Investigator’s Handbook for the Protection of Human Participants in Social and Behavioral Research May 2021 Page 1 of 99 Table of Contents Forward ------------------------------------------------------------------------------------------------- 5 How to Use This Handbook --------------------------------------------------------------------------- 6 CHAPTER 1 - Investigator Responsibilities --------------------------------------------------------- 7 All Research Involving Humans Must Be Reviewed by the IRB ...................................... 7 Oversight of Others Assisting in Research -------------------------------------------------- 8 Human Research Protections Training ............................................................................. 8 Ongoing Training Requirement ...................................................................................... 10 CHAPTER 2 - Authority of the IRB ------------------------------------------------------------------ 11 Federalwide Assurance (FWA) ........................................................................................ 11 Performance Sites ........................................................................................................... 11 Vanderbilt Serving as a Single IRB ................................................................................. 13 Authority of the IRB ........................................................................................................ 16 Jurisdiction of IRB ........................................................................................................... 16 Suspension or Termination of Research ......................................................................... 17 Audits and Monitoring of Research ................................................................................ 18 IMPACTT .......................................................................................................................... 18 CHAPTER 3 - Purpose and History of the Institutional Review Board -------------------------- 20 Federal Requirements for the Protection of Human Research Participants ................. 20 Governing Principles Established in The Belmont Report ............................................. 20 VU and VUMC Oversight of the Protection of Human Participants ............................... 22 The Roles and Responsibilities of the VUMC IRB ........................................................... 22 The Use of a Single IRB and the VUMC IRB ------------------------------------------------- 24 CHAPTER 4 - IRB Review Determinations: Non-Human/Non-Research, Exempt, Expedited and Full Committee ----------------------------------------------------------------------------------------- 25 Determination of “Non-Human” ..................................................................................... 25 Determination of “Non-Research” .................................................................................. 27 Levels of IRB Review ...................................................................................................... 28 Categories of Research Eligible for Exempt Review --------------------------------------- 28 Exemption of Research Involving Children ------------------------------------------------- 31 Exemption of Research Involving Prisoners ----------------------------------------------- 31 Procedures for Requesting Exemption ........................................................................... 31 Amendments to Exempt Research ---------------------------------------------------------- 32 Expedited Review ............................................................................................................ 33 Categories of Research Eligible for Expedited Review ------------------------------------ 33 Procedures Required for Expedited Review ................................................................... 36 Results of Expedited Review .......................................................................................... 37 Full Committee Review ................................................................................................... 37 Criteria for Approval by Full Committee Review ............................................................ 38 Procedures Required for Full Committee Review .......................................................... 39 Results of Full Committee Review .................................................................................. 40 CHAPTER 5 - Informed Consent --------------------------------------------------------------------- 44 Requirements for Informed Consent .............................................................................. 45 Elements of Informed Consent ....................................................................................... 45 Additional Elements of Informed Consent - Required When Appropriate .................... 48 AUTHORIZATION............................................................................................................. 51 Format and Style of Informed Consent Documents --------------------------------------- 52 Consider the age of the participant and cognitive abilities ------------------------------- 53 IRB Approval and Expiration Dates on Consent Documents ......................................... 53 “Deferred Consent” or “Ratification” Not Permitted --------------------------------------- 53 Waiver or Alterations Regarding Informed Consent ..................................................... 54 Waiver or Alteration of the Consent Process ................................................................. 54 Documentation of Consent Process ................................................................................ 55 Use of Mail or Facsimile to Document Informed Consent -------------------------------- 56 Oral Presentation Using Short Form ............................................................................... 56 The Use of a Healthcare Decision-Maker for Research .................................................. 57 Submission to the IRB ------------------------------------------------------------------------ 57 Identifying the Appropriate Health Care Decision-Maker (HCDM) ---------------------- 58 Additional Considerations for Informed Consent .......................................................... 58 Certificates of Confidentiality ---------------------------------------------------------------- 58 CHAPTER 6 - Continuing Review -------------------------------------------------------------------- 61 Substantive and Meaningful ........................................................................................... 61 Continuing Review of Greater Than Minimal Risk Studies Criteria ............................... 62 Materials to be Submitted at Continuing Review .......................................................... 63 Vanderbilt Serving as a Single IRB:................................................................................... 63 Determining the Continuing Review Date – Full Committee Reviews .......................... 64 Determining the Continuing Review Date – “30 Day Rule”........................................... 64 Important Information to Consider with Continuing Review ....................................... 65 No Grace Period ------------------------------------------------------------------------------- 65 Deadlines --------------------------------------------------------------------------------------- 65 CHAPTER 7 - Amendments --------------------------------------------------------------------------- 66 Minor Changes May Be Eligible for Expedited Review ................................................... 66 Changes That Are More Than Minor are Reviewed by the IRB Committee ................... 67 Amendments to Exempt Research ---------------------------------------------------------- 69 Materials to be Submitted for Review ............................................................................ 69 Chapter 8 – Site Additions --------------------------------------------------------------------------- 70 Chapter 9 - Adverse Events or Unanticipated Problems, and Research Plan Deviations or Violations (Non-Compliance) -------------------------------------------------------------------------------- 71 Investigator Responsibility Regarding Adverse Event/Unanticipated Problem Reporting--71 Serious Adverse Event or Problem ................................................................................. 71 Materials to be Submitted for Review ............................................................................ 72 Authority to Terminate or Suspend Approval ................................................................ 72 CHAPTER 10 - Vulnerable Populations as Participants of Research ---------------------------- 74 Children (Subpart D) ....................................................................................................... 74 Four Categories of Research Involving Children ------------------------------------------- 74 Requirements for Permission by Parents or Legal Guardians (45 CFR 46.408) ........... 76 Waiver of Parental or Legal Guardian Permission ----------------------------------------- 77 Documentation -------------------------------------------------------------------------------- 77 Assent by Children .......................................................................................................... 77 Adequate Provisions for Child's Assent -----------------------------------------------------