IRB Policies & Procedures
In addition to federal regulations, research conducted at the University of 老司机福利网 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.
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
IRB Functions and Operations
Records and Documentation
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