Emory University Consent Form Checklist Please - Emory IRB 2025

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The document is a checklist for Emory University staff regarding the preparation of consent forms for research studies. It outlines specific instructions for including site-specific language, HIPAA authorization, and various provisions related to investigational drugs, risks associated with pregnancy and contraception, medical records access, injury costs, and participant compensation. The checklist ensures compliance with institutional review board (IRB) requirements and emphasizes the importance of protecting participants' privacy and health information.

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What is an IRB consent form?

Typically, a consent form documents that the informed consent process has taken place. It must contain all the required components of informed consent, as defined in 45 CFR 46.116, and described below. The consent form must be written in language that is easy for the participant to understand.

What is the timeline for Emory IRB?

General IRB Turnaround Targets Type of SubmissionTurnaround for Pre-Review Screening by IRB StaffTurnaround for Initial IRB Review after IRB Review is Assigned [2] Continuing Review Initial screening: about three to four weeks; sooner if Grady ROC review is required 2 weeks9 more rows

What is an informed consent checklist?

46.116 Informed Consent Checklist - Basic and Additional Elements. A statement that the study involves research. An explanation of the purposes of the research. The expected duration of the subjects participation. A description of the procedures to be followed.

Does my project need an IRB review at Emory?

If you think that your project is indeed research involving human subjects or a clinical investigation, you can go ahead and submit your project in the eIRB system for IRB review. Upon conducting its preliminary review the IRB will confirm that it meets the definition and the review will move forward.

What is an IRB form?

The Consent Form used in a study should be edited to match requirements of the specific study: It should include information about the investigator, the topic under study, and a clear description of purpose, risks, and benefits.

What is IRB consent?

A signed informed consent document is evidence that the document has been provided to a prospective subject (and presumably, explained) and that the subject has agreed to participate in the research. IRB review of informed consent documents also ensures that the institution has complied with applicable regulations.

How to write an IRB consent form?

The consent form provides potential research subjects sufficient written information to decide whether to participate in a research study or not based on an explanation of the proposed research and the nature of the participation that is requested of them.

Emory University Consent Form Checklist Please - Emory IRB 2025

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