Ask the IRB Experts: Answering Your Ethical and Regulatory Questions
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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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Questions on blood draw volumes for clinical research
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Submitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB
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Informed Consent: An IRB Perspective on Navigating the New Normal
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What documentation is needed to prove a parent’s legal authority to consent for a child’s participation in research?
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What are the regulations for training home health individuals who are working remotely to collect study data?
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Ask The IRB Experts
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Should Consent Form updates be aligned with Investigator Brochure updates, or wait for next Protocol amendment?
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What ethical safeguards are needed for research involving observation of group behavior?
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Questions regarding the definition of "human subject"
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What are the requirement for parental permission (consent) in studies involving children?
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Meet the IRB Experts
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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
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
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
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
Ms. Abraham is the Regulatory Lead for the IRB Chairs at WIRB (WIRB).
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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
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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Additional Posts
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How do I handle a deviation in the use of blood specimens collected outside the timeframe?
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Questions on the FDA’s 30-Day IND Review Period and IRB Approval
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Is it possible to make a PI’s name or institution confidential on a consent form?
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