Ask the IRB Experts: Answering Your Ethical and Regulatory Questions

  • An Introduction to Ask the IRB Experts Forum

    An Introduction to Ask the IRB Experts Forum

    Clinical research is complicated. At WCG, we get questions about clinical research all the time— from researchers, from clinical team members at biopharma companies, from members of institutional...

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  • Do we need to submit safety events from another site to our IRB?

    Do we need to submit safety events from another site to our IRB?

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  • How should we handle financial conflicts of interest in FDA-regulated clinical trials?

    How should we handle financial conflicts of interest in FDA-regulated clinical trials?

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  • What are the IRB review requirements for web-based recruitment platforms?

    What are the IRB review requirements for web-based recruitment platforms?

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  • Ask The IRB Experts

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  • Is IRB review required for a research study conducted by a high school student?

    Is IRB review required for a research study conducted by a high school student?

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  • Question: What are the signature requirements for translated informed consent documents?

    Question: What are the signature requirements for translated informed consent documents?

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  • Question: Does the Common Rule apply to Medicare-covered investigational device studies?

    Question: Does the Common Rule apply to Medicare-covered investigational device studies?

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  • Question: What are the IRB submission requirement for observational studies?

    Question: What are the IRB submission requirement for observational studies?

    What regulatory documents do I need to submit for an observation study other than protocol and ICF?

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  • Meet the IRB Experts

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  • Meet Yvonne Higgins

    Meet Yvonne Higgins

    Yvonne has contributed to the cause of ethics and responsibility in human research for more than 20 years.

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  • Meet Lindsay McNair, MD, MPH, MSB

    Meet Lindsay McNair, MD, MPH, MSB

    Dr. Lindsay McNair is the Chief Medical Officer for WCG. In this role, Dr. McNair develops strategic partnerships with pharma/biotech companies for comprehensive ethical and clinical services.

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  • Meet David Forster, JD, MA, CIP

    Meet David Forster, JD, MA, CIP

    Mr. Forster joined Western IRB (WIRB) in 1996 and is currently the Chief Compliance Officer for the WIRB-Copernicus Group (WCG).

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  • Meet Jeffrey A. Cooper, MD, MMM

    Meet Jeffrey A. Cooper, MD, MMM

    Dr. Cooper combines management and regulatory expertise to create systems that promote clinical research while meeting regulatory requirements and high ethical standards.

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  • Meet Lindsay Abraham, JD, CIP

    Meet Lindsay Abraham, JD, CIP

    Ms. Abraham is the Regulatory Lead for the IRB Chairs at WIRB (WIRB).

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  • Meet Daniel Kavanagh, PhD, RAC

    Meet Daniel Kavanagh, PhD, RAC

    Dr. Daniel Kavanagh is scientific lead in the Institutional Biosafety Committee Services division, and works closely with sponsors, CROs, and institutions on IBC oversight of gene transfer trials.

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  • Meet David Borasky, MPH, CIP

    Meet David Borasky, MPH, CIP

    David Borasky, VP of IRB Compliance for the WIRB-Copernicus Group, has 20 years of experience managing IRBs in settings including global public health organizations, large AMCs and independent IRBs.

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  • Meet Stuart Horowitz, PhD, MBA

    Meet Stuart Horowitz, PhD, MBA

    Dr. Horowitz oversees WCG’s partnerships with more than 2,800 of the industry’s leading institutions.

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  • Additional Posts

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  • Questions on regulations for process development and purchased human cells

    Questions on regulations for process development and purchased human cells

    Do the FDA and federal regulations apply to activities such as process development activities that are privately funded? For federally funded research, if the sponsor purchases human cells or specimen

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  • Question: Can participants be reconsented over the phone when an ICF is updated?

    Question: Can participants be reconsented over the phone when an ICF is updated?

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  • Question: What training documentation is required for conducting clinical research studies?

    Question: What training documentation is required for conducting clinical research studies?

    For initial protocol training, do both the trainee and the trainer need to sign as being trained or can we only have the PI sign confirming that training was done with date trained and who was...

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  • Question: What are ethical considerations for a trial with a pre-study washout period?

    Question: What are ethical considerations for a trial with a pre-study washout period?

    We are working with a sponsor on the design and conduct of a double-blind placebo-controlled study of an investigational new drug for Alzheimer’s disease. The study design includes a one-month...

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