The IRB is responsible for the design and implementation of the Human Subjects Protection Program and is therefore responsible for the rights and welfare of human research subjects. 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 the clinical research professionals and IRB staff and IRB administrators who frequently 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. It addresses several of the major areas of interest to clinical research professionals and IRB staff and covers 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..•Focus area 2: IRB administration: IRB staff; IRB audits and Post Approval Monitoring; IRB records and Minutes; IRB membership and Voting; IRB decision making; Single IRB; IRB accreditation; Federal Wide Assurance •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; Engagement in Research •Focus Area 5: Vulnerable subjects: Pregnant Women, Fetuses, Neonates; Prisoners; Children •Focus area 6: Special categories for IRB review : Quality improvement; PPRA,FERPA, COPPA; Deception •Focus Area 7: Ethical frameworks : Nuremberg; Belmont; Declaration of Helsinki; Ethical Milestones •Focus area 8: Interacting committees: IBC; RAC; RDRC; RSC; COIC •Focus Area 9 :FDA related issues: Emergency Use; Emergency Medicine Studies; Expanded access; IND; IDE; Financial Disclosure; Electronic Consent; , Part 11 compliance; DHHS and FDA compared; ICH and FDA compared•Focus Area 10: Clinical Trial Operations : ICH-GCP; Protocol design; Clinical Trial Design, Recruitment; Payments; Withdrawals; Placebo Controlled Trials; Phase 1 Trials in Healthy Volunteers; Phase 1 Oncology Trials in Adults and Children•Focus Area 11: Genetic Research: Genetic Testing; Biorepositories; GINA; GWAS•Focus Area 12: Application of Regulations to Different Study Types: Survey Research; Medical Record Review; Internet Research ;Ethnographic Research ;Public Surveillance and Public Health Research The book also covers a wide array of regulations and guidances and where necessary, draws information from various publicly available websites. A highlight of the book is that it describes in detail the contents of the revised common rule which went into effect in 2019. The implications of the revised common rule for a various types of studies are discussed in several chapters. Some of the regulations addressed in the book include Title 45 part 46 (Protection of Human Subjects) with emphasis on the Revised Common Rule,, Title 21 part 50 ( Protection of Human Subjects), Title 21 part 56 (Institutional review Boards) Title 21 part 54 (Financial Disclosures by Clinical Investigators) . Also addressed are key FDA statutes involved in the regulation of clinical trials Title 21 part 312 (Investigational New Drug Application), Tile 21 part 812 (Investigational Device Exemptions) and Title 21 part 11(Electronic Records and Electronic Signatures). Sections specializing in ICH-GCP and Clinical Trial Design are included as are various OHRP, SACHRP, FDA and NIH guidances.

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