Current IRB Policies and Procedures
COMMUNICATION BETWEEN RESEARCH SITES
- POL029 UAB Policy on Identification and Communication of Human Subjects
- PRO124 Procedure for Identification and Communication of Human Subjects Research to Non-UAB-Affiliated Performance Sites
- PRO152 Procedure for Identification and Communication of Human Subjects Research to UAB-Affiliated Performance Sites
COMPLIANCE
- POL028 UAB Policy on Compliance with Human Subjects Regulations or the Requirements of the IRB
- PRO128 Procedure for Compliance Issues with Human Subjects Regulations or IRB Requirements or Determinations
CONFLICT OF INTEREST
- POL009 UAB Policy on IRB Member and Consultant Conflicting Interest
- PRO109 Procedure for Identifying and Managing IRB Member and Consultant Conflicting Interest
- PRO123 Procedure for Identifying and Managing Investigator and Institutional Conflicts of Interest
FDA-REGULATED STUDIES (DRUGS, DEVICES)
- POL021 UAB Policy on Use of and Investigation with Drugs, Biologics, Devices, or Test Articles under FDA Regulations
- PRO121 Procedures to Ensure Handling of Investigational or Unlicensed Test Articles Meets Organizational Standards Relating to Pharmacy, Inventory Control, and Documentation
- PRO141 Procedure to Ensure Handling of Investigational or Unlicensed Test Articles Meets Organizational Standards Relating to Devices, Inventory Control and Documentation
- PRO151 Procedure for Emergency Use of FDA-Regulated Test Articles
GENERAL ISSUES
- POL001 UAB Policy on the Protection of Human Subjects in Research
- POL002 Guideline on Federal and UAB Requirements for the Protection of Human Research Participants: Ethical and Legal Framework for Human Research Protections at UAB
- POL005 UAB Expectations for Research Sponsors
- POL007 UAB Policy on Assurance of Compliance with Department of Health and Human Services Policy on Protection of Human Subjects
- POL010 UAB Policy on Policy Development and Communication for the Human Research Protection Program
- POL027 UAB Policy on Minimizing Risks to Subjects
- POL034 UAB Policy on Quality Assurance and Quality Improvement for the Human Research Protection Program
- POL039 UAB Policy on Selection and Recruitment of Subjects in Research
- POL040 UAB Policy on Other Laws Affecting Human Subjects Research
- PRO100 Procedure for Evaluating and Training Individuals Involved in the Human Research Protection Program
- PRO103 Procedure for Ensuring Qualifications of Investigators
- PRO107 Procedure for Assurance of Compliance with Department of Health and Human Services Policy on Protection of Human Subjects
- PRO110 Procedure for Policy Development and Communication for the Human Research Protection Program
- PRO118 Procedure for Communicating Among IRBs
- PRO127 Procedure for Determination that Research Risks to Subjects Are Minimized
- PRO134 Procedure for Quality Assurance and Quality Improvement for the Human Research Protection Program
- PRO137 Procedure for Determination that Necessary Resources are Available for Care and Safety of Human Research Participants
- PRO139 Procedure for Selection and Recruitment of Subjects in Research
INFORMED CONSENT
- POL013 UAB Policy on Elements of Informed Consent, the Informed Consent Process, and Documentation of Informed Consent
- POL019 UAB Policy on Waiver of Informed Consent Requirements in Research Planned for Emergency Settings
- POL031 UAB Policy on Inclusion of a Procedure for Participants to Communicate Questions and Concerns to Investigators and the IRB as Part of Informed Consent Process
- POL036 UAB Policy on Waiver, Alterations, and Exceptions to Informed Consent; Waiver of Documentation of Informed Consent
- PRO113 Procedure for the Informed Consent Process and Documentation of Informed Consent
- PRO119 Procedure for Waiver to Informed Consent Process in Research Planned for Emergency Settings
- PRO129 Procedure for Observation of the Informed Consent Process in Ongoing Research
- PRO131 Procedure for Participants to Communicate Questions and Concerns to Investigators and the IRB as Part of Informed Consent Process
- PRO153 Procedure for Approving a Waiver or Alteration of the Consent Process and the Waiver of Consent Documentation
IRBS: ESTABLISHMENT, USE, MEMBERS
- POL004 Roles and Responsibilities of the Institutional Review Board (IRB)
- POL014 UAB Policy on IRB Consultants
- POL018 UAB Policy on the Establishment, Maintenance, and Utilization of IRBs
- PRO114 Procedure for IRB Use of Consultants
MONITORING, REPORTING
- POL006 UAB Policy to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB
- POL016 UAB Policy on Data Safety Monitoring for Human Subjects Research
- POL024 UAB Policy on Reporting to Institutional Officials and Regulatory Agencies
