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The launch of ETHOS on March 27, 2017 will significantly impact how you submit protocols to the IRB. We recommend that researchers wait until March 27th to submit new applications in ETHOS. This will save researchers time overall as those submitting new studies outside of ETHOS will have to complete additional steps during the migration process.
All new applications to the IRB must be submitted in ETHOS, effective March 27, 2017. If researchers want to submit a new study in the old process, researchers must do so by 4:30 p.m. on March 24th. Any new studies submitted after 4:30 p.m. on March 24th will be sent back.
Changes or reports on studies active or submitted to the IRB prior to March 27, 2017, must still be made using legacy forms including the Change in Protocol, Add/Remove/Change Personnel, Add/Remove Funding, and the Report Form. (See below.)These forms should be submitted to firstname.lastname@example.org until further notice.
For non-ETHOS studies requiring continuing review, follow the steps provided to you in the continuing review notification.
These legacy forms are used after the initial application has been approved and should only be used for studies that were not submitted in ETHOS.
When to use
|Change in Protocol||Changes to the approved project must be requested and approved before implementation. This includes:
|Add/Remove/Change Personnel||When adding/changing or removing a principal investigator, co-investigator or other study personnel||Jan 2016|
|Add/Remove Funding||When adding or removing funding associated with a project||Jan 2015|
|Report Form||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.||May 2015|
|IRB Study Document Request||To request copies of documents or correspondence associated with IRB record||Nov 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.||Sep 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.
Non-UPIRTSO AE Log Template
Non-UPIRTSO AE Log Template - Multi-page
Consent, assent, information sheets, HIPAA and protocol templates are commonly included with applications.
Medical & Health Studies Consent Form
Additional protocol template resources are available from the NIH