Author

Resource Library

Robert Romanchuk, BSHS, CHRC, CIP, CCRC

IRB Chair, Advarra

Robert Romanchuck has two decades of experience in clinical research leadership in both realms of research operations and human subjects protections. He has spoken widely on topics ranging from vulnerable populations to the complexities of device studies. He currently serves as a Chairperson at Advarra IRB with dual CIP/CCRC certifications.

Latest Posts by Robert

Webinar

IRB Review of Phase I Healthy Research: Investigator and IRB Perspectives

Join our expert panel to learn about common pitfalls in Phase I study designs and IRB submissions and strategies to plan for success

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Blog

Making Sense of the New HUD Guidance

Understand how the new HUD guidance clarifies responsibilites of the IRB and institutions, while widening the access of small communities to HUDs.

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7 min. read

Blog

Meeting the Challenges of Investigator-Initiated Trials

How does investigator-initiated research differ from other types of clinical research? Advarra IRB Chairperson Robert Romanchuk explains.

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6 min. read

Blog

The Challenge of Unproven Regenerative Stem Cell Therapies

Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.

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7 min. read

Webinar

Preparing for and Responding to an FDA Inspection

Ellen Liedel-Sargent and Robert Romanchuk outline key activities that can help prepare a research site for a positive inspection experience.

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Blog

What’s the Difference Between Right to Try and Expanded Access?

Let’s take a look at the basics of what each program does and does not do for patients seeking to access investigational therapies.

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5 min. read

Webinar

Expanded Access and Right to Try: The Impact of Recent Legislative Changes

This webinar provides an overview of the current state of the FDA’s Expanded Access Program and state and federal “Right to Try” legislative efforts.

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Blog

Informed Consent in Research and Individuals with Impaired Decision-Making Capacity

This blog outlines the principle of equitable selection and the requirement for additional safeguards for certain vulnerable groups.

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4 min. read

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Robert Romanchuk, BSHS, CHRC, CIP, CCRC

Latest Posts by Robert

IRB Review of Phase I Healthy Research: Investigator and IRB Perspectives

Making Sense of the New HUD Guidance

Meeting the Challenges of Investigator-Initiated Trials

The Challenge of Unproven Regenerative Stem Cell Therapies

Preparing for and Responding to an FDA Inspection

What’s the Difference Between Right to Try and Expanded Access?

Expanded Access and Right to Try: The Impact of Recent Legislative Changes

Informed Consent in Research and Individuals with Impaired Decision-Making Capacity

Ready to Advance Your Clinical Research Capabilities?

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