Institutional Review Boards must establish an institutional culture where studies are conducted in an ethical and scientifically rigorous manner. That is why it is important to create and maintain standard operating procedures that adhere to the regulations governing the oversight of human subjects.

This SOP template is provided in a three-ring binder with a CD-ROM containing an MS Word program for Windows and Mac users and is based on the Code of Federal Regulations, guidance and ICH/GCP Consolidated Guideline, and the Association for the Accreditation of Human Research Protection Program’s (AAHRPP) standards for human subject protection.

Template features and topics include:

• Sample job descriptions for staff and IRB members
• Templates for IRB minutes, agendas, and review worksheets
• Chapters on informed consent, quality assurance, IRB organization, and responsibilities of investigators and sponsors

Policies and Standard Operating Procedures for the Institutional Review Board is also designed to be compatible with the other SOP templates in the series, which include:

• Standard Operating Procedures for the Conduct of Clinical Research
• Standard Operating Procedures for Good Clinical Practice by Sponsors of Clinical Trials
• Standard Operating Procedures for Good Clinical Practice by Sponsors of Medical Device Clinical Trials