IRB Policies and Procedures

IRB Policies and Procedures

Institutional Review Board (IRB) Guidance IRB Policies and Procedures

IRB Policies and Procedures

CATEGORIES OF 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
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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
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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
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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
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GENERAL ISSUES

  • POL001 UAB Policy on the Protection of Human Subjects in Research
  • POL​002 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
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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
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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
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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
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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
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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
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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
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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
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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
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