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Webinars

Learn anytime, anywhere with Schulman’s webinars.

Each month, Schulman’s webinar series connects attendees with IRB experts and industry thought leaders to share regulatory insights and best practices.

Schulman IRB Webinars

  • Convenient web-based format
  • No cost for attendance
  • Robust Q&A with webinar presenter
  • Online archive of all recorded webinars

Schulman WebinarsSchulman is committed to sharing our experience and expertise with the research community, promoting professional development, discussion and collaboration.

Webinar presentations offer expert content on a variety of IRB-related topics, including industry trends, regulatory details and IRB processes.

Schulman’s webinars are a great way to support existing training programs. Certificates of attendance are available for each live presentation. The webinars may be eligible for continuing education credits—check with your individual certifying organization for more information.

Navigating the Expanding Regulations of ClinicalTrials.gov Registration and Results Reporting

Anthony Keyes, Program Manager at the Johns Hopkins University School of Medicine ClinicalTrials.gov Program, reviews the federal regulations regarding registration and results reporting of clinical trials.

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Lessons from the Trenches: Avoiding Common Legal Pitfalls in International Research

Emily Chi Fogler and Andrew Rusczek, attorneys practicing at Verrill Dana, LLP, discuss common legal issues for institutions and companies participating in international research.

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Mobile Apps: Considerations for Use in Research Involving Human Subjects

Robert Neff, Director of Innovative Technology Solutions at Thomas Jefferson University, and Michele Russell-Einhorn, Chief Compliance Officer and Institutional Official at Advarra, discuss considerations and issues research professionals should be aware of when developing research projects that involve mobile apps.

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IRB Considerations for Investigator-Initiated Research

Robert Romanchuk, IRB Vice Chair at Schulman IRB, reviews the landscape of investigator-initiated research with a focus on the IRB’s perspective.

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Social Media for Research Recruitment: Ethical and Practical Aspects

Luke Gelinas, Senior Researcher at Harvard Law School’s Petrie-Flom Center and Schulman IRB member, addresses ethical and practical issues involved with social media recruitment.

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The New Common Rule: Why Industry Should Take Note

Andrew Rusczek and Emily Chi Fogler, attorneys practicing at Verrill Dana, LLP, discuss important changes to the Common Rule of which industry should take note.

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Central IRB 101: An Introductory Guide to Working with External IRBs for the First Time

Maria Stivers, Manager of Institutional Services at Schulman IRB, guides institutions through the basics of working with a central IRB for the first time.

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Enrolling Non-English Speaking Participants in Clinical Research: Regulatory and Practical Considerations

Roberto Torres of the Puerto Rico Consortium for Clinical Investigation and Michele Russell-Einhorn of Schulman IRB discuss the regulatory requirements involved in enrolling a non-English speaking study participant and discuss practical considerations for sites working with non-English speaking participants during the informed consent process.

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Humanitarian Use Devices Made Simple

In this presentation, Robert Romanchuk, Vice Chair at Schulman IRB, seeks to simplify the HUD topic, distinguishing humanitarian devices from investigational devices and drugs and identifying key issues and best practices in the review and use of HUDs.

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Evaluating Payment to Participate in Research: Ethical and Regulatory Issues

Luke Gelinas, Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics at Harvard Law School, discusses a practical framework for evaluating offers of payment and provides guidance on challenging ethical and regulatory issues involved in paying research subjects.

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Introduction to Recombinant DNA (Genetic Engineering) and Institutional Biosafety Committees (IBC)

Schulman IRB’s Biosafety Officer Daniel Eisenman discusses the IBC’s role in ensuring research involving genetic engineering is conducted safely and responsibly.

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Federal Initiatives Toward Single IRB Review

Michele Russell-Einhorn, VP of Human Subject Protection Services and Institutional Official at Schulman IRB, discusses recent federal initiatives for single IRB review and their impact on the way sponsors, CROs and institutions conduct research.

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Navigating the Regulatory Requirements of Pediatric Research

Schulman IRB Vice Chair Nathan Lee discusses the specific OHRP and FDA regulations regarding research in pediatric populations and their impact on proposed pediatric research.

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Drug Documents and Device Documents: Definitions and IRB Review

Product Safety Analyst Tricia Henson discusses the drug and device documents that must be submitted to the IRB during initial review and throughout the study.

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In Vitro Diagnostic Device Clinical Trials: Regulation and Review

IRB Member Danielle Macario delves into the various regulatory paths for devices, how those paths impact the regulations devices are subject to, and IRBs review device studies.

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Does the NPRM Get Biospecimens Right? Applying the New Standards to Challenging Ethical Issues

Presenters measure the NPRM’s changes against historical events and personal experiences to determine whether these updates provide improved human subject protections.

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Just Because You Can Measure Everything Doesn’t Mean You Should – Measure What Matters

In this webinar, Eli Alford, COO at Schulman IRB, discusses how to thoughtfully use and report metrics in clinical research.

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It’s Guaranteed Not to Work If You Don’t Use It: Site & IRB Perspectives on Digital/Social Media Recruiting

This webinar explores how IRBs review this type of recruitment material and the basics of using digital and social media in recruiting study participants.

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Adaptive Phase I Studies: The IRB Perspective

In this webinar, IRB member Marilyn Teal reviews why adaptive designs are used and covers areas of special interest when these studies are reviewed by the IRB.

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Oncology Studies from an IRB Perspective

IRB Chair Rebecca Rogers discusses IRB review of oncology studies, paying particular attention to recent innovations in oncology research and how they may impact the IRB’s review.

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