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Frequently Asked Questions

• What is assent?


• When do I need to obtain assent?


• What constitutes a minor/child?


• How do I request a waiver of assent?


• Can I determine who should be assented on a case-by-case basis?


• What information should I include on an assent form?


• What do I do if the parents consent for the minor to participate and the minor does not provide assent?


• Can a minor/child indicate his/her assent by signing the consent form?

• What is the difference between confidentiality and privacy?


• What is a Certificate of Confidentiality?

• What information do I need to include in my informed consent statement?


• When do I need to obtain informed consent?


• Can minors sign in the informed consent statement instead of a separate assent document?


• How do I request a waiver of informed consent or alteration of the informed consent elements?


• What does it mean to document the informed consent process?


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• What does de-identified health information mean?


• What constitutes identifiers in health information?


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• I’ve finished my study. How do I close it with the IRB?


• What do I do if my study was erroneously closed with the IRB?


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• What qualifies as exempt research?


• How do I make a change to an approved exempt study?


• How do I close an approved exempt study?


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• What information/documents do I need to include with my new study submission?


• What is the difference between exempt, expedited and full-board studies? (See also Exempt Review/Studies & Expedited Review/Studies)


• How long does it take to receive a response from my new study submission?


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• Why should I use WIRB instead of the IU IRBs?


• How quickly will my study be reviewed if I use the WIRB submission process?


• Is my study eligible for submission to WIRB?


• What documents do I need to submit for initial submission to WIRB?


• How will I communicate with WIRB after my initial submission and how will I know if my study has been approved, denied, etc.?


• Will the IU IRB be reviewing my study at all after submission to WIRB?


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