91ÌÒÉ«

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 91ÌÒÉ« IRB Standard Operating Procedures (SOPs). If you have any questions or comments regarding these SOPs, please contact the 91ÌÒÉ« 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 and Non-Compliance 

Informed Consent and HIPAA

• 701 - Informed Consent 
• 702 - Consent Documentation
• 703 - Informed Consent: Research Involving Children
• 704 - HIPAA Authorization
• 705 - Translation and Interpretation
• 706 - Posting of Informed Consent for Clinical Trials
• Guidance for Consenting for a COVID-19 Study

Special Topics

• 801 - Research Involving Data and Biological Specimens 
• 802 - Research Involving Secondary Data 
• 803 - Social and Behavioral Research 
• 804 - Internet Research
• 805 - Case Studies/Reports 
• 806 - Involvement in Clinical Research for Non-Healthcare Providers
• 807 - Research Procedures Conducted Without IRB Approval 
• IRB Guidance and Recommendations for Using Mechanical Turk (MTurk) for Social/Behavioral Projects

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

• 1001 - Medical  Devices: Significant Risk/Non-Significant Risk Determinations
• 1002 - Emergency Use: Investigational Drugs, Biologics and Device
• 1003 - Compassionate/Treatment Use 
• 1004 - Humanitarian Use Device
• Guidance for Humanitarian Use Device 

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