency: Balancing flexibility in decentralized models with the need for consistent oversight practices.Policy Evolution: Ongoing dialogue on whether accrediting bodies like AAHRPP or agencies like OHRP should develop complementary guidance to align with FDA standards.In 2024, IRBs face a critical moment to address these challenges while ensuring that decentralized innovations do not compromise participant safety or trial integrity.Support the show

In this episode, Justin Osborne, Associate Vice President at HRP Consulting Group, shares his 17-year journey in clinical research, focusing on his roles in Institutional Review Boards (IRBs) and HRP's consulting services for universities. Justin also highlights the value of networking and resources for universities. The episode concludes with insights into Justin's experience as a podcast host and his goals for expanding the "On Research" podcast.Justin Osborne is the Associate Vice President of the HRP Consulting Group. He has over 15 years of experience in the human subject research field. He began his research career on the commercial IRB side before shifting to the local IRB world. Justin served as a non-scientific board member at the University of Cincinnati's IRB for several years before returning to the commercial IRB arena. Additional resources: HRP Consulting Group  https://thehrpconsultinggroup.com/  CITI Program's Series – Institutional Review Board (IRB) Administration  https://about.citiprogram.org/series/irb-administration/  CITI Program's Series – Human Subjects Research  https://about.citiprogram.org/series/human-subjects-research-hsr/  

In this conversation with Sam Whitaker, we  delve into the pivotal issues faced by underrepresented groups—particularly those from lower-income backgrounds—highlighting the disparity in current demographics and the consequences it bears on the reliability of drug efficacy and safety data for diverse populations. We go beyond the surface to examine the complexities surrounding compensation for trial participants, debunking the myth that stipends serve as an incentive and instead revealing the net financial loss many endure. With Sam's expertise, we explore why the current compensation structures pose significant barriers for those in lower-income brackets.Sam Whitaker's insights prompt us to question the ethical responsibilities of Institutional Review Boards (IRBs) in safeguarding participant welfare, particularly in terms of payment evaluation. The conversation scrutinizes the pressing need for standardized compensation practices, emphasizing the potential financial harm and barriers these present to willing participants. Our discussion raises awareness about the delicate balance between the pursuit of scientific knowledge and the imperative of ethical consideration in the realm of human testing.Lastly, we shine a light on the legislative efforts aiming to dismantle the financial hurdles that deter diverse participation in clinical trials. Tax implications for low-income participants and the risks to their welfare benefits take center stage, with bipartisan support emerging as a beacon of hope in the push for reform. Sam shares the impactful work being done through Mural Health, including the Portrait Project, which seeks to humanize and democratize the clinical research process. Join us to understand how these initiatives are not just transforming patient involvement, but reshaping the landscape of clinical trials for the betterment of all.Guest:Sam Whitaker Mural Health________Reach out to Sam Parnell and Ivanna RosendalJoin the conversation on our LinkedIn page

In this episode of WCG Talks Trials, our expert panel discusses various ethical, safety, and logistical challenges in accelerating clinical trials for gene and cell therapies in oncology. The conversation explores the role of Institutional Review Boards (IRBs), Institutional Biosafety Committees (IBCs), Endpoint Adjudication Committees (EACs), and Data Monitoring Committees (DMCs) in overseeing these trials, addressing issues such as patient safety, complex trial designs, and emerging biosafety concerns. Our panelists emphasize the importance of transparent communication and collaboration between IRBs and IBCs, highlighting the need to balance the urgency of advancing research with ethical considerations. Additionally, the podcast explores unrealized ethical and safety issues, such as the pace of technological advancements and potential risks associated with gene editing. The speakers also touch upon future opportunities in oncology research, including precision medicine, artificial intelligence, wearable devices, and accelerated regulatory pathways.

In this conversation, Daniel Belkin and Mitch Belkin interview Simon Whitney, MD, JD, about his book From Oversight to Overkill. They discuss the history of Institutional Review Boards (IRBs), including ethically questionable experiments such as Chester Southam's cancer cell injections, the Willowbrook experiment, as well as the US Public Health Service Syphilis Study (AKA Tuskegee experiment). They then discuss Peter Buxton, Henry Beecher, James Shannon, and the congressional oversight of federally funded research. Finally, they touch on the ISIS-2 study, Pronovost's checklist, OHRP's crackdown in the late 1990s, and discuss whether research is too safe, IRB infallibility, autonomy in the Belmont Report, and the risks and benefits of restricting research in the name of safety.Who is Simon Whitney?Simon Whitney, MD, JD, is a family medicine physician and ethicist. He previously taught at Baylor College of Medicine for 22 years. He is currently retired from the practice of medicine but continues to publish and teach medical ethics. He is the author of the book "From Oversight to Overkill: Inside the Broken System That Blocks Medical Breakthroughs—And How We Can Fix It."Support the showFollow us at @ExMedPod Subscribe to our Youtube channelConsider supporting us on Patreon

Dr. Reighan Gillam (University of Southern California) discusses how her fieldwork and research on media producers in Brazil shaped her first monograph Visualizing Black Lives: Ownership and Control in Afro-Brazilian Media. She speaks on how her work in anthropology intersects with media and race studies, antiracist visual politics, alternative media in Brazil, Institutional Review Boards (IRBs) and the question of ethics in research.

