Legacy Forms (non-ETHOS)
Use these legacy forms after the initial application has been approved and only for studies not submitted in ETHOS.
|Download||When to Use||Updated|
|Change in Protocol||
Changes to the approved project must be requested and approved before implementation.
|Add/Remove/Change Personnel||When adding/changing or removing a principal investigator, co-investigator, or other study personnel||January 2016|
|Add/Remove Funding||When adding or removing funding associated with a project||January 2015|
Use this form to report events, including unanticipated problems involving risks to subjects or others (UPIRTSO), which fit the definition of promptly reportable events. The IRB defines "prompt" to be within five business days of discovery of the event.
See the Reporting Unanticipated Problems webpage for additional guidance.
|IRB Study Document Request||To request copies of documents or correspondence associated with IRB record||November 2012|
|Continuing Review of Non-ETHOS studies (in eResearch Central)||Until notified otherwise, non-ETHOS studies: Submit prior to deadline indicated in the notice for renewal (expedited and full committee review of medical and social applications)|
|Study Inactivation Request Form||Submit this form to request inactivation of IRB approval. Submit only after all study related activities/interventions have been completed.||September 2014|
|Continuing Review Event Reporting||
Template for tracking and reporting adverse events that do not meet the threshold for prompt reporting to the IRB. These events must be reported at continuing review or when requesting study inactivation.
Share feedback or suggestions regarding how to improve these Toolkit documents, including the protocol and consent templates: HRPP Toolkit Feedback Form.