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Did You Know

  • How do I submit my Investigatorʼs Brochure (IB) update to the IRB?

    Investigator’s Brochures are essential regulatory documents requiring IRB submission and review, but should these documents be submitted as a Modification or as Promptly Reportable Information (PRI)? It depends… IBs are reviewed annually and may be updated with Investigational Product (IP) … Read more

  • Department routing of IRB submissions

    A department’s approval in IRBIS is attesting that the study personnel have the appropriate expertise (e.g., credentialing, licensure, privileges, training), experience (e.g. previous research studies conduct and role in relation to risk level of research), and resources (e.g. committing staff’s … Read more

  • Changes to Multi-Site Screening Question

    With the most recent IRBIS update, the application logic rules were changed regarding the Multi-Site Screening question (#6 on the Screening Questions page). The original purpose of the question was to identify studies that were being conducted at multiple sites … Read more

  • Meeting Dates and Deadlines for 2021

    The IRB Meetings and Deadlines Calendar has been published for 2021 on the OHRE website. With the restructuring of the boards to remove the designations of Biomedical, Non-biomedical, and Safety last year, all submissions are assigned to the board agendas … Read more

  • What information should be in recruitment materials?

    In order to assure recruitment procedures adequately protect the rights and welfare of prospective subjects, the IRB must review and approve all advertisement and recruitment materials for research conducted under the purview of UNC-Chapel Hill. The following information should be … Read more

  • How do I describe my Consent Process?

    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?

    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

  • Updates to CITI Human Subjects Protection training requirements for study personnel

    Collaborative Institutional Training Initiative (CITI) is a web-based training package on issues relating to human subjects research. The program contains modules on topics like informed consent, vulnerable populations, ethical principles, and IRB regulations. The CITI programs can be found at … Read more

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

    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