IRB Staff Corner

IRB Meeting Schedules

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

STANFORD Human Research Protections Program (HRPP)
See STANFORD HRPP policies for researchers, administrators, students, participants, and staff involved in human subject research.

Tools, Checklists and Worksheets

• Additional Worksheet for Research with Children
• Additional Worksheet for Research with Neonates
• Additional Worksheet for Research with Pregnant Women & Fetuses
• Additional Worksheet for VA Research
• Continuing Review Checklist (for associates' use)
• Determining if IRB Public Members are Unaffiliated
• Determining if IRB Members are Nonscientists
• Exemption Eligibility Checklist
• Expedited Eligibility Checklist - Initial Review
• Expedited Modification Checklist - to determine review procedure
• Informed Consent Checklist - Medical
• Informed Consent Checklist - Nonmedical
• Intake Checklist
• Soliciting or Waiving the Permission of Parents or Guardians
• Presenter Checklist for Nonmedical IRB Members
• Presenter Worksheet - for new protocols
• Reviewer Tool - for review of protocols
• Protocol Checklist Medical
• Protocol Checklist Nonmedical
• Soliciting or Waiving Assent of Children
• Waivers

IRB Staff Resources

• Approval: Criteria for IRB Approval of Research
• Blues: Blues Instruction Sheet
• Charges:
  • Charge to the Administrative Panel on Human Subjects in Medical Research
  • Charge to the Administrative Panel on Human Subjects in Non-Medical Research
• COI:
  • Guidelines for IRB Members when Potential Conflicts of Interest Arise
  • IRB Conflict of Interest Memorandum
  • IRB Member Conflict of Interest Declaration
  • IRB Conflicting Interest Statement
• Confidentiality: Confidentiality of Administrative Panel Proceedings
• Consent:
  • Alteration or Waiver of Consent and Waiver of Documentation
    in Nonmedical Research and International Research
  • General Requirements for Informed Consent
  • 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: Disapproval Memo
• Emergency Use:
  • Emergency Use of a Test Article - guidance
  • Emergency Use of a Test Article - web page
• eProtocol News: Information about current issues and future plans
  
• 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
• Participant Inquiry: Procedure for Handling a Prospective Participant Inquiry
  
• Payment: Stanford University Job Aid: Paying Human Subjects
• Reporting:
  • Events and Information that Require Prompt Reporting to the IRB
  • Reporting Incidents to OHRP
• Reports: Return Reports
• Scientific Review:
  • Review of Scientific and Scholarly Validity (Dept Chair or School Dean)
  • Review of Scientific and Scholarly Validity, and Oversight (Faculty Sponsor)
• 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

Evaluations

• Evaluation of IRB Chairs
• Evaluation of IRB Chairs Instructions
• Evaluation of IRB Members
• Evaluation of IRB Members Instructions

Definitions