Welcome to WCG IRB Insights

Featured

Whitepapers

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

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

woman handing her credit card for payment

Whitepapers

An Overview of the Recent SACHRP Recommendations Around Payments in Clinical Research

Read More about An Overview of the Recent SACHRP Recommendations Around Payments in Clinical Research

Ask the IRB Experts

Questions on the FDA’s 30-Day IND Review Period and IRB Approval

Read More about Questions on the FDA’s 30-Day IND Review Period and IRB Approval

Whitepapers

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

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

doctor with clipboard speaking to elderly patient

Ask the IRB Experts

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

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

Group of doctors gathered around whiteboard

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

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

read questions

Most Recent

Nurse with patient, reviewing consent forms.

Whitepapers

Providing Research Participants with New Information: Is “Re-Consent” Always Necessary?

Read More about Providing Research Participants with New Information: Is “Re-Consent” Always Necessary?

Ask the IRB Experts

What are IRB submission requirements for post marketing safety reports?

Read More about What are IRB submission requirements for post marketing safety reports?

Ask the IRB Experts

May I pay a physician for referring a patient to our study?

Read More about May I pay a physician for referring a patient to our study?

Business person reviewing paperwork late in office.

Ask the IRB Experts

What is the IRB’s role in making the nonsignificant risk device determination?

Read More about What is the IRB’s role in making the nonsignificant risk device determination?

woman on couch with headset writing in notepad

News & Events

WCG IRB Experts to Present at PRIM&R’s Advancing Ethical Research Conference

Read More about WCG IRB Experts to Present at PRIM&R’s Advancing Ethical Research Conference

Ask the IRB Experts

Submitting protocol changes to the IRB prior to submitting to FDA

Read More about Submitting protocol changes to the IRB prior to submitting to FDA

Business people participate in review meeting.

Videos

Institutional Biosafety Committee Review for Genetically Modified Vaccines and Gene Transfer Products

Read More about Institutional Biosafety Committee Review for Genetically Modified Vaccines and Gene Transfer Products

News & Events

WCG Announces the Formation of WCG IRB and the Launch of New WCG IRB Connexus™

Read More about WCG Announces the Formation of WCG IRB and the Launch of New WCG IRB Connexus™

Ask the IRB Experts

Is IRB review required to collect specimens for a new test to diagnose COVID-19?

Read More about Is IRB review required to collect specimens for a new test to diagnose COVID-19?

stethoscope on medical document and doctor studying data

Ask the IRB Experts

Submitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB

Read More about Submitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB

view the insights archive

Meet the IRB 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

QA Advisor

Full Bio

Lindsay McNair, MD, MPH, MSBioethics

Chief Medical Officer, WCG

Full Bio

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

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.

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.

Disclaimer

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.

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.