IRB members and staff use these checklists to consider and document regulatory items and enhance compliance with federal, state and local requirements.
|402||Non-Committee Review||July 2016|
|410||Waiver or Alteration of Consent Process||February 2018|
|411||Waiver of Written Documentation of Consent||June 2018|
|412||Pregnant Women||March 2017|
|413||Non-Viable Neonates||March 2017|
|414||Neonates of Uncertain Viability||March 2017|
|417||Adults with Impaired Decision-Making Capacity||May 2018|
|418||Non-Significant Risk Device||March 2017|
|419||Waiver of Consent Process for Emergency Research||March 2017|
|431||Minutes Quality Improvement Assessment||April 2017|
|441||HIPAA Waiver of Authorization||March 2017|
|482||IRB Member Addition||March 2018|
|483||IRB Member Removal||March 2018|
Share feedback or suggestions regarding how to improve these Toolkit documents, including the protocol and consent templates: HRPP Toolkit Feedback Form.