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What Can Institutions with Local IRBs Do to Prepare for a Proposed FDA Single IRB Mandate?

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Reviewing the FDA’s Proposed Single IRB Mandate

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Reviewing the FDA’s Proposed Informed Consent Rule Changes

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Drafting a Research Plan for IRB Review and Research Conduct: Information that Must Be Included in a Clinical Trial Protocol

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Ethical and Regulatory Considerations in Patient-to-Patient-Referral Recruitment Plans

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The Basics of the Individual Expanded Access Request Process: A Resource for Physicians

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The Role of IRBs in Research Oversight: Information for Research Teams to Support Diverse Research Participation

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The Role of IRBs in Research Oversight: Information for Potential Participants in Clinical Research

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Changes in Research: What are They and When do They Need to be Submitted to the IRB?

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Do You Know Me?: The Subtle Distinction Between “Anonymous” and “De-identified” Data in Clinical Research

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