Children & Youth Institutional Review Board (CYIRB)
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CYIRB Site Index

TopSECTION 1: GENERAL INFORMATION

  • About the CYIRB
    • Types of Projects the CYIRB Reviews
    • Office Location and Hours
    • Staff List
    • Contact Information

  • IRBNet Information for Researchers

  • Recruitment Study Finder

  • CYIRB Meeting Dates

  • Submission Deadline Dates and How To Submit Materials For CYIRB Review

  • Quality Assurance / Quality Improvement Program
    • What is the UB HRPP QA/QI Program
    • Site Visits
    • HRPP and IRB Training Wokshops
    • HRPP Topics Newsletter
    • Contact Information

  • IRB Training for Researchers

  • UB Federalwide Assurance (FWA)

  • HRPP Topics / Newsletters

  • USEFUL RESOURCES AND LINKS

      General Resources

      1. Other UB IRBs that Review Human Subjects Research
          2. n
        1. Health Sciences IRB
        2. Social and Behavioral Sciences IRB
      2. Office of the Vice President for Research
      3. CITI Human Subjects Protection Tutorial
      4. Lay Terms for Use in Consent Forms
      5. NIH (National Institutes of Health)
      6. Tips for Writing an Understandable Consent Document
      7. UB HIPAA Web Site
      8. UB HRPP Standard Operating Procedures (SOP)
      9. UB Sponsored Projects Services (SPS)

      Ethical Principles and Guidelines

      1. Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
      2. Nuremburg Code

      Regulations

      1. DHHS Regolations (Department of Health and Human Resources)
        1. DHHS 45 CFR Part 46 - Protection of Human Subjects/ Institutional Review Boards
        2. OHRP Site (Office for Human Research Protections)
      2. FDA Regolations (Federal Drug Administration)
        1. FDA 21 CFR Part 50 - Protection of Human Subjects
        2. FDA 21 CFR Part 56 - Institutional Review Boards
        3. FDA 21 CFR Part 312 – Investigational New Drug Application
        4. FDA 21 CFR Part 812 – Investigational Device Exemptions
        5. FDA Site (Food and Drug Administration)

  • What's New

  • CYIRB Membership List

  • FOR CYIRB MEMBERS ONLY

      CYIRB Meeting Dates

      Reviewer Evaluation and Guidesheets

      1. Initial Review
      2. Continuing Review
      3. Amendment
      4. Exempt Status
      5. Children
      6. Pregnant Women
      7. Prisoners
      8. Serious Events and Problems (SEPs)
      9. Short Form Consent Process
      10. Waiver of Consent and Waiver of Documentation of Consent

TopGUIDELINES/ REQUIREMENTS

  • Advertising for Research Participants
    • What are "Advertising and Recruitment Materials"?
    • What to submit to the IRB
    • When and How to submit advertising and recruitment materials for approval
    • Video or Audio Advertisements
    • Internet Advertisements
    • Content Requirements

  • Amending/Making Changes to an Approved Research Project
    • What amendments or changes must be submitted for CYIRB approval?
    • “What and “How” to submit amendments/changes to the CYIRB
    • CYIRB review of amendments/changes to approved projects

  • Case Reporting

  • Certificates of Confidentiality
    • What are Certificates of Confidentiality and under what circumstances would I apply for one?
    • Who may apply for a Certificate?
    • Do I need IRB approval before I apply for a Certificate?
    • To whom should I apply for a Certificate?
    • Does the Privacy Rule preclude the need for Certificates of Confidentiality?
    • Who must sign the Certificate?
    • Some Important Caveats

  • Completed / Closed Studies
    • When to notify the CYIRB
    • What to submit to the HSIRB
    • How to submit the CYIRB
    • Investigator responsibilities after study closure

  • Conflicts of Interest (Financial): Annual Requirements for PIs and co-PIs

  • Continuing Review
    • Overview
    • Level of Review: Expedited or Full Board Review
    • Investigator Responsibilities for Continuing Review of Projects
    • What and When to Submit for Continuing Review
    • How to submit documents to the CYIRB

