For IRB Members | Research Affairs

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IRB Member Guidance

Adverse Events/Unanticipated Problems Reporting (AE/UP) & Reviewing

Authority and Independence of IRB

Conduct of Convened Institutional Review Board Meetings

Continuing Review SOP

Determination of Human Subject Research

Devices in Human Subject Research

Device [Significant Risk (SR)/Non Significant Risk (NSR)] Determination SOP

Humanitarian Use Device

Informed Consent in Human Studies Research SOP

Waiver or Alteration of Informed Consent SOP

Institutional Official for Human Subject Research

Institutional Review Board Membership

IRB Members: Roles and Responsibilities

Institutional Review Board Member Conflict of Interest

Institutional Review Board Member Conflict of Interest Guidelines

Institutional Review Board Member Conflict of Interest SOP

Review Level-Initial Submissions of Human Subject Research

Review of Research by the Convened IRB SOP

Specific Findings SOP

Unanticipated Problems (Examples)

Reviewer's Tools

IRB Reviewer's Script (Template)

Reviewer Checklists

Amendment Review

Informed Consent

Social/Behavioral

Reviewer Worksheets

Initial Expedited

Initial Full Board

Federal Policies Pertaining to Human Subject Research

Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

U.S. Food and Drug Administration: Protection of Human Subjects (21 CFR 50)

U.S. Food and Drug Administration: Institutional Review Boards (21 CFR 56)

U.S. Office of Human Research Protections: Protection of Human Subjects (45 CFR 46)