Get Emory Consent Checklist

The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame.

Waiver of Documentation of Informed Consent (45 CFR 46.117) This means that the study team must provide a subject with the required consent information, but the study team is not required to obtain the subject's signature on the informed consent document.

The form of documentation could include any of the following: Note written in the study subject's record. On a consent/assent documentation form with a signature page. On a consent form with a page for documentation of verbal consent and when applicable, assent and HIPAA Authorization.

Most IRB reviewers are full-time faculty/clinicians, and while they have target turnarounds, delays sometimes occur. Continuing reviews will generally be held until the study is within 45 days (Full Board) or 30 days (Expedited) of expiration, to preserve more of your approval period.

When required, researchers must complete this form: Review Application-ESCROC form (PDF), and sign, scan, and e-mail it to the Office of Research Integrity and Compliance (ORIC) at oric@emory.edu along with the required attachments. HIPAA Waiver Review: For IRB office use only.

The IRB full committee generally meets twice a month to review and approve proposals. A current meeting schedule along with due dates for submission can be found here. Materials to be reviewed at a full committee meeting must be submitted two full weeks in advance of the meeting to allow time for pre-review.

A description of the procedures to be followed. Identification of any procedures which are experimental. A description of any reasonably foreseeable risks or discomforts to the subject. A description of any benefits to the subject or to others which may reasonably be expected from the research.

Generally, studies are reviewed within four weeks of submission. The exact timing depends on whether or not there are conflicting demands and the volume of submissions. For 2021, the average days from submission to Exempt determination is 42 calendar days.