PRODUCT DESCRPTION FOR HANDBOOK This book is designed for IRB members, but may be equally of interest for IRB staff. Information pertinent to IRB management, administration and function is spread out in a diverse array of regulations, guidances, and web sites. This presents a formidable challenge to IRB members who have to access each of these source documents separately to assemble a working guide for daily reference and use. This book is designed to make this task simpler. The book brings together a wide array of regulations and guidances. The book has several focus areas of information and these are outlined below:•Focus area 1: Informed consent: Elements of informed consent; Exculpatory Clauses; Waivers of Informed Consent; New aspects of the Revised Common Rule; Risk and the Common Rule.; Updates on New Aspects of the Revised Common Rule.•Focus area 2: IRB administration: IRB membership and Voting; IRB decision making; •Focus area 3: Reports to the IRB: Continuing review; Amendments; Study closure; Protocol deviations; Unanticipated events and SAEs; DSMB and DSMB reports; Noncompliance; Certificates of Confidentiality •Focus area 4: IRB review categories: Exempt research; Expedited review; Full Committee Review; HIPAA; Deception •Focus Area 5: Vulnerable subjects: Types of Vulnerability, Pregnant Women, Fetuses, Neonates; Prisoners; Children •Focus Area 6: Ethical frameworks : Belmont; Ethical Milestones •Focus Area 7: Clinical Trial Operations : Clinical Trial Design, Recruitment; Payments; Withdrawals; Placebo Controlled Trials