However, the IRB will conduct an Administrative Update annually. For minimal risk studies approved 1/21/19 or after, continuing review is not required.For all studies approved 1/20/19 or prior, continuing reviews are required to be conducted annually.Use the "Amendments" form within IRBManager when you must make a change to a previously approved protocol.Ĭontinuing Review/Administrative Updates:.Revisions/Amendments to Previously Approved Studies: For additional information regarding CIRB studies, please refer to the HRPP Procedures, Sections IV. Whenever a study will utilize hospital departments such as lab, radiology, etc., you must follow the Request for Reliance on an External IRB process outlined in the HRPP Procedures (Sections IV.P). Examples of an external Central IRB would be NCI-CIRB, Western IRB, Quorum, etc.Please note that study subjects cannot be enrolled in the study until you have received the IRB acceptance letter from the UnityPoint Health – Des Moines IRB. This should be used when an external Central IRB is overseeing the research. The Application for New Protocol should be completed and select "CIRB/WIRB/Other IRB" as your study type.New Study Applications - Central IRB Notification: Patient Participation Statement - Can also be used when study subjects include children between 12-17 years old.Child Assent - To be used when study subjects include children between 12-17 years old.Request for Waiver/Documentation of Informed Consent.Certificate of completion of Human Subject training (CITI training) for all study team members (must be updated every three years).Certificate of completion of Conflict of Interest training (CITI training) for all study team members (must be updated every four years.Completed Conflict of Interest forms for all study team members (must be completed annually). All other pertinent study documents (data collection forms, tools to be used, etc.).All handouts that will be given to the study subjects, including any scripts for verbal surveys.Protocol (who, what, when, where, why & how of the study).
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