The following protocol and consent templates are used by researchers in preparation for IRB submission (see Investigator Manual for additional guidance on completing these documents). Additional IRB templates are provided to promote transparency of IRB operations. HIPAA and data use agreements are not part of the Toolkit and can be found in the Contracts Library.
|503||Human Research Determination Form||March 2019|
|508||Local Protocol Addendum - With Instructions
Local Protocol Addendum - No Instructions
|590||Medical Template Protocol - With Instructions
Medical Template Protocol - No Instructions
|595||Data or Specimen-Only Protocol||March 2019|
|537||Business and Industry Funded Study Fee||April 2019|
|538||Scientific Review||April 2019|
|574||Certification of Attestation of Translation||June 2018|
|501||Minutes Cover Sheet||September 2017|
|515||Letter—Suspension or Termination||December 2018|
|519||Letter—Information Item||December 2018|
|520||Letter - External Report||January 2019|
|543||CoC Assurance Letter||December 2018|
Share feedback or suggestions regarding how to improve these Toolkit documents, including the protocol and consent templates: HRPP Toolkit Feedback Form.