- POL038 UAB Policy on Suspension or Termination of IRB-Approved Research and Administrative Hold
- PRO102 Procedure for Quality Assurance (Monitoring of Human Subjects Research)
- PRO106 Procedure to Ensure Prompt Reporting Of Unanticipated Problems Involving Risks to Subjects or Others to the IRB
- PRO116 Procedure for Data and Safety Monitoring for Human Subjects Research
- PRO140 Procedure for Suspension or Termination of IRB-Approved Research and Administrative Hold
OIRB ADMINISTRATION
- POL026 UAB Policy on Maintenance of IRB Records
- PRO101 Procedure for IRB Member Roster and Quorum
- PRO104 Procedure for Qualifications and Composition of IRBs and OIRB
- PRO115 Procedure for Organization of Protocol Files
- PRO126 Procedure for Maintenance of IRB Records
- PRO136 Procedure for Documentation of Research Undergoing Initial or Continuing Review by the Expedited Procedure
- PRO142 Procedure for IRB Meeting Agenda Development
- PRO143 Procedure for IRB Member Selection for Convened Meeting
- PRO144 Procedure for Formation and Assignment of IRB Member Primary Review Teams for Initial or Continuing Review or Review of Modifications to Research at Convened IRB Meetings
- PRO145 Procedure for Timing of Document Distribution for Meetings
- PRO146 Procedure for Documentation of Convened IRB Proceedings
PARTICIPANT INTERACTIONS
- POL011 UAB Policy on Complaints and Inquiries for Research Participants, Investigators, Research Staff, and the Community
- POL030 UAB Policy for Educational Activities on Human Research Protections for Participants, Prospective Participants, and the Community
- PRO111 Procedure for Complaints and Inquiries for Research Participants, Investigators, Research Staff, and the Community
- PRO130 Procedure for Conducting and Evaluating Activities Designed to Educate the Public about Human Subjects Research
PRIVACY, CONFIDENTIALITY
- PRO112 Procedure for Confidentiality of Data; HIPAA Authorization and Waiver
- POL012 UAB Policy on Confidentiality of Data
- POL037 UAB Policy on Maintaining the Privacy of Research Subjects
- PRO155 Procedure on Maintaining the Privacy of Research Subjects
SPECIAL POPULATIONS
- POL008 UAB Policy on Additional Safeguards for Children Involved in Research
- POL015 UAB Policy on Definition of Child, Parent, Guardian
- POL025 UAB Policy on Definition of "Legally Authorized Representative" for Decisionally Impaired Adults
- POL032 UAB Policy on Additional Safeguards for Pregnant Women and Fetuses and Neonates Involved in Research
- POL033 UAB Policy on Additional Safeguards for Prisoners Involved in Research
- POL041 UAB Policy on Additional Safeguards for Students Involved in Research
- PRO108 Procedure for Additional Safeguards for Children Involved in Research Including Assent
- PRO125 Procedure for Review of Decisionally Impaired Adults Involved in Human Subjects Research Including Assent
- PRO132 Procedure for Review when Pregnant Women, Fetuses, and Neonates are Involved as Participants in Research
- PRO133 Procedure for Review when Prisoners are Involved as Participants
TYPES OF REVIEW
- POL003 UAB Policy on Scientific/Scholarly Review of Protocols
- POL017 UAB Policy on Determination of Human Subject Research and Research Exempt from Federal Human Subjects Protection Regulations; IRB Review of Exempt Research
- POL020 UAB Policy on Expedited Review of Human Subjects Research
- POL022 UAB Policy on IRB Review of Human Subjects Research by Convened IRB
- POL035 UAB Policy on Repositories of Human Tissue and Databanks
- POL042 UAB Policy on Determination of Human Subject Research on Cell Lines
- POL043 UAB Policy on Case Reports
- PRO105 Procedure for Determination of Exemption from Human Subjects
- PRO117 Procedure for Not Human Subjects Research Designation
- PRO120 Procedure for Initial Review Using the Expedited Procedure
- PRO122 Procedure for Initial Review of Proposed Research at the Convened IRB Meetings
- PRO135 Procedure for Repositories of Human Tissues and Databanks
- PRO138 Procedure for Scientific/Scholarly Review of Protocols
- PRO147 Procedure for Continuing Review of Research Approved by the Convened IRB
- PRO148 Procedure for Review of Modifications to Previously Approved Research by the Convened IRB
- PRO149 Procedure for Facilitated Review of Research for NCI Pediatric Central IRB-Approved Research Protocols
- PRO150 Procedure for Continuing Review of Research by the Expedited Procedure
- PRO154 Procedure for Facilitated Review of Industry-Sponsored Research by Western IRB (WIRB)
- PRO156 Procedure for Reviewing and Signing of Independent Investigator Agreements
- PRO157 Procedure for Request for Documentation Regarding Use of Established Human Cell Lines Not Requiring IRB
