Explore steps and tools for efficient regulatory enrollment. Learn about IRB reliance agreements, central document repository, and electronic delegation processes for quick approval.

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Learn about the significance of IRB review, levels of review, and categories of expedited review. Discover the criteria for IRB review, including whether the study involves human subjects and contributes to generalizable knowledge. Explore the different levels of IRB review and the specific categori

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The basics of the IRB, researcher responsibilities, IRB members, and the role of faculty advisors and student investigators in navigating the IRB application process. Understand the importance of ancillary approvals for research projects involving human subjects.

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The content provides an overview of the IRB review process for research studies, including what necessitates IRB review, the levels of IRB review (exempt, expedited, full board), examples of full board research, and criteria for an Investigational New Drug.

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Delve into the world of research ethics through an overview of Institutional Review Boards (IRB), regulations governing human subjects research, historical events shaping research ethics, and examples of research controversies. Explore key ethical principles and the role of the IRB in protecting res

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Explore the concept of Single IRB arrangements, learn when reliance is appropriate, discover how reliance agreements are documented, and understand LSUHSC's requirements for study teams when relying on external IRBs.

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The Institutional Review Board (IRB) at AUCA plays a vital role in reviewing and approving research projects involving human subjects to ensure ethical standards are met. This includes obtaining informed consent, protecting privacy, and following international guidelines. Research must contribute to

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Explore key aspects of VA Central IRB approval, continuing review for multi-site projects, process structure, changes in documentation, and future updates. Learn about criteria for approval, VHA policy compliance, informed consent requirements, and more.

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Reflecting on the personal narratives of IRB professionals at UNMC during the COVID-19 pandemic reveals the intense challenges faced in balancing urgency with ethical research standards. Stories of panic, pressure, overlapping studies, and rapid turnaround shed light on the complexities of navigatin

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Reviewing IRB applications involves checking for completion of necessary information, ensuring proper student researcher listing with faculty sponsor, verifying logical data collection dates and participant numbers, reviewing research design, assessing instruments used, examining recruitment and sel

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Explore the levels of IRB review for human participant research, including Exempt, Expedited, and Full Board reviews. Learn about the categories of Exempt Determinations and the criteria for Limited IRB Review. Understand if your study requires IRB review based on research and human subject involvem

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Explore the distinctions in roles and responsibilities of Institutional Review Boards (IRBs), VA Facility Research and Development Committees (R&D), and VA Facility Institutions in reviewing and approving human subjects research. Delve into key differences and examples of exceeding national policy o

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Providing essential guidance for first-time researchers submitting to the Barry University IRB in January 2023. Covers initial steps such as creating an IRBNet account, completing ethics training, determining the review category, and selecting the appropriate protocol form.

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Human Subject Research Protections at Villanova IRB, including regulatory background, review process, and key information for investigators. Learn about the Institutional Review Board structure, ethical principles, and historical background of human subjects research at Villanova University.

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IRB reliance agreements allow institutions to delegate IRB review responsibilities or collaborate with other institutions for human subjects research. Federalwide assurance (FWA) documents ensure compliance with regulations. Different types of agreements, such as IRB authorization agreements and ind

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Explore the significance of IRBs in research, tracing back to historical events like WWII and ethical violations that led to the establishment of principles such as the Belmont Principles. Learn about the diverse scope of IRB oversight, from medical to social science studies, and the core mission of

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This update covers significant changes in clinical trial administrative fees, aiming to reduce burdens on the research community. The new fee structure includes a flat fee for new studies and additional charges for subject enrollment during IRB renewal. Furthermore, a new coverage analysis process h

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Exploring different types of research and IRB applications in academic studies, including processes related to contact registries, data/tissue banks, and consent management. The content provides insights into engaging specific populations for future research, collecting and storing clinical data, ut

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This content delves into the challenges and approaches in recruitment and retention processes for research studies. It covers topics such as review of recruitment tools, engagement in discussions on effective practices, utilization of mass mailings and social media for participant recruitment, and m

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Pathology Department's IRB protocol enables the screening of electronic medical records for research purposes, allowing members to review patient records and pathology slides. By fulfilling specific requirements and obtaining blanket IRB approval, researchers can access and analyze patient data for

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Research Compliance Administrator, Sharla Miles, M.Ed., CIP, provides guidance on using Cayuse IRB for creating and completing initial study submissions. Learn to navigate the system, enter study details, and submit for review efficiently.

