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

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WCG IRB’s Response to COVID-19 in 2020: Supporting the Clinical Trial Industry When It Needed It the Most

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Infectious Disease Challenge Studies: Ethical Issues in Causing Disease for Medical Knowledge

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Ethical and Biosafety Oversight of Gene Transfer Clinical Research: What Sponsors and CROs Need to Know

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Should Consent Form updates be aligned with Investigator Brochure updates, or wait for next Protocol amendment?

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Whitepapers

Interventional Clinical Trial or Registry Study? Writing Protocols that Demonstrate the Difference

Read More about Interventional Clinical Trial or Registry Study? Writing Protocols that Demonstrate the Difference

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What questions can be asked when screening patients prior to them signing consent?

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When do I report a protocol deviation to the IRB? Do I need to report a summary of deviations at the time of continuing review?

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What documentation needs to be submitted to the IRB for an IND exemption request?

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News & Events

[Video] Institutional Biosafety Committee Review: Strategies to Secure Rapid IBC Approval for Human Gene Transfer Trials

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[Webinar] The Do’s and Don’ts of Compensating Research Participants: Guidance for Clinical Research Stakeholders

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Can you provide an IRB approval before FDA’s review of the IND?

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Does research involving retrospective review of patient charts require IRB review?

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

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WCG IRB Connexus Training Schedule

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Case Studies

Toolbox Medical Relies on WCG IRB’s Prompt, Personalized Expertise in an Unsettled Environment

Read More about Toolbox Medical Relies on WCG IRB’s Prompt, Personalized Expertise in an Unsettled Environment

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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

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Lindsay McNair, MD, MPH, MSBioethics

Chief Medical Officer, WCG

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David Forster, JD, MA, CIP

Chief Compliance Officer, WCG

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Jeffrey A. Cooper, MD, MMM

Vice President, Process & Strategic Improvement

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Lindsay A. Abraham, JD, CIP

IRB Chair – Regulatory Lead

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Daniel Kavanagh, PhD, RAC

Senior Scientific Advisor, Gene Therapy, WCG

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David A. Borasky, MPH, CIP

Vice President, IRB Compliance

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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.