We continue our conversation with Marianna Azar, director of NYC Department of Education’s Institutional Review Boards (IRBs). This week, Ms. Azar discusses the potential privacy dangers created by collection and dissemination of research data, strategies to combat them, and the need to strengthen the Family Educational Rights and Privacy Act (FERPA).

Welcome to the DNP Project Podcast where we share tips, inspiration, and more!It's time to get back to school. Our goal is to offer some quick tips for DNP Students. Today's Tip: COVID Compliance and the DNP ProjectThe COVID-19 Pandemic has had a serious impact on the DNP Project. In our experience, we are noting that some Institutional Review Boards (IRBs) are adding requirements to scholarly works that must specifically address compliance to COVID precautions. On June 24th, we partnered with Springer Publishing to host a free webinar entitled, “The Impact of COVID-19 on DNP Projects.” To view this free webinar, visit YouTube at https://youtu.be/g4OSaAZcVSw. In the webinar we basically group DNP Projects into “Projects in Progress” and Projects being Planned.” For those of you that are planning DNP Projects, here is a short list of considerations:What is the current state and local policies on social distancing, use of masks, size of gatherings, etc.?Is there an institutional policy on COVID at your partnering organization?How will you ensure the safety of your DNP Project participants in regard to COVID?How will you ensure that your DNP Project is compliant to these requirements?Has your IRB(s) set requirements on COVID compliance?Does your DNP Project Methodology, include a paragraph specific to COVID? (We believe it should)In the webinar, we also discuss strategies for redirection of DNP Projects and visions for DNP Projects of the future. Please take some time to listen to the webinar. We hope that discussion and this checklist helps you think through some of the logistical challenges of COVID compliance and the DNP Project. Remember to “Subscribe,” hit “Like,” and “Write a Review” so that we can help others. Find us on YouTube, Apple Podcasts, Google Play, Spotify, and other platforms.To get your copy of The DNP Project Workbook, go to:Springer: https://www.springerpub.com/the-dnp-project-workbook-9780826174321.html*** Always follow the guidelines from YOUR DNP Program

EMplify August 2020 – Racism In Medicine with Dr. Maurice Selby, Assistant Professor, Emergency Medicine, Emory School of Medicine Host- Health In Harlem radio show (WHCR 90.3 FM)and podcast   Topics: History of racism in medicine Niggerology Experimentation on Women Pain thresholds, endurance to harsh environments, food and water Institutional Review Boards (IRBs) and their role in racism Non-compliant patients Believing your patient Poor outcomes in medicine due to racial bias Bereaving families Racism among physicians and providers Micro agressions What it’s like to experience racism as a physician. Next steps. Leave us a voicemail at 678-336-8466, ext 128 Write us at emplify@ebmedicine.net

Research on human beings saves countless lives, but has at times harmed the participants. To what degree then should government regulate science, and how? The horrors of Nazi concentration camp experiments and the egregious Tuskegee syphilis study led the US government, in 1974, to establish Research Ethics Committees, known as Institutional Review Boards (IRBs) to oversee research on humans. The US now has over 4,000 IRBs, which examine yearly tens of billions of dollars of research -- all studies on people involving diseases, from cancer to autism, and behavior. Yet ethical violations persist.

Laura Stark‘s lucid and engaging new book explores the making and enacting of the rules that govern human subjects research in the US. Using a thoughtfully conceived combination of ethnographic and archival work, Behind Closed Doors: IRBs and the Making of Ethical Research (University of Chicago Press, 2012) locates the emergence of a system of “governing with experts” by Institutional Review Boards (IRBs) in the middle of the twentieth century. Stark shows how the features that now characterize the IRB deliberations that consider whether research on people can proceed in institutional contexts emerged in the particular context of the NIH Clinical Research Committee in 1950s and 1960s, and she explains how they managed to spread thereafter across the US and the globe. Behind Closed Doors draws from a wide and transdisciplinary set of methodological resources in articulating the power of performative language in shaping negotiations around human subjects research, suggesting innovative ways to read documentary evidence as a narrative of voices in time. True to its title, Stark’s story takes us behind the closed doors of occasionally heated IRB deliberations. It also introduces us to some of the spirited and disruptive “healthy patients” of the Clinical Center at the National Institutes of Health (NIH), prisoners and conscientious objectors among them, as they were dosed with LSD or infected with malaria and influenza, making a kind of home in the Center or cleverly escaping from it. It’s a wonderfully stimulating book that should be widely read and included on the syllabi of many graduate seminars to come. Learn more about your ad choices. Visit megaphone.fm/adchoices

