Ask the IRB Experts: Answering Your Ethical and Regulatory Questions

  • An Introduction to Ask the IRB Experts

    An Introduction to Ask the IRB Experts

    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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  • Question: Can the IRB approve reimbursement of copays for routine costs in a clinical trial?

    Question: Can the IRB approve reimbursement of copays for routine costs in a clinical trial?

    Will an IRB allow reimbursement for co-pays for routine patient care costs associated with participation in a clinical trial when the costs are covered by insurance, but the subject is responsible for

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  • Ask The IRB Experts

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  • Question: Is IRB review required for survey results that may be published?

    Question: Is IRB review required for survey results that may be published?

    I am working with a for-profit company to develop survey questions for patients who have a specific illness. Without IRB approval I may not be able to publish any results; but, getting IRB approval or

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  • Question: What are the requirements for submitting protocol deviations?

    Question: What are the requirements for submitting protocol deviations?

    Some deviations from the IRB approved protocol are planned while others are unintentional or unplanned. The FDA and HHS (45 CFR §46.103(b)(4) and 21 CFR §56.108(a)(4)), position is that...

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  • Questions on IRB Review of Grant Applications

    Questions on IRB Review of Grant Applications

    In NIH Policy NOT-OD-19-055, what does the term "certification" entail, and how is "recipient" defined? In the NIH Policy NOT-OD-18-211, if an institution chose to adopt this policy, were all three...

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  • Question: Can we transfer patient data from our CTMS to our parent medical practice?

    Question: Can we transfer patient data from our CTMS to our parent medical practice?

    Our research site is a subsidiary of a medical practice. The financial controller, who works for both the practice and the research site, wants to export data from our clinical trial management system

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  • Question: What elements of Informed Consent must we include when pre-screening?

    Question: What elements of Informed Consent must we include when pre-screening?

    We want to create a “pre-screening protocol” to screen patients for a specific mutation, with permission to recontact them when we have a study open for people with that mutation. Does the informed..

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  • Question: Do sponsors have to change their informed consent documents?

    Question: Do sponsors have to change their informed consent documents?

    I work for a small biotech company. We’ve been hearing some of our investigators talk about a new regulatory requirement for informed consent documents that includes a summary section in the front...

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  • Question: Does the IRB need to review news stories?

    Question: Does the IRB need to review news stories?

    The local newspaper is planning to run a story on a new clinical trial that will highlight the development of an exciting new drug and the work done by our principal investigator...

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  • Question: When can research participants be paid?

    Question: When can research participants be paid?

    As a sponsor, what do the regulations say about paying research subjects? What are acceptable practices for compensating subjects for participating in a clinical trial?

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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 Daniel Kavanagh, PhD

    Meet Daniel Kavanagh, PhD

    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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