IRB Policies & Procedures

In addition to federal regulations, research conducted at the University of South Alabama is subject to institutional policy and procedures. Below is a complete list of USA IRB Standard Operating Procedures (SOPs). If you have any questions or comments regarding these SOPs, please contact the USA IRB Administrator at irb@southalabama.edu or 251-460-6308.

Human Subjects Research

Table of Contents: IRB Policies and Procedures

Human Subjects Protection Program 

  • 101 - Regulatory and Ethical Mandate
  • 102 - Mission and Authority
  • 103 - Activities Requiring Review
  • 104 - Conflicts of Interest: IRB Members and Staff
  • 105 - Conflicts of Interest: Investigators
  • 106 - Training and Education 
  • 107 - Policy and Procedures Maintenance
  • 108 - Common Rule 2018 Implementation 

IRB Organization and Administration

  • 201 - IRB Membership and Duties
  • 202 - Ancillary Committee Reviews

IRB Functions and Operations 

  • 301 - Meeting Preparation
  • 302 - Materials for Review
  • 303 - Meeting Procedures and IRB Actions 

Records and Documentation

  • 401 - IRB Meeting Agenda
  • 402 - IRB Meeting Minutes
  • 403 - IRB Record Keeping 

IRB Review

  • 501 - IRB Review
  • 502 - Exempt Research
  • 503 - Exempt Research - Limited IRB Review
  • 504 - Expedited Research
  • 505 - Study Completion, Suspension or Termination
  • 506 - Criteria for IRB Approval of Research
  • 507 - Risks to Subjects

Incident Reporting

  • 601 - Unanticipated Problems and Adverse Event Reporting
  • 602 - Protocol Deviations, Violations and Exceptions 

Informed Consent and HIPAA

Special Topics

Vulnerable Populations

  • 901 - Research Involving Children
  • 902 - Research Involving Pregnant Women, Fetuses, and Neonates
  • 903 - Research Involving Prisoners
  • 904 - Decisionally Impaired Participants
  • 905 - Students and Employees

FDA-Regulated Research

External IRB Review

  • 1101 - WCG IRB
  • 1102 - National Cancer Institute: Central IRB
  • 1103 - External Institutional Review Boards
  • 1104 - Single IRB Policy for Multi-Site Federally Funded Research  
  • 1105 - IRB Procedures: Relying on a Single IRB for Multi-Site Federally Funded Research 

Participant Protection

  • 1201 - Advertising and Subject Recruitment Materials
  • 1202 - Recruitment of Research Participants
  • 1203 - Compensation/Incentives for Participation
  • 1204 - Data Safety Monitoring Plan
  • 1205 - Certificate of Confidentiality 
  • 1206 - Data and Safety Monitoring Board 

Quality Assurance and Improvement 

  • 1301 - Quality Assurance Review Program