Standard Operating Procedures
IRB Review
Note: policies with new substantial revisions or newly added policies will have an asterisk (*) beside the date listed on this page.
- Authority, Membership and Permanent Positions - 01/23/2023
- Member Education - 02/28/2013
- Criteria for IRB Approval - 01/21/2019
- Full Board Review - 10/04/2022
- Expedited Review - 10/04/2022
- NHSR or Exempt Status: Determination - 10/04/2022
- International Research - 01/21/2019
- Local IRB Reliance Agreements - 10/04/2022
- Reliance Agreements - 10/04/2022
- Utilization of the NCI CIRB - 01/10/2022*
- Use of Anonymized Human Cell Lines - 01/21/2019
- Case Studies - 01/21/2019
- NHSR Status for De-identified Repositories - 01/10/2023
Informed Consent & Confidentiality
- Informed Consent - 06/28/2023
- Informed Consent for Genetic Analysis & Repositories - 01/21/2019
- Informed Consent of Subjects Who Do Not Speak English, Illiterate English-Speaking Subjects, and Visually/Hearing Impaired Subjects - 10/04/2022
- Emergency Medicine Research Exemptions from Informed Consent Requirements - 07/12/2017
- Privacy and Confidentiality - 01/21/2019
- HIPAA Authorization for the Use of PHI in Research - 10/04/2022
- Use of PHI Without Subject Authorization - 10/04/2022
- Certificates of Confidentiality - 03/08/2018
Vulnerable Populations in Research
- Additional Protections: Pregnant Women and Fetuses - 01/21/2019
- Additional Protections: Prisoners - 01/21/2019
- Additional Protections: Children - 06/28/2023
Continuing Review/Revisions/Closures/Records
- Continuing Review of Research - 01/21/2019
- Revisions in Approved Studies - 10/07/2022
- Study Closure and Record Retention - 11/30/2022
Safety Reports & Protocol Deviations
- Adverse Event & Unanticipated Problem Reporting - 10/04/2022
- Review of Progress and Safety Reports - 01/21/2019
- Protocol Waivers and Deviations - 01/21/2019
Advertisements & Recruitment Materials
- Review of Advertisements and Recruitment Materials - 04/15/2023
Drug/Biologic/Device
- Significant Risk/Non-significant Risk Determinations - 02/28/2013
- Emergency Use - 10/04/2022
- Compassionate/Treatment Use - 02/02/2024
- Humanitarian Use Devices - 09/01/2018
Regulatory Compliance
- Responsibilities of Investigators - 04/15/2019
- Conflicts of Interest - 01/21/2019
- Appeal of IRB Decisions - 04/29/2021
- Investigator Noncompliance - 04/13/2021
- Auditing of Research Studies - 04/13/2021
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: