Standard Operating Procedures
IRB Review
- Authority, Membership and Permanent Positions
- Member Education
- Criteria for IRB Approval
- Full Board Review
- Expedited Review
- NHSR or Exempt Status: Determination
- International Research
- Local IRB Reliance Agreements
- Reliance Agreements
- Utilization of the NCI CIRB
- Use of Anonymized Human Cell Lines
- Case Studies
- NHSR Status for De-identified Repositories
Informed Consent & Confidentiality
- General Data Protection Regulation
- Informed Consent
- Informed Consent for Storage & Use of Repository Materials
- Informed Consent of Subjects Who Do Not Speak English, Illiterate English-Speaking Subjects, and Visually/Hearing Impaired Subjects
- Emergency Medicine Research Exemptions from Informed Consent Requirements
- Privacy and Confidentiality
- HIPAA Authorization for the Use of PHI in Research
- Use of PHI Without Subject Authorization
- Certificates of Confidentiality
Vulnerable Populations in Research
- Additional Protections: Prisoners
- Additional Protections: Children
- Additional Protections: Pregnant Women & Fetuses
Continuing Review/Revisions/Closures/Records
Safety Reports & Protocol Deviations
- Adverse Event & Unanticipated Problem Reporting
- Review of Progress and Safety Reports
- Protocol Waivers and Deviations
Advertisements & Recruitment Materials
Drug/Biologic/Device
- Significant Risk/Non-significant Risk Determinations
- Emergency Use
- Compassionate/Treatment Use
- Humanitarian Use Devices
Regulatory Compliance
- Responsibilities of Investigators
- Conflicts of Interest
- Appeal of IRB Decisions
- Investigator Noncompliance
- Auditing of Research Studies
Related UT System Policies
The following UT system human subjects research-related policies are available via the UT Policy page or by clicking the below hyperlinks:
- CM001-H Advertising
- F10320-H – Indicia Licensing, Promotions, and Sponsorships
- CM0004-H Logo Usage
- CM006-H Social Media
- GE0002 – Conflicts of Interest & Commitment
- GE0002 – What to Disclose
- Financial Interest Disclosure Form for PHS Investigators - 20120821
- Outside Interest Disclosure Form Faculty and Staff - 2019
- TN State Laws on Conflict of Interest
- F10205 – Sponsored Projects
- FI0313 – Gift Cards and Gift Certificates
- FI0525 – Petty Cash
- COM117 Infection Control and Prevention of Exposure to Environmental Hazards – COM Medical Education
- RS002 – Exposure Control Plan
- IBC130 – IBC Charter
- IBC120 – General Guidelines – IRB Research
- IBC140 – Simplified Guidelines for Recombinant DNA Research
- IBC100 – Additional Guidelines for the Transfer of Recombinant DNA Molecules into Human Subjects
- RE0001 – Policy and Procedures on Responsible Conduct in Research and Scholarly Activities
- RE0002 – Policy on Visitors Engaged in Research
- FI0120 – Records Management
- GP-002 – Data & System Classification
- HR0580 – Code of Conduct
Related UTHSC Policies
The following are UTHSC human subjects research-related policies: