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How do I describe my Consent Process?

July 28, 2020

Informed consent is more than a just a form for the subject to sign, it is a verbal and written process by which the investigator provides adequate and appropriate information to the prospective subject so that the individual can make … Read more

What should be in my Concise Summary?

June 26, 2020

All initial studies approved on or after January 20, 2019 are governed by new IRB regulations (the Revised Common Rule). One of the new requirements is the addition of a section at the beginning of the consent form that provides … Read more

De-identified, Coded, or Anonymous? How do I know?

May 1, 2020

These can be confusing adjectives when referring to study data. Included below is a mini-glossary to help you with your IRB applications.  If you have questions about the IRB or need any assistance with your submission, email the IRB at irb_questions@unc.edu.  To submit … Read more