Laura Stark‘s lucid and engaging new book explores the making and enacting of the rules that govern human subjects research in the US. Using a thoughtfully conceived combination of ethnographic and archival work, Behind Closed Doors: IRBs and the Making of Ethical Research (University of Chicago Press, 2012) locates the emergence of a system of “governing with experts” by Institutional Review Boards (IRBs) in the middle of the twentieth century. Stark shows how the features that now characterize the IRB deliberations that consider whether research on people can proceed in institutional contexts emerged in the particular context of the NIH Clinical Research Committee in 1950s and 1960s, and she explains how they managed to spread thereafter across the US and the globe. Behind Closed Doors draws from a wide and transdisciplinary set of methodological resources in articulating the power of performative language in shaping negotiations around human subjects research, suggesting innovative ways to read documentary evidence as a narrative of voices in time. True to its title, Stark’s story takes us behind the closed doors of occasionally heated IRB deliberations. It also introduces us to some of the spirited and disruptive “healthy patients” of the Clinical Center at the National Institutes of Health (NIH), prisoners and conscientious objectors among them, as they were dosed with LSD or infected with malaria and influenza, making a kind of home in the Center or cleverly escaping from it. It’s a wonderfully stimulating book that should be widely read and included on the syllabi of many graduate seminars to come. Learn more about your ad choices. Visit megaphone.fm/adchoices

Laura Stark‘s lucid and engaging new book explores the making and enacting of the rules that govern human subjects research in the US. Using a thoughtfully conceived combination of ethnographic and archival work, Behind Closed Doors: IRBs and the Making of Ethical Research (University of Chicago Press, 2012) locates the emergence of a system of “governing with experts” by Institutional Review Boards (IRBs) in the middle of the twentieth century. Stark shows how the features that now characterize the IRB deliberations that consider whether research on people can proceed in institutional contexts emerged in the particular context of the NIH Clinical Research Committee in 1950s and 1960s, and she explains how they managed to spread thereafter across the US and the globe. Behind Closed Doors draws from a wide and transdisciplinary set of methodological resources in articulating the power of performative language in shaping negotiations around human subjects research, suggesting innovative ways to read documentary evidence as a narrative of voices in time. True to its title, Stark’s story takes us behind the closed doors of occasionally heated IRB deliberations. It also introduces us to some of the spirited and disruptive “healthy patients” of the Clinical Center at the National Institutes of Health (NIH), prisoners and conscientious objectors among them, as they were dosed with LSD or infected with malaria and influenza, making a kind of home in the Center or cleverly escaping from it. It’s a wonderfully stimulating book that should be widely read and included on the syllabi of many graduate seminars to come. Learn more about your ad choices. Visit megaphone.fm/adchoices

Laura Stark‘s lucid and engaging new book explores the making and enacting of the rules that govern human subjects research in the US. Using a thoughtfully conceived combination of ethnographic and archival work, Behind Closed Doors: IRBs and the Making of Ethical Research (University of Chicago Press, 2012) locates the emergence of a system of “governing with experts” by Institutional Review Boards (IRBs) in the middle of the twentieth century. Stark shows how the features that now characterize the IRB deliberations that consider whether research on people can proceed in institutional contexts emerged in the particular context of the NIH Clinical Research Committee in 1950s and 1960s, and she explains how they managed to spread thereafter across the US and the globe. Behind Closed Doors draws from a wide and transdisciplinary set of methodological resources in articulating the power of performative language in shaping negotiations around human subjects research, suggesting innovative ways to read documentary evidence as a narrative of voices in time. True to its title, Stark’s story takes us behind the closed doors of occasionally heated IRB deliberations. It also introduces us to some of the spirited and disruptive “healthy patients” of the Clinical Center at the National Institutes of Health (NIH), prisoners and conscientious objectors among them, as they were dosed with LSD or infected with malaria and influenza, making a kind of home in the Center or cleverly escaping from it. It’s a wonderfully stimulating book that should be widely read and included on the syllabi of many graduate seminars to come. Learn more about your ad choices. Visit megaphone.fm/adchoices