Lines of Authority and Responsibilities Collaborative Research Transnational Research Coordination between the IRB and the IBC Educations and Training Education and Training: Principal Investigators and Research Team Members Review of Research Activities Determination of Activities that Require IRB Review Exempt Determination Expedited Review: Initial IRB Review Full Committee Review: Initial IRB Review Modifications, Deviations, and Exceptions Continuing Review and Project Completion Use of Consultants in IRB Review Informed Consent/Assent Informed Consent: Process, Documentation, and Waivers Informed Consent: Research Involving Children Informed Consent: Emergency Research Under FDA 50.24 Vulnerable Populations Vulnerable Subjects: Children Vulnerable Subjects: Pregnant Women, Human Fetuses and Neonates 51³Ô¹ÏºÚÁÏ Students as Research Subjects Vulnerable Populations - Economically Disadvantaged Adults with Questionable Decision Making Capability Drugs and Biologics FDA Regulated Drugs and Biologics FDA Regulated Medical Devices Recruitment and Remuneration Subject Recruitment and Study Advertising Subject Compensation Reporting Problems and Noncompliance Problems and Adverse Events, Record and Report Researcher Noncompliance: Investigation, Reporting, and Corrective Action IRB Suspension or Termination of Approved Research Managing Research Concerns and Complaints Records and Documentation IRB Records and Documentation IRB Minutes Conflict of Interest Conflict of Interest/Compensated Outside Services Related to Research with Human Subjects Quality Improvement & Audits (Compliance Monitoring) Assessing the Quality, Effectiveness, and Efficiency of the Human Research Protection Program