Ask the IRB Experts: Answering Your Ethical and Regulatory Questions
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Read PostAn 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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Read PostQuestions on blood draw volumes for clinical research
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Read PostSubmitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB
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Read PostInformed Consent: An IRB Perspective on Navigating the New Normal
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Read PostWhat documentation is needed to prove a parent’s legal authority to consent for a child’s participation in research?
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Read PostWhat 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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Read PostShould Consent Form updates be aligned with Investigator Brochure updates, or wait for next Protocol amendment?
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Read PostWhat ethical safeguards are needed for research involving observation of group behavior?
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Read PostQuestions regarding the definition of "human subject"
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Read PostWhat are the requirement for parental permission (consent) in studies involving children?
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Meet the IRB Experts
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Read PostMeet Yvonne Higgins
Yvonne has contributed to the cause of ethics and responsibility in human research for more than 20 years.
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Read PostMeet 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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Read PostMeet 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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Read PostMeet 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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Read PostMeet Lindsay Abraham, JD, CIP
Ms. Abraham is the Regulatory Lead for the IRB Chairs at WIRB (WIRB).
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Read PostMeet 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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Read PostMeet 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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Read PostHow do I handle a deviation in the use of blood specimens collected outside the timeframe?
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Read PostQuestions on the FDA’s 30-Day IND Review Period and IRB Approval
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Read PostIs it possible to make a PI’s name or institution confidential on a consent form?
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