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The GPS IRB at Pepperdine University focuses on protecting the rights and welfare of human research subjects. Applications cover social, behavioral, and educational research, following federal regulations. IRB approval is required before starting any research activities, and different application ty

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This comprehensive overview delves into the IRB application process, covering topics such as human research protections, IRB oversight requirements, different types of reviews, informed consent, response to IRB correspondence, common errors, and the significance of ethics in research. Key historical

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Institutional Review Board (IRB) plays a crucial role in ensuring research involving human subjects adheres to ethical standards. This summary provides insights into the IRB process, including determining the need for IRB review, defining human subjects research, and the importance of human subjects

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Learn about key regulatory requirements and best practices for convening and conducting an Institutional Review Board (IRB) meeting. This guide covers pre-meeting activities, achieving quorum, member attendance, conflicts of interest, and more.

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Institutional Review Board (IRB) plays a crucial role in protecting the rights and welfare of research participants, ensuring the validity, ethics, and compliance of human research. This content covers the functions of IRB as a Privacy Board, distinguishes Downstate and non-Downstate workforce inves

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Enhance your understanding of the IRB application process with helpful resources, step-by-step instructions, and access to training modules. From CITI certification to Cayuse navigation, this comprehensive guide aims to simplify the protocol submission journey for researchers. Explore hints, example

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Understanding the IRB process is crucial for conducting ethical research involving human subjects. This guide outlines federal regulations, protective mechanisms, IRB goals, and the definition of human subjects in research. It also provides insights into the level of intervention, considerations whe

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Update on the significant changes in the Revised Common Rule and Proposed VHA Directive 1200.05, focusing on the impact on the IRB, membership, functions, and review of research. Details provided on the status of the Revised Common Rule, VHA Handbook 1200.05, and applicability of pre-2018 and 2018 r

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This resource provides detailed guidance on the requirements and processes for consulting with the Human Subjects Division (HSD) for single Institutional Review Board (IRB) studies involving multiple institutions, federally-funded research, and new NIH funding. It includes information on when a sIRB

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Comprehensive instructions for submitting continuing review information when utilizing an external Institutional Review Board (IRB), including steps such as completing questions, selecting study status, updating funding, adding personnel, and uploading necessary documents.

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Maria Drayton, an IRB Analyst at the University of Maryland, presents important information on Not Humans Subjects Research (NHSR). This includes definitions, IRB review requirements, evaluation criteria, and actions to take based on research determinations. The process involves careful consideratio

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Explore the essential criteria for human subjects research, the process of applying to the IRB for determinations, understanding regulated research, and common errors in exemption submissions. Delve into expedited vs. full board reviews and different categories of research review, in this detailed g

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Comprehensive tutorial for researchers with an approved IRB protocol on submitting amendments, renewals, closures, or modifications. Steps include logging into Cayuse, selecting the study type, completing protocol details, and finalizing submissions through certification.

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This tutorial is for researchers (PIs) with an approved IRB protocol who want to make changes to their study titles and submit renewals, modifications, incidents (adverse events), or closures. Learn about the process in Cayuse, from initial study to amending/modifying, renewing, or closing protocols

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Explore the potential VHA policy changes that can streamline IRB and R&D committee responsibilities to better serve veterans while upholding the VA's mission. Delve into questions concerning beneficial and challenging policy changes, the need for a single R&D committee model, and considerations on t

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This tutorial provides step-by-step instructions for submitting a new IRB protocol in Cayuse IRB. It covers essential preparatory steps, authentication requirements, logging in to Cayuse, navigating the platform, and initiating a new study application. Helpful tips are included for Primary Investiga

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Changes in the VA Central IRB process include updates regarding IRBNet access, project ownership, submission workflow, and COI review procedures. Important points include registering for an IRBNet account, transferring project ownership to PIs or LSIs, and submitting new projects to local research a

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Explore the different types of IRB review processes, including exempt, expedited, and full/convened reviews. Learn about human subjects research, not human subjects research, and exempt categories. Discover the importance of obtaining informed consent and navigating IRBNet for research compliance at

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Discover the Saint Leo IRB review process, its purpose, requirements for research approval, definitions of human subjects and research, and how to apply for IRB approval. Learn about the exclusion criteria for class activities and access useful resources and guidance for conducting research at Saint

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