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IRB Policies and Procedures

Current IRB Policies and Procedures

 

Summary of Reporting Requirements for Investigators to the IRB (GUI325)

 

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
  • P​OL034 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