The new Third Edition explains the changes under the revised Common Rule requirements, providing solutions for both new and common problems that Institutional Review Boards (IRBs) face. Compliance with the revised Common Rule requires a close examination of IRB, facility, and research practices. This book provides full explanations of important changes such as:

• Changes in applicability and exemptions
• Collection, use, and storage of private information and bio specimens
• Use of broad consent
• And more

In addition, the Third Edition incorporates a number of all new chapters which address:

• Investigator Responsibilities including coverage of supervision, compliance, record keeping, and reporting
• IRB Compliance and Internal Audits addressing regulatory requirements, assignment of responsibility and delegation of duties, information collection, components of a compliance audit, elements of a compliance plan, common deficiencies, and areas of risk
• Secondary Findings in Genomic Research with analysis of the ethical, legal, and practical considerations involved in deciding whether to communicate findings to subjects
• Scientific Misconduct in Clinical Research including how to identify, investigate, and respond to allegations of misconduct