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 PostDo we need to submit safety events from another site to our IRB?
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Read PostHow should we handle financial conflicts of interest in FDA-regulated clinical trials?
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Read PostWhat are the IRB review requirements for web-based recruitment platforms?
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Ask The IRB Experts
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Read PostIs IRB review required for a research study conducted by a high school student?
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Read PostQuestion: What are the signature requirements for translated informed consent documents?
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Read PostQuestion: Does the Common Rule apply to Medicare-covered investigational device studies?
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Read PostQuestion: 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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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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Read PostMeet 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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Read PostQuestions 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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Read PostQuestion: Can participants be reconsented over the phone when an ICF is updated?
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Read PostQuestion: 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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Read PostQuestion: 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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