Protection of Human Subjects Hummingbird IRB (HUMMINGBIRD ... Handbook_2016-03.pdf¢ ...

download Protection of Human Subjects Hummingbird IRB (HUMMINGBIRD ... Handbook_2016-03.pdf¢  someone from Hummingbird

of 72

  • date post

    28-Jun-2020
  • Category

    Documents

  • view

    43
  • download

    1

Embed Size (px)

Transcript of Protection of Human Subjects Hummingbird IRB (HUMMINGBIRD ... Handbook_2016-03.pdf¢ ...

  • Hummingbird IRB Investigator’s Handbook

    Version 3, June 2016

    Investigator and Research Site Staff Handbook

    for the Protection of Human Subjects

    Hummingbird IRB (HUMMINGBIRD IRB)

    Version 3, June 2016

  • Hummingbird IRB Investigator’s Handbook

    Version 3, June 2016

    Table of Contents Forward ................................................................................................................................................... 1

    How to Use This Handbook ............................................................................................................... 2 CHAPTER 1 - Investigator Responsibilities ................................................................................. 3 All Research Involving Humans Must Be Reviewed by the IRB ....................................................... 3 Oversight of Others Assisting in Research .............................................................................................. 4 Adequate Facilities and Study Population .............................................................................................. 4 Human Research Protections Training .................................................................................................... 4 Disclosure and Management of a Financial Conflict of Interest ...................................................... 5 Communicating a COI to the IRB ................................................................................................................ 6 Frequency of Disclosure ................................................................................................................................ 6 Institutional Management ............................................................................................................................ 6 Federalwide Assurance (FWA) ................................................................................................................... 8 Performance Sites ........................................................................................................................................... 8 Authority of the IRB ..................................................................................................................................... 10 Suspension or Termination of Research .............................................................................................. 10 Audits and Monitoring of Research ........................................................................................................ 11 Suspension or Termination of Approval of Research ...................................................................... 12 Post Approval Review (PAR) by HUMMINGBIRD IRB ...................................................................... 13

    CHAPTER 3 - Purpose and History of the Institutional Review Board ............................. 14 Federal Requirements for the Protection of Human Research Subjects ................................... 14 Governing Principles Established in The Belmont Report .............................................................. 14 The Roles and Responsibilities of Hummingbird IRB ...................................................................... 15

    CHAPTER 4 - IRB Review Determinations: Non-Human/Non-Research, Exempt, Expedited and Full Committee ...................................................................................................... 17 Definition of Research (DHHS) ................................................................................................................ 17 Determination of “Human” and “Non-Human” ................................................................................... 17 Determination of “Non-Research” .......................................................................................................... 19 Levels of IRB Review ................................................................................................................................... 19 Non-Human Subject Research .................................................................................................................. 19 Exempt Research .......................................................................................................................................... 20 Categories of Research Eligible for Exempt Review ......................................................................... 20 Exemption of Research Involving Children ......................................................................................... 23 Exemption of Research Involving Prisoners ....................................................................................... 23 Procedures for Requesting Exemption ................................................................................................. 23 Continuing Review for Exempt Research ............................................................................................. 23 Amendments to Exempt Research .......................................................................................................... 24 Expedited Review ......................................................................................................................................... 24 Research Eligible for Expedited Review ............................................................................................... 24 Categories of Research Eligible for Expedited Review .................................................................... 24 Procedures Required for Expedited Review ....................................................................................... 26 Results of Expedited Review .................................................................................................................... 27 Full Committee Review ............................................................................................................................... 27 Hummingbird IRB Actions ........................................................................................................................ 28 Criteria for Approval by Full Board Review ........................................................................................ 29 Procedures Required for Full Board Review ...................................................................................... 31

  • Hummingbird IRB Investigator’s Handbook

    Version 3, June 2016

    Results of Full Committee Review .......................................................................................................... 31 CHAPTER 5 - Informed Consent .................................................................................................... 33 Requirements for Informed Consent ..................................................................................................... 34 Elements of Informed Consent ................................................................................................................. 34 ClinicalTrials.gov .......................................................................................................................................... 36 Additional Elements of Informed Consent - Required When Appropriate ............................... 36 Exculpatory language prohibited! .......................................................................................................... 37 Format and Style of Informed Consent Documents .......................................................................... 37 Consider the Age of the Subject and Cognitive Abilities .................................................................. 38 IRB Approval Dates on Consent Documents ....................................................................................... 39 “Deferred Consent” or “Ratification” Not Permitted ........................................................................ 39 Waiver or Alterations Regarding Informed Consent ....................................................................... 39 Waiver or Alteration of the Consent Process ...................................................................................... 39 Waiver for Research Activities Designed to Study Certain Aspects of Public Benefit or Service Programs ......................................................................................................................................... 40 Waiver for Minimal Risk Studies ............................................................................................................. 40 Documentation of Consent Process ........................................................................................................ 40 Use of Mail or Facsimile to Document Informed Consent ............................................................... 41 Oral Presentation Using Short Form ...................................................................................................... 41 Additional Considerations for Informed Consent ............................................................................. 42

    CHAPTER 6 - Continuing Review ................................................................................................... 43 Substantive and Meaningful ..................................................................................................................... 43 Continuing Review of Studies Meeting Expedited Criteria ............................................................ 44 Research Closed to Accrual of New Subjects Still Requires Continuing Review ..................... 44 Materials to be Submitted at Continuing Review ....................................................