Welcome to WCG IRB Insights

Featured

Whitepapers

Decentralized Clinical Trials: Best Practices in Moving Toward a Patient-Centric Research Model

Blog Posts

Four Key Elements You Need to Know About the Role of IBCs in Gene Therapy Trials

Whitepapers

The IRB’s Perspective: Determining Optimal Compensation for Clinical Trial Participants

Most Recent

News & Events

WCG IRB Regulatory Compliance, Patient Advocate, and Cell and Gene Therapy Experts to Present at MAGI’s Clinical Research vConference

News & Events

[Webinar] Increasing Clinical Trial Participation Through Eligibility Expansion and Inclusivity Considerations

Blog Posts

Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”

News & Events

[Virtual Conference] MAGI’s Clinical Research vConference – Fall 2021

News & Events

[Virtual Conference] ABSA International Biosafety and Biosecurity Virtual Conference

News & Events

[Virtual Conference] PRIM&R Advancing Ethical Research vConference

Ask the Experts

Does the IRB need to approve doctor-to-doctor letters?

Ask the Experts

What are the IRB review requirements for human factors/usability testing?

Whitepapers

Changes in Research: What are They and When do They Need to be Submitted to the IRB?

News & Events

[Webinar] Do I Need to Submit THIS to the IRB? A Discussion of Changes in Research and Other Reportable (and Non-Reportable) Events

VIEW The Insights Archive

Meet the Experts

Our experts, with decades of experience and a deep knowledge of regulations, ethics, and research best practices, will answer anything related to research ethics and research oversight including institutional review board operations, practice and regulations. We post the questions (anonymized) and answers on our website, as a resource for our industry.

Yvonne K. Higgins, CIP

QA Advisor

Full Bio

Lindsay McNair, MD, MPH, MSBioethics

Chief Medical Officer, WCG

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David Forster, JD, MA, CIP

Chief Compliance Officer, WCG

Full Bio

Jeffrey A. Cooper, MD, MMM

Vice President, Process & Strategic Improvement

Full Bio

Lindsay A. Abraham, JD, CIP

IRB Chair – Regulatory Lead

Full Bio

Daniel Kavanagh, PhD, RAC

Senior Scientific Advisor, Gene Therapy, WCG

Full Bio

David A. Borasky, MPH, CIP

Vice President, IRB Compliance

Full Bio

Alisha Rodenbach, JD, CIP

Regulatory Chair

Full Bio

Kelly Fitzgerald, PhD

Executive IRB Chair and Vice President of IRB Affairs

Full Bio

Christopher Doyle, PhD

IBC Chair and Director of IBC Services

Full Bio

Sheri Spivey, MPH, CIP

Regulatory Chair Director

Full Bio

View clinical trial ethical or regulatory questions sent to our IRB experts

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Submit Your Question Here

Submit questions to us on anything related to research ethics and research oversight including institutional review board operations, practice and regulations. Our experts, with decades of experience and a deep knowledge of regulations, ethics, and research best practices, will answer. We’ll post the questions (anonymized) and answers on our website.

Before using this form, please note:

Protocol-specific questions for studies under the oversight of a WCG IRB should be submitted through your IRB contact person, not through this form.
If your question is about what needs to be promptly reported to the IRB during a study, please see form HRP-204 and this manual for guidance.

Disclaimer

WCG may not be able to respond to all questions and cannot respond to any medical questions or provide referrals for clinical care or studies.

You acknowledge that any question submitted to this site may be publicly available and that your use of this site is subject to the WCG Terms of Use.