Standard Operating Procedures

All documents are in PDF format unless otherwise noted.

• SOP 101: Policies and Procedures Management
• SOP 102: Training and Education
• SOP 103: Management of IRB Personnel
• SOP 104: IRB Authority and Signatory Authority
• SOP 105: Non-Federally Funded Research
• SOP 106: Implementation of the Final Rule
• SOP 201: Management and Composition of the IRB
• SOP 202: Duties of IRB Members
• SOP 301: Research Submission Requirements
• SOP 302: Administrative Review and Distribution of Materials
• SOP 303: IRB Review of Submissions
• SOP 304: IRB Convened Meeting Administration
• SOP 305: Documentation of IRB Discussions, Decisions and Findings
• SOP 306: Ad Hoc Consultant Reviewers
• SOP 307: Expiration of Approval
• SOP 308: Document Management
• SOP 401a: Non-Human Subjects Research
• SOP 401b: Research Activities Exempt from IRB Review
• SOP 402: Expedited Review
• SOP 403: Initial Review - Criteria for IRB Approval
• SOP 404: Continuing Review
• SOP 405: Review of Amendments to Research Studies
• SOP 406: Final Project Reports
• SOP 407: IRB Actions to Approve or Disapprove Research
• SOP 408: Medical Case Reports
• SOP 409: Alternative IRB Review Arrangements and Agreements
• SOP 410: Appeal of IRB Decisions
• SOP 501: Vulnerable Populations in Research
• SOP 502: Clinical Research Involving Investigational Drugs and Devices
• SOP 503: Genetic Research
• SOP 504: Research Involving Tissue Use and Banking (RETIRED) Please see Data and Biospecimens Page
• SOP 505: Research Materials in Participants' Medical Records
• SOP 506: Emergency Use of a Test Article and Planned Emergency Use
• SOP 507: Expanded Access
• SOP 601: Screening, Recruiting, and Advertising for Participant Enrollment
• SOP 602: Payment for Participation in Research Studies
• SOP 701: General Requirements of Informed Consent
• SOP 702: General Requirements of Documentation of Consent
• SOP 703: Waiver or Alteration of Consent
• SOP 704: Assent
• SOP 801: Conflict of Interest
• SOP 802: Privacy and Confidentiality
• SOP 803: Research Related Injury
• SOP 901: Unanticipated Problems Involving Risks to Participants and Others
• SOP 902: Protocol Deviations
• SOP 903: HRPP and Non-Compliance
• SOP 904: Administrative Hold, Suspension and Termination of Approved Research
• SOP 905: Institutional Reporting Procedures
• SOP 906: Protection of Research Participants
• SOP 907: Research Complaints and Concerns
• SOP 908: Routine and For-Cause Audits
• SOP 909: Institutional Review Board (IRB) Community Outreach