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FAQs
FAQs for Investigators
Review Process
What is the difference between exempt and expedited research?
What are the deadlines for Full Board review?
Should I wait to get my grant approved before submitting the protocol to the IRB?
What is the estimated time line from submission of the protocol to approval?
How will I hear about the results of the IRB review?
Informed Consent
Is a signed consent form always required for each protocol?
What has to be on a consent form? Which elements are necessary? What wording is required?
Is a witness signature required on the consent form?
Protocol
How do I submit revisions to my protocol and/or consent form?
What must I do to close my study?
Is my study considered closed even though I still have to analyze my data?
When are changes to an existing protocol significant enough to warrant it being submitted as a new protocol?
Why are changes to my protocol required during continuing review? I thought my protocol was already approved.
How do I submit a continuing review or request for renewal?
Class Projects
What would qualify as a class project?
What activity would not qualify for class project review?
Who reviews my proposed class project if I am only doing the project for my class?
Who reviews my proposed class project if I want to use it for an honor's thesis?
What do I do if I decide I want to continue my class project from a previous semester as a research project?
What do I do if I decide during the activity of my class project that I want to use it for an independent research project?
Adverse Events & Other Problems
What is the difference between an unanticipated problem (UP) and a serious adverse event (SAE)?
Vulnerable & Special Populations
My research will take place at sites outside of CU. Is there anything special that I have to do?
What special requirements exist when research involves a school district?
What special requirements exist when involving subjects who are under 18 years of age?
What is an IND?
Do I have to obtain an IND every time I use drugs in a protocol?
What is the definition of "prisoner"?
My protocol includes prisoners as subjects. What is the review process for this population?
Several of the subjects who are enrolled in my protocol have become incarcerated. Are they still allowed to participate in the study?
Are there any special restrictions on the type of research that can be conducted using prisoners as participants?
Other Questions
Do I have to take the CITI tutorial every year?
Who is required to complete the CITI tutorial?
Is proration of subject payment required?
As a student, can I recruit students for my research from my own class?
What does "anonymous" mean, and how is that different from "confidential"?
Are there special considerations for snowball recruitment?
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FAQs
FAQs for Investigators
Review Process
Informed Consent
Protocol
Class Projects
Adverse Events & Other Problems
Volnerable & Special Populations
Other Questions
FAQs for eRA
FAQs for Research Participants
General Questions
Research Subjects
Problems & Concerns