  • Data and Safety Monitoring
    • Overview
    • Elements of a Data and Safety Monitoring Plan (DSMP)
    • Determining the Appropriate Level of Monitoring
    • Data Monitoring Committees (DMCs) and Data and Safety Monitoring Boards (DSMBs)
    • For Pharmaceutical Clinical Trials
    • NIH Sponsored Research
    • IRB Review of DSMPs and DSMB/DMC summaries and reports at Continuing Review
    • Additional Information

  • Education and Training
    • UB HRPP Required Training:
      1. Who must complete the CITI training?
      2. What is CITI training?
      3. What are the initial training requirements?
      4. What if I completed equivalent CITI training at another institution?
      5. What are the continuing training requirements?
      6. How do I access CITI training courses?
    • CITI Optional Courses and Optional Modules
      1. What are CITI Optional “Courses” and Optional “Modules”?
    • HRPP and IRB Training Workshops available for researchers

  • Exemption Requests

  • FDA REGULATED PRODUCTS: RESEARCH INVOLVING INVESTIGATIONAL DRUGS, AGENTS, BIOLOGICS, AND DEVICES
    • Overview
    • Investigational new drug (IND)
      1. B-1. Overview
      2. B-2. Types of IND Applications
      3. B-3. Phases of a Clinical Trial
      4. B-4. Requirements for Submission of an IND Application to the FDA for Research Involving Drug or Biologics that Have Not Yet Reached the Market
      5. B-5. Clinical Investigations of Marketed Drugs Not Requiring Submission of an IND Application
      6. B-6. Research Involving Combinations of FDA Approved Drugs, Agents or Biologics
      7. B-7. Investigator Responsibilities for Research Involving Investigational Drugs, Agents and Biologics
      8. B-8. Investigator Responsibilities for Storage, Handling, and Dispensing of Investigational Drugs, Agents, and/or Biologics
      9. B-9. Emergency Use of an Investigational Drug or Biologic
      10. B-10. Emergency Exemption from Prospective IRB Approval
      11. B-11. Exception from Informed Consent Requirement
      12. B-12. Expanded Access to Investigational Drugs
      13. B-13. Communication with Hospital-Based Pharmacies
    • Investigational Device Exemption (IDE)
      1. C-1. Overview
      2. C-2. Investigational Device Exemption (IDE)
      3. C-3. Exemptions from Obtaining an IDE
      4. C-4. Significant Risk vs. Non-Significant Risk Devices
      5. C-5. Investigator Responsibilities for Studies Involving Investigational Devices
      6. C-6. Responsibilities of Investigators Who Also Sponsor the Research
      7. C-7. Investigator Responsibilities Involving Unanticipated Adverse Device Effects
      8. C-8. IRB Review of Investigational Devices in Determining SR/NSR
      9. C-9.Investigator Responsibility for Maintaining the Distinction Between Research and Therapy
      10. C-10.Concurrence of FDA, Sponsor and IRB Determinations for SR/NSR
    • Humanitarian Use Devices (HUDs)
      1. D-1. Overview
      2. D-2. Investigator Responsibilities for HUDs
      3. D-3. Additional Reporting Requirements for Serious Events/Problems (SEPs) Involving HUDs
      4. D-4. IRB Review of HUD Use
    • Emergency Use of Unapproved Medical Devices
      1. E-1. Overview
      2. E-2. Requirements for Emergency Use
      3. E-3. After-use Procedures
      4. E-4. Exception from Informed Consent Requirement for Medical Devices
      5. E-5. Exception from Informed Consent for Planned Emergency Research
      6. E-6. Investigator Responsibilities for Conducting Planned Emergency Research
      7. E-7. IRB Review of Planned Emergency Research
    • IRB Responsibilities for Emergency Use of FDA Regulated Products

  • Fees Associated with IRB Review of a Commercially Sponsored Research Project

  • Forms and Templates (All CYIRB Forms and Templates)

  • HIPAA (Health Insurance Portability and Accountability Act): Guidelines/Forms/Templates
    • HIPAA Guidelines
    • HIPAA Forms
      1. Worksheet
      2. Authorization
      3. De-Identification
      4. Full Waiver
      5. Partial Waiver

