IRB Member Corner

WELCOME to the IRB Member Corner. Your comments and suggestions are welcomed; please contact the IRB Training Specialist.

STANFORD Human Research Protections Program Policies and Procedures (HRPP) - please see STANFORD HRPP policies and procedures for researchers, administrators, students, participants, and staff involved in human subject research.

Frequently Referenced Gudiances

Reviewing Tools, Checklists and Worksheets

• Continuing Review Checklist
• Parental Permission Checklist
• Presenter Checklist for Nonmedical IRB Members
• Soliciting or Waiving Assent of Children Checklist
• Waivers Checklist
• Presenter Worksheet - for new protocols
• Reviewer Tool - for review of protocols
• Worksheet for Research with Children
• Worksheet for Research with Neonates
• Worksheet for Research with Pregnant Women & Fetuses
• Worksheet for VA Research

Evaluations

• Evaluation of IRB Chairs
• Evaluation of IRB Chairs Instructions
• Evaluation of IRB Members
• Evaluation of IRB Members Instructions
• Determining if IRB Public Members are Unaffiliated - Checklist
• Determining if IRB Members are Nonscientists - Checklist

IRB Member Resources

• Approval: Criteria for IRB Approval of Research
• Auditing: Auditing for Excellence PPT Presentation
• Blues:
  • Blues Instruction Sheet
  • The "Blues" PPT Presentation
• Charge:
  • Charge to the Administrative Panel on Human Subjects in Medical Research
  • Charge to the Administrative Panel on Human Subjects in Nonmedical Research
• COI:
  • Guidelines for IRB Members when Potential Conflicts of Interest Arise
  • IRB Member Conflict of Interest Declaration
• Confidentiality: Confidentiality of Administrative Panel Proceedings
• Consent:
  • General Requirements for Informed Consent
• Alteration or Waiver of Consent and Waiver of Documentation
  in Nonmedical Research and International Research
• Basic Research Consent Requirements
• Glossary of Lay Terms for use in Preparing Consent Forms
• Observation of the Consenting Process
• Observation of the Consenting Process Checklist
• Regulations for Waiver or Alteration of Consent Requirements
• Surrogate Decision Makers
• Cooperative Research: Letter of Agreement
• Disapproval Memo
• Emergency Use:
  • Emergency Use of a Test Article - guidance
  • Emergency Use of a Test Article - web page
• Exempt Review Categories
• Expedited Review Categories
• Expertise or an Expert Consultant: Guidance on Obtaining Additional Expertise or an Expert Consultant
• Expiration: Notice of Protocol Expiration
• Payment: Stanford University Job Aid: Paying Human Subjects
• Presenter Checklist: Presenter Checklist PPT Presentation
• Quality Improvement: Continuous Quality Improvement (CQI) Plan
• Reporting:
  • Events and Information that Require Prompt Reporting to the IRB
  • Non-compliance and Unanticipated Problems Flow Chart
  • Reporting Incidents to OHRP
  • IRB Procedures Regarding Processing of Reports
• Training: Training in the Protection of Human Subjects in Research
• Waivers: Examples of Documenting Determinations Required By the Regulations and Protocol Specific Findings Justifying Those Determinations

Definitions