Click IRB Library Revisions – July 2018

What is changing in the Click IRB Library and how will I know a document has been revised?

  • Many of the documents in the Click IRB library have undergone recent revisions; substantial revisions are outlined in a list below. This list of revised documents is not comprehensive, as some changes were largely administrative.
  • Revised documents have a June or July 2018 version date.

Why are Click Library documents being revised?

  • Revisions to documents in the Click IRB library are required when there are regulatory/policy changes or content needs to be clarified.
  • Highlights of these include changes in FDA and newborn dried bloodspot regulations and how Seattle Children’s is applying “identifiability” standards.

How will these changes impact study teams?

  • Key changes include:
    • New and improved protocol templates for new IRB submissions
    • Some IRB submissions using data/specimens from deceased participants approved in the past as human subjects research may now receive not human subjects research determinations. See more information.
    • Some minimal risk FDA-regulated research will now be eligible for consent waivers.
    • Studies using newborn dried bloodspots will be eligible for consent waivers.
    • Process for obtaining Genomic Data Sharing (GDS) Certifications has been revised.
  • Study teams should use the most recent library documents and should not use older versions. Using older versions may result in re-work for your study team or possibly being non-compliant with regulatory changes. Use of the new protocol templates will be required as of August 13, 2018.
  • If you have questions about these changes, contact the IRB for more information.

Highlights of July 2018 Click IRB Library Revisions

    • HRP-001 Definitions: Changes related to NIH single IRB policy
    • HRP-064 NIH Genomic Data Sharing Institutional Certification: New SOP outlines procedures for institutional certification of genomic data submissions
    • HRP-0912 Submission of Data to GWAS Repositories: Removed; replaced by HRP-064
  • HRP-103 Investigator Manual:

    • Added appendix related to single IRB studies (sIRB)
    • Revised information for radiation safety review
    • Added information about RCW 70.02.210 to comply with Washington state law. Read more information.
    • Updates to the re-consent flowchart for participants who turn 18 during a study to comply with changes in FDA regulations
    • HRP-308A Protocol Requirements Worksheet: Updated to reflect revisions in various protocol templates
    • HRP-310 Human Research: Removal of restrictions on newborn dried blood spots and revising definition of human subject under Washington state law
    • HRP-332 NIH GDS Institutional Certification: New worksheet outlines requirements for an Institutional Certification for Genomic Data Sharing (GDS)
    • HRP-333 Certificate of Confidentiality: New worksheet related to NIH COC policy
    • HRP-410 Waiver or Alteration of Consent Process: Inclusion of FDA waiver of consent criteria; removed restrictions on newborn dried blood spots
    • HRP-411 Waiver of Written Documentation of Consent: removed restrictions on newborn dried blood spots
    • HRP-416 Children: Inclusion of FDA waiver of parental permission criteria; removed restrictions on newborn dried blood spots
    • HRP-441 HIPAA Waiver of Authorization: Added RCW Determination to comply with Washington state law
    • HRP-503 and HRP-508 Protocol and Site Supplement: Revised format and content to make more user friendly and reduce errors
    • HRP-503A and HRP-503B No Direct Contact and Exempt Protocols: Revised waiver section to include RCW determination to comply with Washington state law
    • HRP-503C Other Status Determination Protocol: Added HIPAA section to cover any necessary HIPAA waivers
    • HPR-2142 Genomic Data Sharing (GDS) Certification Request form: Updated form for requesting GDS certifications from the IRB