  • Informed Consent Process: Guidelines and Forms
    • Overview
    • Requirements for Informed Consent
      1. B1. Elements of consent: What must be said about the research
        • Basic Elements
        • Additional Elements
        • Specific FDA requirements
      2. B2. Providing enrolled subjects with new information
      3. B3. Reporting missing signatures/dates and other consent irregularities
    • Documentation of consent
      1. C1. Overview
      2. C2. Signature Requirements
        • The subject or LAR’s signature
        • Person Obtaining consent
        • A witness
        • Time of Consent
        • PI Signature:
      3. C3. Give a signed copy to the subject/LAR
      4. C4. Retain a signed copy in the repository
    • Waivers
      1. D1. Waiver of consent
      2. D2. Waiver of written documentation of consent
    • Parental Permission and Child Assent
      1. E1. Definitions
      2. E2. Overview
      3. E3. Documentation of permission of parents/guardians
      4. E4. Assent of the child
      5. E5. Documentation of child assent
      6. E6. Waiver of parental/guardian permission
      7. E7. Waiver of child assent
      8. E8. LARs for minors in New York State
      9. E9. Minors in NYS who may be able to give legally effective informed consent
      10. E10. When a child reaches the legal age of consent while enrolled in a study
      11. E11. Research involving wards of the state
    • Consenting documents formats/templates
      1. F1. Required use of “CYIRB-approved” documents
      2. F2. CYIRB formats/templates
      3. F3. Sponsor-prepared templates
    • Amendments/modifications to consent documents during the study
      1. G1. What and when to submit
    • Who may obtain consent, permission, and assent?
    • How and where to obtain consent
    • Special consenting situations
      1. J1. Non-English consents
      2. J2. Illiterate English-speaking individuals
      3. J3. Physically incapacitated individuals
      4. J4. Decisionally incapacitated adults
        • Capacity assessment
        • Legally authorized representatives (LAR)
        • Documentation of LAR consent
        • Assent by decisionally incapacitated adult subjects
        • Consent of adult subjects who regain capacity
        • Anticipated loss of decisional capacity by adult subjects enrolled in research
      5. J5. Genetic research
      6. J6. Pregnant women or fetuses prior to delivery
      7. J7. Neonates
      8. J8. Students, employees, and others in subordinate positions

  • Leaving the Institution (When Principal Investigators Leave)

  • New/Initial Submissions:
    • Expedited Review
      1. Overview
      2. What to submit
      3. When to submit
      4. How to submit
    • Full Board Review
      1. Overview
      2. What to submit
      3. When to submit
      4. How to submit

      (See also Exemption Requests)

  • Privacy and Confidentiality
    • Privacy vs. Confidentiality – What is the difference?
    • Protecting Participant Privacy Interests

  • Protocol Requirements

  • Quality Control Projects

  • Reportable Events and Problems
    • "On-Site" events/problems
      • Determining "Serious" or "Non-Serious"
      • Reporting "Serious" Events/Problems (SEPs)
      • Requirements for follow-up reports
      • Reporting "Non-Serious" events/problems
    • "Off-Site" SEPs
      • Safety Reports
      • Other types of off-site SEP notifications
      • How to report an off-site SEP
    • PI responsibilities at the time of continuing review
    • PI responsibilities for further reporting of events/problems

  • Retrospective Chart Reviews

  • Roswell Park Cancer Institute (RPCI) - Research Agreement

  • Survey Research

  • Veteran's Administration WNY (VAWNY) – Research Agreement

  • Vulnerable Subject Populations
    • A. Overview
    • B. Research involving Pregnant Women, Human Fetuses and Neonates
      1. B1. Overview
      2. B2. IRB Requirements for Approval of Biomedical Research Involving Pregnant Women and Fetuses
    • C. Research Involving Prisoners
      1. C1. Overview
      2. C2. If an enrolled subject becomes a “prisoner”
    • D. Research Involving Children
      1. D1. Overview
      2. D2. Wards of the State
    • E. Other Groups and Research Situations Requiring Special Consideration
      1. E1. Overview
      2. E2. Adults Unable to Provide Consent
      3. E3. Research in Schools
      4. E4. Students, Employees, and Others in Subordinate Positions
      5. E5. Economically or Educationally Disadvantaged Persons and Other Groups Requiring Special Consideration
      6. E6. Minors in New York State Who May Consent for Themselves