Click IRB Resources
Click IRB Library Updates
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